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About the Authors

Editor

Georgette Eaton is a clinical academic advanced paramedic in primary and urgent care. She is currently employed as the clinical practice development manager for advanced paramedic practitioners in urgent care in London Ambulance Service NHS Trust. Prior to this appointment, she split her employment between clinical practice and education, balancing work as a specialist paramedic in urgent care across a range of settings with being a senior lecturer in Paramedic Science at Oxford Brookes University. Alongside this, she has been the regional South Central trustee for the College of Paramedics (2017–19) and continues to be the trustee for research. She was a graduate paramedic from Coventry University in 2011 and after ‘topping up’ to BSc (Hons) began practising as a specialist paramedic (then an emergency care practitioner). She completed her first MSc in Critical Care at Cardiff University in 2017 and her second in Education Research Design and Methodology at the University of Oxford in 2018. She is currently reading for a DPhil in Evidence-Based Healthcare at the Nuffield Department of Primary Health Care, University of Oxford.

Contributors

Aidan Baron is a paramedic researcher and educator from Sydney, Australia. His main interests are paramedic point of care ultrasound, evidence-based practice education, applied ethics and patient advocacy. He has been a visiting researcher in emergency, cardiovascular and critical care at Kingston University and St George’s, University of London in the UK, a member of faculty in the discipline of Paramedicine at Charles Sturt University, Australia, and sits on the editorial board of the Journal of Paramedic Practice.

Edd Bartlett is a paramedic with an interest in mental capacity, mental health and human rights. After completing a BSc (Hons) in Paramedic Practitioner (Community Emergency Health) at the University of Plymouth, he went on to gain an MA in Medical Ethics and Law at King’s College London. Alongside this, he worked full time as a paramedic at the South East Coast Ambulance Service, before being seconded onto its frequent caller team. Moving away from full time employment in the ambulance service, he then worked as a Court of Protection and mental health paralegal at Bison Solicitors before taking up his current position as legal services manager for Surrey and Borders Partnership NHS Foundation Trust. Edd is also a visiting lecturer for paramedic education at Birmingham City University. He supports reform of the Mental Capacity Act 2005 and the Mental Health Act 1983, moving towards a ‘fusion’ approach and compliance with the United Nations Convention on the Rights of Persons with Disabilities. Edd is grateful to dissertation tutors, Professor Penney Lewis and Alison Ross from King’s College London, for their guidance and support during his Master’s, from which his chapter (Chapter 7) on mental capacity draws. He would also like to thank Dr Gareth Clegg, Dr Matthew Reed and Mr Gabriel Oniscu for sharing the Royal Infirmary of Edinburgh Maastricht Category II Donation after Circulatory Death procedures and their correspondence in the writing of Chapter 10.

Will Broughton registered as a paramedic in 2013 and continues to hold frontline clinical roles with two NHS ambulance services. He holds a BSc (Hons) in Paramedic Science and PGCert in Business Administration from the University of Hertfordshire, a PGCert in Learning and Teaching (Higher Education) from Anglia Ruskin University and an MSc in Paediatrics and Child Health from Imperial College London. Will is a Fellow of the Higher Education Academy and is the UK National Coordinator for the National Association of Emergency Medical Technicians’ (NAEMT) Education Programmes. Alongside his clinical and academic work, he is a paramedic expert witness commenting on breach of duty and clinical negligence cases involving paramedics and ambulance staff. His research interests are in paediatric emergency care, and he is the paramedic advisor to the National Paediatric Early Warning Score (PEWS)/System-wide Paediatric Observations Tracking (SPOT) programme led by NHS England and the Royal College of Paediatrics and Child Health. Will is also a member of a National Institute for Health and Care Research (NIHR) Health Technology Assessment Prioritisation Committee, who consider clinical and cost-effectiveness for the NHS in comparison with the current best alternative(s). Will is a fellow of the College of Paramedics and is currently Professor of Paramedicine at Buckinghamshire New University, with responsibility for their undergraduate paramedic programme.

Iain Campbell is a paramedic with 10 years’ experience working in the London Ambulance Service. In addition, he has worked as a senior lecturer in Paramedic Science at the University of the West of England, and as a humanitarian medical worker, having worked in refugee camps in Greece and France, in occupied Palestine, and in East Ukraine. He is currently an honorary research associate in the Centre for Ethics in Medicine, University of Bristol. He holds an MSc-R in Bioethics and currently researches and publishes on paramedic ethics with a special interest in decision-making and prejudice in paramedic practice.

Vince Clarke works as the programme leader for the BSc (Hons) Paramedic Science course at the University of Hertfordshire, where he has been employed since 2016. He joined the London Ambulance Service in 1996, qualiﬁed as a paramedic in 1998 and entered the Education and Development Department in 2001. Vince worked as part of the Higher Education Team and developed in-house paramedic programmes as well as working closely with higher education partner institutions. A Health and Care Professions Council (HCPC) partner since 2006, Vince has been involved in the approval of a wide range of paramedic educational programmes across the country, as well as assessing continuing professional development submissions and sitting on conduct and competence fitness to practise panel hearings. He works closely with the College of Paramedics, undertaking the role of trustee for education and chairing the Education Advisory Group and Education Committee. Vince also works as an independent paramedic expert witness for the courts and prepares reports on breach of duty for both claimants and defendants.

Andy Collen is a consultant paramedic at South East Coast Ambulance Service, leading on the Trust’s urgent care specialist/advanced paramedic practice programmes, professional standards and scope of practice. He has recently finished a secondment at the Healthcare Safety Investigation Branch as a national investigator. He is also the medicines and prescribing project lead for the College of Paramedics, having worked alongside NHS England on independent prescribing for advanced paramedics, as well as other projects such as the review of paramedic medicines exemptions. Andy is responsible for the College’s published documents relating to medicines, and has prepared Practice Guidance for Prescribers, Implementation Guidance for Prescribing and Practice Guidance for Exemptions. Andy has written and contributed to several publications relating to paramedic practice, such as Decision Making in Paramedic Practice. He is a visiting senior lecturer at the University of Surrey.

Antonia Cook is a paramedic with special interests in human factors, values-based practice and organ and tissue donation. Antonia works full time as a paramedic team leader and clinical educator for South Central Ambulance Service NHS Foundation Trust, alongside her work as an expedition and austere environment medic and as an associate lecturer at Buckinghamshire New University. She is a graduate paramedic from Oxford Brooke’s University and is currently studying for a master’s degree in Advanced Practice at the University of Hertfordshire.

Simon Kersey is a specialist paramedic and educator. He has spent the past 22 years involved in prehospital care and clinical education working across a wide variety of settings including the University of the West of England’s Bristol Nightingale hospital project team, the Gloucestershire emergency care practitioner/out-of-hours urgent care programme, South Western Ambulance Service Learning and Development and as a critical care paramedic for both Great Western and Midlands Air Ambulance. In 2015, Simon made the decision to focus on education, working initially as a senior lecturer in paramedic science at the University of the West of England and currently as skills and simulation lead for the University of Gloucestershire. He has a broad range of interests including simulation-based education and technology-enhanced learning, trauma, major incident/disaster response, haematology, person-centred care, and transfusion alternatives. Simon would like to recognise the significant contribution made by Mr. Neil Bebbington and Mr. David Smith to his chapter (Chapter 9).

Carly Lynch is a consultant nurse in mental health currently working for the London Ambulance Service. She is a qualified mental health nurse and social worker with a background in crisis care. She has developed pre-hospital responses to patients in a mental health crisis to ensure they get an individualised response and that both their mental and physical health needs are met. Previously, she worked as an advanced practitioner within an emergency department mental health team and a crisis team before joining the ambulance service.

Tom Mallinson began his career in London, with Institute of Healthcare Development (IHCD) Paramedic Training and a degree in Paramedic Science with the University of Hertfordshire. After working for the London Ambulance Service NHS Trust, he studied Medicine at Warwick Medical School and undertook further education in primary care, wilderness medicine and healthcare education. He is a fellow of the Royal Geographical Society, the Higher Education Academy and the Academy of Wilderness Medicine. Tom has published both primary research and educational materials, and is a member of the editorial board for the Journal of Paramedic Practice. He is also a faculty member and year two lead for the bachelor’s programme with the College of Remote and Offshore Medicine. Tom lives in the Scottish Highlands with his wife, chickens, dog and flock of Hebridean sheep.

Samantha McCabe-Hogan is a senior lecturer at Sheffield Hallam University, lecturing in theoretical subjects such as research, law, ethics and public health. Before joining the ambulance service, she was in the Royal Air Force and worked at her local hospital as a nursing assistant. Samantha joined the Lincolnshire Ambulance Service in 2001 in health transport and moved into emergency operations in 2003, qualifying as a paramedic in 2006. As well as working on the front line, Samantha worked in both the education and research departments at the East Midlands Ambulance Service. Her undergraduate degree is in Health Studies (2003) and her Master’s is in Clinical Research (2009).

John Renshaw is a senior lecturer in Paramedic Science at the University of Wolverhampton and a part time PhD student at Kingston University and St George’s, University of London. He first graduated with a foundation degree in Paramedic Science in 2011 and subsequently worked as a paramedic and clinical team mentor for West Midlands Ambulance Service NHS Foundation Trust. John then studied for BSc (Hons) in Pre-hospital and Emergency Care, a postgraduate certificate in Academic Practice in Higher Education, and moved into higher education as a senior lecturer in 2016. Alongside this role, John is an editorial board member for the Journal of Paramedic Practice and is a student member of the Emergency Cardiovascular and Critical Care research group at Kingston University and St George’s, University of London.

Ceri Sudron is a paramedic and head of department for Midwifery and Allied Health Practice at Staffordshire University. Previously, Ceri was course lead for Paramedic Science at the University of Wolverhampton. Ceri commenced her career as a paramedic with West Midlands Ambulance Service progressing to Paramedic Clinical Mentor with South Central Ambulance Service in 2007 and later to a clinical education development specialist with East Midlands Ambulance Service. She has enjoyed a varied career both as a paramedic and within higher education institutes. Ceri is an active reviewer for the Journal of Paramedic Practice and her research interests include LGBTQ+ issues, CPR-induced consciousness and professionalism.

Katie Viggers studied Law at the University of Southampton and went on to complete her Legal Practice Course at the College of Law in Guildford. She qualified as a solicitor in 2010 and opted to specialise in healthcare law, as she found the work incredibly interesting and rewarding. She has worked in a number of leading law firms in London, advising both NHS and private healthcare providers on a range of healthcare law matters, including mental health law, mental capacity law and inquests. In 2017, Katie became the head of legal services for Surrey and Borders Partnership NHS Foundation Trust – a mental health and learning disabilities trust. Here, she met and worked closely alongside Edd Bartlett, with whom she has co-authored Chapter 5 in this book. Katie currently works as a professional development lawyer for Browne Jacobson LLP and is also a part time healthcare law trainer. During her career to date, Katie has attended numerous inquests up and down the country, representing healthcare bodies and their staff. She has acted in some complex and difficult inquests, including ‘Article 2’ style inquests and those concerning deaths of patients whilst detained in hospital under the Mental Health Act.

Note from the Editor

I am incredibly proud of the contributing author team within this book. This book is unique in two aspects: firstly, every chapter is written by a paramedic, whether as an individual or a co-author alongside another specialist in the field of which they write. Secondly, all authors have specialised (clinically, within education, leadership or research) in the areas in which they write about. We are at a point in the development of the profession that paramedics are not only writing their own textbooks but they are also specialising in subjects relevant to our profession. It is an incredibly exciting time to be a paramedic, and if you are joining the profession now, then the world really is your proverbial oyster. Regardless of your stage in practice, I am confident this book has something for everyone – from student through to consultant. As you read through these chapters, think about you. Take pride in your professional title and know what it means. Continue to look, listen and learn – from your patients, your peers and those senior to you. Think about who you are, what values you hold dear to you and where you sit within the profession – and the wider world. Remember the legal boundaries that govern your practice. Consider how you can use the skills of your profession for good. Above all, enjoy it. There is no job in the world that is more rewarding than being the person who is called upon to help humanity in its worst moments … and by your very presence, allows humanity to act its best. Regardless of where you sit within clinical practice, education, leadership or research, of all the healthcare professionals, we are the most privileged. Be proud of that.

Georgette Eaton

Preface

There has been much change since the last edition of this text was published. The health system has continued to see unprecedented demand beyond that which could be predicted: issues with retention of healthcare professionals across all sectors, compounded with a reduction in funding and a population that is both ageing and has a greater awareness of their rights and services as patients have all contributed to the pressure on paramedics seen today. The Covid-19 pandemic saw a renewed public interest in the role of the ‘evidence base’ when it comes to health treatment, and decisions about what is moral in terms of the allocation and prioritisation of this treatment have been widely debated professionally (and informally in pubs and staff rooms) across the country.

Yet, cresting the wave of these changes comes our profession. The paramedic profession has evolved considerably since its inception some twenty years after the founding of the NHS (Collen, 2017), and with many NHS ambulance services now positioned as mobile healthcare providers, the paramedic role has consequently evolved. Paramedics increasingly provide clinical assessment and management, using a variety of delivery methods both remotely (using a hear-and-treat approach) or face-to-face (using a see-and-treat or see-and-refer model) (NICE, 2017). Paramedics are no longer confined to four wheels, and the modern paramedic has the opportunity to practice in diverse clinical areas, such as acute hospital trusts, forensic healthcare, primary care practices, critical care services, minor injury units and urgent care centres – to name but a few (Evans et al., 2013; Williams et al., 2013; O’Meara, 2014). Paramedics are also not limited to clinical practice, with an emerging presence within the academy as well as research. Leadership posts across a range of NHS and private services also boast paramedics. The changing demands on the ambulance service have birthed a twenty-first century paramedic who is expected to be nothing if not a generalist (Eaton, Mahtani and Catterall, 2018).

A key driver of the transformation of paramedics in care provision has been their level of autonomy as allied health professionals. Unlike other parts of the world, UK paramedics are required to register with the Health and Care Professionals Council (HCPC). Registration changed many aspects of paramedic practice, with the professional standards becoming central to professional practice and underpinning patient care. It also ensured that paramedics became accountable for their actions and, while this is discussed more in Chapter 1: Professional Regulation and Accountability, it is worth noting that this accountability reflects the professional identity of the profession. As well as ensuring the modern paramedic acts competently, this registration also outlines ethical standards that paramedics must comply with to ensure both quality of care and patient safety.

The Law, Ethics and the Paramedic?

It is an incredibly exciting time to be a paramedic. Clinical practice is open to paramedics across NHS, military, charity, civilian and business settings. Whether working in the NHS ambulance service, other NHS settings, private health providers, expedition medicine or retrieval support, the versatility offered by paramedics is finally being recognised across the world. This is not, however, without its challenges. Each setting will require a slightly different skill set, a slightly different scope of role, a slightly different governance structure and a slightly different approach to problems. One constant is the day-to-day issues of the moral and legal contours of the paramedic–patient relationship. While these settings may be different in terms of environment and clinical practice, each is full of its own ethical dilemmas and legal influence, which can sometimes be difficult to navigate. As a profession underpinned by registration territories in education, research and leadership also bring with them the obligations owed in matters of public health. Each territory brings a similar number of problems, albeit concerning different ethical and legal principles. Ethics allows the justification of a particular course of action by reference to wider, socially accepted norms or values. An understanding of the law ensures that actions are legally robust and without criticism of negligence. Arguing to ethical principles or legal concepts will help clinicians to make a judgement during a difficult decision – which path is the better option? Although there may be more than one ‘right’ answer, the ‘wrong’ answer is the path that is not justifiable – both legally and ethically. An understanding of how to navigate such concepts is key to personal and professional development, as well as the continued growth of the paramedic profession as a whole.

How this Book Works

Written by paramedics, for paramedics, this book presents an introduction to the law and ethics within paramedic practice. Each chapter will use case studies to develop further insights into the concepts discussed, and conclude with recommended readings or resources for readers to peruse. Throughout the book, in addition to images used to demonstrate specific areas of learning, the below icons are used to draw attention to important areas within the text:

Pause Point: consider how this relates to your practice.

Case Law: presenting detailed facts of a legal case that have been resolved by courts or similar tribunals.

Case Study: apply your knowledge from this chapter so far.

Tips for practice: important points you may find useful in your practice.

A Table of Cases and Legislation cited within the text can be found at the rear of the book. Otherwise, this book is broken down into fifteen distinct chapters:

Ceri Sudron introduces Chapter 1 with a concise history of the paramedic profession and what it means to be a professional. She’ll then explore contemporary practice and the role of the HCPC in regulation for our profession. I’ll provide an introduction to ethics, or moral philosophy, in Chapter 2. Giving an overview of some of the most popular ethical schools of thought which will (hopefully) help to set the tone of the text, and the chapters that will follow. In Chapter 3 I’m delighted to co-author with Iain Campbell, where we will outline four vignettes relevant to paramedic practice and discuss applied ethics for each scenario. Chapter 4 deals more complexly with clinical negligence, in which Edd Bartlett and I discuss the development of clinical negligence within case law and promote candidness when faced with medical error. Edd Bartlett returns in Chapter 5, co-authoring alongside Katie Viggers to give an overview of coroner’s court and inquests in England and Wales. It is a regret that this chapter could not cover the same judicial process in Scotland or Northern Ireland – and something we plan to solve for future editions. Vince Clarke outlines the differing types of consent readers may face in practice, discussing relevant case law and advice in Chapter 6. Edd returns in Chapter 7 to explore the legislation relating to mental capacity assessments, citing relevant case literature to apply it to paramedic practice. Building on the two previous chapters, issues surrounding consent, capacity and negligence for patients under the age of 18 are outlined by Will Broughton and myself in Chapter 8. Simon Kersey and I take this further in Chapter 9, where we look specifically at the issues of consent and decision-making capacity in the refusal of blood products by adults and children. Edd returns again in Chapter 10, this time with Antonia Cook, to explore the role of organ and tissue donation within the paramedic profession, and both the ethical complexity and legislation that relates to this. Samantha McCabe-Hogan is joined by consultant nurse in mental health Carly Lynch in Chapter 11, aiming to give the reader a more solid understanding of the legislation relating to mental health. This is followed by Andy Collen in Chapter 12, who places specific emphasis on the ethical practice of medicines management within the legislation relating to medicines for paramedic practice. Dual registered GP and paramedic Tom Mallinson focuses on the specific legal and ethical issues pertaining to decision making in palliative and end of life care, and the role of the paramedic in Chapter 13. In our penultimate chapter, Aidan Baron lends his voice to applying the legal mechanisms alongside professional and ethical considerations in the professional use of social media in Chapter 14. This text then concludes with John Renshaw appealing to aspiring paramedic researchers in Chapter 15, offering a summary of medical research ethics and outlining the legislation relating to health research – inspiring readers to continue in the ethos of our evidence-based profession.

Learning from the experience of the author team, each with their own specialism and background within this setting, this book presents a guide to applying law and ethics to paramedic practice. No single set of instructions can hope to cover the multitude of experiences, settings, issues and dilemmas a paramedic may face in the diverse range of settings in which they work. So, in place of a guide, this book will provide an introduction to understanding the essential legal and ethical issues pertinent to paramedic practice.

References

Collen A (2017). Decision Making in Paramedic Practice. Bridgwater: Class Professional Publishing.

Eaton G, Mahtani K and Catterall M (2018). The evolving role of paramedics: NICE problems to have? Journal of Health Services Research & Policy, 23(9): 193–195.

Evans R et al. (2013). Which extended paramedic skills are making an impact in emergency care and can be related to the UK paramedic system? A systematic review of the literature. Emergency Medicine Journal, 31(7): 594–603.

National Institute for Health and Care Excellence (2017). Consultation: Chapter 4 Paramedic remote support [Forthcoming]. Available at: https://www.nice.org.uk/guidance/GID-CGWAVE0734/documents/draft-guideline-4 (accessed 27 June 2023).

O’Meara P (2014). Community paramedics: a scoping review of their emergence and potential impact. International Paramedic Practice, 4(1): 5–12.

Williams B et al. (2013). Next generation paramedics, agents of change, or time for curricula renewal? Advances in Medical Education and Practice, 4: 245–250.

Chapter 1

Professional Regulation and Accountability

Ceri Sudron

If we can understand what we do, develop a robust knowledge base, be true to ourselves and have a sense of the future, we can truly become a profession in our own right.

(O’Meara, 2009, p. 57)

Introduction

Professionalism as a concept is complex, often subjective, and couched in altruistic terms that may sometimes mean little to the individual practitioner. All professions demand adherence to ethics and law, this in itself necessitating extended education, to practice with knowledge, skill and competence which is maintained by the individual. Inherent to the concept of professionalism is the regulation of a group through standards of behaviour and a focus on public interest, over self-interest.

A Concise History of the Paramedic Profession

Prior to the 1970s, ambulance services within the United Kingdom (UK) were predominantly voluntary services provided by individual hospitals. Scotland has the earliest recorded recognised service as early as 1775, with Staffordshire General being one of the first to be recognised in England in the 1800s and Liverpool boasting a horse-drawn service serving the Northern Hospital in 1884 (Liverpool Medical Institution, 2017). It was not until the National Health Services Act 1946 that local authorities across the UK were expected to provide dedicated Local Authority Ambulance Services ‘where necessary, for the conveyance of persons suffering illness or mental defectiveness or expectant or nursing mothers’ (NHS Act, 1946, p. 24).

The beginnings of the paramedic profession are argued to have started with the Miller Report of 1964, where recommendations for ambulance services to treat patients, rather than just transport, were outlined (Brooks et al., 2016). The first ‘extended training schemes’ began in Brighton in 1971 under the stewardship of cardiologist Dr (now Professor) Douglas Chamberlain. Dr Peter Baskett, a consultant anaesthetist, followed with a similar scheme in Bristol the next year and other pilot schemes spread across the UK during the early 1970s (College of Paramedics, 2019b). The first recognised performance standards came a decade later in 1974, when responsibility for the Ambulance Service moved from the local authority to National Health Service (NHS) control (Pollock, 2012).

What’s in a Name?

The earliest mention of the word ‘paramedic’ is from 1911 (Aronson, 2017) with the prefix ‘para’ meaning ‘related to’ or ‘working alongside’. Prior to the 1990s, the word ‘paramedical’ denoted those working alongside the medic (the physician), and became a noun, then name. Thus, the title paramedic emerged. The original term paramedic could be used for anyone involved in medical care who was not a physician, including both social workers and clergy. By 1990, it became the term used for non-physicians engaged in prehospital and emergency care.

Under the control of the NHS, ambulance services continued to develop, with ambulance drivers requiring a first aid certificate to provide initial treatment prior to transport to definitive care. In 1981 a National Health Service Training Authority (NHSTA) was formed to provide the extended care ambulance staff course, which in 1985 was endorsed by the Department of Health to become the nationally recognised course locally trained paramedics had to convert to (College of Paramedics, 2019a). The NHSTA courses eventually became the Institute of Health and Care Development (IHCD), awarding ambulance care assistant, ambulance technician and ambulance paramedic vocational qualifications right up to being taken over by Edexcel in 1998, followed by Pearson in 2004. Courses continued to be delivered in this guise until being disbanded in 2006. These initial developments in the education and training of the staff working in the ambulance service have gradually led to the role of the paramedic as it is known today. Although vocational training began in 1985, paramedic education started within higher education in 1996, with the first UK undergraduate paramedic degree starting at the University of Hertfordshire. Since September 2021, new student paramedics have only been able to start degree level programmes (Health and Care Professions Council, 2021).

Developing into a profession, paramedics became the twelfth allied health profession with compulsory professional registration with the Council for Professions Supplementary to Medicine in 2000, which subsequently evolved into the Health Professions Council in 2003, and has since been renamed as the Health and Care Professions Council (HCPC) in 2012. Registration was more than just a legally recognised title, its primary aim being to protect service users, their families, carers and other practitioners from unprofessional practice (Woollard, 2009).

Defining a Profession

The concept of a profession, as a body of persons engaged in an occupation, dates back to the middle ages and was usually reserved for lawyers, the clergy and physicians (First et al., 2012). Today, many more occupations meet the criteria of a profession by virtue of requiring the individual to exhibit autonomy, self-direction, accountability and education (Bossers et al., 1999). A profession is now regarded as an occupation that embodies an element of trust and the need for honesty and confidentiality (Burford et al., 2011; Evetts, 2013).

Registration with the HCPC also guaranteed a standardised level of competence with adherence to the Standards of conduct, performance and ethics (2016a) and (the newly revised) Standards of proficiency (2023). With adherence to these shared standards comes accountability, self-regulation and responsibility for both individual and profession-wide conduct.

With inclusion on the HCPC register, and the formation of the Joint Royal Colleges Ambulance Liaison Committee (JRCALC) to provide clinical practice guidance for UK ambulance services, paramedicine has become a profession with guidelines, autonomy and self-direction (Evetts, 2013). Modern paramedic practice lays greater emphasis on decision making, accountability and best practice for individual patients, rather than former strict adherence to local protocols. This move to a profession also necessitated the formation of a professional body and the British Paramedic Association was founded in 2001, becoming the College of Paramedics in 2009. Today, a registered charity, it remains the voice of the developing paramedic profession.

Evolving Practice

The paramedic profession continues to develop at pace. Now with degree-level entry to the profession, and independent and supplementary prescribing available, paramedics have opportunities to undertake a much greater variety of positions as the profession evolves into multiple advanced roles across a range of healthcare settings.

Paramedics may have historically been known for their delivery of emergency and urgent care (Eaton, 2019); however, no longer do all paramedics wear green. The profession has crossed a boundary into roles and clinical settings that had previously been simply aspirational. As well as the range of clinical settings, at a range of clinical levels, paramedics may now sit exclusively in education, research, patient safety and clinical audit, as well as leadership and management.

With this ever-evolving role and expanding scope, is it now time to re-frame the theory of practice for paramedics so that patients, members of the public and other healthcare professionals may begin to see what paramedics really do?

From the humble beginnings of horse-drawn volunteers conveying sick people to hospital, to the profession of autonomous clinicians that we see today, it is clear that paramedics are now marked out by their generalist knowledge and the autonomy of their actions. These actions demand accountability and ethical considerations within an evidence- and values-based framework.

More Than Just Drivers?

Even today, the terms ‘paramedic’ and ‘ambulance driver’ are used synonymously within the British media. This is not surprising, given that the initial role of the ambulance service was as a retrieval service, transporting patients to definitive, in-hospital, care. However, the requirement for clinicians in the ambulance service has evolved to what is now the paramedic profession. As a profession then, is it any wonder we become offended when called ‘ambulance drivers’? This may be part of the role a paramedic in the ambulance service undertakes, but to some it devalues the professional autonomy, knowledge and integrity required to be a paramedic.

While ‘job about’ (swapping between attending the patient and driving the ambulance for each new patient), staying ‘on the board’ (attending the patient for the whole shift) or splitting the shift ‘half and half’ (one person attends patients for the first half of the shift while the other drives, swapping over halfway through the shift) are common phrasing relating to driving during shift-work in the ambulance service, this conversation becomes irrelevant if only one member of the crew is a paramedic, since the paramedic may always be required to stay with the patient in the back of the ambulance depending on clinical need and condition. The opportunity for paramedics to drive throughout their shift is long gone and when paramedics are driving, there is the expectation of not only concentrating on driving, but also of being fully aware and cognisant of what is occurring behind the driving seat (Bullard, 2020).

Despite the professional evolution, there exists still a clear perception of paramedics as ‘drivers’, with the expectation that patients are quickly conveyed to hospital, with little regard for the clinical scope of practice, or for possible referral or pathway use over conveyance to an emergency department. There is a public perception that a 999 or 111 call will result in a hospital conveyance, even with minor ailments or injuries, or even dental problems. This suggests a much greater mismatch of understanding that inevitably will perpetuate an inability to meet public expectation (Lucas et al., 2019). Public perception is perhaps best summed up in the health promotion campaign from NHS ambulance services, reminding the public of when they should be using emergency services. That ambulance service employers continue striving to remind people when to call an ambulance suggests that we desperately need to redefine the paramedic role, educate the public and publicise what it is we actually do (Eaton, 2019). However, the developing and evolving nature of the paramedic, and the aggregation of skills that now allow a much wider scope of role, must first be understood by individual clinicians, and communicated clearly to our patients and the public. The development of the profession has transitioned from a protocol-driven practice to much more autonomous, problem-solving, solutions-based and holistic approach. It is fair that within this change of approach we also have a responsibility to communicate and approach public expectation and perception.

Professionalism – The Sociology That Underpins Our Identity

Freidson (1994) discusses professionalism as a social construct, but when applied to the healthcare system, conflicting assumptions often arise. For the paramedic, when wearing green, and particularly when not, we are often subjected to this conflict of underpinning assumptions and ethos. It is perhaps this reason that Eaton, Baron and Townsend (2021) were so vocal in their objection to the dual registered nurse-paramedic role, arguing that the conflation of two professional identities did little to advance either profession.

Professionalism is an ethos that encompasses behaviour, knowledge and a commitment to development. We have a responsibility to educate and to seek a sense of formal rationality that determines an expected level of behaviour, and an expected response in often complex and conflicting situations (Freidson, 1994). As a profession we have a responsibility not only as individuals but also as a wider collective to continue to advance and develop our paramedic professional identity. Professionalism and professional identity are central to both an individual and profession-wide commitment. This is not just skill and competence, but must also include a commitment to the use of that skill and competence and the way we apply it to any given patient scenario (Freidson, 1994).

While as paramedics in the UK we are considered professionals by a protected title, are we fully professionalised? The culture of professionalism is perpetuated on an individual, organisational and profession-wide level. Townsend (2017), like Friedson (1994), discusses the way in which people can be part of a recognised profession and demonstrate the skill, behaviours and characteristics required to look like a professional, yet individuals can still lack the ethical and moral behaviours demanded. Belonging to a profession does not make an individual a professional; professionalism is a choice to display ethical and moral behaviours in line with the code shared amongst those within it. However, professionalism is not just about the Standards of conduct, performance and ethics (HCPC, 2016) or the Standards of proficiency (HCPC, 2023) becoming individualised and rooted in the professional culture. We should consider the culture we continue to propagate and the stories we tell (Noordegraaf, 2011).

Are there degrees of professionalism? Is it a continuum?

Freidson (1994) also discusses the degree of privilege and trust afforded to a profession. This was key to the term he coined regarding professional autonomy and power – the right to control the work undertaken. Professional self-regulation is applauded by Freidson (1994), who acknowledged that outsiders to the profession would not fully understand the intricacy or the detail, and thus must be governed by its members. As well as autonomy, this concept is rooted in the need for discretion, decision making and morality – and the specialised skills and knowledge demanded by the role played by paramedics (Freidson, 1994; Townsend, 2017). Registration as a profession allowed individuals to identify with a standardised title and to cultivate the skills, behaviours, and competencies associated with the role. Professionalism, however, is the concept of regulation of the profession and offers ‘flexibility to deal with the complex matters associated with the complex nature of humans that naturally arise in healthcare’ (Townsend, 2017, p. 36).

Professionalisation

The professionalisation of the role of paramedic is best summarised by First et al. (2012) who suggest a process whereby practitioners with a certain level of education, skills and behaviour ‘close the market’ so that only similarly qualified practitioners can then assume both the title and role. The six domains of professionalism in Box 1.1 are altruistic terms that when unpicked can be seen as echoed through the literature of the HCPC and by paramedics themselves. In the Consensus towards Understanding and Sustaining Professionalism in Paramedic Practice Project (CUSPPP), both qualified paramedics and paramedic students agreed that professional behaviour needed to encompass responsibility and accountability (Gallagher et al., 2016). These individual qualities of social responsibility, respect and ethical practice may be innate, but can arguably be better enhanced with education. However, the enactment of professionalism based on these qualities is practice dependant and influenced by individual values and beliefs (Gallagher et al., 2016; Eaton, 2018). In short, professionalism is grown, not made (Burford et al., 2014).

Box 1.1 Six Domains of Professionalism (Hilton, 2004)

Responsibility and accountability

Reflection/self awareness

Social responsibility

Respect for patients

Teamwork

Ethical practice

When considering professionalisation of the paramedic role, core values and behaviours that are considered to constitute professionalism have been previously outlined (O’Meara, 2009; McCann et al., 2013) aligning with the Standards of conduct, performance and ethics (HCPC, 2016a) and the Standards of proficiency (HCPC, 2023). Professional behaviour encompasses everything from personal presentation, benevolence, and through to individuals advancing the profession. This all translates into practice as paramedics being directed to put the patient’s best interests foremost in all decisions, in their performance, their behaviour, their attitude, their communication and in their endeavour to provide the utmost quality of care for the patient experience. However, it is not just operational paramedics that fall within professional boundaries. These principles also apply to the professionalisation of the paramedic workforce, thus encompassing all employees of all grades from student at a clinical entry level, through to chief executives (Wagner et al., 2007).

Actions-based Practice

The catalogue of serious adverse events at the Mid Staffordshire Hospital suggested that there must be a focus upon training for professionalism, an assurance of the possession of appropriate attitudes and behaviour that aligns with both code and expression of meritorious practice (Mid Staffordshire NHS Foundation Trust Public Inquiry, 2013). Professionalism encompasses individual self-awareness, values and key attributes that put the professional second to the needs of the patient and the quality of the care they are giving (First et al., 2012). Therefore, the expectation is for a professional to embody the drive to excel, to continually develop their skills, knowledge and attitudes to ensure professionalism at all times (Mid Staffordshire NHS Foundation Trust Public Inquiry, 2013). The failings of the Mid Staffordshire Hospital recognised that individual practitioners’ professional values had become compromised by a culture of collusion, silence and acceptance of poor practice. Therefore, self-awareness, honesty and values-based practice are key to ensuring an occupational culture of professionalism, and thus become action based.

Noordegraaf (2011) outlines three main areas that need to be examined in order to promote a culture of awareness, honesty and professionalism:

Cognitive areas:

These include education, knowledge, skills, conference- and evidence-based healthcare.

Normative mechanisms:

Which include entry criteria to education and professional registration, certification of continuing professional development, codes of conduct and disciplinary procedures.

Symbolic mechanisms:

Set out as cultural rites of passage, interpersonal communication, story-telling, personal codes of ethics, service ideals and missions.

As posited by Gallagher et al. (2016), students and paramedics alike continue to highlight the importance of regulation as a normative mechanism, and a key component of professionalism. This suggests that professionalism for paramedics – in the eyes of the clinicians – was about following the standards of the HCPC meaning ‘you can’t go far wrong because they are the people that tell you what a paramedic essentially is, and if you don’t follow their rules you can’t call yourself a paramedic’ (Gallagher et al., 2016, p. 4). Although simplistic, this statement summates the necessity of regulation in determining that individuals meet levels of competence, decision making, attitudes and behaviours.

While the cognitive and normative areas may be set out within a curriculum from the professional body, or standards for registration, the symbolic area often has little uniformity but offers great importance. The stories that paramedics tell, the behaviour they applaud as being that of a good clinician, and the rites of passage they adhere to are key to full acceptance as a clinician within the profession, and the professionalisation of all grades of staff. This implies a need to look more closely at the organisational culture in which our professional practice sits: do we tell stories and applaud behaviour that matches up to the professionalism we seek?

Mason et al. (2014) have published a professional charter which allows students within the allied health disciplines (such as paramedicine) to evidence their growth within personal and interpersonal areas – two elements set within symbolic mechanisms. The charter (Table 1.1) defines the construct of professionalism in a way that allows students to plot their strengths and weaknesses within a framework, demonstrating achievement of standards of professional behaviour both in and out of practice.

Table 1.1 Allied health professions professionalism charter.

Responsibility

Description

Altruism and respect for others

The ability to demonstrate a commitment to patients, the profession and society through ethical practice

Clinical reasoning

The ability to analyse, synthesise and interpret information

Cooperation

The ability to work effectively with others, honouring commitments and being loyal to decisions made

Commitment to improve

The ability and will to strive for excellence

Competence

Commitment to competence in technical knowledge and skills, ethical and legal obligations and communication skills

Confidentiality

Appropriate safeguarding of the disclosure of patients’ information

Effective verbal communication

The ability to share information with clarity and quality of content

Effective written communication

The ability to communicate information clearly and concisely in written form

Empathy and compassion

The ability to be sensitive and respond to the feelings and behaviours of others

Honesty and integrity

The ability to be fair, truthful, to keep one’s word and be straightforward

Initiative

The capacity to create and initiate ideas

Judgement

The ability to make wise decisions

Maintenance of appropriate relationships with service users

The commitment to avoid inappropriate relationships with patients or their carers

Organisation

The ability to systematically manage tasks, manage self and manage others

Professional presentation

The ability to present oneself in a manner acceptable to clients, peers and colleagues

Reflective practice

The ability to reflect on one’s own behaviour and the underlying dynamics and to develop learning as a result

Responsibility

The commitment to having responsibility to society, to the profession and to self

Self-awareness

The ability to be insightful, particularly about the state of one’s knowledge, skills and behaviours

Supervision

The ability to modify performance in response to meaningful feedback

Trustworthiness and dependability

The capacity to demonstrate reliability and honouring commitments

The creation of a professional organisational culture is important in raising the expectations and professionalism of a paramedic, regardless of the employment setting. In developing the profession, the behaviour, values and beliefs preventing unprofessional behaviour and the culture of the past must be challenged.

The Mid Staffordshire NHS Foundation Trust Public Inquiry (2013) highlighted concerns that the NHS can be an organisation of collusion, outlining silence in the face of poor practice that resulted in patient harm. An HCPC report (2016b) concluded that there were still elements of an acceptance of poor practice within the ambulance service, compounded by a culture of not speaking out due to fear that other practitioners would then ostracise the complainant. Despite a report released at the first edition of this book, setting out recommendations to overcome a culture of bullying and sexual harassment within ambulance services in England (NHS Employers, 2018), an internet search will show that many ambulance trusts across the UK still suffer the effects of poor culture – often highlighted in reports by the Care Quality Commission. It is evident that such culture highlights gross misunderstanding of what it means to be professional. Professionalism at all levels and roles involves raising of concern, not only for the patient, but also for colleagues. In doing so, self-awareness, responsibility and individual accountability is maintained. While it is unlikely that any paramedic would intentionally set out to harm patients and colleagues, professionalism encourages a culture of awareness and openness – of learning from error to enhance clinicians’ abilities, rather than punishment for error.

Consider how you would demonstrate your professional behaviours.

Values-based Practice

In 2012, the HCPC commissioned a report to explore professionalism across three registered professions, one of which was paramedicine. This report determined that professionalism in terms of definition is context dependant and that there is subjectivity due to the individual practitioner, the patient and the setting. Professionalism is dictated by internalised values, attitudes and ethical behaviour that is personal to the practitioner, therefore being innate rather than taught (HCPC, 2012).

Values in healthcare are more often based on medical ethics, such as beneficence and non-malevolence (Beauchamp and Childress, 2019); however, the term also encompasses needs, preferences, wishes, personal expression, evaluation and judgements (Fulford, 2011). Values are highly personal – we all have them, professions have them, organisations have them – but sometimes personal values do not match with the profession or the organisation. Therefore, values-based practice operates as a twin framework to evidence-based practice to ensure that professional values encompass both who and what we profess to be (Fulford, 2011).

Within the paramedic context, behaviours that may constitute professionalism are encompassed in arguably nebulous terms such as altruism, advocacy, excellence and humanism. Values that align with these behaviours are not necessarily exhibited by all paramedics given that values are highly subjective, intensely personal and often conflict (Eaton, 2018). Notions such as confidentiality, best interests and capacity are clear practice terms; however, the enactment of them at the patient’s side can be complex, which is likely down to the values of the patient and the clinician. There can be a conflict with the practitioner’s internal values and their need to disclose information or work in a particular manner to achieve gold standard care (Fulford, 2011).

Professionalism should begin with the individual and extend to practice that reflects both occupational and organisational values (Stern et al., 2005). Perhaps more importantly there needs to be a realisation of the diversity and the complexity of terms such as values, attitudes and behaviours. There is an acknowledgment within the published literature that paramedics have not yet fully realised a status of professionalism, due in part to such things as an organisational culture which prohibits this enactment of professional values, ethics and behaviours (O’Meara, 2009; McCann et al., 2013). Values-based practice looks to outline the understanding of values as a theoretical basis before then empowering the realisation of values within the clinical setting (Fulford, 2011).

Professionalism is a concept that, while it starts with regulation and registration, pertains to the quality of care given, the level of competence held by the clinician and ultimately the passion and pride in the delivery of quality care (Scottish Government, 2012). Both professionalism and values-based practice interlink, with the definition of fitness to practise as ‘having the skills, knowledge and character to practise safely and effectively’ (HCPC, 2016a, p. 6). Inherent individual values and beliefs may predispose an individual to professional behaviour; however, the ability to understand one’s own values, and apply them within a values-based practice framework would suggest that this is more a determinant of individual, rather than organisational, competency.

HCPC Professional Regulation and Accountability

Exploration of the HCPC Tribunal archives and the most recent fitness to practise annual reports indicate that paramedics as a profession often have the highest number of concerns raised (HCPC, 2022). More importantly they also have one of the highest rates of closed concerns that do not progress, as the concern does not meet the criteria or threshold for the standard of acceptance for fitness to practise hearing (HCPC, 2016b).

Despite this, the HCPC has often been discussed by paramedics in terms usually reserved for a headmaster, a regimental sergeant major, or some such authority figure who demands absolute adherence to a code of behaviour. In fact, the ethos of the HCPC is not one of punishment but of regulation and registration to assure the public of a level of competence from individual clinicians (HCPC, 2019). The HCPC, alongside individual employers, use policy, procedure, standards and guidelines to outline the expectations of the registrant within any working environment. However, although these systems are designed to reduce error of judgements, they are not infallible, and it should be remembered that paramedics, particularly those who work in pre-hospital emergency settings, are exposed to a level of risk not experienced by other areas of healthcare (Shaban et al., 2004). The Standards of conduct, performance and ethics (2016) and the Standards of proficiency (2023) are designed as a framework of expectations of character, skill and personal attributes to ensure consistency in the public expectation of paramedic practice. The expectations are not onerous and apply to all paramedics, regardless of the setting of employment.

All registrants (and arguably anyone who contacts patients) should be mindful of how they behave, how they communicate, and the need to be honest when things go wrong. Human judgement and decision making is never infallible (Collen, 2017). It is always subjective, can be flawed, and always holds inherent risk of error that may well affect the patient (Shaban et al., 2004). Registered paramedics should not fear being held accountable to the standards expected of the profession. Expectations are mirrored across the other health and social professions.

Health and Care Professions Tribunal Service

If a concern is passed to the HCPC, an initial investigation is undertaken. If the standard of acceptance is met, the case will be allocated to a case manager in the Investigations team. The team will gather evidence to make a full assessment of the allegation. The case manager will manage the case through to the Investigating Committee Panel (ICP). The ICP will consider the case and determine whether it should be closed at that stage, or whether there is a case to answer, and the case should be referred for a hearing. If there is a case to answer, it is passed to the fitness to practise adjudication service of the HCPC, the Health and Care Professions Tribunal Service (HCPTS). Hearings are conducted and managed by independent panels, which are set away from the HCPC. Both the HCPC investigative process and the HCPTS operate within Part V of the Health and Social Work Professions Order 2001, and as such are responsible for the safety and assurance of patient care. Therefore, being struck from the register is a first action reserved for only the most heinous mistake, criminal or illegal proceedings, or failure to disclose significant issues of suitability or inability to practice.

Historic mess room folklore would suggest that the HCPC are keen to strike people from the register, and anecdotal evidence supports this idea of paramedics operating from a position of ‘it is my ticket’ and the fear of losing it. However, the HCPC in their Standards (HCPC, 2016a; HCPC, 2023) and within their own report on professionalism (HCPC, 2012) suggest that their interest is not necessarily about the mistake, but what a professional does with the mistake. With their Standards, HCPC promotes a culture of accountability and honesty around a practitioner’s own behaviour, actions and decisions (2016; 2023). If previous and upcoming cases before the HCPTS are reviewed, many allegations concern the decision making regarding the patient’s care and the learning associated with the mistake made.

In HCPC v. Edwards [2015] the paramedic received a caution for a drug error and dishonest conduct. These serious events were found to be mitigated by:

The exceptionally high degree of insight achieved by the registrant

The genuine remorse and contrition shown by the registrant throughout the course of the hearing

His openness and unconditional acceptance of responsibility for his actions

The positive testimonials submitted by persons of standing

His voluntary actions in participating in a paramedic training course allowing others to learn from his mistakes.

HCPC v. Edwards [2015]

These findings, even within a serious case of falsely documenting administered drugs and attempted concealment, acknowledged the registrant’s attempts to rectify mistakes, take responsibility and show insight. Due to the registrant’s insight, remedial behaviour and reflection, the panel were satisfied that the re-occurrence of such behaviour was unlikely, even given the seriousness of the original referral. They concluded that a conditions of practice order or even a suspension order would be disproportionate given the paramedic’s behaviour in attempting to rectify mistakes and take responsibility, and that a caution was therefore appropriate.

However, a different case highlights the need for individual self-awareness and accountability for skill. In HCPC v. Fisher [2017] the registrant was suspended as the paramedic did not undertake an adequate assessment or adequately complete documentation for Patient A, nor complete documentation for Child A, and failed to arrange appropriate referral or safeguarding. The paramedic’s length of service was considered, but a lack of responsibility for skills erosion and poor decision making was acknowledged. The decision to not complete adequate paperwork was a key finding, being a core expectation of a registered professional’s practice. The findings of this case were that the paramedic lacked insight into the seriousness of his failings and two vulnerable service users had been put at risk. In summarising the case, the panel stated that in deciding the sanction of suspension, they were mindful of not being seen to punish the paramedic, but to protect the public.

This case is a good example of how these processes focus on protecting patients rather than punishing clinicians. The process should allow the individual professional to evidence accountability, responsibility and the values of honesty, candidness and insight or self-awareness.

In HCPC v. Garnham [2018], the registrant failed to ensure that a disconnected 999 call was followed up correctly after contact with the caller was lost. The caller was the patient, and this error of judgement was considered to result in their death. The panel decided to afford an opportunity for the registrant to remedy his mistake, and be able to demonstrate insight and responsibility, so a suspension order was given for 12 months. At the review hearing it was recorded that the registrant now gave evidence that was honest, detailed and showed his acceptance of accountability and responsibility for his actions. The notes from the case specifically attest to the registrant admitting his defensiveness and previous misconduct in not accepting that he was at fault. It was therefore noted that the registrant now evidenced insight into his own behaviour, showed self-awareness and acceptance of responsibility and accountability for his actions. In being allowed the time to remedy his mistakes the registrant was afforded the opportunity to show that there is little risk of repetition and therefore the HCPTS decided on a course of no further action.

In the eyes of the HCPC, responsibility and accountability are fundamental elements of registration. Therefore, if a mistake is made, professional development to overcome the knowledge gap, lack of competence or episodes of poor decision making that resulted in a mistake is crucial to retaining registration.

Professional Regulation and Accountability in the Ambulance Service

The HCPC is not a registration body to be feared and it is worth remembering that registration as a paramedic is about protection: of patients, of practitioners and of the title of paramedic. Without this adherence to a minimum standard, the foundation of a recognised profession would not be a reality.

Examination of relevant case law from the ambulance service demonstrates that there is an expectation for all clinicians to adhere to minimum standards, professional behaviour and common-sense approaches.

In the case of London Ambulance Service NHS Trust v. S Small [2009], the registrant was dismissed for gross misconduct in respect of his handling of an elderly patient. While the claimant exercised his right of appeal, the decision to dismiss was upheld. An employment tribunal subsequently concluded that the dismissal was procedurally unfair, despite the clinical failings of the registrant. After subsequently going through an Employment Appeal Tribunal (UKEAT/0395/07), this case went through to the Court of Appeal. The Court of Appeal then advised that while its place is not to tell tribunals how to write their judgments, it might be better practice in unfair dismissal cases for employment tribunals to keep their findings for liability purposes separate from any findings on disputed issues that are only relevant to other matters, such as clinical competency within this case.

Inadequate assessment alongside failure to take responsibility to exercise a duty of care was seen as a key element in Choudhury v. South Central Ambulance Service NHS Trust and Portsmouth Hospitals NHS Trust [2015]. In this case, two paramedics were dispatched separately to Mr Choudhury, and both misdiagnosed his condition. The initial symptoms were of head pains, which the first paramedic did not record a diagnosis for. The second paramedic diagnosed hyperventilation, although the patient was now also vomiting, and this was recorded as food poisoning. There were also serious failings once he arrived at hospital nearly 12 hours after the initial onset of symptoms. The treatment of the patient was so significantly delayed by the failings of both the paramedics and the hospital that the basilar artery occlusion the patient was suffering from resulted in both brainstem and cerebellar infarction and locked in syndrome.

King v. Sussex Ambulance NHS Trust [2002] highlights the complex relationship between the employer’s duty of care to both the employee and the patient. When a non-registered clinician was injured, the judgment acknowledged that while the ambulance service must adhere to procedure and standards to enable safe practice, the onus is also on the decision making of the practitioner to complete risk assessments and make sound decisions for themselves.

Another contested employment tribunal involves an Emergency Medical Technician (EMT), who was not investigated by the HCPC as they were not a registered clinician. In East of England Ambulance Service NHS Trust v. Mrs J Sanders [2016], the employment tribunal was contested as the EMT was dismissed following the Trust’s internal investigation. In the employment appeal tribunal, the Judge highlighted that all clinicians were responsible for their patient care, and that the EMT’s excuse of being turned down for paramedic training and lack of extended education ‘did not excuse her poor patient care’. This case highlights why registration for non-paramedic roles, particularly within the ambulance service, would be of value. The claimant in this case was tasked to take a patient to hospital after they had been seen by a GP with a suspected hip fracture. In brief, there was a catalogue of attitudinal problems, and the crew did not transfer the patient to hospital, where he was later discovered to have had a fractured hip. The Judge in this case highlights that all healthcare professionals operate under an assumption of skill, knowledge and behaviour encompassed within the concept of a duty of care. Other healthcare professionals, patients and their relatives, and the public at large, have an assumption or expectation of the care that should be delivered by generic ambulance staff. This concept of a benchmark of behaviour, of a need for quality regardless of role within a service, is a key element of registration, and therefore would give a clear and distinguishable framework for all healthcare clinicians.

Although training and education may be relevant to professionalism, these cases highlight the importance of individual responsibility for the failure to behave in line with organisational expectations. All clinical staff are required to enact a degree of professionalism to promote quality patient care. Defining quality expectations from the patient, members of the public and other clinical professionals is what the HCPC was set up to achieve, and to meet expectations is the mark of professionalism. Thus, non-paramedic clinicians such as associate ambulance practitioners (or similar), EMTs, students paramedics and voluntary community first responders should be held accountable to a base level of professional competence, behaviour and quality of care. The case law explored previously demonstrates that the Courts see a clear duty of care; a certain level of competence and behaviour is expected from all those working in the ambulance service and not just registered paramedics. This behaviour, skill and duty of care, consummate with that of a professional, should be demanded of non-registered staff too. These elements of competence, duty of care, decision making, behaviour and attitudes are what all those who work in healthcare delivery are judged against, and so is it time that we enhance the value of paramedic registration and explore levels of registration for the different grades of staff within the ambulance service? Registration of all grades of ambulance staff, rather than just paramedics, would potentially assure the quality of care, a level of competence and the enactment of professional behaviour at all levels of the organisation. Registration with the HCPC should be seen as an embodiment of professionalism, the ability to evidence professional competence, professional growth and, overall, a commitment to continually raise the quality of care for the patient.

Should registration be opened up to include other roles within emergency and unscheduled care?

Should all ambulance staff and first responders adhere to a recognised minimum standard of care?

Summary

The paramedic profession should be applauded for its march to professionalism. However, it is imperative that individual paramedics understand the importance of professionalism across the whole context of practice. Professionalism extends from the individual context to the interpersonal context and the organisational culture. It not only demands that quality patient care be placed at the forefront of practice, but that individual practitioners show self-awareness, and exhibit behaviours and attitudes that align with this. For individual paramedics, however, the concept of professionalism is complex and varied, and the societal or organisational expression of professionalism is very much dictated by the organisational culture (Burford et al., 2014). Perhaps we also need to consider the professionalisation of all staff under this umbrella who contribute to patient care. Registration for other members of frontline staff working within ambulance services may grow professionalism in all contexts of practice. The creation of a professional identity or organisational culture must raise the expectations and professional behaviour of all ambulance roles; the culture of the past and unprofessional behaviour must be challenged so that all healthcare practitioners are mindful of behaviour and communication and are honest in their practice.

The development of a professional culture is not a journey that is finished, and oversight of personal reflection threatens to hold the profession in a culture of blame, what Francis outlined in his report of the Mid Staffordshire NHS Foundation Trust Public Inquiry (2013) as a culture of collusion and silence. Paramedics must work hard to continue their journey to full accountability and a culture of professionalism, and reflective practice will be at the heart of this. The journey to professionalism, the creation of our professional role and a professional culture is not yet finished; the journey is still underway and future generations of paramedics must continue to shape what it is we do, how we do it and how we fulfil the expectations of our patients. It is very much an exciting time to be a paramedic.

Recommended Reading

Fulford KWM (2011). The value of evidence and evidence of values: bringing together values-based and evidence-based practice in policy and service development in mental health. Journal of Evaluation in Clinical Practice, 17: 378–381.

Mason R et al. (2014). Knowing about and performing professionalism: developing professionalism in interprofessional healthcare education. International Journal of Practice-based Learning in Health and Social care, 2(1): 96–107.

McCann L et al. (2013). Still blue-collar after all these years? An ethnography of the professionalization of emergency ambulance work. Journal of Management Studies, 50(5): 749–776.

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Chapter 2

An Introduction to Ethics

Georgette Eaton

Ethical discourse is concerned with the search for justification for our actions.

(Laurie, Harmon and Porter, 2016, p. 5)

Introduction

Ethics (also known as moral philosophy) is concerned with how people ought to act and how people conduct themselves towards achieving a good life – a life that is worth living. Here, the first hurdle in theorising about ethics arises – not everyone will agree on the principles that govern good conduct, or a good life, and there are many different views on what makes a life ‘good’. It should not be thought that ethics is necessarily about discovering what is ‘right’ or ‘good’, but that it is instead a vehicle to explore the nature of morality.

Ethics differ from morals, in that ethics denote the theory of something that is right, whereas morals indicate their practice. Ethics also differ from values, where actions are treated as abstract ideas. Both morals and values deal with the right conduct and living a good life, but what makes an action moral or value-driven depends on the whole of a person’s ideals and behaviours – the person’s weltanschauung (their philosophy of life). Essentially, ethics are a system of principles that assist in decision making.

While the subject is undoubtedly fascinating, other texts are far better suited to portraying the history of ethics, and A Short History of Ethics (2002) by Alasdair MacIntyre covers an insightful history of moral philosophy from ancient to contemporary times. A detailed overview of ethics remains largely out of the scope of the paramedic curriculum; this chapter will give an overview of the different ethical branches within moral philosophy, as well as discussing applied ethics broadly within medicine. Ethical standpoints are outlined, and the reader is encouraged to reflect upon and consider their own personal experiences and guiding actions towards developing a self-awareness of moral philosophy.

Normative Ethics

Normative (or prescriptive) ethics is concerned with developing a set of rules to govern human conduct. Looking to provide a set of norms for action, this branch of ethics is concerned with how things should be, what is good or bad (or right or wrong) and how to value actions and objects. Normative ethics is split into three main categories.

Consequentialism

Also known as ‘teleological ethics’, consequentialism argues that an action is judged either ethically right or wrong by the consequences produced. An action is considered ‘good’ if, all things considered, the outcome or result is good. Therefore, in assessing the morality of an action, all of the good and all of the bad consequences must be weighed up. Similarly, if two different courses of action are presented, then the one chosen should have the best overall consequence. Any person who may be affected should be considered, and one person’s interests should not be considered over another’s. From a utilitarian perspective, healthcare resources, finances and staffing are finite and should be appropriately accommodated to ensure society receives the best healthcare.

It is an attractive theory – it seems difficult to argue that achieving the best outcome would be a bad thing. It relies on a similar style of reasoning when making purely practical decisions: when I am trying to decide how best to extricate the patient from the house, I will consider all the available options, judge the value of each option, and then predict the option that will most likely lead to the best outcomes: safe extrication and lack of manual handling for me. Using a mixture of personal and practical knowledge, I select the equipment. It is, fundamentally, a ‘common sense’ approach.

However, the problem with consequentialism is defining ‘good’. What is a ‘good’ method of extrication for me, may not be a ‘good’ method for my crewmate, or for the patient! The most common consequentialist theory is ‘utilitarianism’. Initially posited by Jeremy Bentham, utilitarianists claim that the most important good is for people to be happy – the greatest happiness for the greatest number. Utilitarianism claims to offer a science of morality based on measuring and calculating happiness, within which everyone’s preferences would count equally. Therefore, in making ethical judgements, utilitarians ask which act will most increase the sum of human happiness. ‘Act utilitarianism’ claims that the morality of each action is decided by which action, in certain or particular circumstance, is likely to promote the greatest happiness of the greatest number. In contrast, ‘rule utilitarianism’ rejects that decisions should be based on circumstance and claim that it is the type of action that, if done by most people, promotes the greatest happiness of the greatest number. A good way to differentiate between act and rule utilitarianism is to consider the concept of lying.

Suppose my husband dislikes his cup of tea being stirred with the spoon that I have made my coffee with, and I tell him that I used two different spoons, when I have not. Act utilitarians may consider that, in this particular case, this ‘porky pie’ is justified because it maximises the happiness of all those concerned (using one spoon saves on washing up and is it really likely he knows that I use the same spoon?). However, a rule utilitarian would claim that since lying would diminish happiness (if he can taste the difference,¹ he would be upset that I did what he asked me not to, and I would be upset if we argued about it), it would be best to adopt a rule against lying, even if in some cases telling a ‘porky pie’ may appear to be benign in consequence.

This brings forward another problem of consequentialism: ‘good’ for whom? Not using two spoons saves on washing up, but if you can taste the mix of drinks, it could be less pleasant. More seriously, what about when deciding on treatment for multiple patients at a large incident – is it only a question of what is best for one patient, or best for all patients at that scene? Once every conceivable consequence of an action is considered, the decision-making process becomes much more complex.

This is not helped by the fact that we cannot predict what the consequences of our actions are (Smart, 1993). If the consequences are so unpredictable, can we really use them as a guide to assess the morality of actions? Much of this is values based, and ‘preference utilitarianism’ allows individuals to be judged according to their own values (Singer, 1994). Teleology also provides a moral basis for the professional ethics of medicine, as clinicians are generally concerned with outcomes and must therefore know the telos (the end goal) of a given treatment paradigm.

Other consequentialist theories hold different values at the centre of the ideology:

Altruism prescribes that individuals should take actions that have the best consequences for everyone, except for themselves. It holds central to a moral obligation to serve others and, if necessary, at the sacrifice of self-interest.

Asceticism describes a life abstinent from egoistic pleasures in order to achieve a spiritual goal.

Egoism holds that an action is right if it maximises good for the self. Acting in one’s own self-interest.

Hedonism holds that pleasure is at the centre of the pursuit of mankind, and that individuals should strive to maximise their own pleasure (but not at the consequence of any pain or suffering).

Deontology

Contrasting consequentialist theories, deontology holds that our actions (or moral obligations) – whatever they may be – are independent of the consequences they produce. An action is good because it is right in itself. Going back to my earlier example, deontology would advocate that we should tell the truth, not because it makes people happy or gives them pleasure, but because truth-telling is the right thing to do. The paramedic–patient relationship is by nature, deontological and duty bound.

Immanuel Kant is perhaps the best advocate of this maxim; his writings inspire Kantian ethics, a deontological ethical framework. Kant’s ‘Formula of Universal Law’ posited the categorical imperative to ‘act in accordance with that maxim which can at the same time make itself into universal law’ (Wood, 2008, pp. 82–83) and this is one of the central tenets of this theory. Kant advocated that no individual should be treated as a means to an end – a person should not be used merely to help others. Central to Kant’s version of deontology is personhood: a moral person must construct their own moral law, which guides their actions. It is the ideal that one should treat others as one wishes to be treated oneself. Such principles may be demonstrated within medical research, where someone should not be used in research without their consent, even if that person may contribute to ‘good’ (for example, finding a cure for cancer). Clarity is often claimed as a deontological approach: if there is a clear deontological principle (such as not treating a patient without consent), then no further guidance is required. This is one reason why deontology is so attractive. The Kantian principle of respect lends itself to doctrines of universal human rights. For Kant, justice requires us to uphold the human rights of all persons, regardless of how they live or how well we know them, simply because they are human beings – capable of reason and therefore worthy of respect (Kant, 1785).

However, there are disagreements and these generally centre around what the principles of good and bad behaviour are. Those with a religious faith may argue that what is good or bad is set by their gods. Those without may argue that some principles are naturally right or wrong. Principles such as truth, honesty and knowledge are considered ‘self-evident’, but in an increasingly multicultural, multi-faith and non-binary society, determining a social contract under which moral principles should be ranked is increasingly difficult.

In a similar way to consequentialism, those who hold deontological viewpoints may be split. Some deontologists argue that all deontological principles are absolute and cannot be breeched under any circumstance. Others deviate from Kant’s view that there should be a universal formula and may accept that, if there are overwhelmingly good consequences, a breach may be justified (Morrison, 2005). Consider the community first responder who breaks the speed limit to attend to a patient in cardiac arrest. Some would argue this is the highway code and should not be broken unless by a trained advanced driver. Others will accept that, if there are overwhelmingly good consequences, a breach may be justified. So, although a community first responder should not normally exceed the speed limit, some deontologists would argue it may be appropriate if they may save a life. However, Kant would argue that doing good deeds out of compassion, however amiable or right it may be, lacks moral worth. This seems a little counterintuitive for the altruistic nature of such a community first responder, but Kant is distinguishing between the motive for helping others (that good deeds give pleasure) and the motive of duty. For Kant, the good deed is undertaken because it is the right thing to do – regardless of whether or not doing it gives us pleasure.

Generally, deontology is seen as an important response to consequentialism, although Kant places more emphasis on obligations rather than rights. Kant ‘describes humanity as having “absolute and objective worth” as an end in itself, and the dignity of rational nature as an “inner worth” that is “beyond all price”’ (Wood, 2008, p. 59). It is for this reason that many deontologists are against euthanasia. Humans have intrinsic dignity and there is a universal law against killing. The distinction is not always clear, however. While deontology may regard the consequences of an action irrelevant (for example, ignoring the importance of medical treatment), consequentialism may permit a paramedic to treat a patient without the patient’s consent if the overall consequences of treatment were beneficial.

Essentially, these are perspectives and two different approaches to a problem, and sometimes clearer guidance is needed.

The Trolley Problem

Imagine you are standing on a footbridge above tram tracks. You can see a runaway trolley (tram) hurtling towards five unsuspecting track workers who cannot hear it coming. Even if they do spot it, they could not move away in time.

However, there is a morbidly obese man standing next to you on the footbridge. He is unkempt, smells strongly of alcohol and fish, and you know he has no job nor makes any material contribution to society. You are confident that his bulk would stop the tram in its tracks.

So, would you push the man on to the tracks, sacrificing him in order to stop the tram and thereby saving the five workers?

This is the crux of the classic thought experiment known as the trolley problem, developed by philosopher Philippa Foot in 1967 and adapted by Judith Jarvis Thomson in 1985. In the case of this dilemma, a utilitarian may advocate pushing one person to their death, while saving five others – thereby using one person as a means to an end.

I have made a deliberate effort to describe the person who may be pushed onto the track to be as unappealing as possible, in the context of the aesthetics of our modern western society (though this is happily changing). Would your decision be any different if the person on the footbridge next to you was a decorated war veteran, a heavily pregnant mother, or a child?

The trolley problem allows us to think through the consequences of an action and consider whether its moral value is determined solely by its outcome and is a good way to illustrate the differences between utilitarianism and deontology. We also approach this in the context of our own ethics of value – in this case, the value of beauty.

There are lots of other thought-provoking examples of the trolley problem, and they are well worth a review to help you determine your own ethical standpoint.

Virtue Ethics

Clearer guidance is not offered by virtue ethics. Virtue ethics is highly philosophical and emphasises the virtues (moral character) in contrast to the approach that emphasises the consequences of actions (consequentialism) or that emphasises duties or rules (deontology). Essentially, virtue ethics focuses on the inherent character of the person, rather than their actions or the nature of their consequences. This strand of ethics holds that a virtue is an excellent trait of character. It is a disposition – something intrinsic and deep in its possessor – to notice, expect, value, feel, desire, choose, act and react in certain characteristic ways (Rachels, 1999). Virtue ethicists hold that it is these behaviours that allow a person to achieve a good life (virtues) and guide the ability to achieve happiness. To possess a virtue is to be a certain sort of person with a certain complex mindset, and a significant aspect of this mindset is the whole-hearted acceptance of a distinctive range of considerations as reasons for action.

Aristotle outlined that moral virtues come about as a result of habit – we learn by doing. Iain Campbell sets out an interesting vignette regarding this in Chapter 3: Applied Ethics in Paramedicine, but suffice to say ‘we become just by doing just acts, temperate by doing temperate acts, brave by doing brave acts’ (Aristotle, 350BCE, pp. 1103a–1103b). Being steeped in virtuous behaviour helps us to acquire the disposition to act virtuously. The challenge is to do the right thing, and this is what Aristotle set out as practical wisdom. Practical wisdom is a moral virtue with political implications – it can deliberate about what is good and seeks to identify the highest human good attainable under the circumstances.

Thinking back to our example about lying. In virtue ethics, an honest person is not simply someone who is honest. The motivation behind the action is important. Honesty should not be out of fear of being caught out, or the outlook that ‘honesty is the best policy’, but related to a strong reason for not making false statements or actions. A virtue ethicist gives an overriding weight to ‘truth’ as the reason against dishonesty. Virtues are good habits that direct human nature towards good actions (Herring, 2022).

Within healthcare, the ‘6Cs’ were born from the Francis Report, which highlighted many examples of appalling care at Mid Staffordshire Hospital in 2013. England’s Chief Nursing Officer, Jane Cummings, launched the 6Cs strategy which set out the shared purpose of nurses, midwives and health visitors against the backdrop of the Francis Inquiry. However, it is not only limited to nursing and midwifery, having been adopted effectively across the NHS in its subsequent years. We therefore expect healthcare professionals to act compassionately, competently, with care and commitment alongside good communication and courage to speak up when things go wrong. While these are attractive principles, and without doubt underpin the virtues healthcare professionals should possess, in the heat of the moment can the professional be confident that their decision was based on compassion and kindness, or confident that the right course of action was chosen?

Ethics of Care

Virtue ethics are largely rooted in Plato and Aristotle, who defined that the right action was the one that led to ‘well-being’ and can be achieved by a lifetime of practising virtues subject to practical wisdom. More recently, the ethics of care has been developed by feminist (a doctrine advocating for the social, political and economic equality of the sexes) writers and holds that moral action centres on interpersonal relationships and care, as well as benevolence as a virtue. Ethics of care avoids abstract tools and seeks to find an approach that fits within individual cases (Tronto, 1993).

One of the biggest criticisms is that the notion of care is too vague. Without a clear concept of what ‘good’ care is, it arguably should not form the basis of an ethical approach. Not all caring relationships are good ones, and problems with power and respect give criticism to this approach (Twigg, 2000). Care should be explained in relational terms, in order to not only promote caring relationships, but also to explain that respect is central to good care.

Respect is also central to the universal vulnerability thesis, which outlines that everyone is vulnerable. The law has traditionally assumed people are self-sufficient and autonomous, and therefore individuals who do not fit into these categories are labelled as vulnerable. This approach indicates that our own health and well-being relies on that of others, and so the law should recognise societies’ mutual interdependence (Wrigley, 2015). Ethics of care and moral philosophy overlap in several ways, and to understand more about this complex subject, I would recommend Virginia Held’s The Ethics of Care: Personal, Political, and Global.

Feminist Medical Ethics

What makes an ethical-approach feminist? Is it because I am a female author that I have included this section? The feminist approach ‘takes gender and sex as centrally important analytic categories, seeks to understand their operation in the world, and strives to change the distribution and use of power to stop the oppression of women’ (Purdy, 1996, p. 8).

Feminist ethicists have worked to develop approaches to medical ethics that challenge how morality and virtues historically exemplified by women, such as patience, nurture and self-sacrifice, are viewed. Such challenges are influential within the ethics of care, previously discussed, and they are also used to identify the inequalities in healthcare provision. Feminist work has highlighted disparities in gender health research (Scambler, 2008), disproportionate gender views (Purdy, 1996), and ignorance in the medical justification for the treatment of women (Lupton, 1994). One only needs to see the annual MBRRACE-UK perinatal mortality surveillance reports to see how contemporary this problem is.

Feminist ethics seeks to overcome the abstract theories applied by traditional medical ethics to complex clinical cases, in order to understand the realities of the individuals and their relation to the case overall (Marway and Widdows, 2015). Perhaps we should pay more attention to this view going forward.

Hermeneutics

In its simplest form, hermeneutics is based on listening. It encourages the use of ‘stories’ and narratives, with the aim that listening brings about a shared understanding of the situation (Boyd, 2005). It, therefore, offers an approach which does not suggest what the right answers are, but more what is right for those involved. This strand of ethics is central to the patient consultation, where the paramedic and the patient discuss a course of treatment. It seems somewhat idealistic that such a conversation can occur without the impact of other factors (such as fatigue) and requires a willingness to engage from all parties. However, where engagement does occur, this approach may enable the development of a solution that is tailored specifically to meet the needs of those involved.

Meta-ethics

A meta-ethical theory, unlike the normative ethical theories we have discussed, does not attempt to evaluate specific choices as being better or worse or good or bad, rather it tries to define the essential meaning and nature of the problem being discussed. With ‘meta’ meaning above or beyond, meta-ethics consequently offers a ‘bird’s-eye view’ of ethical concepts. Meta-ethics is concerned primarily with the meaning of ethical judgements and seeks to understand the nature of ethical judgements and how they may be defended or disputed. It concerns itself with questions specifically around the semantics, epistemology and ontology of ethics. It is highly theoretical, and perhaps the least obviously applied to clinical practice. However, it is an important proponent for those wishing to, or undertaking, further education or research.

Meta-ethics is complex, and there are two main schools of thought within meta-ethics. While these may be broken down into further forms of their respected subjects, this chapter will deal with the overarching themes as an introduction.

Moral Realism

Moral realists hold that moral judgements describe moral facts, which are as accurate as mathematical or scientific facts. Moral realism is the view that moral facts and moral values exist independently of one’s own perception of them, or one’s attitudes, beliefs or feelings towards them. Ethical sentences are therefore ‘truth-apt’ (they can be true or false) in their description of the real world. Some moral realist ethicists argue that an action should be taken at face value. If I have told my husband that I have put sugar in the tea, then I have. Moral claims imply that the facts reported are correct. In this way, moral realism allows straightforward logic to be applied to moral statements – so we could say that a moral belief is true, in the same way we would say it about a factual belief. However, some critics argue that the moral fact posited by this strand of ethics is non-material and therefore not accessible to the scientific method. That is, that moral realism cannot replace observable science.

However, one advantage of moral realism is that this outlook allows moral conflict to be resolved; if two moral beliefs contradict each other, moral realism implies that they cannot both be right and therefore the situation may be resolved.

Moral Anti-realism

On the other hand, moral anti-realism holds that there are no objective moral values, and is further split into:

Ethical subjectivism – where any ethical sentence implies an attitude, opinion, personal preference or feeling held by someone.

Non-cognitivism – where moral knowledge is impossible as ethical claims are neither true nor false, thereby do not express genuine propositions.

Moral nihilism – where ethical claims are generally false and there are no objective moral values because there are no objective moral truths (an example would be that an act of murder is neither wrong nor right).

Garner and Rosen provide an excellent summary on major topics within moral philosophy in their book Moral Philosophy: A Systematic Introduction to Ethics and Meta-Ethics, and Alexander Miller presents not only a contemporary, but an applied view of meta-ethics in his Contemporary Metaethics: An Introduction. Both books provide a substantial overview to understand the complex principles concerning meta-ethics and are recommended for those wishing to pursue this somewhat thorny subject further.

Descriptive Ethics

Descriptive ethics examines ethics from the perspectives of the actual choice made by people in practice. It is value-free and, rather than prescribing theories of conduct or values, it looks at beliefs surrounding morality. Unlike normative ethics, it does not look to provide guidance in making moral decisions, nor does it evaluate the reasonableness of ethical norms like meta-ethics. Instead, it is often used to compare ethical systems (between past and present, one society to another, or the ethics people claim to follow with the actual conduct of their actions). It is incredibly popular within the social sciences, including education, sociology, anthropology and history, although it still has a place in psychology and biology too.

Applied Ethics

As the name suggests, applied ethics is the discipline of philosophy that attempts to apply ethical theory to real-life situations. An ethical dilemma arises when two or more courses of conduct may be justified in a given circumstance – what then is the right thing to do? The approaches to ethics already portrayed can often be strict and principle-based, without giving solutions to specific problems, and as such may not be acceptable or applicable to implement. Applied ethics overcomes this by using a mixture of sociological and psychological insights to deliberate certain situations. Chapter 3: Applied Ethics in Paramedicine outlines four vignettes where applied ethics are considered within our profession.

Bioethics

Bioethics concerns the controversies brought about by advances and research in biology and medicine. Chapter 15: Legal and Ethical Considerations in Paramedic Research discusses some of the historical context that has shaped ethics in research, but with ongoing technical development, bioethics remains a fast-paced and professional area of inquiry.

Perhaps the most influential book concerning bioethics is that by Tom Beauchamp and James Childress, Principles of Biomedical Ethics (2019). This book advocates ‘principlism’, so called because it is based on set of principles that can be applied to any bioethical issue. The authors advocate four principles that represent a ‘common morality’ (2019) across global cultures and that can be applied in a wide range of practical contexts. With uptake of this framework underpinning a variety of disciplinary teachings on medical ethics, these principles also ensure consistency in identifying moral issues in practice. While not providing right or wrong answers to ethical issues, these principles allow clinicians to approach an issue flexibly, and enable clinicians and ethicists to balance these different principles to come to an agreement about a problem.

Beneficence

Beneficence is the principle that medical professionals must do good for their patients. This resonates with the Health and Care Professions Council’s Standards of proficiency’, which asks for paramedics to ‘understand the need to act in the best interests of service users at all times’ (2016, p. 9). Across the medical disciplines, as well as within the military and the law, professionals are expected to put the needs of their service user first, even if it involves self-sacrifice (Downie, 1988). This seems somewhat altruistic in a set of principles that do not align to any particular branch of ethics. However, this principle focuses on the positive ethical obligations applied within the medical context and deals with seeking to benefit others. This concept is central to most people’s ethical thinking and remains a central pillar in the practice of medical ethics.

Non-maleficence

Non-maleficence is the principle that one person should not cause harm to others. It is best understood as the concept that, as a whole, a medical intervention should not cause harm. Evidently, most attempts to benefit a patient require the infliction of harm or involve risk of harm. Inserting a cannula or performing a needle chest decompression are good examples of this. Taking non-maleficence literally would lead the clinician to do nothing at all. Therefore, this is often taken as balancing the principle of beneficence (a clinician’s obligation to help a patient) against the obligation not to cause harm.

There is also a wide-ranging understanding of harms. The concept of harm is inextricably bound to human vulnerability, and as such Harrosh (2011, p. 494) outlines four modes of human vulnerability which may cause harm:

1.As conscious beings, negative experiences including (but not limited to) pain, discomfort, disappointment, irritations, sadness, anxiety and humiliation can be harmful.

2.The presence of disease and improper functioning of the body’s systems, organs, cognitions or emotions can harm the physical and psychological integrity of what makes someone human.

3.Interests formed as rational human beings can leave us vulnerable to harm if we experience setbacks or if the goals and values of our lives are compromised.

4.To enable a fully human life, we can be harmed if we do not have the opportunity to engage with the basic goods of life, such as relationships, and experience connectedness with others.

It is worth noting that these are not mutually exclusive, and neither is this list exhaustive. Nevertheless, it presents an idea of the different ways in which humans can be harmed, and therefore the different ways in which maleficence can occur. In order to act in a truly non-maleficent way, clinicians should bear in mind the varying guises under which harm may occur, to ensure a profession free from it.

Autonomy

The principle of autonomy is the respect given to individuals as independent moral agents with the right to choose how to live their own lives. It is seen as a fundamental aspect of humanity and is one of the individual rights under the European Convention of Human Rights (ECHR) (also known as Convention for the Protection of Human Rights and Fundamental Freedoms) and protected by law. To respect autonomy is to accept a person has the right to hold views, make choices and take actions based on personal values and beliefs (Herring, 2022). John Locke offered an early form of the choosing self, outlining individuals as free and independent beings. A century later, Kant offered the more powerful version that we see today: to be free is to be autonomous, and to be autonomous is to be governed by a law I give myself. The notion that we are freely choosing supports the idea that the principles of justice that define our rights should not rest on a particular moral or religious conception – instead these should be neutral among competing versions of the ‘good life’.

However, while respecting the ‘good life’, it is important to outline that the patient does not have a right to the type of medical treatment given or to demand specific treatments, such as cosmetic surgery – regardless of their thoughts on the ‘good life’. But what is claimed is a right to bodily integrity – a right to not have something done to the body without consent. Equally, autonomy does not mean that every choice is respected, but only those that are competent. This book will later outline problems surrounding decisions made by children (Chapter 8: Legal and Ethical Treatment of Children), in the refusal of blood products (Chapter 9: A Note on the Refusal of Blood Products) and those with mental ill-health (Chapter 11: Legislation Relating to Mental Health).

However, care must be taken with competence – just because a person’s decision may be considered foolish, this does not mean they are incompetent. A clinician may believe a patient’s decision to be ill-advised, but the decision remains the patient’s to make and must be respected. In many cases, following a patient’s decision will be promoting their welfare. In others, if treatment is forced upon a patient against their will, then the patient will suffer. A common example of this is the patient who is a Jehovah’s Witness, who refuses a blood transfusion even though without it, they will die – which is discussed in more detail in Chapter 9: A Note on the Refusal of Blood Products. Autonomy is not respected because it promotes welfare; rather it respects the patient’s human rights (Molyneux, 2009).

Justice

Justice is concerned with what is fair and reasonable. In healthcare, this often relates to the distribution of resources, both financial and in terms of access to healthcare. The justice of health often looks to overcome issues apparent in healthcare inequality, where, in many systems, certain ethnic groups or those of lower socio-economic status suffer worse health than those who are not (Bartley and Bane, 2008). Such inequalities can present a major political issue, and therefore the justice of health is often related to the politics of the time.

Central to the principle of justice is the theory of formal equality: everyone is equal. William Frankena (1966) sums this up particularly well: ‘all men are to be treated as equals, not because they are equal, in any respect, but simply because they are all human’. This principle is uncontroversial, but there seem to be broad problems with its application. For more reading surrounding the application of social justice, I would recommend ‘Displacing the Distributive Paradigm’ by Iris Young (Chapter 51 in Ethics in Practice: An Anthology) or Justice by Michael J. Sandel.

Medical Ethics

Medical ethics is the study of moral values and judgement as they are applied to the practice of medicine. As a profession allied to medicine, these moral values translate within all aspects of paramedic practice. Arguably, medical ethics should reflect the moral values that are regarded as acceptable among healthcare professionals, as well as society as a whole.

A Little History

While MacIntyre (2002) covers the history of ethics beautifully, I wanted to pay homage to the development of ethics within medicine. Historically, Western medical ethics has been traced to guidelines concerning the duty of physicians, with initial outlines of this duty within the Hippocratic Oath. The oath required a new physician to swear upon a number of healing gods that they will uphold the professional standards. It also bound the student physician to their teacher, and the greater community of physicians. As well as being recognised as an early stage of medical training, the oath was also the earliest expression of medical ethics in the Western hemisphere. The oath has, in many contexts, allowed medicine to develop paternalistically – where the clinician acts for the benefit (and in the best interests) of another, without specific consent. Up until the last half century, paternalism has meant patients have often been treated without adequate explanation of their illness or injury.

Sometimes caught up within this oath is the saying ‘First, do no harm’ (or primum nonn nocere if your Latin is up to scratch). Contrary to popular belief, this phrase was coined as recently as 1860 and attributed to Thomas Inman (a house surgeon at Liverpool Royal Infirmary), and it remains central to ethics in today’s Western medicine (Sokol, 2013). The perception of what constitutes harm will be different across service users, and the expected benefits will also be different. The limits to interpreting this phrase verbatim are similar to the discussion within non-maleficence, and the principles of beneficence and non-maleficence remain central to understanding this. Ultimately, these principles are best assessed in the principles respecting autonomy and justice.

Current Medical Ethics

The ideal of principlism is adopted into a majority of medical systems and, although not without its criticisms (see Holm, 1995 and Gillon 2012), it provides a good example of how ethical discourse necessitates reflection and justification of our actions by reference to accepted morals and values (Gordon, Rauprich and Vollman, 2011).

The state of current medical ethics is attributed to a tapestry interwoven with a range of philosophical theories (Laurie, Harmon and Porter, 2016); however, out of all those discussed, deontology and utilitarianism continue to remain the most evident attitudes across a majority of healthcare settings. Nevertheless, different ethical paradigms are required for each healthcare setting; while deontology may still work in a clinician–patient relationship, public health focuses much more on a consequentialist approach. One set of principles that draws on both deontology and utilitarian thinking is communitarianism. Communitarian ethics emphasises both the obligations we owe to others (the deontological angle) and the consequences of our individual decisions (consequentialism). It allows different values to be at stake, responding to the clinical context involved.

However, autonomy is the principle that has dominated medical law and ethics for the past 50 years. This directly clashes with the historical paternalistic culture on which medicine (as well as paramedicine) has evolved, and has empowered the patient to be at the centre of medical care, rather than just the recipient. However, there are warnings with the current empowerment of autonomy. Accepting individualistic autonomy as ‘good’ can lead to disregarding other values and can have negative effects. There must be a social dimension to autonomy and personal autonomy should be measured against the needs of society as a whole. Western society demands a just distribution of resources. Therefore, while in an ideal world, a sick person should be able to demand the treatment of their choice, the choice is limited by the framework provided by the society in which they reside (Campbell, 1994).

Rights theory also plays another important role in current medical ethics. Hearing patients say ‘it is my right to have [such and such]’ is a good example of how the language of rights has become combative and assertive, where it hinders rather than helps moral consensus. Rights do exist in ethics (and law), but misunderstanding has often boiled them down into declarations, rather than the original intentions of principled behaviour. Rights talk often leads to a moral impasse, where neither the patient’s, nor the clinician’s rights are taken into account. A confrontational declaration of rights is unlikely to be constructive in guiding decision making, but it should be remembered that the rights on both sides have the obligation to work towards the ideal.

Ethics and Law

The different branches of ethics create a particular problem for medical law: should the law be based on ethical principles? If so, whose principles should be followed? In the western hemisphere Judeo-Christian values predominantly guide the law, with strong emphasis on intrinsic human dignity. However, this is slowly being eroded and laws within a historical religious context are now being revoked, such as the availability of abortion.

Eighth Amendment of the Constitution of Ireland

The Eighth Amendment of the Constitution Act 1983 amended the Constitution of Ireland by recognising the equal right to life of both the unborn foetus and the pregnant woman. Abortion had been subject to criminal penalty in Ireland since 1861 and the amendment ensured abortion was only allowed in circumstances where the life of a pregnant woman was at risk. This was approved by referendum on 7 September 1983 and signed into law on 7 October 1983. The Campaign to Repeal the Eighth Amendment gained traction following an un-successful anti-amendment campaign in 1983, and on 25 May 2018 a referendum was passed overwhelmingly to delete the constitutional ban on abortion, and was signed into law in September that same year.

The Hippocratic Oath also sets out principles that have been adopted to form the foundation of ethics in medicine. Alongside autonomy (which is both covered in the Hippocratic Oath and in principlism), two other principles seem to be particularly special, as they are also expressed as rights within medical law: the right to life and the right to dignity.

The right to life, right of autonomy and right to dignity are protected within individuals’ rights under the ECHR, which sets out the minimum standard of treatment people are entitled to expect under the law. The ECHR is a ‘living instrument’, which means that the articles must be interpreted in the context of contemporary conditions. Societies and values change, and the court takes account of these changes when interpreting the ECHR.

The human rights most frequently discussed in the context of medicine are:

The right to life

The right to health

The right to autonomy

The right to dignity

The right to privacy

The right to equality

The right not to be tortured or subjected to cruel or inhumane treatment

The right to bodily integrity.

This book focuses on three that are considered the most fundamental.

The Right to Life

For many people, the right to life is a key human right. It is also the cause of many disagreements within ethics, as well as within legal systems across different countries. Debate over the meaning of life, and what it means to respect the right to life, has particular implications in the context of euthanasia and abortion. Additionally, the right to die is not incumbent. Article 2 protects the right of every person to their life.

The Right to Autonomy

Personal autonomy, protected by Article 8, is the right of an individual to decide what medical treatment they receive. However, it is much more complex than just that and more closely follows the right to refuse treatment. Conceptually, personal autonomy includes both the physical freedom to act as a free agent, as well as the ‘psychological sense’, which is the freedom ‘to know what we can do if we want to’. It also includes such matters as choosing how to pass one’s final days and how to manage one’s death. While the focus is on the individual, the right to autonomy must not interfere with the rights of others, and a balance must be found between the interests of the individual and the public. The right of autonomy is often used in conjunction with the right to dignity.

The Right to Dignity

Dignity refers to what is special about an individual. The right to dignity is founded on a very Kantian outlook, where human dignity rests on autonomy (in the context of living under a universalisable law that self-legislating reason prescribes for itself, as opposed to making your own choices), which is inherent in each individual (Kass, 2002). The dignity interests protected by the ECHR include, under Article 3, the right to die with dignity and the right to be protected from treatment, or from a lack of treatment, which would result in someone dying in avoidably distressing circumstances. A failure to provide life-prolonging treatment in circumstances exposing the patient to ‘inhuman or degrading treatment’ would in principle involve a breach of Article 3. Even if the patient’s suffering had not reached the severity required to breach Article 3, a withdrawal of treatment in the same circumstances might still breach Article 8 if there were sufficiently adverse effects on the patient’s physical or moral integrity or mental stability.

Respecting a person’s dignity requires far more than respecting their choices, and at the heart of the right to dignity is the concept that all humans have an intrinsic worth, and their moral agency should be respected (Neal, 2012).

Summary

This chapter has presented an overview of ethics concerned with paramedic practice. The ethical principles outlined are applicable to clinical, research, educational and leadership environments – indeed any environment where a paramedic may find themselves. Ethical dilemmas will exist when these theories or principles clash, but an awareness of the reader’s own morals will ensure that any such clashes are acknowledged and can be dealt with to ensure the autonomy, and best interests, of all those concerned.

Recommended Reading

Garner RT and Rosen B (1967). Moral Philosophy: A Systematic Introduction to Normative Ethics and Meta-ethics. Ann Arbor, MI: Macmillan.

Glover J (1990). Causing Death and Saving Lives. London: Penguin.

Harris J (1985). The Value of Life. London: Routledge.

Held V (2006). The Ethics of Care: Personal, Political, and Global. Oxford: Oxford University Press.

MacIntyre A (2002). A Short History of Ethics. London: Routledge.

Miller A (2013). Contemporary Metaethics: An Introduction. 2nd edn. Cambridge: Polity Press.

Sandel M (2008). Justice. London: Penguin.

Young (1997). Displacing the distributive paradigm. In Ethics in Practice: An Anthology, LaFollette H (ed.), Oxford: Blackwell Publishers: 547–558.

References

Aristotle (350BCE). The Politics. Book III, Chapter ix [1280b].

Bartley M and Blane D (2008). Inequality and social class. In Sociology as Applied to Medicine, Scambler G (ed.), New York: Saunders: 115–132.

Beauchamp T and Childress J (2019). Principles of Biomedical Ethics. 8th edn. Oxford: Oxford University Press.

Boyd K (2005). Medical ethics: Principles, persons and perspectives: From controversy to conversation. Journal of Medical Ethics, 31(8): 481–486.

Campbell A (1994). Dependency: The foundational value in medical ethics. In Medicine and Moral Reasoning, Fulford KVM and Gillet GJM (eds), Cambridge: Cambridge University Press: 184–192.

Downie R (1988). Traditional medical ethics and economics in health care: A critique. In Medical Ethics and Economics in Health Care, Mooney G and McGuire A (eds). Oxford: Oxford University Press: 40–55.

Frankena WK (1966). The Concept of Morality. The Journal of Philosophy, 63(21): 688–696.

Gillon R (2012). When four principles are too many: A commentary. Journal of Medical Ethics, 38(4): 197–198.

Gordon JS, Rauprich O and Vollmann J (2011). Applying the four-principle approach. Bioethics, 25(6): 293–300.

Harrosh S (2011). Identifying harms. Bioethics, 26: 493–498.

Health and Care Professions Council (2016). Standards of proficency–Paramedics. London: Health and Care Professions Council.

Herring J (2022). Medical Law and Ethics. 9th edn. Oxford: Oxford University Press.

Holm S (1995). Not just autonomy–the principles of American biomedical ethics. Journal of Medical Ethics, 21: 332–338.

Kant I (1785). Groundwork for the Metaphysics of Morals. Gregor M (trans.), Cambridge: Cambridge University Press.

Kass L (2002). Life, Liberty and the Defence of Dignity: The Challenge for Bioethics. San Francisco: Encounter Books.

Laurie G, Harmon S and Porter G (2016). Mason and McCall Smith’s Law and Medical Ethics. 10th edn. Oxford: Oxford University Press.

Lupton D (1994). Medicine as Culture. London: Thousand Oaks.

Marway H and Widdows H (2014). Philosophical feminist bioethics. Cambridge Quarterly of Healthcare Ethics, 24(2): 165–174.

Molyneux D (2009). Should healthcare professionals respect autonomy just because it promotes welfare? Journal of Medical Ethics, 35(4): 245–250.

Morrison D (2005). A holistic approach to clinical and research decision-making. Medical Law Review, 13(1): 45–79.

Neal M (2012). Not gods but animals: Human dignity and vulnerable subjecthood. Liverpool Law Review, 23(3): 177–200.

Purdy L (1996). A feminist view of health. In Feminism and Bioethics, Wolf S (ed.), Oxford: Oxford University Press.

Rachels J (1999). The Elements of Moral Philosophy. London: McGraw-Hill.

Scambler A (2008). Women and health. In Sociology as Applied to Medicine, Scambler G (ed.), London: Saunders.

Singer P (1994). Rethinking Life and Death. Oxford: Oxford University Press.

Smart J (1993). Utilitarianism: For and Against. Cambridge: Cambridge University Press.

Sokol DK (2013). First do no harm: revisited. British Medical Journal, 347(7932): 23.

Tronto J (1993). Moral Boundaries: A Political Argument for an Ethic of Care. New York: Routledge.

Twigg J (2000). Carework as a form of bodywork. Ageing and Society, 20(4): 389–411.

Wrigley A (2015). An eliminativist approach to vulnerability. Bioethics, 29(7): 478–487.

Wood A (2008). Kantian Ethics. London: Cambridge University Press.

¹ I‛m sure he can–t.

Chapter 3

Applied Ethics in Paramedicine

Iain Campbell and Georgette Eaton

Introduction

Applied ethics, also called moral philosophy or practical ethics, aims to define and examine principles for moral behaviour and apply them to real-world scenarios. Socrates was very much a practical ethicist – for him, the most important question for anyone is how we should live. Applied ethics today is concerned with what we should do in any given situation. It reflects on personal, professional, political and social choices. Applied ethics relies on an in-depth understanding of the relevant real-world facts and issues and seeks to balance or prioritise different values and interests. In this way, it is often interdisciplinary – and considers a wide variety of approaches and different ethical theories that could apply. Particularly in the context of medicine, applied ethics entails the pursuit of rational and well-grounded solutions when faced with conflicting moral concerns, interests or priorities (Sommerville, 2003). So, it is quite complex! However, it is fundamental to everything we do as paramedics. We particularly like this quote that describes applied ethics as ‘a debate between egoism (the view that each of us has reason only to advance our own good), consequentialism (according to which we should bring about the best state of affairs), and deontology (which states that there are reasons grounded in more than one’s own well-being or the bringing about of the best state of affairs). And each of these views is practical, in so far as it tells us what our ultimate reasons for action are’ (Crisp, 2018).

In this chapter, we are going to take you through four vignettes that are relevant to paramedic practice. Our primary focus is on engaging in thoughtful contemplation regarding norms, values, moral judgments, and appropriate courses of action within the realm of medical practice. We’ve outlined some ethical thinking, but do note that (as altruistic as we have tried to be) this will be in the context of our own egos, and our own values. Take these vignettes and consider your own opinions – both as an individual and as a clinician. What is your response? Why is that your response? We hope these will help you reflect on your practice, and also help you see the practical side of effects in everyday situations we may face as a paramedic.

Termination of Resuscitation

Vignette One

A paramedic-led ambulance is called to a 60-year-old in cardiac arrest. They are just around the corner and so arrive within 3 minutes. The patient has collapsed at home in front of their spouse who is unable to perform cardiopulmonary resuscitation due to having a disability.

When the crew reach the patient, they appear cachexic: their ribs are visible, and there is an up-turned walker beside them. There is evidence of some clinical frailty. They learn from asking the spouse that there are no known long-term medical conditions but a car accident a decade previously resulted in mobility issues which have been worsening with age.

The ambulance crew start to provide basic life support. As the defibrillation pads are applied, the initial rhythm is of pulseless electrical activity, confirmed by the absence of central pulses. Resuscitation is continued, and with every round of chest compressions, the patient’s chest becomes more and more caved in. Despite advanced life support being provided, the patient continues to be in a pulseless electrical activity (PEA) rhythm.

This scenario is probably very familiar; a patient with some evidence of frailty and likely to have a poor outcome, but not enough evidence to forego starting resuscitation, is a common cardiac arrest presentation. With only around 9% of out-of-hospital cardiac arrest patients in the United Kingdom (UK) surviving until discharge from hospital, it is highly unlikely that such patients survive (Perkins et al., 2021). Thus, paramedics are faced with these difficult decisions around commencing resuscitation and balancing the needs of both the patient, their families and wider society, making these clinical encounters rich in ethical dilemmas.

Beauchamp and Childress’ principles are often taught as the approach to medical ethics in paramedic education (Beauchamp and Childress, 2019; Ebbs et al., 2020).¹ Despite their apparent popularity, some ethicists consider the approach lacking in the complexity required for in-depth ethical analysis, and that there are too many instances where it can provide no real insight in recognising how to act (Clouser and Kert, 1990; Campbell, 2003). However, the principles can offer a useful framework for helping to understand ethical dilemmas in paramedic clinical practice so long as one does not look to them for all the answers. It is therefore worth understanding how to apply them to clinical scenarios.

Now let us consider vignette one through a principlist lens. It seems the major issue facing a clinician encountering a case like this is whether it is right to attempt resuscitation or not.

In the immediate situation, the principle of respect for autonomy is of scant significance – the patient in question has no advance decision to refuse treatment, and there is no indication of their wishes, therefore the treating paramedic will make a best interests decision (see Chapter 6: Consent), which – in this case – must favour treatment. Decision making in cardiac arrest has to happen at great speed to allow any chance of survival, hence clinicians often immediately commence resuscitation until space can be created to understand their patient’s wishes (Anderson et al., 2018). Considering the vignette, once the resuscitation has begun, the clinician should have a more in-depth discussion with the patient’s spouse to learn more about the patient and specifically what they would consider an acceptable outcome from a resuscitation attempt. In doing this, the patient’s autonomy will be respected.

Considering the principle of non-maleficence, this is a case where harm could result from the decision to treat. The concern is that rather than extending the life of this patient, all we manage to do is extend their death or leave them with neurological injuries which they would find intolerable. Unfortunately, such prognostication is difficult in the out-of-hospital environment. We know that high frailty scores are associated with lower rates of survivability and higher rates of morbidity from resuscitation (Ibitoye et al., 2021). However, we do not know how accurate the first impression clinical frailty score is;² therefore, in this patient with no other co-morbidities, it is hard to judge whether harm would be likely to arise from the resuscitation attempt. What is known is that not treating would certainly result in this patient’s death. Therefore, the principle of non-maleficence would likely lead us toward resuscitation, as we know harm would occur were we to forego it, whereas there is just the possibility of harm from commencing.

The principle of beneficence can be hard to separate from that of non-maleficence; however, there are some important differences. Essentially beneficence is the claim that, in order to be moral, the act we undertake must be doing good. We can therefore expand our moral thinking here to a broader utilitarian perspective: will the proposed act (in this case commencing resuscitation) be likely to provide greater good than harm? With what we know about resuscitation it is unlikely that this patient will survive? However, that in itself does not imply that attempting to save this patient’s life would not be an act of beneficence. Rather, the opposite is likely true – even a failed resuscitation is likely to provide some level of comfort to the spouse, the clinician and wider society, as it is important to know that should your heart stop, there are people who will try to start it, even against the odds.

According to the principle of justice, treatment should be offered in this case so long as there is some chance of success and it is a treatment that is generally offered to others. Theories of distributive justice become more relevant when thinking about this case study from a wider societal perspective. As we have a limited number of resources, there ought to be wider considerations of when we should be offering (or not offering) resuscitation in order to ensure a fair distribution of healthcare. Although, for the individual paramedic facing a patient in cardiac arrest, this should not influence them to commence or forego resuscitation, but rather this is something those in a position to write guidelines must consider.

Using the principlist approach in this case settled most of the issues encountered and was free from a conflict of the principles; it was perfectly reasonable to consider all these points without compromising one or the other. However, it still feels as if it is lacking to a certain extent. For example, where does the range of other non-clinical relationships sit within this somewhat narrow framework? What of the spouse on scene – do we reengage the principles in considering our interactions with them? What about considerations of dignity – do these just get rationalised as merely an expression of respecting autonomy as some would argue? (Macklin, 2003). Does it matter how we relate to our patients so long as we attempt to meet these principles?

This is where we can turn to virtue ethics for some inspiration. Virtue ethics provides guidance about how we can start to consider these further interactions (Campbell, 2003). It allows us to understand how to act during the more intensely human side of these clinical encounters.

Essentially, we must ask ourselves how a virtuous paramedic would relate to the spouse in this case. This is a time where empathy and an essentially human part of a clinician’s role must take centre stage. The ‘good’ paramedic in this case would ensure that the spouse feels supported, is told the honest truth and has their expectations managed. There is no set of rules to be remembered which will make this encounter better; rather, the clinician must strive to act with a strength of character – hence the importance of teaching virtue from an early career stage.

Difficult Conversations

Breaking bad news and difficult conversations are an excellent example of where a virtue ethics approach shows superiority over deontological or principlist approaches. Breaking bad news in the out-of-hospital environment is not an act which can easily fit into a proforma method (despite many excellent attempts). A more satisfactory way of describing breaking bad news is that the act is like a dance – it involves true empathy and courage to do well; you feed off each other and act and react (Mannix, 2021). To be done well these intensely human moments require moral strength rather than rules. This is where virtue ethics education comes into play.

Prioritisation of Resources

Vignette Two

An advanced clinical practitioner paramedic is working in a busy emergency department during the Covid-19 pandemic. The emergency department has been sectioned off into cold, warm and hot zones, relating to the absence of COVID-19, the potential for COVID-19 and the confirmation of COVID-19-infected patients.

Since the pandemic started, the daily caseload has tripled due to increased pandemic-related issues, as well as the increase in COVID-19 infection among the hospital staff, particularly the emergency department team.

The ACP reviews a patient in the warm zone; a 74-year-old who is ‘generally unwell’. The patient has been a smoker for 40 years and worked as a senior academic at a prestigious university. The patient lives with their partner and has a high level of independence. An initial chest X-Ray shows a white/grey mass across both lungs and in the plural cavity, and the patient has been started on antibiotic and steroid treatment, as well as oxygen therapy.

Throughout the course of the day, the patient does not respond to the treatments administered to assist their breathing. A subsequent CT scan confirms the presence of pleural effusion in both lungs, as well as lesions in both lungs, the right second rib and axillary lymph nodes.

Under pre-pandemic circumstances, the patient’s medical condition would typically warrant a transfer to the respiratory clinic in ambulatory care. However, the ACP’s request for such transfer is declined by a senior clinician, based on the patient’s age and potential diagnosis. This is because of the hospital’s newly implemented COVID-19 policy to optimise allocation of resources (in this case, consultant respiratory involvement and bed space) for those most likely to survive and thrive.

This clinical vignette highlights that a fundamental shift in philosophy of healthcare happens during an acute healthcare crisis, and this results in substantial changes in usual healthcare delivery. Specifically, the focus of healthcare prioritisation shifts from an individual to a population level. Unlike normal circumstances, the principlist approach of autonomy, beneficence and non-maleficence have limited value in acute healthcare crisis, where many decisions are made based on resource scarcity and keeping the whole population in mind. Despite the difficult circumstances outlined in this vignette, there is no obvious, unambiguous, wrong. Principles to be borne in mind in resolving such a dilemma include fairness and distributive justice, proportionality and reciprocity. However, approaches need to remain consistent with human rights and promote empowerment, autonomy and recovery.

In such cases, the principle of utility is often considered in ethical deliberations to account for the whole population. For example, the moral principle behind the hospital’s policies to ration personal protective equipment (PPE) despite immediate need is the principle of utility which lies at the core of utilitarian ethics. Utilitarianism emphasises the maximisation of benefit and prioritises consequences rather than rules. Here, the concepts of good and bad are considered before the ideas of right and wrong. According to the utilitarian view, right actions that lead to good outcomes are intrinsically right, while wrong actions that lead to good outcomes are instrumentally right (Häyry, 2006). Therefore, the act of declining escalation in active treatment for a patient who likely has advanced cancer becomes instrumentally right in the light of maximising the utilisation of resources that will produce the maximum possible survival of a population.

Now consider this through a Kantian lens. Kant’s moral theory rejects the consequentialist approach to moral problems (Kant, 1785). By subjecting actions to the categorical imperative, Kant’s moral theory claims that there are kinds of action which are always wrong because the maxims of those actions cannot be adopted by all rational beings as moral law. Therefore, a believer in Kant’s moral theory would consider declining such a referral and the potential for active treatment a wrong act in all circumstances. Through this lens, the lack of treatment for this patient could be perceived as a morally injurious event as a witness to an act (based on a hospital administration’s moral judgment) that was against one’s own moral framework.

Historically, the standoff between the two perspectives has been demonstrated by the well-known trolley problem outlined in Chapter 2: An Introduction to Ethics. However, in this trolley problem, you (as the clinician) have a therapeutic relationship with the patient, and within such a relationship will strive to abide by your registration standards – a principle that strives to maximise net utility for the individual patient and not for the whole population (Veatch, 2007). This adds a relationship-affective dimension to the trolley problem. Teper et al. (2011) suggest such an addition plays a significant role in moral decision making and often leads to a dissociation between moral judgment and actual moral behaviour in the real-world setting. For example, the writers of the hospital policy are not in a direct relationship with the patient, and therefore may find it easy to be agent-neutral to maximise the overall benefit (ideal for utilitarian moral judgments). You, however, have a relationship with the individual and cannot be impartial. This is made manifest when we either identify with or admire one with whom we have such a relationship – hence the position of this patient as a prestigious and well-known researcher. One could argue that duties of special relationship apply to the clinician–patient relationship and that not only are we permitted to do more for those close to us, but we are often required to put their interests first. In fact, a deontologist may claim that we are sometimes required not to maximize the good of many at the expense of the good of one (McNaughton and Rawling, 1998). Under normal healthcare circumstances, these deontological principles are emphasised in ethical teachings and contribute significantly to the individual and professional integrity of paramedics. Therefore, as we have pointed out, when the interests of the individual patient are sacrificed to favour the provision of care to certain groups of patients in a utility-driven system, healthcare workers often perceive this as a threat to professional and individual integrity (Thomas and McCullough, 2015).

How will it impact your psychological well-being if, as a clinician, it is your patient who is pushed into the trolley's path to save five other people?

However, such an argument implies that not only is the health-related suffering caused by the pandemic morally problematic and unjust in the obvious sense, there is also potential that the pandemic’s health-related effects are unjust in the sense of being unfairly distributed. National guidance issued at the time (and now subsequently withdrawn) (Department of Health and Social Care, 2020) offered a series of ethical principles to consider when implementing ‘challenging decisions on how to redirect resources where they are most needed and to prioritise individual care needs’. Yet this guidance was for interpretation at a local, regional and national level, resulting in differing approaches across different settings. At the heart of considering this is the concept of procedural fairness – the idea of fairness in the processes that allocate resources (Rawls, 1972). In the context of the vignette, we may draw between the different forms of procedural fairness. What we might hope to come up with is a triage protocol that is procedurally fair and arrives at a fair outcome (what Rawls calls perfect procedural justice), though there is little prospect of that; reasonable clinicians already disagree about the outcomes we should aim for in allocating health resources and triage, and undertaking this in the context of COVID-19 is no exception. Instead, we should work toward a transparent and fair process, what Rawls would describe as imperfect procedural justice.³

Twelve years before the COVID-19 pandemic, Daniels (2007) developed ‘a theory of justice and health’. In contrast to allocating resources guided only by expected outcomes and maximisation of net utility, Daniels proposes a focus on a fair process for making resource allocation decisions that is:

Decisions and their rationales must be publicly accessible (publicity condition)

Decisions must be based on objective evidence or reasons and principles generally accepted as relevant (relevance condition)

There must be mechanisms for appeal and revision of decisions in place (revision and appeals condition)

Mechanisms to control and guarantee compliance with these principles must be established (regulative condition).

Such principles for triage demonstrate imperfect procedural justice through both fairness and transparency. Daniels outlines this as ‘accountability for reasonableness’, and as such demonstrates a useful basis for deliberations on a fair distribution of limited healthcare resources.

The conflict between the utilitarian nature of healthcare delivery systems and the deontological nature of clinician–patient relationship may very well be the reason for many morally injurious events in healthcare. This took relevance during the Covid-19 pandemic as an example of how public health took precedence and the introduction of many policies which were utilitarian in nature. Such utilitarian decisions may then conflict with individual decisions based on Kantian or Aristotelian (virtue) ethics. However, looking beyond this is the importance in viewing such ethical challenges via a lens of justice, to enable the framing of collective obligations and interests. In doing so, we may produce utilitarian policies that may alleviate moral injury, even during acute healthcare crises, such as seen during the Covid-19 pandemic.

Ethics in Education

Vignette Three

A paramedic mentor and their student are working in primary care and call through a 27-year-old male with abdominal pain. The student paramedic is working under direct supervision of the paramedic.

The patient becomes increasingly rude and short with his answers as the student paramedic asks questions about the history of the patient’s symptoms leading to this appointment. The student paramedic becomes frustrated with this response and their questions also become equally short – eventually telling the patient if they did not want an appointment in primary care, they shouldn’t have called.

The paramedic mentor, upon seeing this interaction, interjects and takes over the consultation. They apologise to the patient and take the time to understand what is wrong with them, slowly winning the patient’s trust through good communication and empathetic responses. The paramedic mentor is then able to diagnose and treat the patient accordingly.

Once the consultation is finished and the patient has left, the mentor and mentee have a long debrief.

Ethical theory applies to paramedic education in a number of ways; however, an interesting theme to explore is how we teach our paramedic students to be moral actors. This applies to everyone involved in student education – both university lecturers and practice placement educators. In this section we propose virtue ethics, combined with a strong emphasis on teaching theories of social justice, as a means of ensuring paramedic students are adequately prepared for practice.

When student paramedics undertake their practice placements, we take them out of their normal environment into the unpredictable world of unplanned patient care – whether this is in an ambulance service, primary care setting, or within emergency departments. During such placements, they will encounter all manner of situation and ethical dilemmas which they likely have never encountered before. Across the years of their education, they will slowly get more responsibility until they are qualified and are suddenly in a position where they are expected to take an autonomous clinical position – with or without support as a newly qualified paramedic. There is a huge amount of information students must learn to become a good paramedic, but there is also a type of moral character we expect them to have at the end of their education. As educators, we should accept responsibility for this part of their education and prepare adequately to provide it. It could be argued that this is just teaching the professional way of acting, but we think it is more nuanced than that, and the role of the educator is to help guide the student towards being a good moral actor (something which has benefits for both them and their patients).

Consider the vignette three, a common clinical experience for us all: a patient who is uncooperative with us when we make first contact. The student’s reaction to this attitude, mirroring the behaviour back to the patient, is perfectly understandable and human. However, it leaves them unable to diagnose this patient. The practice educator here is giving both a practical and a moral education to the student. Practically, they show the student how to manage the uncooperative patient in such a way as to diagnose them. The moral lesson here is that reacting with anger or impatience only makes the situation harder and potentially leads to harm, but through using empathy, understanding and patience, harm can be alleviated, and a good outcome gained. For the student this is an important lesson. They are amazed, as it seemed to come naturally to their mentor, whereas this sort of reaction was a learned behaviour. Through discussion and debriefing after, the student will hopefully realise they need to work on their initial reactions – a step towards the virtuous response becoming the norm for them.

This is virtue ethics in action. To quote David Carr in his chapter on virtue ethics and education:

…moral life and experience are more than grasping universal principles (of either duty or utility) and require appreciation of the complex ways in which the various elements of human character are implicated in the struggle to achieve what Aristotle calls eudaimonia, or a flourishing life.

(Carr, 2018, p. 645)

The practice educator is teaching through example and then allowing space for the student to reflect upon the interaction afterwards. This should then be followed up with guidance from the mentor and from their university educators to begin an analytical process to understand how they could act in future so the student can start to appreciate the complexities of their own reactions and their own character. In this, we recognise the powerful tool that reflection on practice is. However, such learning can be a longer process – and does not offer the quick fix of learning a practical skill often associated with our profession.

Awareness, however, should be given to the pitfalls of learning virtue ethics through the practice placement, where it becomes embedded in a more informal (or hidden) curriculum (Becker et al., 1977; Hafferty and Franks, 1994; Inui, 2003). In research focussing on values-learning among student paramedics (note, this is different from virtues – but arguably the potential of emulation is the same), students reported that they would blindly imitate the behaviours and attitudes of their practice educators (Eaton, 2019). This may demonstrate one of two things: either that the students are fully immersed in the practicum and benefiting from the social learning of professional behaviours to become a paramedic (as a form of tacit knowledge) as something inherent within a community of practice (Le May and Wenger, 2009), or students may not be learning about such behaviours in the practicum but are more readily imitating those of their practice educators without question (Suchman et al., 2004). Both scenarios are problematic if the practice educators have no self-awareness of their own behaviours – and again, reflection provides a tool through which all can consider themselves.

Although I believe virtue ethics to be an important part of moral education for paramedic students, both deontological and principlist approaches have their use and place. For the early career paramedic having a set of rules to adhere to in order to (mostly) do right in situations is both realistic and useful, and therefore both deontological and principlist approaches should remain a part of the curriculum. However, as these paramedics become more experienced, grey areas of moral issue will become more apparent in their practice. In order to deal with these issues, a strong moral character developed through years of reflective moral practice is essential – hence why we ought to also be utilising a virtue ethics approach in education.

However, this sort of moral education ought to come alongside an education on social justice. Ill health and inequalities have a synergistic relationship. In the UK, for example, it is well documented that people from lower socioeconomic groups and Black or minority ethnic communities experience worse health and have worse health outcomes (Marmot et al., 2020). Paramedics therefore have a large amount of contact with these groups. Traditional virtue ethics often fails to highlight one’s positionality within an unequal society, and this has the potential to leave the clinician incidentally worsening inequalities despite (apparently) acting in a virtuous manner. Feminist philosopher Lisa Tessman recognised this flaw in virtue ethics and suggested a reimagining of the virtues to include a strive towards social justice, suggesting ‘… a trait that contributes to one’s own well-being cannot count as morally praiseworthy if it detracts from the flourishing of an inclusive social collectivity’ (2005, p. 53). There is not space in this chapter to do this important text justice; however, I would suggest further reading of Camillia Kong’s work and some of her takes on assumptions when defining mental capacity.

Furthermore, learning about inequalities can help us to both recognise our own inherent biases and develop greater empathy and understanding. Thus, it is important to ensure there is a strong emphasis on teaching theories of social justice as a part of moral education in paramedic training. Modern paramedic curricula should therefore include the basic ideas of intersectionality (that unique injustices can lie in intersected identities that require special consideration), for student paramedics to understand, evaluate and eventually apply in the course of their clinical practice or research. Combining both the knowledge of such theories (as well as the critique of individual ideologies in isolation) with virtue ethics ought to prepare the next generation of paramedics to be honourable and moral practitioners.

Research Ethics

Vignette Four

A paramedic undertaking a part-time Master’s degree aims to understand other paramedics’ perceptions of the types of calls which are attended by the ambulance service.

They develop a survey to be shared via social media and obtain ethical approval from their university to undertake this data collection. They share the survey on their personal Facebook, X (formally known as Twitter) and LinkedIn profiles, and encourage their friends and followers to repost it. Over the course of a few days, their posts are shared multiple times, and have attracted further comments, discussion and debate about the issue.

The paramedic notices that some of what is discussed has not featured in the survey responses received so far, and they are concerned that unless they find a way to access and include these views, they will not have achieved the aim as fully as they otherwise may have if they did include them.

It is an anecdotal fact that more and more paramedics are undertaking research. This is either through specific employment posts (such as research paramedic or research fellow) or through undertaking further postgraduate education. As in this vignette, many paramedics in the latter may wish to explore an area that has real-world implications and generate new knowledge. Applied ethics in research is less nuanced than adopting a specific ethical standard (such as utilitarianism, deontology or principlism, for example). Research ethics are the moral principles that govern how researchers should carry out their work. These principles are used to shape research regulations agreed upon by groups such as university governing bodies and research communities, as well as governments. Chapter 15: Legal and Ethical Considerations in Paramedic Research gives far more detail surrounding the guidelines and practical steps a researcher should take to make sure that their research is ethical.

This vignette raises potential ethical issues across several principles of research ethics. Can they use this data, given that the approved research design may not allow them to gather data in this way? Is it ethical to reproduce and reuse these social media posts without explicit permission from their authors?

First, an analysis of social media posts or discussions did not form part of this paramedic’s original research design, and so they do not have ethical approval from the university to pursue this. Such ethical approval is project-specific, as defined on application. Now, the paramedic could apply to make an amendment to their research project, and ethical review boards have the capacity to consider such amendments. However, this can be time-consuming for both applicant and reviewers – and projects submitted for postgraduate modules, such as a Master’s degree, may be time-sensitive.

A second concern raised here is, if the paramedic used the social media posts as data, they would not be adhering to ethical principle of informed consent: authors would not be aware that their posts were being used and would therefore not have the opportunity to give, or withdraw, their voluntary informed consent. Researchers should recognise the right of participants to be able to withdraw from the research, and participants should be informed of this right when they consent to their involvement in research. However, some of these social media posts are in the public domain. Each platform outlines privacy statements within its terms and conditions, many will consider content posted on social media to be public, unless the author’s profile is protected or private. However, it also depends on whether those in online communities perceive their data to be in a private or public space. It is likely that those who posted on X (formally known as Twitter) considered it a public space, whereas those who responded to the paramedic’s post on Facebook may consider this more private (Burkell et al., 2014). Regardless of it being a public domain, the researcher needs to consider whether participants on the platform view it (and their contributions) as private or public. It goes without saying that if participants view and treat online social networks as public venues, the content they post may be markedly different if they viewed it instead as a private network.

This discussion is now entertaining a different methodological approach: netnographic research. It is outside the scope of this chapter (and this book) to give more details on this, but Netnography: The Essential Guide to Qualitative Social Media Research by Robert Kozinets is the seminal text on this topic.

As well as consent and perception of participants regarding their posts, there are also issues regarding anonymity and the traceability of quotations in digital contexts. The confidential and anonymous treatment of participants’ data is considered the norm for the conduct of research; however, it can be much harder to guarantee in a digital context where direct quotations used in research could simply be reverse searched through a search engine to find the original source (Franzke et al., 2020).

Tied in with this is the duty of care the researcher has to recognise potential risks and prepare to minimise these should they arise. If the paramedic chooses to undertake a new research approach, based on the potential new data, then not only will they need to apply for an amendment to the ethical review board, but they will also need to ensure they are adequately trained to undertake the newly proposed methodology.

Using social media to raise awareness of a study can result in offshoot discussions and debates that may shed important light on the research topic. However, when these fall outside the remit of a researcher’s data collection method and/or research design, this can pose new ethical challenges and raise related concerns with research methodology and the researcher’s ability to adopt a new methodology. While social media posts may be in the public domain, they are not necessarily viewed as such by those who author them and, even if they are, it does not necessarily follow that they would permit their posts to be used for research purposes.

As well as the time-consuming nature of navigating such unexpected events in research, such events can also leave the researcher dealing with feelings of dissatisfaction (if they are unable to use data that directly relates to the aims of the research project) or inadequacy (if they do not have the methodological training to do so). We should not underestimate the potential for moral distress this can have on researchers. While usually considered in a more clinical context, moral distress is understood as the feeling of unease stemming from being unable to undertake an ethically correct action due to external constraints (British Medical Association, 2021). These can be in the form of institutional or resource constraints or, as relevant to this vignette, constraints on time or knowledge.

Summary

These four vignettes, spread across four different pillars that paramedics may find themselves working in, outline the complexity of ethics as applied in paramedic practice. We have drawn on specific ethical theory to respond to these vignettes, but caution that applied ethics is complex and relates to an individual’s values, virtues and principles. Space and opportunity to reflect are paramount.

Recommended Reading

Bellazzi, F and Boyneburgk K (2020). COVID-19 calls for virtue ethics. Journal of Law and the Biosciences, 7(1): lsaa056.

Kong C (2018). Mental Capacity in Relationship: Decision-Making, Dialogue, and Autonomy. Cambridge: Cambridge Bioethics & Law.

Kozinets RV (2019). Netnography: The Essential Guide to Qualitative Social Media Research. London: Sage Publications.

Pluckrose H and Lindsay J (2021). Cynical Theories. London: Swift Press.

References

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Becker H, Geer B, Hughes E and Strauss A (1977). Boys in White: Student Culture in Medical School. Chicago: Transaction Books.

British Medical Association (2021). Moral distress and moral injury: Recognising and tackling it for UK doctors. Available at: https://www.bma.org.uk/media/4209/bma-moral-distress-injury-survey-report-june-2021.pdf (accessed 28 June 2023).

Burkell J et al. (2014). Facebook: Public space, or private space?. Information, Communication & Society, 17(8): 974–985.

Campbell AV (2003). The virtues (and vices) of the four principles. Journal of Medical Ethics, 29(5): 292–296.

Carr D (2018). Virtue ethics and education. In The Oxford Handbook of Virtue, Snow NE (ed.). Oxford: Oxford University Press, pp. 640–658.

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Daniels N (2007). Just Health: Meeting Health Needs Fairly. Cambridge: Cambridge University Press.

Department of Health and Social Care (2020). [Withdrawn] Responding to COVID-19: the ethical framework for adult social care. Available at: https://www.gov.uk/government/publications/covid-19-ethical-framework-for-adult-social-care/responding-to-covid-19-the-ethical-framework-for-adult-social-care (accessed 28 June 2023).

Eaton G (2019). Learning values in shared decision-making in undergraduate paramedic education. Journal of Evaluation in Clinical Practice, 25(6): 1094–1101.

Ebbs P, Carver H and Moritz D (2020). Principlism in paramedicine: An examination of applied healthcare ethics. Journal of Paramedic Practice, 12(8): 1–6.

Franzke AS, Bechmann A, Zimmer M, Ess C and the Association of Internet Researchers (2020). Internet Research: Ethical Guidelines 3.0. Available at: https://aoir.org/reports/ethics3.pdf (accessed 28 June 2023).

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Ibitoye SE et al. (2021). Frailty status predicts futility of cardiopulmonary resuscitation in older adults. Age and Ageing, 50(1): 147–152.

Inui TS (2003). A Flag in the Wind: Educating for Professionalism in Medicine. Washington DC: Association of American Medical Colleges. Available at: http://users.clas.ufl.edu/msscha/Readings/flaginthewind_professionalism_med.pdf (accessed 10 July 2023)

Kant I (1785). Groundwork for the Metaphysics of Morals. Gregor M (trans.), Cambridge: Cambridge University Press.

Le May A and Wenger E (2009). Communities of Practice in Health and Social Care. London: Wiley-Blackwell Publishers.

Macklin R (2003). Dignity is a useless concept. British Medical Journal, 327(7429): 1419–1420.

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Marmot M et al. (2020). Health Equity in England: The Marmot Review Ten Years On. London: Institute of Health Equity.

Perkins G et al. (2021). Epidemiology of Cardiac Arrest. Available at: https://www.resus.org.uk/library/ 2021-resuscitation-guidelines/epidemiology-cardiac-arrest-guidelines (accessed 28 June 2023).

Rawls J (1972). A Theory of Justice. Oxford: Clarendon Press.

Sommerville A (2003). Juggling law, ethics, and intuition: Practical answers to awkward questions. Journal of Medical Ethics, 29: 281–286.

Suchman AL et al. (2004). Toward an informal curriculum that teaches professionalism: Transforming the social environment of a medical school. Journal of General Internal Medicine, 19(5 Pt 2), 501–504.

Teper R, Inzlicht M, and Page-Gould E (2011). Are we more moral than we think? Exploring the role of affect in moral behavior and moral forecasting. Psychological Science 22(4): 553–558

Tessman Lisa (2005). Burdened Virtues: Virtue Ethics for Liberatory Struggles. Oxford: Oxford University Press.

Thomas TA and McCullough LB (2015). A philosophical taxonomy of ethically significant moral distress. Journal of Medicine and Philosophy, 40(1): 102–120.

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¹ They are so prevalent in medical education that they appear in the College of Paramedics guides for university curricula.

² And, at the start of a resuscitation, it is unlikely that a clinician can determine a full Rockwood frailty score, which involves understanding patient conditions two weeks prior.

³ Rawls’ example of imperfect procedural justice is a criminal trial where we adopt processes that we have reason to believe are our best chance of determining guilt, but which do not guarantee the truth of a verdict, and this is a reason why they must be transparent and consistent (Rawls, 1972)

Chapter 4

Clinical Negligence

Edd Bartlett and Georgette Eaton

Introduction

In law, negligence is a civil wrong (a ‘tort’ in English Law or a ‘delict’ in Scots Law). In order for a clinical negligence claim to be successful, the claimant needs to prove that three criteria have been met:

1.That the clinician owed the patient a duty of care.

2.That the clinician breached their duty of care.

3.That ‘but for’ that breach in duty, the patient would not have suffered harm (causation).

These criteria apply to both adult and paediatric cases across the whole of the United Kingdom (UK). A claim in negligence is an understandable concern for all clinicians, with phrases such as ‘if you didn't write it down, it never happened’ often reinforcing litigious thoughts in the back of clinicians’ minds when they are in training. Good quality documentation is, of course, essential to quality patient care, as well as important in the event of a claim in negligence. This chapter aims to ease some of the anxiety surrounding litigation by outlining the key concepts of a claim in negligence and highlighting the move towards a culture of learning from mistakes in the NHS.

Duty of Care

A duty of care is not a concept unique to medical negligence; it was established in the 1932 Scottish case Donoghue v. Stevenson, known as the ‘snail in the ale’ case. A duty of care is established when it is reasonably foreseeable that a person’s actions could cause either harm to another person or damage to their property.

Donoghue v. Stevenson [1932]

The Facts of the Case

Mrs Donoghue drank a bottle of ginger beer which turned out to contain a dead snail. Following this, she became unwell and suffered ‘severe gastroenteritis and shock’. She sued Mr Stevenson, who had manufactured the ginger beer.

The Judgment

The case went to the highest court at the time, the House of Lords, where it was ruled that Mr Stevenson had owed a duty of care to Mrs Donoghue and had not taken reasonable care to ensure that harm did not come to people who consumed his products.

In clinical negligence claims, the duty of care is normally easy to establish. In the hospital environment, it is established as soon as a person presents for treatment (Barnett v. Chelsea and Kensington Hospital Management Committee [1969]). When a person calls 999 and asks for the ambulance service, this is when a duty of care is established (Kent v. Griffiths [2000]). In the case of Kent v. Griffiths, there was no reasonable excuse for the delay of the ambulance, which resulted in the patient, who was having an asthma attack, suffering a respiratory arrest followed by memory impairment and miscarriage. The judge ruled that the ambulance service had breached its duty of care and because of this breach had caused the patient harm.

Breach of Duty

In the law of tort, the test for breach of duty is: did the person act in a way that a reasonable person would have acted? The reasonable person is an average member of the public, often referred to as ‘the man on the Clapham omnibus’.

The Man on the Clapham Omnibus

This is a hypothetical ordinary and reasonable person, used by the courts in English law where it is necessary to decide whether a party has acted as a reasonable person would – for example, in a civil action for negligence. The character is a reasonably educated, intelligent but nondescript person, against whom the defendant's conduct can be measured. The origin of this phrase, however, is somewhat unclear.

In medical cases, a different test is used. A clinician must meet the standard of care that is expected from a skilled clinician. The standard of care that a health professional is expected to exercise is that of those in the speciality of the profession involved. A paramedic is to be assessed by the skills expected of a paramedic, not a physician of any kind (Stockdale v. Nicholls [1993]). Therefore, a paramedic would not be negligent in failing to diagnose a condition that would only be apparent to a specialist in that field. However, a paramedic may be found negligent for not referring a patient with unusual symptoms for a follow-up appointment or secondary consultation (Judge v. Huntingdon Health Authority [1995]).

Further, it would be negligent for a paramedic to attempt a medical procedure that should be attempted only by a specialist in that particular field (De Freitas v. O’Brien [1995]). So, if a paramedic practises a skill that is not within their normal scope of role (for example, wound closure is a skill typically found in the roles for specialist and advanced paramedics), this will be judged against the standard of care expected of a reasonable clinician skilled in wound closure. If they do not meet that standard, then they may be found to be negligent. This also means that if a person is acting in a particular capacity, then they must exercise the level of skill expected of such a person.

Inexperience is irrelevant as long as the person is deemed competent to perform a task expected of them within their specialism (Jones v. Manchester Corporation [1952]). However, an inexperienced member of staff may not be negligent in following the advice of a senior colleague. In Wilsher v. Essex Area Health Authority [1986], a junior colleague was not found to be negligent for following the instructions of a senior colleague, who then subsequently checked the work. Despite this, a defence of ‘only following orders’ is not acceptable and first, the junior colleague must check their understanding of the instructions given by a senior colleague, and these instructions should not be blatantly wrong. A pharmacist who failed to confirm a prescription that was incorrect was found to be negligent (Horton v. Evans [2006]). Interestingly, in Antoniades v. East Sussex Hospitals NHS Trust [2007], the team leader was found to be negligent for having inadequately trained his team. This is an important consideration both for clinical team leaders as well as those working in education.

There are two main tests that are used to establish breach of duty: the Bolam test and the Bolitho test. In addition, clinical guidelines are increasingly being used to set the benchmark for a reasonable standard of care, although this does not mean they must always be adhered to (C v. North Cumbria University Hospitals NHS Trust [2014]).

The Bolam Test

When care is delivered by any health professional, the standard of care expected is that of any reasonable health professional. The Bolam principle addresses the first element of breach of duty and summates that a health professional is not negligent if they act in accordance with a practice accepted at the time as proper by a responsible body of medical opinion.

Bolam v. Friern Hospital Management Committee [1957]

Mr Bolam was a voluntary patient at Friern Hospital, a mental health hospital. He was prescribed electroconvulsive therapy (ECT) as a treatment for depression, but was not warned of any of the risks involved (such as convulsive shaking and risk of injury). He underwent the procedure without muscle relaxants or restraint. During treatment, he sustained a fractured hip and additional complications.

At the time, there was a division of medical opinion regarding the benefits of physical restraint and muscle relaxants during ECT, as well as the need to warn patients of the risk. Therefore, Mr Bolam failed to prove that the defendants had been negligent.

At the time of Bolam, medical negligence cases in England and Wales were decided by a jury. In his direction to the jury, McNair J (the judge) said that:

A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.

Therefore, in situations which involve the use of some special skill or competence, the standard expected is not that of the ordinary reasonable man, but that expected by the ordinary skilled man who professes to have, and exercises, that special skill. Importantly, this test applies not only to doctors, but also any healthcare professional.

McNair J also added that a man ‘is not negligent if he is acting in accordance with such a practice, merely because there is a body of opinion that takes the contrary view’. This has been taken to mean that even if a body of opinion does not agree with a professional’s actions in given circumstances, if a body of opinion which did agree could be found, the professional would not be considered negligent. In Maynard v. West Midlands Regional Health Authority [1985], the House of Lords held that a judge is not in a position to choose between the views of competing medical experts. As long as there is a competent school of thought that supports the belief that the defendant’s actions were reasonable, the judge will find the defendant not to have been negligent.

The effect of the Bolam decision is that it is difficult to show a doctor breached the duty of care: it is not about whether the defendant acted in the ideal way, but that their actions were above the minimal acceptable practice. Some of these criticisms of the Bolam test argue that doctors (or other health professionals) should not dictate whether conduct is negligent and that the court should more actively scrutinise the standard of care given.

Another issue is that the actual size of the body of medical opinion that Bolam requires is not explicit. In De Freitas v. O’Brien [1995], expert evidence for the defendant showed that only a small number of peers would endorse the defendant’s conduct, but Otton LJ states that the size of the medical body was less important than the fact that there was a reasonable body. This implies that the defendant’s actions may be defensible even if there is only minority support.

Similarly, there can be a lack of objectivity. The Bolam test depends upon a body of medical opinion that endorses the defendant’s practice. This could be based on a single expert, rather than evidence-based guidelines such as those from the National Institute for Health and Care Excellence (NICE). Objective evidence for clinical guidelines informed the outcome in Richards v. Swansea NHS Trust [2007]; however, this does not mean that a health professional who deviates from clinical guidelines will be negligent if something goes wrong. There is a danger in applying clinical guidelines rigidly in dynamic clinical situations, where they may not necessarily present ‘best practice’. Nevertheless, the objectivity of the evidence-based guideline or the expert opinion used may in some situations impact on informing the standard of care expected. As will be discussed in Chapter 6: Consent, the outcome of Montgomery v. Lanarkshire Health Board [2015] means that the Bolam test cannot be held when gaining consent.

The Bolitho Test

However, the law’s approach is less clear cut after the House of Lords’ decision in Bolitho v. Hackney Health Authority [1997].

Bolitho v. Hackney Health Authority [1997]

Two-year-old Patrick Bolitho suffered brain damage during an attack of croup, leading to cardiac arrest. Evidence of the case accepted that the on-call paediatric registrar negligently failed to attend the patient and the question of causation concerned whether the attendance would have altered the outcome in any event. Expert witnesses were (unequally) divided and the decision was appealed to the House of Lords, which held that there needed to have been a logical basis for the decisions of the defendant and the expert witnesses.

The obiter¹ comments of Lord Browne-Wilkinson provide an important understanding for how the court might adopt a more interventionalist approach when determining a standard of care. He referred to McNair J’s comments in Bolam: the ‘use of these adjectives – responsible, reasonable, and respectable – all show the court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such an opinion has a logical basis’. In deciding whether the standard has been breached, the endorsement has to be from a source that can be relied upon and should have a logical basis that can withstand objective scrutiny. Bolitho indicates that it is not enough to have only opinion to support the practice in question and that the judge will need to scrutinise the evidence, especially in competing views.

Notably, many cases after Bolitho do not cite this ‘second’ measure and refer simply to the Bolam test. This in itself indicates that Bolitho and the comments of Lord Browne-Wilkinson may not have made as much of an impression as they probably should have. However, of the cases that have cited Bolitho, it does seem that this had a significant (if conflicting) impact on the scrutiny given to the expert opinion.

In Marriott v. West Midlands Health Authority [1999], the trial judge (supported by the Court of Appeal) held that although a reasonable body of experts agreed with the actions of the defendant, such an approach was held to be irresponsible by the courts. This indicated that Bolitho authorises a judge to consider the views of medical experts, but can also deem them irresponsible if appropriate.

In Burne v. A [2006], the trial judge rejected the views of experts concerning what a reasonable course of conduct would be. However, at appeal, it was outlined that the judge should have done one, or both, of two things: should they find the expert evidence unacceptable, to ask the claimant’s counsel whether they should consider the credibility of the expert evidence in support of the doctor and, if the claimant’s counsel said yes, to ensure that the defendant’s side had a proper opportunity to respond. Essentially, this case demonstrated that a judge could reject the views of experts on what is a reasonable course of conduct, but before doing so, the experts must be given the chance to justify practice.

Overlapping significantly with the law concerning mental health, in the case of Border v. Lewisham and Greenwich NHS Trust [2015], a patient did not consent to the insertion of an intravenous line, but despite her mental capacity, this was undertaken. While a body of experts believed the actions of the doctor had been appropriate, the Court of Appeal, citing Bolitho, found that treating a competent person against their wishes would be negligent.

Concerning Bolitho, if there is a conflict between experts, the judge must explain which expert is preferred and why (Smith v. Southampton University Hospital NHS Trust [2007]), and it is not enough to only say that the expert is responsible alone (Hanson v. Airedale Hospital NHS Trust [2003]). Ultimately, the judge should not simply accept expert opinion, and it should be tested for internal consistency and against the other evidence of the trial (Mulholland v. Medway NHS Foundation Trust [2015]).

Mulheron (2010) outlines an excellent summary of the case law post-Bolitho, describing how to overrule medical practice under the Bolam test. If any of these points raise an answer in the negative, it constitutes a ground where English courts have previously rejected expert medical opinion as indefensible. The court should consider whether the expert evidence:

Took account of a clear and simple precaution which was not followed, but which, more probably than not, would have avoided the adverse outcome

Considered conflicts of duties among patients, and resource limitations governing the medical practice

Weighed the comparative risks/benefits of the medical practice, as opposed to other course(s) of conduct

Took account of public/community expectations of acceptable medical practice

Was correct in light of the factual context as a whole

Was internally consistent

Adhered to the correct legal test governing the requisite standard of care.

While it is difficult to generalise from the small number of selected cases presented here, this discussion demonstrates that the courts are reluctant to abandon Bolam in respect of medical opinion, and that Bolitho is sometimes used as a second ‘back-up’ position. Regardless of the criticism and the fact that these cases feature medical doctors, the point remains that these two main tests are used to establish breach of duty and determine negligence.

Causation

The final step to establishing a successful claim in negligence, and the stage at which many claims fail, is establishing causation. Causation requires that the breach of duty made a significant contribution to the harm caused to the patient. The test is commonly known as the ‘but for’ test: but for the breach in duty, no harm would have come to the patient. This is often complicated to prove, as there can be multiple factors that affect a patient’s outcome, the clinician’s negligence being only one. In addition, the legal causation must be satisfied by the test for remoteness.

There are complex issues that can arise when the defendant is not shown definitely to have caused harm, but has been involved in the cause or exposed the claimant to risk. In Barnett v. Chelsea and Kensington Hospital Management Committee [1969], a doctor refused to see a man who presented to the emergency department with abdominal pain and died shortly afterwards. While it was clear that the doctor was negligent for refusing to see the patient, the evidence from the post mortem suggested that even if the doctor had seen the patient, the patient would have died from arsenic poisoning. This negligence did not cause the injury.

More recently, such complex issues are typically seen in cases relating to the delayed dispatching of ambulances to attend 999 calls. In Leigh v. London Ambulance NHS Trust [2014], the judge said that it was impossible to predict on any scientific or mathematical bases whether the patient would or would not have developed post-traumatic stress disorder (PTSD) ‘but for’ the negligent failure of the ambulance to arrive in good time.

However, the arrival of an ambulance is not dependent on singular forces, and exists within a complex context of multiple, often competing, factors. These often produce a cumulative effect, which is set out by Waller LJ in Bailey v. The Ministry of Defence & Anor [2008] as an approach to cumulative cause cases:

1.If the evidence demonstrates, on a balance of probabilities, that the injury would have occurred as a result of the non-tortious cause or causes in any event, the claimant will have failed to establish that the tortious cause contributes.

2.If the evidence demonstrates that ‘but for’ the contribution of the tortious cause the injury would probably not have occurred, the claimant will (obviously) have discharged the burden.²

3.In a case where medical science cannot establish the probability that ‘but for’ an act of negligence the injury would not have happened, but can establish that the contribution of the negligent cause was more than negligible, the ‘but for’ test is modified, and the claimant will succeed.

This modified ‘but for’ approach was applied in Leach v. North East Ambulance Service NHS Foundation Trust [2020], where the High Court ruled that the negligent delay in the arrival of emergency ambulance service made a material contribution to the PTSD suffered by the claimant.

Causation may also be established from the ‘loss of a chance’, which is where but for the clinician’s omission to offer treatment, the patient would on the balance of probabilities have made a recovery.

Hayes v. South East Coast Ambulance Service [2015]

The Facts of the Case

Two ambulance technicians attended a 41-year-old brittle asthmatic (H), who presented as not being able to speak and having difficulty in breathing. They gave the patient one dose of salbutamol before walking them to the ambulance. They had only documented a blood sugar reading and Glasgow Coma Score. The crew did not give the patient ipratropium bromide or adrenaline; they also did not give any further doses of salbutamol. On the way to the ambulance, the patient suffered a respiratory and cardiac arrest, which resulted in his death.

The Judgment

The crew were found to be negligent as:

They had not identified that the patient’s condition was life threatening

According to guidelines, he should have been given ipratropium bromide following the administration of salbutamol

Insufficient clinical observations were taken

They did not administer adrenaline.

It was found that, given the above, ‘On the balance of probabilities, but for the negligent treatment, H would have survived … H’s prospects of survival would have been 60 per cent’ (paragraphs 137–141).

Hayes v. South East Coast Ambulance Service demonstrates how the tests for negligence are applied:

1.There was a duty of care to the patient, which was established when H called 999, and the ambulance technicians had a duty of care when they were sent to the incident.

2.The breach of duty occurred when they failed to identify the severity of H’s condition, did not take sufficient observations and failed to administer the drugs according to UK clinical practice guidelines (this would be measured against the guidelines that were being used at the time – JRCALC 2013 guidance). The Bolam test was applied and the opinion of an expert witness was sought. The expert witness, Dr Moore, confirmed that a reasonable technician would have recognised the severity of H’s condition, taken suitable observations and administered the correct drugs.

3.Causation was established by the 60% chance that H would have survived but for the negligence of the attending crew.

After proving causation, the claimant must establish that the type of injury was not too remote; the type of harm must be a foreseeable consequence of the negligence. In clinical negligence situations, this can usually be shown.

Criminal Negligence

A criminal action can be brought in circumstances where the death of a patient is caused by the grossly negligent act or omission of a health professional. In R v. Adomako [1995], the House of Lords held that criminal negligence can be found where the health professional – in this case, a doctor – is:

Indifferent about an obvious risk of injury to a patient

Aware of a risk, but decides to proceed in any event

Intending to avoid a known risk, but does so with a high degree of negligence

Inattentive or fails to be alert to a serious risk.

Providing an Expert Opinion

The role of healthcare professionals in assisting courts goes back to at least 1218, when a surgeon assisted a coroner as to whether an arrow injury to the chest could be fatal (Rix and Powers, 2021).

At the outset of most clinical negligence claims the legal team acting for the claimant (the party who is bringing the claim against the care provider or clinician) will obtain expert evidence to test how likely the claim is to be successful.

Where the claim concerns care and treatment provided by a paramedic, at least some of this expert opinion is likely to be sought from a paramedic, as experts should only comment on matters within their area of expertise (General Medical Council, 2018). Although some matters, such as whether a breach of duty caused the relevant harm, might require evidence from those with a different area of expertise; for example, a cardiologist if a matter related to a delay in treatment for a myocardial infarction.

Paramedics who give expert opinion in any legal proceedings should therefore ensure they are able to identify and take into account important issues and, most importantly, that they know what the court expects them to opine on and how to apply the relevant legal tests to any opinion they provide (ZZZ v. Yeovil District Hospital NHS Foundation Trust [2019]).

They must also ensure they have access to all the relevant materials that they need to complete their report, and should be provided with any material that is subsequently provided to the court that might be relevant to their report (Arksey v. Cambridge University Hospital NHS Foundation Trust [2019]).

Finally, the case of Johnson v. Williams [2022] EWHC 1585 (QB) (Johnson) at [61] highlights the importance of experts being clear and honest about their expertise and experience in their curriculum vitae (Corkill, 2022). Corkill (2022) notes that Johnson ‘is a good example of why a balanced and cautious expert is more compelling than an inflexible one’, going on to observe that ‘[b]eing an expert is a tough business… Experts must know the papers inside out. They must take a firm and consistent view and not change their position without very good reason. Against that, they are expected to make appropriate concessions where necessary’.

A 29-year-old patient presents to a specialist paramedic (SP) in a busy urgent care centre. The patient has lacerated their hand while washing up glasses in the sink. The patient is a jeweller, currently commissioned to design and make pieces for a well-known retail company. The laceration is across the right palm and the patient complains of slight numbness to the fingers, as well as an inability to move their fingers well. The patient is worried this may impact their job.

The SP has recently joined the urgent care centre, having completed their portfolio of competencies. They look at the wound, seeing that it is quite deep and the tendons are visible, but note that there is no neurovascular tenderness distal to the injury and there is active, passive and resisted range of movement in the fingers and wrist. The SP thinks the wound is suitable for suturing and proceeds to irrigate the wound, remove any remaining glass, and meticulously suture it closed. They have never performed this procedure to a hand before, but have read about suturing palms in the past. The unit team leader is already attending to a complex patient and so they go ahead. The SP informs the patient of worsening advice concerning infection or poor healing to the hand and discharges the patient home. They document the care provided and later discuss the case with the unit team leader, who felt that their actions were appropriate.

Three weeks later, the patient is concerned that the movement of their fingers is not back to normal and there is still some numbness present. The patient has been finding it difficult to perform the fine motor skills their work requires. They seek an emergency appointment with a GP, who notes that they cannot bend three fingers partially or fully and that there is altered sensation present in two of these fingers. The GP sees the wound on the patient’s hand, and the patient explains that this was caused by glass. The GP refers the patient to the hand clinic, where they are seen the following day.

The clinic determines a flexor tendon injury, with some glass embedded in the wound, and repairs the tendon under general anaesthetic. The patient is put in a splint for six weeks and is unable to finalise the design for the commission they were working on. Despite hand therapy, three months later the patient has still not regained full motor movement to the hand and subsequently loses their employment.

Evidence suggests that if the patient had had an X-ray to determine the presence of glass in the wound and an immediate referral to the hand surgeon for assessment, the flexor tendon injury would have been spotted and repaired more quickly and the patient would have had a 40% chance of full recovery. The delay meant that the chances of having full movement of the fingers to undertake the patient’s employment were reduced to 5%.

As an ‘expert witness’, what advice would you give this patient?

Problems with the Current System

Although negligence claims form a small proportion of both the number of incidents and complaints reported in the NHS and the many millions of individual episodes of care that are delivered by the NHS each year, it is recognised that the fear of litigation is a very real concern for healthcare professionals. In 2018, 8,000 members of the British Medical Association (BMA) were surveyed about what impacted on their working lives; 45% of doctors reported that they were often fearful of making a medical error in their daily workplace and 55% reported to be more fearful than they were five years previously. Fifty-five per cent also said they were worried that they would be unfairly blamed for errors that were due to system failings and pressures (House of Commons, 2022).

All NHS employers are ‘vicariously liable’ for the negligence of their employees and for any claims arising while employees are working within the scope of their employment. Paramedics should check with their employer that such indemnity is current for the employment proposed or being undertaken. Paramedics practicing on their own account or delivering services through their own corporate entity may wish to invest in separate cover.

There are many factors influencing the reasons why individuals bring a claim against the NHS, including factors in the legal market (NHS Resolution, 2021). There is also a significant time lag between an incident occurring and a claim being received – on average 3.1 years. It may also take several years to settle a claim, particularly high value claims (for example, where brain damage has occurred at birth), and payments may be made on those claims many years into the future. Currently, maternity claims make up 60% of the claims for Clinical Negligence Schemes for Trusts (CNST), making maternity care a key priority in regard to both clinical negligence and patient safety initiatives in the next five years (Figure 4.1) (NHS Resolution, 2021).

Figure 4.1 The percentage of clinical negligence claims reported in 2021/22 by specialty, with a breakdown by volume (total 10,284 claims) and by value (total £6,033.4 million).

Source: NHS Resolution (2021).

Clinical negligence claims against the ambulance service accounted for 1% of the total value of clinical negligence claims in 2021/22 (NHS Resolution, 2021).

Another criticism is that only compensating patients for injury caused by a medical error (a fault-based system) means that patients who suffer injury where no one is at fault receive no compensation (Douglas, 2009). Douglas (2009) gives three example cases:

1.Mr Smith suffers a brain haemorrhage as a result of a genetic defect in the arteries supplying his brain. He is taken immediately to hospital, where he is rushed to the operating theatre, unconscious, to have the blood drained from his skull. During the course of the operation, the surgeon negligently damages the part of his brain that controls his right leg. Though Mr Smith subsequently recovers from his haemorrhage, the damage inflicted by the surgeon leaves him with a permanently paralysed leg.

2.Mrs Jones, like Mr Smith, suffers a brain haemorrhage as a result of a genetic defect. She too is rushed to the operating theatre and, as with Mr Smith, the surgeon damages the part of her brain that controls her right leg. In her case, however, the damage is not due to negligence on the surgeon’s part. It is instead an unusual side-effect of good surgical practice: the surgeon (correctly) believes that it is necessary to damage this part of the brain in order to stop the haemorrhage and thus save Mrs Jones’ life. However, the result is the same. Mrs Jones recovers from the haemorrhage, but is left with a permanently paralysed leg.

3.Mr Williams, like Mr Smith and Mrs Jones, suffers a brain haemorrhage as a result of a genetic defect. He too is rushed to hospital. However, his haemorrhage is particularly severe and before he can be taken to the operating theatre, the part of his brain which controls his right leg is irreversibly damaged. Thus, like Mr Smith and Mrs Jones, he is left with a paralysed leg, though in his case, the paralysis is a result of the genetic condition (and subsequent haemorrhage), not of its treatment.

Douglas (2009) points out that Mr Smith would have a successful claim in negligence, whereas Mrs Jones would not. In a fault-based compensation system, only Mr Smith would be compensated, which Mrs Jones may argue is unfair as she too suffered an injury from the surgery, albeit not as a result of negligence. However, in some jurisdictions, for example, New Zealand, she would receive compensation, as it operates a no-fault system.

A no-fault compensation system offers a person compensation regardless of whether their injury was caused by negligence. New Zealand’s publicly funded compensation scheme, which was introduced in 1974 and reformed in 2005 to introduce a no-fault approach to medical error, provides patients with compensation for injury following medical treatment without the need to prove negligence (Wallis, 2017).

Douglas points out that the no-fault system still does not provide compensation equality. What about Mr Williams from case 3? He would not receive any compensation as his injury was caused by a natural occurrence. Douglas (2009) argues that a jurisdiction focusing on fair compensation for all who suffer illness or injury, from any cause other than self-infliction, should implement a system that compensates everyone equally. Douglas suggests that this could be achieved by moving away from a compensation system, be it fault or no-fault-based, and instead allow the broadening of social security and public healthcare systems to provide support to those who have suffered illness or injury, regardless of the cause.

In a fault-based system, in addition to worries about the cost of litigation against the NHS and compensation inequality, there are also concerns about the influence that the fear of litigation has on medical practice, meaning that clinicians may be afraid of owning up to errors.

The Bristol Royal Infirmary Inquiry (2001, p. 366)

‘The culture and the practice of clinical negligence litigation work against the interests of patients’ safety. The system is positively counterproductive, in that it provides a clear incentive not to report, or to cover up, an error or incident. And, once covered up, no one can learn from it and the next patient is exposed to the same or a similar risk.’

Learning from Error

In response to the Bristol Royal Infirmary Inquiry (2001) and Department of Health (2001) reports, a move towards open reporting was instigated. The National Patient Safety Agency (NPSA) was established and in 2003 a National Reporting and Learning System was set up. This was a central database of over four million patient safety incident reports that was used by NHS Improvement to develop advice and guidance for the NHS, reducing risks to patients (NHS Improvement, 2016). In June 2012 the NPSA became part of the NHS Commissioning Board Special Health Authority.

In 2005 and 2010, the NPSA published Medical Error, which were guidance booklets that provided advice and guidance for junior doctors on preventing and reporting patient safety incidents. In both versions, senior doctors discuss mistakes they have made and how they have learnt from them, as well as key steps for how to report something that does go wrong, including how to handle complaints. Sadly, these documents are no longer available or in print, which is a loss to all clinicians as they demonstrated that everyone can make mistakes, but it is how they are learned from which results in the development of a safer and more effective health system, both in the NHS and outside of it, aligning with the Department of Health’s vision for a learning, not blaming, culture (2015).

Acknowledging that an error took place requires personal insight, courage and a desire to improve. These are characteristics that are fundamental to the development of individual clinicians within the healthcare setting and that must be supported by the workforce culture overall. The Health and Care Professions Council (HCPC) places much emphasis on the need for honesty amongst its registrants, and a statutory Duty of Candour (a professional responsibility to be honest with patients when things go wrong) applies to all care providers registered with the Care Quality Commission (CQC). The intention of this regulation is to ensure that providers are open and transparent with service users and others, and are acting lawfully on their behalf in relation to care and treatment. It also sets out specific requirements for providers to follow when things go wrong with care and treatment, including informing people about the incident, and providing support, honest information and an apology.

In 2015, NHS England adopted a Serious Incident Framework that adopted a no-blame approach to investigating incidents (NHS England, 2015). Combined with the statutory Duty of Candour brought in by the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, this worked towards adopting recommendations set out in the Francis Report of ‘openness, transparency and candour’ (Mid Staffordshire NHS Foundation Trust Public Inquiry, 2013).

In July 2019 a new patient safety strategy was published by NHS England, setting out a plan to implement a new Patient Safety Incident Response Framework (PSIRF). This was published on the 16 August 2022, replacing the Serious Incident Framework (NHS England 2022). Implementation is a contractual requirement for those providing services under the NHS Standard Contract; this will include ambulance services. Primary care providers are not required to adopt the framework but should work with their integrated care board should they wish to do so (NHS England, 2022; Petts and Bateman, 2022).

NHS England are clear that the PSIRF is not prescriptive on what needs to be investigated and represents a fundamental shift in how the NHS responds to patient safety incidents for learning and improvement (NHS England, 2022).

PSIRF Key Aims (NHS England, 2022)

The new PSIRF guidance sets out the following four key aims that is intends to integrate into an effective patient safety incident response system:

1.Compassionate engagement and involvement of those affected by patient safety incidents.

2.Application of a range of system-based approaches to learning from patient safety incidents.

3.Considered and proportionate responses to patient safety incidents.

4.Supportive oversight focused on strengthening response system functioning and improvement.

The NHS England Guidance also continues to maintain that the PSIRF framework ‘explicitly exclude[s] activities that apportion blame or determine culpability, determine preventability, or identify cause of death’ (NHS England, 2022, p. 10). It also notes that where incidents require a separate response, not focused on learning, such as a coronial inquiry, police investigation or fitness to practise investigation, these responses should be conducted entirely separately (NHS England, 2022).

The Case of Dr Bawa-Garba

Despite the improvement in reporting and the move away from a blame culture since 2000, there remain concerns about the treatment of clinicians by the clinical negligence system. This was bought to the forefront of clinicians’ minds by the case of Dr Bawa-Garba.

The details in General Medical Council v. Bawa-Garba [2018] demonstrate the complexity of decision making for seriously unwell children, as well as the consequences of medical error. In this case, a child was admitted to hospital with dehydration and subsequently died as a result of systemic sepsis. What is important to note from this case is that the clinician involved was experienced, knowledgeable and qualified for the role that was being undertaken. The child died, it is held, as a result of a delay in recognition and management of systemic sepsis by the admitting hospital.

In some cases, clinicians can be found to be so negligent that they are found to be criminally liable.

In 2015, Dr Bawa-Garba, a specialist registrar in paediatrics, was found guilty of gross negligence manslaughter following the tragic death of Jack Adcock, a six-year-old with Down’s syndrome, from septic shock (Dyer, 2015). The treatment she provided was considered to be ‘truly, exceptionally bad’, as she failed to identify test results that indicated the patient’s kidneys were failing and mistakenly stopped resuscitation efforts after mistaking him for another patient with a do not resuscitate order. Although resuscitation was resumed after the error was identified, it was not successful, and Jack was pronounced dead.

In 2017, a Medical Practitioners’ Tribunal decided it was appropriate for Dr Bawa-Garba to be suspended from practice for 12 months. This decision considered the ‘multiple systemic failures’ that contributed to the tragic events that day and Dr Bawa-Garba’s ‘unblemished record before and since along with evidence from colleagues and consultants who called her an excellent doctor’ (Dyer, 2017). The General Medical Council (GMC) did not agree with the decision of the Tribunal, believing that public trust could have been eroded by the decision, and in 2017, it appealed to the High Court to have Dr Bawa-Garba removed from the medical register, a move which was successful (GMC v. Bawa-Garba [2018]). Many doctors raised concerns about the GMC’s actions, believing that it endangers the national move towards an open and honest safety culture (Cohen, 2017; Johannsson and Rook, 2018). This has had such an impact that legislation to strip the GMC of its power to appeal decisions by medical practitioner’s tribunals is set to be introduced.

Following a campaign that funded over £360,000 for her reinstatement, Dr Bawa-Garba appealed against the High Court ruling and the Court of Appeal rejected the High Court’s decision. Dr Bawa-Garba was reinstated to the medical register in August 2018 and gained consultant status in 2022.

This incident happened in 2011 and a final ruling was issued in August 2018. Similar to the case of Bolitho (which occurred in 1984 and a final decision held in 1997), this highlights that not only is paediatric clinical negligence complex, it can also take a significant amount of time to reach a final conclusion. In addition, the associated costs are high, as a child who suffers as a result of medical error in early life will need to be supported for as long as is necessary, which may be the rest of their life.

The double tragedy of Jack Adcock’s death and Dr Bawa-Garba’s prolonged journey within the criminal justice system has shaken the medical and its associated professions. In particular, the inclusion of Dr Bawa-Garba’s reflective e-portfolio used as evidence against her in court has provoked fear within of legal sanctions across many professions (Delport et al., 2018). All healthcare professionals are encouraged to acknowledge and reflect on mistakes that they have made to improve patient care and safety, yet inclusion of such reflections in a criminal case has hitherto been sparse. However, this case has been a watershed moment in patient safety, which has highlighted critical issues within hospitals of understaffing, long working hours, and poor communication structures between professionals. This case has also highlighted the detrimental effect of ‘blame culture’. There is a lot to be learnt from Dr Bawa-Garba who throughout her journey has been critically honest about her errors. She unselfishly stated that she hoped the decision would in some way improve the working conditions of many junior doctors. It is this ethos of a learning, not blaming, culture that will ensure the safety of patients, and staff, within the NHS.

Paramedics must uphold the highest standards of clinical care and record keeping, as required by the HCPC (2023). It is the accurate record of care that will be of most use during an allegation of negligence, which may be several months or years after the initial care episode.

Recommendations for the Future

Sir Ian Kennedy KC, who chaired the Bristol Royal Infirmary Public Inquiry, continues to have significant concerns about the ‘stranglehold that lawyers exert over a system that should be putting […] patients first’ and considers that ‘[t]he introduction of a radical alternative to the outdated, arbitrary and scandalously expensive system of clinical negligence remains one of the few bits of unfinished business for [him]’ (Kennedy, 2021).

On 16 November 2021 the first session of evidence for the Health and Social Care Select Committee inquiry into NHS litigation reform was heard (House of Commons, 2021). The inquiry was ordered due to a number of concerns about the current clinical negligence system, including that it is adversarial and distressing, expensive, takes too long and does not promote learning (House of Commons, 2022).

The final report of the inquiry, set out a number of recommendations including (House of Commons, 2022):

Removing the clinical negligence threshold for compensation by changing the law so that compensation is agreed on the basis that correct procedures were not followed and the system failed to perform.

Changing the assumption that additional care will be provided privately and basing compensation on the cost of providing top up care through the NHS.

Making the use of alternative dispute resolution before issuing of court proceedings mandatory.

All hospitals should have adequate staff trained in just culture.

Introduction of a standardised process across the NHS that focuses on learning lessons where a potential litigation case arises, this should be independently led and last a maximum of six months and any learning should be communicated to the wider NHS.

In parallel to this process, there should be an alternative dispute resolution investigation (an administrative system) that will make a determination on liability and compensation for the trust and NHS resolution to consider.

The option for families to pursue clinical negligence cases and redress via litigation would remain, but it is anticipated families would prefer the simpler administrative system.

Finally, the administrative system, unlike litigation that results in compensation on a ‘once and for all basis’, would be able to review cases and adjust compensation as the needs of the person develop.

Whether these recommendations will be adopted and the clinical negligence system reformed is yet to be seen.

Summary

This chapter has considered the legal aspects that make up a clinical negligence claim, paying particular attention to the duty of care and causation. What we present here is an introduction to these concepts, and we would recommend those who are looking for a more comprehensive understanding to read Medical Law and Ethics by Jonathan Herring. We also discuss the problems with the current system and how the healthcare culture may learn from error. The current system does not yet encourage an open culture whereby health professionals can openly learn from their mistakes, but the law does ensure that those who behaved wrongly can be held to account. While more needs to be done to develop a culture of transparency within the health service, individual clinicians must be willing to create change by talking openly and honestly about mistakes they may make, demonstrate they have learned from them and encourage others to learn from them too. This process of learning not only creates a transparent culture, but also creates a learning environment and ultimately a safer environment for patient care.

Recommended Reading

Herring J (2022). Medical Law and Ethics. 9th edn. Oxford: Oxford University Press.

National Patient Safety Agency (NPSA) (2005). Medical Error. London: National Patient Safety Agency.

References

Bristol Royal Infirmary Inquiry (2001). Learning from Bristol: The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984–1995. Available at: http://webarchive.nationalarchives.gov.uk/20090811143822/http://www.bristol-inquiry.org.uk/final_report/the_report.pdf (accessed 28 June 2023).

Cohen D (2017). Back to blame: the Bawa-Garba case and the patient safety agenda. British Medical Journal, 359(j5534).

Corkill E (2022). Inflexible Experts. Available at: https://www.39essex.com/information-hub/blog/inflexible-experts (accessed 9 November 2022).

Delport S et al. (2018). Implications for reflective practice and safer care in paramedicine: The Bawa-Garba case. Journal of Paramedic Practice, 10(11): 236.

Department of Health (2001). An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS Chaired by the Chief Medical Officer. Available at: http://webarchive.nationalarchives.gov.uk/20130105144251/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4065086.pdf (accessed 28 June 2023).

Department of Health (2015). Learning Not Blaming. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/445640/Learning_not_blaming_acc.pdf (accessed 28 June 2023).

Douglas T (2009). Medical injury compensation: beyond ‘no-fault’. Medical Law Review, 17(1): 30–51.

Dyer C (2015). Paediatrician found guilty of manslaughter after boy’s death from septic shock. British Medical Journal, 351: h5969.

Dyer C (2017). Doctor convicted of manslaughter is suspended from register for a year. British Medical Journal, 357: j2928.

General Medical Council (GMC) (2018). Protecting Children and Young People. The Responsibilities of All Doctors. Manchester: GMC.

Health and Care Professions Council (HCPC) (2023). Standards of proficiency – Paramedics. London: HCPC.

House of Commons (2021) Health and Social Care Committee Oral Evidence: NHS Litigation Reform, HC 740. Available at: https://committees.parliament.uk/oralevidence/3060/pdf/ (accessed 28 June 2023).

House of Commons (2022). NHS Litigation Reform Thirteenth Report of Session 2021–22. Available at: https://committees.parliament.uk/publications/22039/documents/163739/default/ (accessed 28 June 2023).

Johannsson H and Rook W (2018). Avoiding blame and liability is vital to learning from errors and engineering a safer NHS. British Medical Journal, 360(k447).

Kennedy I (2021). Clinical negligence reform is an ethical and financial necessity. Available at: https://www.prospectmagazine.co.uk/politics/clinical-negligence-reform-is-an-ethical-and-financial-necessity-law-hospitals-medicine (accessed 28 June 2023).

Mid Staffordshire NHS Foundation Trust Public Inquiry (2013). Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry: Executive summary. The Stationery Office. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/279124/0947.pdf (accessed 28 June 2023).

Mulheron R (2010). Trumping Bolam: A critical legal analysis of Bolitho’s gloss. Cambridge Law Journal, 69(3): 609–638.

NHS England (2015). Serious Incident Framework. Available at: https://www.england.nhs.uk/wp-content/uploads/2015/04/serious-incidnt-framwrk-upd.pdf. (accessed 28 June 2023).

NHS England (2022). Patient Safety Incident Response Framework. Available at: https://www.england.nhs.uk/wp-content/uploads/2022/08/B1465-1.-PSIRF-v1-FINAL.pdf (accessed 28 June 2023).

NHS Improvement (2016). Patient Safety Incident Reporting and Responding to Patient Safety Alerts. Available at: https://www.england.nhs.uk/2016/04/patient-safety-incident-reporting-and-responding-patient-safety-alerts/ (accessed 24 July 2023).

NHS Resolution (2021). Annual Report and Accounts 2020/21. Available at: https://resolution.nhs.uk/wp-content/uploads/2022/07/NHS-Resolution-Annual-report-and-accounts-2021_22_Access.pdf (accessed 28 June 2023).

Petts C and Bateman C (2022). New Patient Safety Incident Response Framework (PSIRF) Published by NHS England – A Fundamental Shift in the Investigation of Patient Safety Incidents. Available at: https://www.clydeco.com/en/insights/2022/08/new-patient-safety-incident-response-framework-psi (accessed 28 June 2023).

Rix K and Powers M (eds) (2021). Rix’s Expert Psychiatric Evidence. Cambridge: Cambridge University Press.

Wallis KA (2017). No-fault, no difference: no-fault compensation for medical injury and healthcare ethics and practice. British Journal of General Practice, 67(654): 38–39.

¹ Short for obiter dictum – a Latin phrase referring to a remark in a legal opinion that is ‘said in passing’ by any judge or arbitrator.

² This refers to the burden of proof, where it is the obligation of the prosecutor, not the defendant, to prove the case of the charge (which in this case would be negligence).

Chapter 5

Coroner’s Court and Inquests in England and Wales

Edd Bartlett and Katie Viggers

Introduction

Due to the nature of traditional ambulance service ‘999’ frontline work, a number of deaths attended to by paramedics are likely to be investigated by the coroner. It therefore follows that, as a paramedic, you are likely to be called to give evidence at a coroner’s court at some stage during your career (James, 2018). This likelihood increases if you work with those under state detention, such as in a prison or a mental health in-patient unit.

Being called to give evidence in court is likely to provoke some worry and anxiety, particularly if things haven’t gone to plan, or you are simply unable to remember the incident in much or any detail. This chapter therefore explains the purpose of an inquest and how the process works, to allay a clinician’s fears as to what might happen. It outlines the key functions and powers of coroners and the different types of inquest that might occur. It also explains the key issues that may arise in an inquest, gives tips on statement writing and guidance on what to do if you are called to attend court.

Coroners – An Overview in England and Wales

History of the Office of the Coroner

The Office of the Coroner was formally established in 1194. Mediaeval coroners had a wide range of powers besides investigating sudden, unnatural or suspicious deaths. Inquests were also held into ‘cases of serious bodily injury, burglary, arson, rape, prison-breaking and concealment of treasure-trove or wreck’ (Gross, 1892, p. 662).

Over time, the role of the coroner has evolved. Nowadays, coroners are independent judicial officers, whose primary duty is to investigate deaths if there is reason to suspect that:

The death was violent or unnatural

The cause of death is unknown

The deceased died in custody or while in state detention (for example, in prison, in an immigration removal centre or while detained in hospital under the Mental Health Act 1983).

As the coronial system is so archaic, it has been subject to much scrutiny and change over the years. The most recent legislative reforms came about in 2013, when the Coroners and Justice Act 2009, the Coroners (Investigations) Regulations 2013 and the Coroners (Inquests) Rules 2013 were implemented. These still govern the coronial system in England and Wales today.

The Coroners and Justice Act 2009 introduced a number of important changes to the coronial system, including the following: a new position of Chief Coroner; the requirement for all Senior Coroners to be legally qualified; the creation of the Medical Examiner (a person who scrutinises and confirms the cause of all deaths that are not investigated by coroners); the provision of legal aid to families whose relatives die in state custody or in active service in the Armed Forces; and imposing a duty on coroners to report matters to organisations or authorities that arise in the inquest, and that give rise to a concern that deaths might occur in the future (these are known as Prevention of Future Death Reports, or Regulation 28 Reports) (Glasson and Knowles, 2010).

Although the Coroners and Justice Act 2009 introduced a number of reforms to coronial law, many remain concerned that they did not go far enough, with criticisms that the coronial system remains fragmented and of potentially inconsistent quality (Thomas et al., 2014). The charity INQUEST is the loudest voice calling for reform of coronial law and has three main changes it is campaigning for, namely:

1.Automatic and non-means-tested legal aid funding for families’ legal representation, following any state-related death to cover preparation and representation at the inquest (recently progress was made on this front, with families being able to apply for legal representation through exceptional case funding without means testing from 12 January 2022 (His Majesty’s Government, 2021)).

2.A new and independent public body to analyse and monitor recommendations arising out of post-death investigations, inquiries and inquests, in particular to ensure the recommendations are being implemented.

3.The imposition of a duty of candour for all state authorities and officers and private entities with an impact on public safety (INQUEST, 2021).

Coroners – Who Are They?

Coroners are independent judicial office holders, that is members of the judiciary, whose primary role is to investigate certain deaths. They are appointed (but not employed) by the relevant local authority for the ‘coroner area’. There are currently 83 coroner areas in England and Wales. However, the Chief Coroner and the Ministry of Justice have a long-term plan to reduce the number of coroner areas to 75, by merging coroner areas where possible. This is in the hope of providing a more consistent and standardised service for bereaved families and ensuring coroner areas are of the same size and population (Judiciary, 2022a).

In years gone by, coroners could either be a doctor or a lawyer. However, since the introduction of the Coroners and Justice Act 2009 in 2013, newly appointed coroners must have the five-year judicial eligibility qualification, which requires five years of legal practice or part-time judicial practice. ‘Newer’ coroners are therefore less likely to have a medical background, and it is increasingly common for junior barristers to be appointed as coroners in their local area.

Each coroner appointment is subject to the approval of the Chief Coroner and the Lord Chancellor. Coroners are usually referred to as ‘Assistant Coroners’, and often serve part-time while continuing to work as lawyers or doctors.

Every coroner area has a Senior Coroner. The Senior Coroner oversees the coroner service for his or her coroner area. Sometimes, in particularly busy coroner areas, an Area Coroner is also appointed. The Area Coroner will assist the Senior Coroner in his or her functions.

Each coroner’s service will also have several coroner’s officers. The coroner’s officers support the coroners in their investigations and undertake a number of functions, such as receiving reports of deaths, requesting and gathering evidence (as directed by the coroner), liaising with the bereaved family, taking witness statements, liaising with organisations who are ‘interested persons’ to the inquest and preparing ‘bundles’ of evidence, if there is to be an inquest hearing.

The Chief Coroner provides national leadership for all coroners in England and Wales, and the role includes providing training for all coroners and coroner’s officers, keeping a register of coroner investigations lasting more than 12 months and publishing Prevention of Future Deaths reports and responses.

Key Functions of Coroners

It is the coroner’s duty to investigate any death within their area where the coroner has reason to suspect that the death meets the criteria outlined previously (Coroners and Justice Act 2009, Section 1).

Of course, coroners need to be notified that such a death has occurred. Often, such deaths will be reported to the coroner by the deceased’s own family members or friends, or by the police. However, there is also a duty on registered medical practitioners, imposed by the Notification of Deaths Regulations 2019, to notify the coroner of a death if one or more of the circumstances set out in the Regulations apply. Any deaths caused or contributed to by the following should therefore be reported to the Senior Coroner for the relevant area, regardless of how much time has passed since the death (Ministry of Justice, 2022):

Poisoning, including by an otherwise benign substance, for example salt/sodium. It also includes acute poisoning caused by alcohol and smoking.

Exposure to or contact with a toxic substance, for example, radioactive material.

The use of a medicinal product, controlled drug or psychoactive substance, for example, ‘legal highs’, ‘designer drugs’ and herbal highs.

Violence, trauma or injury – either inflicted by someone else, or the deceased themselves, or as a result of an accident (such as a fall or road traffic collision).

Self-harm, for example, as a result of poisoning, trauma or injuries inflicted by the deceased him or herself.

Neglect, including self-neglect. Neglect applies if the deceased was in a dependent position, for example, a child, an elderly person, a person with disability or serious illness, and it is reasonable to suspect that there was a failure to provide them with, or to procure for them, certain basic and obvious requirements, such as nourishment, liquid, shelter or warmth, medical assessment, care or treatment. The death may be from natural causes, but resulting from some human failure, act or omission. Self-neglect applies if the death is as a result of the deceased intentionally or unintentionally not preserving their own life. This does not, however, include circumstances where there has been a documented reasonable and informed decision by the deceased not to preserve their own life. Nor does it extend to deaths where the lifestyle choices of the deceased, for example, excessive eating, drinking or smoking, may have resulted in their death.

The person was undergoing treatment or a procedure of a medical or similar nature. For example, if the death was caused by errors in the medical procedure or treatment (such as incorrect drug dosage), or death arose from a recognised complication of a procedure given for an existing disease or condition, or the original diagnosis was delayed or erroneous, leading to either death or an acceleration of death.

Injury or disease attributable to any employment held by the person during their lifetime, for example, a fall from scaffolding or being crushed in machinery. It also includes diseases in the course of employment, such as asbestos-related lung disease or pneumoconiosis.

Any unnatural death not falling within the previous categories.

If the cause of death is unknown.

The deceased died while in custody or in state detention, including detained in hospital under the Mental Health Act 1983, detained in prison, detained in a young offender institution, detained in immigration detention centres or in court cells.

If the identity of the deceased is unknown.

If you attend a call and the person either dies by the time you have arrived, or during your attendance, you should have in the back of your mind whether the circumstances of the death mean it will need to be referred to the coroner. It may be prudent for you to document in the notes as much info as possible about the circumstances of the death, so this can be handed over to hospital medical staff or the police (depending on the circumstances of the death). This in turn will help the coroner with their investigations. Having full notes will also help with statement writing, if required.

Next Steps After Report

Once a death has been reported to the coroner, the coroner must decide whether an investigation is needed and, if it is, investigate the case appropriately.

Coroners are required by law to establish the medical cause of death (where possible) and to answer the following four questions (Coroners and Justice Act 2009, Section 5):

Who died?

Where did they die?

When did they die?

How did they come by their death?

The answer to the first three questions is, in most cases, relatively straightforward. It is the question as to ‘how’ a person came by their death that can prove more difficult to answer. In some cases, the coroner may be able to determine the ‘how’ by speaking to family members, or the clinician last involved in the deceased’s care, or by directing a post-mortem examination to be carried out. However, in other more complex cases, or where family members/carers/friends have concerns over what happened to their loved one in the lead up to their death (particularly if statutory agencies were involved), then the coroner may open an inquest, which is a fact-finding inquiry into the death, held in a coroner’s court.

Prevention of Future Deaths

Coroners also have a duty to take action to prevent future deaths. During the course of a coroner’s investigation, if it appears that there is a risk of other deaths occurring in similar circumstances, then the coroner must write a report to the relevant people or organisation(s) who are in a position to take action to prevent the risk. This is known as a Prevention of Future Deaths (PFD) report or a Regulation 28 report, because the power to write such a report comes from Regulation 28 of the Coroners (Inquests) Rules 2013. The person or organisation must then respond within 56 days (unless granted an extension), setting out what action has been taken or will be taken to address the coroner’s concerns (Chief Coroner, 2020).

PFD reports are vital to ensure learning from deaths; they are not intended as a punishment and are made for the benefit of the public (Chief Coroner, 2020). Organisations will, however, normally seek to avoid receiving a PFD report, as it can result in action or investigations by regulatory bodies and negative media coverage. It is therefore likely that when a coroner indicates that they are considering writing a PFD report, organisations will provide documentary evidence or witnesses to give oral evidence in court in order to address and alleviate the coroner’s concerns. Where there has been an internal investigation into the death (e.g., by an NHS Trust), the coroner may seek assurance that any action plans or improvement work identified as a result of that investigation have been completed, or are in the process of being completed.

While there is no requirement for organisations to make changes following receipt of a PFD report, it is well advised that they do so. Should a future death occur in circumstances where a coroner has previously identified an issue and issued a PFD report, this could have serious implications for an organisation and is something that the coroner as a local judge can identify and raise in future PFD reports (Chief Coroner, 2020).

PFD reports are public documents. The reports themselves and the response(s) provided by individuals or organisations can be found on the Courts and Tribunals Judiciary website (Judiciary, 2022b).

Inquests

An inquest is a public court hearing, presided over by a coroner to decide the answer to those four key questions: Who died? When did they die? Where did they die? How did they die?

It is important to remember that an inquest is a fact-finding inquiry, and it is not meant to apportion blame on any individuals, nor impose any criminal or civil liability (Coroners and Justice Act 2009, Section 10(2)). An inquest will therefore not be able to find that any individual has been negligent or committed a criminal offence. A coroner’s court is not the proper place to explore questions of clinical negligence, and warnings have been given to those who seek to try to use an inquest to get a negligence claim ‘on its feet’ (R v. Birmingham and Solihull Coroner ex p Cotton [1996]). In 2021, the Bar Standards Board produced a guidance document entitled Competencies for Lawyers Practising in the Coroners’ Courts. In its foreword, the Chief Coroner applauded the guidance’s emphasis on the inquisitorial nature of coronial proceedings, reiterating that an inquest ‘is not a means of apportioning blame, let alone a form of litigation’ (Bar Standards Board, 2021).

The Inquisitorial Nature of Inquests

Matthews (2020, p. 7) illustrates the important distinction between inquests and an accusational process by quoting Lord Lane CJ in R v. South London Coroner Ex p. Thompson [1982]:

Once again it should not be forgotten that an inquest is a fact finding exercise and not a method of apportioning guilt. The procedure and rules of evidence which are suitable for one are unsuitable for the other. In an inquest it should never be forgotten that there are no parties, there is no indictment, there is no prosecution, there is no defence, there is no trial, simply an attempt to establish facts. It is an inquisitorial process, a process of investigation quite unlike a trial where the prosecutor accuses and the accused defends, the judge holding the balance or the ring, whichever metaphor one chooses to use.

At an inquest, you are not required to answer any question that is put to you that could incriminate you. If you are asked such a question, the coroner will give you a warning and must inform you that you may refuse to answer (Matthews, 2020).

Having said all of that, inquests will often explore facts that have a bearing on criminal and civil liability (Thomas et al., 2014), and it can sometimes feel like you are ‘on trial’ when giving your evidence in a coroner’s court, particularly if you are being asked lots of difficult questions about what you did or didn’t do. Understandably, therefore, healthcare practitioners can feel very stressed and anxious about attending court to give evidence.

Different Types of Inquest

Inquests can vary hugely from one case to another, and also arguably from one coroner area to another. Each coroner’s service tends to have its own way of handling inquests, and so your experience in one coroner’s court can be completely different from another in a different coroner area.

Some inquests are ‘documentary’ inquests. This means that no live witnesses are called, because the coroner and the deceased’s family/next of kin do not have any concerns about the death. Documentary inquests therefore tend to be short and straightforward.

Other inquests, however, can take days, weeks and even months to conclude (the ‘fresh’ inquests into the deaths of those at Hillsborough Stadium in 1989 are the longest-running inquests in British legal history. The inquests started on 31 March 2014 and the jury heard 296 days of evidence. The inquests ran for over 2 years). The length of an inquest will be influenced by many factors, including the number of ‘interested persons’ involved, the number of witnesses called, whether the inquest engages Article 2 of the European Convention on Human Rights and whether a jury is required.

Interested Persons

An ‘interested person’ is a person or organisation who is entitled to participate in the inquest and who has certain rights, such as the right to receive a copy of all the evidence collated by the coroner, the right to ask questions of the witnesses during the inquest hearing and the right to make submissions to the coroner on what the inquest conclusion should be. There is a list of people/organisations that qualify as interested persons, which is set out in Section 47(2) of the Coroners and Justice Act 2009. Interested persons will always include family members or personal representatives of the deceased.

The list of interested persons also includes, ‘a person who may by any act or omission have caused or contributed to the death of the deceased, or whose employee or agent may have done so’ (Coroners and Justice Act 2009, Section 47(2)(f)). Typically, therefore, if a person has died and there are concerns held by either the coroner or the deceased’s family about the care provided to the deceased by an organisation in the lead up to the death, that organisation will be designated an interested person by the coroner. NHS Trusts, local authorities, private healthcare providers, GP practices, police constabularies, schools and prison authorities are all therefore capable of being interested persons. It would be unusual for an individual paramedic to be made an interested person in their own right – it is usually their employing NHS Trust that is designated the interested person.

If an Ambulance NHS Trust (as an example) is made an interested person, that is not of itself something to be overly concerned about and is in fact quite common. By making the NHS Trust an interested person, the coroner is allowing that organisation to have all the corresponding rights, such as the right to receive all the evidence obtained for the inquest, and to ask questions at the inquest hearing. This is of course helpful to the organisation concerned and will allow for effective preparation and participation in the inquest.

Properly interested persons are also entitled to be legally represented at the inquest hearing. NHS Trusts that are designated interested person status will often instruct legal representation, particularly if the inquest is likely to be complex or if multiple witnesses from the Trust have been called. While the lawyer will represent the NHS Trust/organisation as a whole, individual witnesses will typically fall under the Trust’s ‘umbrella’ and will be afforded guidance and representation by the legal team. The Trust’s lawyer should speak to the witnesses in advance of the inquest hearing, to explain the inquest process and outline the issues that are likely to arise. The lawyer must not, however, rehearse or practice your evidence with you, must not coach you in respect of your evidence and cannot tell you what to say (or what not to say). The lawyer should also attend the inquest hearing itself, to represent the Trust and its witnesses. The legal representative will be entitled to address the coroner, ask questions of the witnesses and make submissions to the coroner on what the inquest conclusion should be.

If you as a paramedic are made an interested person in your own right, then it is recommended that you seek legal advice or support from either your employing organisation or indemnity provider as soon as possible.

Article 2 Inquests

Some inquests are deemed by the coroner to be ‘Article 2’ inquests. These are also sometimes referred to as enhanced or Middleton inquests. This means that Article 2 of the European Convention on Human Rights is engaged, Article 2 being the Right to Life. An inquest is required to be Article 2 compliant where one of the two substantive obligations that Article 2 places upon the state have been arguably breached. These are:

1.The positive obligation to protect life

2.The negative obligation to not to take life deliberately (except in certain circumstances) (Matthews, 2020).

The first obligation, to protect life, is further broken down into a systemic duty and an operational duty. The systemic duty requires public bodies to have systems in place (for example, policies and procedures) to protect life. The operational duty requires preventative measures to be taken to protect life where there is a real and immediate risk to life that the state knew, or ought to have known, about (Matthews, 2020). Any arguable breach of these obligations will result in Article 2 being engaged.

There are further legal tests that are applied to determine if Article 2 is engaged for an inquest, but there are also some circumstances where it is essentially engaged automatically, such as a death by suicide in a prison, or of a person detained under the Mental Health Act 1983 (Thomas et al., 2014).

Whether Article 2 is engaged or not can involve some difficult legal arguments, which individual practitioners do not need to concern themselves with (this is for the lawyers and the coroner to debate). However, it is important for paramedics to understand that when Article 2 is engaged, the coroner will not only explore how the deceased died but also in what circumstances the person died. To look at the wider circumstances surrounding the death, a more extensive range of evidence can be considered. An Article 2 compliant inquest should ascertain the following (Thomas et al., 2014):

Any shortcomings in the system

Defects in the instructions and training of the state agents involved, and the planning, management and control of the actions under consideration, including the distribution of information and the supervision of staff

The relevant legal or regulatory framework in place

Individual failings that a sound system is expected to detect and remedy before harm is done.

Article 2 inquests are therefore likely to be longer in length, and it is expected that more witnesses will be called to give evidence. Importantly, engaging Article 2 also means that the coroner (or jury) can make critical findings in their conclusion. The prohibition on apportioning civil or criminal liability remains, however (Chief Coroner, 2021).

Where Article 2 is found to be engaged, the bereaved family will be eligible to apply for legal aid funding to assist with legal representation at the inquest.

Inquests with a Jury

For some inquests, there is a statutory requirement for the coroner to sit with a jury. The jury will hear the evidence, can ask questions of witnesses and will ultimately answer the statutory questions (who, when, where and how the person died) in place of the coroner. A jury ensures the inquest is a ‘more democratic and accountable process’ and represents a separation of the state in the investigation of the death. This is because although a coroner is an independent judicial officer, they remain an agent of the state (Thomas et al., 2014).

Historically, all inquests were held with a jury. Today, the circumstances in which a jury is required are prescribed by law and set out in Section 7 of the Coroners and Justice Act 2009. The circumstances when a jury is mandated are as follows:

When the deceased died in custody or state detention and the death was violent or unnatural, or the cause of death is unknown. ‘State detention’ includes deaths in prison or deaths in hospital while detained under the Mental Health Act 1983.

When the death resulted from the act or omission of a police officer.

When the death was caused by a notifiable accident, poisoning or disease.

There is also a provision allowing a coroner to sit with a jury if the Senior Coroner thinks there is ‘sufficient reason’ for doing so. In exercising their discretion whether to sit with a jury, the coroner will consider the wishes of the family, the circumstances of the death and, in particular, if they bear any resemblance to the types of situations where a jury is mandated, and how complex the medical evidence is (Chief Coroner, 2016).

It is generally accepted that a jury adds an element of unpredictability to an inquest, but there are strict legal tests that are applied to ensure that a jury is not able to come to a conclusion that is ‘unsafe’; i.e., not legally or factually correct (Chief Coroner, 2013). Inquests involving a jury also tend to be more lengthy, as each witness’s evidence takes longer (for example, complicated medical procedures will need to be explained in detail to the jury, and the jury may ask the witnesses lots of questions) and numerous breaks are required throughout the day. Juries can also take a long time in deliberating, agreeing and formulating their conclusion at the end of the inquest hearing.

Experts

In some circumstances, the coroner will obtain expert evidence to assist with their inquiries (Matthews, 2020). Where this concerns paramedics, it will typically be because there are complex medical issues involved, or because there is some complaint about the treatment provided (Matthews, 2020), and the coroner needs to understand whether the action or inaction taken by the individual practitioners was reasonable and appropriate in the circumstances.

In inquests involving paramedic care, the expert will typically be sent all the evidence gathered for the inquest, including any clinical notes, and be asked to comment on the care provided. In particular, the expert will usually be asked to comment on whether the care provided was appropriate, or whether there were any deficiencies or omissions in the care that may have caused or contributed to the death.

If an expert is to be instructed, it is good practice for the coroner to share the curriculum vitae (CV) of the proposed expert with the clinicians whose practice they are to comment on. This is to ensure there are no conflicts of interest and that the expert has the appropriate calibre and expertise (Matthews, 2020; R v. Pabon [2018]). Usually, the CV will be sent to either the legal or risk management department of the relevant ambulance trust, or their lawyers (if lawyers have been instructed). The CV should in turn be shared with the individual clinicians involved in the case. If there are concerns about the coroner’s choice of expert, they should be raised with the coroner as early as possible.

Once completed, the expert report should be sent by the coroner to all the interested persons in advance of the inquest. It should in turn be sent to any individual clinicians whose practice is commented upon, so they have an opportunity to review the report and, importantly, consider any criticisms that may have been made about the care they provided. The expert will be called to give evidence at the inquest, and all interested persons will be afforded the opportunity to question him or her, to test and explore his or her findings.

Any paramedic providing an expert report for a coroner should ensure that they only comment on matters within their scope of expertise. They should ensure that they have access to all the relevant materials that they need to complete their report and should be provided with any material that is subsequently provided to the coroner that might be relevant to their report (Arksey v. Cambridge University Hospital NHS Foundation Trust [2019]). They should also ensure they are able to identify and take into account important issues and, most importantly, that they know how to apply the relevant legal tests to the opinion they provide (ZZZ v Yeovil District Hospital NHS Foundation Trust [2019] at [82–85, 87–89]).

As expert reports are likely to be read by families, and possibly read out at the inquest, it is important that they can be easily understood by lay people, including the coroner (Rix, 2021, 281). The report should include all the relevant detail, even if this might be upsetting for families or clinical colleagues to read (Rix, 2021, p. 281). When writing reports for inquests, experts ‘should restrict themselves to questions of fact, diagnosis and opinion, refraining from argument or the expression of views which appear to usurp the function of the court’ (Re LM (Reporting Restrictions: Coroner’s Inquest) [2007]; Rix and Powers, 2021, p. 281).

Possible Inquest Conclusions and the Record of Inquest

At the end of an inquest, the coroner will typically summarise their findings of fact and give their conclusion as to how the deceased came to their death. The conclusion will form part of the Record of Inquest (RoI). The findings of fact that underpin the conclusion are read in open court, but are not usually written up in a formal judgment and neither are they readily available to the public (Dolan QC, 2022).

The RoI is made up of five sections that are referred to as ‘boxes’. A template for the RoI can be found as an annex to Chief Coroner’s Guidance No. 17 (2021) and is reproduced in Figure 5.1. Boxes 1, 2 and 5 are self-explanatory and consist of the demographic details and medical cause of the person’s death. It is unusual for the information that populates these boxes to be in question or controversial.

Figure 5.1 Record of Inquest.

The information that is likely to be of most interest to clinicians is recorded in Boxes 3 and 4. Box 3 records how, when and where the person came by their death, and in Article 2 inquests, in what circumstances the person came by their death. Box 4 records the coroner’s (or jury’s) conclusion as to the death.

In Box 4, the conclusion can be either one of nine possible short-form conclusions taken from an ‘official’ list (although there are no statutory requirements for the coroner’s conclusion to take any particular form (Matthews, 2020). The nine short-form conclusions are set out in Figure 5.2 (The Coroners (Inquests) Rules 2013, Schedule).

A narrative conclusion, or a combination of short-form and narrative conclusion (Matthews, 2020), can also be used. However, it is preferred that, where possible, short-form conclusions are used (Chief Coroner, 2021). A narrative conclusion is considered appropriate where a combination of Box 3 and a short-form conclusion is insufficient to ‘seek out and record as many of the facts of the death as the public interest requires’ (Matthews, 2020).

It is now considered to be good practice that narrative conclusions should be brief, neutral, factual and non-judgemental, unless Article 2 is engaged (Matthews, 2020). Where Article 2 is engaged, the narrative can include judgemental language, such as ‘missed opportunities’, or ‘inadequate failures’ (Chief Coroner, 2021). The Chief Coroner’s Guidance No. 17 (2021) gives an example of what the difference might look like:

Non-Article 2:

‘The evidence leads me to find that the registrar did not seek advice from the consultant who was nearby and available at the time and the registrar knew that. The registrar acted on his own.’

Article 2:

‘There was a missed opportunity when the registrar failed to seek advice from the consultant.’

In addition to the conclusions set out previously, in some cases consideration can be given to adding neglect as a ‘rider’ to the coroner’s (or jury’s) conclusion. This applies where there is evidence (in the medical context) that the deceased was in a dependant position and that there was a gross failure to provide basic medical care. There must also be a clear causal link between the neglect and the death (Matthews, 2020).

Figure 5.2 Short form conclusions for Record of Inquest.

It is of note that a finding of neglect or other failures at an inquest does not automatically mean that a person or organisation is civilly liable to any other person. Establishing and obtaining compensation for civil liability requires separate civil litigation; for example, a civil claim for clinical negligence. Further, in civil litigation the findings of the inquest are not conclusive, and sometimes not admissible (Matthews, 2020). The statements prepared for the inquest, however, are highly likely to be used in any subsequent litigation or proceedings. For this and other reasons subsequently explored, time and care should be put into the preparation of your statement for the coroner.

If you are criticised in a coroner’s RoI or findings, or during the inquest hearing, you should consider if your duty to inform the Health and Care Professions Council is triggered. You should seek support from your employer, professional body, union or legal representative if you are unsure whether you need to self-refer.

Statement Writing

The first indication that you might be required to attend an inquest will be when you are asked to provide a statement for the coroner. This request will likely come from your manager or legal services department. Sometimes, the request will come directly from the coroner’s officer or a police officer (on behalf of the coroner). If you are approached for a statement, you should always let your line manager know so that they can liaise with the appropriate people or departments within your organisation to ensure you are appropriately supported.

Although it may come as an unwelcome surprise, it is best to attend to the request for a statement as quickly as possible. There may well be a deadline for your statement, as stipulated by the coroner. If you ignore or delay the preparation of your statement, you are unlikely to meet the deadline, which will start you off on the wrong foot with the coroner.

When drafting your statement, it is important that you give it proper time and attention. Often your organisation will provide you with a template to assist with the completion of your statement.

Before drafting your statement, you should ensure you have all the relevant information and documents you require. Often, due to the passage of time, you may not remember the incident, or have a poor recollection. It is therefore essential that you have all the relevant documents to ensure you provide an accurate account of your involvement with the deceased. It is important to remember that relevant information may not be limited to the patient’s clinical record and may include other information, such as call recordings and email exchanges. It is important that you set out all the materials you have used to draft your statement, in case the coroner wants a copy of the original document at a later stage. It is important to note here that it is a criminal offence to:

Do anything that is intended, or is likely, to have the effect of distorting, altering or preventing any evidence or document that is given for the purposes of a coroner’s investigation

Intentionally suppress, conceal, alter or destroy a relevant document. A document is relevant if it is likely that a coroner conducting an investigation would, if aware of its existence, wish to be provided with it.

When you have collated and reviewed all the relevant information, you should then draft your statement. Having regard to the tips set out below will assist you (James, 2018):

Use numbered paragraphs. This will help you if you need to be taken to specific points in your statement should you be called to give evidence.

Make sure your statement is a detailed, chronological and honest account of your involvement with the deceased.

Include details of your professional qualifications, background and experience, and specify how you came to be involved with the deceased.

Identify anyone else who was with you during your involvement with the deceased, and state their professional status.

Refer to key entries in the medical records or PRF, and explain your investigations and findings.

Explain medical terminology in full rather than using abbreviations.

Stick to the facts and avoid including speculation or comments on the actions of others.

Be sure you have read your statement through and are happy with its contents before you sign and date it. Once you have signed your statement, ensure that you keep a copy, as you may need to refer to it again at a later date if called to attend the inquest.

Attending an Inquest

After you have submitted your statement, some time may pass before you hear anything further. Sometimes, the coroner will decide to hold a documentary hearing, or decide that you are not required as a witness. If so, then that will be the end of the matter.

However, in other cases, the coroner may decide to hold a hearing and decide that you are required to attend to give evidence. As soon as you are notified that you are required as a witness, make a note of the inquest date in your diary and ensure that you do not book any other commitments or holidays on this day. If you cannot make the date of the inquest, you must ensure the coroner is informed of this immediately. There needs to be a good reason why you cannot attend, however – only things such as pre-booked holidays abroad or vital medical appointments would be an acceptable excuse. The coroner is able to issue a summons for your attendance if needs be. Failure to attend court once a summons has been issued can result in a fine or imprisonment.

Before attending the inquest, you should ensure you know where the inquest is going to be held (and in the current climate if it is going to be held ‘in person’ or held remotely via video conferencing software). You should arrive in good time and ensure that you have reviewed your witness statement, the medical records, the Trust’s internal investigation report (if there is one), expert report (where applicable) and any documents that you or your legal representatives have identified as relevant to your evidence. You may wish to take hard copies with you to the hearing. If do this, it is preferable to have the coroner’s pagination on your copies as this will assist you in navigating the documents when you are asked questions.

For some inquests, particularly those where Article 2 is engaged, the coroner may also ask you about your employer’s policies and procedures, or other relevant policies, procedures and guidelines. You should find out if any of these have been disclosed to the coroner before you attend the inquest and ensure you are familiar with them before you attend. If you have deviated from any of these, you should be prepared to explain your reasoning for this, or where there is not a good reason for deviation, be candid and provide assurance that you have reflected on the incident and that your practice has now changed.

Inquests are held in a variety of locations, generally in council buildings or purpose-built courts. On arrival, there may be rooms available for you to sit with other witnesses or your legal team, or you may be asked to wait in a foyer or corridor. When you enter the courtroom, you should sit where directed by the ushers. Court formalities will normally apply, such as standing when the coroner enters the room. Should you need to address the coroner you should use ‘Sir’, ‘Ma’am’ or ‘Madam’.

When it is time for you to give evidence, you will be led to a witness box or chair. You will be asked to swear (taking an oath that you will tell the truth on a holy book) or affirm (a secular alternative, making a promise that you will tell the truth) before you give your evidence, as it needs to be given ‘under oath’. This is arguably the most important point to remember when giving evidence at an inquest. Your evidence should be your own honest and independent recollection, and you must not give evidence that is misleading or untruthful.

You are allowed to take your witness statement into the witness box with you, and it is recommended that you do so, so you can refer to it if necessary. The coroner will likely start by asking you some generic questions, including your name, professional address, qualifications and how long you have been qualified for (it is helpful to include details of your qualifications in the introductory paragraph of your statement). They will then typically take you through your involvement with the deceased in a chronological order. They will have your statement in front of them, and will use this as a guide or a prompt in order to formulate their questions. The coroner may also ask you questions about the Trust’s internal investigation report and expert report (where applicable), or other documents in the coroner’s bundle.

If the coroner asks you a question to which you do not know the answer, then you should say so, and explain why you do not know. If you are asked about an issue and you simply cannot remember anything more than you have already explained, then again you should say so. It is important that you do not make up or fabricate evidence. Although you are likely to be nervous, try to talk as clearly as you can into the microphone. The coroner and the other interested persons will be taking a detailed note of what you say, so it is frustrating for everyone when a witness talks too quietly or quickly.

When the coroner has finished asking you questions, the other interested persons will have the opportunity to ask you questions. This includes the deceased’s family. Questions may come directly from family members if they are not legally represented, or from their lawyer if they are. However nervous you are, you must remember that this is an extremely difficult and often distressing time for the family. Be patient and calm when they are asking questions of you. If the questions are difficult to follow, then the coroner should intervene to help them formulate what they want to ask. If, however, you remain unclear as to what the question is, it is fine for you to say so, and to ask for the question to be repeated or rephrased.

If there is a jury, jury members can also ask questions of you. Lastly, if your organisation is legally represented, your lawyer can ask you questions. They will only usually do so if there is something important to bring out in evidence, or if something requires clarification.

Once all the questions have been asked, your evidence will be concluded. You should not leave the court until the coroner informs you that you are ‘released’, you can then stay in court to hear other people’s evidence or you may prefer to leave. You can be re-called if something arises in another witness’ evidence that means the coroner has further questions for you, but this is relatively uncommon.

When the inquest has concluded, the coroner (or jury) will produce a Record of Inquest. This is a publicly available document, and you can request a copy at the end of the inquest should you wish to read it. The coroner, or jury, will also read their conclusion at the end of the hearing in court, which you can attend if you wish.

As inquests are public proceedings, any member of the public can attend the hearing. For ‘high profile’ inquests, this may include journalists, who can report anything that is said during the proceedings, including your name and occupation. Should you be approached by a journalist at any point for a statement or comment, you should follow your organisation’s guidance on communicating with the media. Usually, you will be required to direct them to either your organisation’s legal representative or communications department and asked not to provide any comment on the case.

Summary

The role of the coroner is very specific, limited to establishing four statutory questions, namely: who the deceased was and how, when and where they died. Coroners are not concerned with matters of civil or criminal liability. Coronial proceedings can, however, be used as a springboard to litigation, and in complex or sensitive cases can also attract media interest. Preparation is therefore essential, not only to properly assist the coroner in fulfilling their statutory functions, but also to protect yourself from easily avoided mistakes or complications during the inquest process. Good clinical records and a well-prepared statement are the foundations for making the inquest, and any other legal proceedings, run as smoothly as possible. It is therefore essential that paramedics maintain good clinical records and make sure that any statement prepared for the coroner is accurate, clear and truthful.

Investigating Deaths – Scotland

The Scottish equivalent of coroners fall under the Crown Office and Procurator Fiscal Service (COPFS), with the Scottish Fatalities Investigation Unit (SFIU) (a specialist team in the COPFS) investigating all sudden, suspicious, accidental and unexplained deaths, including those of children (Crown Office and Procurator Fiscal Service, 2021).

Investigating Deaths – Northern Ireland

In general terms, deaths in Northern Ireland are investigated in a similar way to those in England and Wales, as Northern Ireland has a Coroner’s Service and holds inquests to investigate deaths (Department of Justice, 2022).

Recommended Reading

Thomas L, Straw A, Machover D and Friedman D (2014). Inquests: A Practitioner’s Guide. London: Legal Action Group.

References

Bar Standards Board (2021). Competences for Lawyers Practising in the Coroners’ Courts. Available at: https://www.barstandardsboard.org.uk/uploads/assets/c2e4cb09-7793-4c03-b39a84507d709932/Coroners-Court-competences-Sept2021.pdf (accessed 28 June 2023).

Chief Coroner (2013). Law Sheet No. 2 Galbraith Plus. Available at: https://www.judiciary.uk/wp-content/uploads/2020/08/law-sheets-no-2-galbraith-plus.pdf (accessed 28 June 2023).

Chief Coroner (2016). Law Sheet No. 5 The Discretion of the Coroner. Available at: https://www.judiciary.uk/wp-content/uploads/2020/08/law-sheets-no-5-the-discretion-of-the-coroner.pdf (accessed 28 June 2023).

Chief Coroner (2020). Revised Guidance No. 5 Reports to Prevent Future Deaths. Available at: https://www.judiciary.uk/wp-content/uploads/2020/11/GUIDANCE-No.-5-REPORTS-TO-PREVENT- FUTURE-DEATHS.pdf (accessed 28 June 2023).

Chief Coroner (2021). Guidance No. 17 Conclusions: Short-form and Narrative. Available at: https://www.judiciary.uk/wp-content/uploads/2021/09/GUIDANCE-No-17-CONCLUSIONS-7-September- 2021.pdf (accessed 28 June 2023).

Crown Office and Procurator Fiscal Service (2021). Our Role in Investigating Deaths. Available at: https://www.copfs.gov.uk/about-copfs/our-role-in-investigating-deaths/ (accessed 28 June 2023).

Department of Justice (2022). Coroners Service for Northern Ireland. Available at: https://www.justice-ni.gov.uk/articles/coroners-service-northern-ireland (accessed 28 June 2023).

Dolan QC B (2022). Do buttered parsnips taste better? Publishing coronial conclusions. Available at: https://www.ukinquestlawblog.co.uk/butteredparsnips/ (accessed 28 June 2023).

Glasson J and Knowles J (2010). Blackstone’s Guide to the Coroner’s and Justice Act 2009. London: Oxford University Press.

Gross C (1892). The early history and influence of the Office of Coroner. Political Science Quarterly, 7(4): 656–672.

His Majesty’s Government (2021). Civil news: exceptional case funding for families at inquests. Available at: https://www.gov.uk/government/news/civil-news-exceptional-case-funding-for-families-at-inquests (accessed 28 June 2023).

INQUEST (2021). Inquest Campaigns. Available at: https://www.inquest.org.uk/Pages/Category/campaigns (accessed 28 June 2023).

James A (2018). Attending an Inquest. Available at: https://andreajameslegal.com/attending-an-inquest-paramedic-insight-1-march-2018/ (accessed 28 June 2023).

Judiciary (2021). Chief Coroner’s Guidance, Advice and Law Sheets. Available at: https://www.judiciary.uk/related-offices-and-bodies/office-chief-coroner/guidance-law-sheets/coroners-guidance/ (accessed 28 June 2023).

Judiciary (2022a). Mergers of Coroner Areas. Available at: https://www.judiciary.uk/courts-and-tribunals/coroners-courts/coroners-appointments-contacts-and-areas/mergers-of-coroner-areas/ (accessed 28 June 2023).

Judiciary (2022b). Prevention of Future Death Reports. Available at: (accessed 28 June 2023).

Matthews P (2020). Jervis on Coroners. London: Sweet & Maxwell.

Ministry of Justice (2022). Guidance for Registered Medical Practitioners on the Notification of Deaths Regulations. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1062499/registered-medical-practitioners-notification-deaths-regulations-25-march-2022.pdf (accessed 28 June 2023).

Rix K and Powers M (eds) (2021). Rix’s Expert Psychiatric Evidence. Cambridge: Cambridge University Press.

Thomas L et al. (2014). Inquests: A Practitioner’s Guide. London: Legal Action Group.

Chapter 6

Consent

Vince Clarke

Introduction

Paramedics, along with other healthcare professionals, usually need to make contact with their patients in order to assess, examine and treat them. The right to undertake such contact is limited in law and should only be done with the permission of the patient concerned. Such permission is termed ‘consent’.

In some cases, the ability of the paramedic to obtain consent from a patient is interfered with, perhaps due to the clinical presentation of the patient (for example, if they are unconscious) or due to the circumstances in which the patient is presented (such as if they are in situations where family or friends may influence their decision making).

This chapter will set out what is meant by consent in relation to adult patients aged eighteen and above and will seek to clarify both the importance of gaining consent and the possible ramifications when appropriate consent is not gained. Consent in those under the age of 18 is discussed separately in Chapter 8: Legal and Ethical Treatment of Children.

What Is Consent?

Consent can be considered simply as the giving of permission by a patient for a clinician to act. When considering medical ethics, Gillon (2007) defined consent in the following way:

Consent means a voluntary, uncoerced decision, made by a sufficiently competent or autonomous person on the basis of adequate information and deliberation, to accept rather than reject some proposed course of action.

(Gillon, 2007)

This is a seminal definition and, while debates around the definition have progressed considerably since this was written, this definition offers the important, underpinning features of consent.

Obtaining consent from patients is a central tenet of the special relationship between healthcare professionals and service users, and has legal, moral and clinical functions. Legally, the gaining of consent can protect the clinician from what might otherwise be considered to be unlawful touching. Morally, it is essential in fulfilling the ethical duty of respect for autonomy. Clinically, the gaining of consent engenders cooperation and trust between the clinician and the service user enabling an easier treatment experience for all parties.

Without gaining consent, any invasive medical treatment could amount to assault and/or battery. Patients who have capacity have the right to refuse to give consent to any assessment or treatment, even if their reasons may appear to the healthcare professional to be bizarre, irrational or non-existent. This right to refuse applies even if such a refusal might result in the death of the patient.

A Brief History of Consent

In the past, when the paternalistic approach of ‘doctor knows best’ was the mainstay of the medical profession, consent was something that was, on the whole, presumed. Doctors were not questioned, nor did they explain their actions or intentions to their patients. This approach began to change in the middle of the 20th century when patients started to become both better informed and more litigious. This evolution coincided with developments in the field of medical ethics, the principles of which require patients to be placed in a position of greater control of their medical treatment.

Emphasis on the importance of consent was provided early in English law, within Beatty v. Cullingworth [1896], where the patient underwent surgery to remove one diseased ovary, but while under the anaesthetic, the surgeon found both ovaries to be diseased and removed both, without the tacit, verbal or written consent of the patient. Following on from this, it was advised that consent should be either in writing or in the presence of witnesses. From this point various cases were seen within Britain and America, with perhaps one of the best known being Schloendorff v. Society of New York Hospital [1914] and Hunter v. Burroughs [1918]. In the latter, as well as gaining consent, it was found that ‘it is the duty of a physician in the exercise of ordinary care to warn a patient of the danger of possible bad consequences of using a remedy’. From these cases, the foundation for the legal application of consent in the medical setting was quite clearly established.

The 1957 case of Salgo v. Leland Stanford Jr. University saw the term ‘informed consent’ used for the first time, beginning a debate regarding the distinction between cases which could be brought alleging battery and those alleging a breach of duty. The main focus of any litigious claim around consent was based on the degree of information that was shared with a patient, the basic principle being that, had the patient known of the (undisclosed) risk, they would not have consented to the procedure.

In the United Kingdom (UK), the cases of Bolam v. Friern Hospital Management Committee [1957] in England and Hunter v. Hanley [1955] in Scotland set the standard for what was considered to be ‘reasonable’ in respect of the amount of information expected to be given to a patient prior to their consent. Using the Bolam test when considering breach of duty was discussed separately in Chapter 4: Clinical Negligence.

The Bolam test also stood as the standard in respect of consent until it was overruled in 2015 when the case of Montgomery v. Lanarkshire Health Board was heard. In Montgomery, the test of materiality (what is material, or relevant, to be disclosed) was amended and moved on from the standard set in the Bolam test. The test of materiality defined in the Montgomery ruling was whether ‘a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it’.

Up to this point, using the Bolam test, it may have been the opinion of a doctor, and their peers, that it was reasonable, or in the best interests of a patient, to not disclose details of certain risks associated with a procedure in gaining consent to undertake the procedure. However, this position cannot be held following the Montgomery ruling.

Montgomery v. Lanarkshire Health Board [2015] SC 11

Nadine Montgomery was a diabetic woman of small stature. She delivered her son vaginally, but he unfortunately experienced complications owing to shoulder dystocia, resulting in hypoxic insult, which resulted in cerebral palsy. Montgomery’s obstetrician had not disclosed the increased risk of this complication in vaginal delivery, despite her specifically asking if the baby’s size could present a potential problem. Montgomery sued for negligence, arguing that, if she had known of the increased risk, she would have requested a caesarean section instead of opting for a vaginal delivery. The Supreme Court of the UK announced judgment in her favour in March 2015. This ruling overturned the previous decision made by the House of Lords in the case of Bolam, which had been law since the mid-1950s (Heywood, 2015). It established that, rather than being a matter for clinical judgment to be assessed by professional medical opinion, a patient should be told whatever they want to know, not what the doctor thinks they should be told (Chan et al., 2017).

The nature of obstetric cases is such that they can be very complex and situations can change in a matter of moments. The ruling in Montgomery is likely to have the greatest impact on such cases, where the ‘what if’ discussions between patient and obstetrician while gaining consent will need to be particularly thorough and based on an individual patient’s needs, following the guidelines already in place by the General Medical Council (GMC) (2020).

A non-obstetric example of the application of the Montgomery ruling can be found in Spencer v. Hillingdon Hospital NHS Trust [2015]. In this case, the patient had consented to a hernia operation. After the operation, he suffered from bilateral pulmonary emboli. Because he had not been advised of the risk of deep vein thrombosis or pulmonary embolism, or of symptoms that might indicate these, he did not seek immediate treatment. The judge considered the Montgomery ruling and found that failure to inform the patient of the risks as part of the consent gaining process was a breach of duty of care (Chan et al., 2017). Breach of duty is discussed more thoroughly in Chapter 4: Clinical Negligence.

At the time of writing, the Montgomery ruling has not yet been applied to a case concerning a paramedic, but professional guidance promoting best practice would always seek to involve the patient in their care decisions so any overt changes to practice are not likely to be seen. Indeed, the ruling in Montgomery was seen by a number of commentators to simply recognise the professional guidance regarding consent which had already been in place for a number of years (Chan et al., 2017).

What Makes Valid Consent?

As alluded to by Gillon (2007), consent relies on three factors to be considered valid:

1.The patient must have capacity

2.Consent must be given voluntarily

3.The nature of the proposed treatment must be understood, in broad terms, by the patient.

Each of these areas will now be briefly explored.

Capacity

Autonomy is a fundamental ethical right of patients. Treatment can only be undertaken with consent, otherwise a patient’s autonomy will have been ignored. The result is that a patient with capacity can lawfully refuse to give their consent to a proposed treatment. If this is the case, then the clinician who goes against the wishes of the patient can find themselves liable for battery. In cases where the adult patient lacks capacity, there is a requirement to act in the best interests of the patient. The matter of capacity will be further explored in Chapter 7: Legislation Relating to Mental Capacity, but it is important to note that consent, or the refusal of consent, cannot be valid without capacity.

Voluntariness

Consent is only valid when it is given voluntarily. The nature of medical consent is such that the circumstances in which it is sometimes sought (such as in life-threatening situations), may result in the degree of voluntariness being adversely affected. There are three main elements to be considered when judging the voluntariness of a patient’s decision; coercion, undue influence and mistake.

Coercion

Coercion occurs where one party successfully and intentionally influences another by presenting a credible threat of unwanted and avoidable harm so severe that the person is unable to resist acting to avoid it. Acts of coercion are often seen in abusive relationships, where the abusive partner controls the actions of the abused by controlling their behaviour. This type of controlling or coercive behaviour in intimate or familial relationships was made a specific offence in England and Wales as part of Section 76 of the Serious Crime Act 2015, later replicated in Northern Ireland and Scotland. If there is any suspicion that a patient is being coerced into a decision regarding their treatment, the patient may need to be considered as a vulnerable adult, and this would need to be reported through the appropriate local channels. Coercion is less likely to be encountered than undue influence.

Undue Influence

Undue influence is not the same as persuasion. In many clinical contexts, the clinician is undertaking to persuade a patient to agree to a particular course of treatment because it is considered by the clinician to be in the patient’s best interests. The act of persuasion usually involves giving a greater amount of information, and supporting evidence, to enable the patient to make an informed decision. This makes it distinct from undue influence.

Undue influence can, in law, be presumed in situations where the relationship between the patient and the persuader is one where there is an actual or perceived imbalance of power. For example, a parent can be presumed to have undue influence over their child or an employer over an employee. Persuasive arguments where there exists an imbalanced power relationship may be found to constitute undue influence. This was found to be the case in Re T (Adult: Refusal of Medical Treatment) [1993] where a mother was found to have unduly influenced her daughter’s decision-making process (although this was not the only factor material in the decision).

Re T (Adult: Refusal of Medical Treatment) [1993]

The patient, T, was an adult female who was pregnant and had been involved in a road traffic collision. T consented to an operation to manage her internal bleeding but refused a blood transfusion following discussions with her mother, a Jehovah’s Witness. T was not, herself, a Jehovah’s Witness. Subsequent to that refusal, T’s condition deteriorated and her baby was stillborn. T’s father, supported by her boyfriend, applied for a declaration that it would be lawful to give her a blood transfusion. It was found by the Court that there was no binding refusal and that blood could be lawfully administered in the best interests of T. On appeal, the Court of Appeal held that T’s refusals were invalid due to both her incapacity and because they did not cover the extreme situation that had arisen. The undue influence of the patient’s mother was also cited as leading to the invalidation of the refusal to consent to treatment.

As with most cases involving consent, T’s was a matter of refusal to consent to treatment. Had the persuasive influence of her mother resulted in an agreement to the life-saving treatment recommended by the medical team, it is unlikely that a claim of undue influence would have been made by the doctors or other family members. This case demonstrates the key consideration for paramedic practice is to consider the role of any third parties in the decision-making process of their patients.

Mistake

A mistake may occur where there is a material misunderstanding or a change of circumstances. In the case of Re T, the initial refusal was informed, in part, by assurances that a blood transfusion may not be necessary and other alternative treatments could be used. As T’s condition deteriorated, this was no longer the case, casting doubt on the validity of the initial refusal of consent. Mistake in this context is less likely to influence the validity of consent in cases involving paramedics.

Understanding the Proposed Treatment

Obtaining consent in paramedic practice presents a number of different challenges when compared to the medical profession. Medical doctors and surgeons often propose treatment that will be elective and undertaken at a point later in time relative to the gaining of consent. There is, therefore, sufficient time for a patient to gather the necessary information to become ‘informed’, either from the doctor or by their own means. The expectation of the patient to behave in a ‘reasonable’ manner in respect of their treatment is also a relatively recent development in the case law regarding consent.

Previously, the degree of information that was expected to be shared by a clinician in order to represent the gaining of ‘informed’ consent was based on the opinion of the profession itself. The case of Montgomery v Lanarkshire [2015] moved this position by finding that there was a patient component within the informed aspect of consent, with individual patients requiring differing degrees of information based on their particular circumstances.

While it may be professional opinion that a clinician would not be expected to disclose a potential risk that had a 0.1% probability, it may be that the relevance of that risk to the individual patient may be considerably higher in comparison to other members of the general population.

A (hypothetical) example might be a patient who is partially sighted and is undergoing a surgical procedure on their right shoulder. The 0.01% chance of sensory deficit in the fingertips associated with this procedure would not normally be considered by the profession to need be shared with a patient undergoing this operation due to the extremely low incidence. For this patient, however, the loss of sensation in their fingertips would have a direct impact on their ability to read Braille. The relevance of this risk is, therefore, greater in the context of this patient.

The test of informed consent is not necessarily that the patient would have refused to have the treatment if they had been informed of the associated risks, rather that such information might be used by them to better prepare for such an outcome and be better informed prior to the procedure.

The risks associated with completing clinical observations, such as a pulse check, respiratory assessment or blood pressure reading, are so minimal as to require the lowest threshold of informed consent. Of these examples, only blood pressure assessment may cause some direct discomfort to the patient. The ‘harm’ brought about must be balanced against the ‘benefit’ of gaining a blood pressure reading, following the principles of ethical clinical practice (Chapter 2: An Introduction to Ethics). By explaining to the patient that they may feel some discomfort during the procedure, but that it is necessary in order for an appropriate clinical decision to be made about their care, the requirements of ‘informed’ have been met. The patient may then present their arm or pull up their sleeve in order for the blood pressure measurement to be undertaken. This action is sometimes considered as being ‘implied consent’, but it is also appropriately informed.

Where the assessments become more invasive, such as a blood sugar measurement or taking of blood samples, the potential risks should be shared with the patient. Again, the risks associated with these procedures are extremely minimal and would not require an in-depth, prolonged discussion to take place.

Information regarding treatment and interventions should be more obviously considered and shared with the patient. The risks associated with the majority of paramedic interventions are set out by way of contraindications or cautions with procedures or medications. Ensuring that all information is shared with the patient prior to administering any medication or undertaking a procedure should appropriately cover all aspects of ‘informing’ in respect of consent to specific, potentially life-saving, treatments. Challenges tend to arise in the lower acuity situations, where there are several possible treatment pathways available to a patient. Information is key to supporting a patient in making the decision that is right for them and, therefore, meets the expectations of informed consent.

Clearly, when a patient is unresponsive, consent cannot be gained in the same way as previously described. This should not be seen as negating the need to consider how the patient should be informed; they may be unable to respond but they may be able to hear what is being said, and such a dialogue may reassure them. Additionally, discussing proposed assessments and treatments aloud informs any relatives or bystanders of what is being done and why, reducing any chance of misunderstandings that may lead to complaints of impropriety.

Patients must be given sufficient information to be able to decide what treatment they want to agree to and what treatment they want to refuse. The information should always be given in a way that the patient is able to understand, using appropriate language which the person understands.

Any information provided should address:

The nature of the injury or illness, including its severity

The nature of the proposed treatment and its purpose

Any risks or side effects associated with the proposed treatment that the person would find materially relevant

Any alternative approaches, including doing nothing

The principle risks and benefits of the treatment and any anticipated consequences.

The following potential challenges should also be considered:

Information framing can be confusing: for example, when explaining the odds of an adverse impact of treatment as being ‘1 case in 1000’ or as the same risk being ‘0.1%’. Be honest about clinical uncertainty.

Medical complexity: as much information as the patient needs should be provided, with procedures explained to the level of detail they require, avoiding jargon and acronyms.

A patient’s illness may impact on their decision-making ability: clinicians should show patience and give as much support as practicable.

Being a patient can be disempowering. Patients should be supported to make their own decisions by the sharing of information.

Consent in the Emergency Setting

Valid consent must be sought and gained in all circumstances. However, gaining consent is not always possible in an emergency. Having established the core principles of consent, the applicability of these now needs to be considered in the setting that the majority of paramedics work within – emergency and unscheduled care.

There are some exceptions when it may be permissible to provide care or treatment without explicit consent:

When a person is not able to provide consent in an emergency, and treatment is needed to save their life

Where a person has been assessed under the Mental Health Act 1983 as unable to consent to medical treatment due to a significant mental health disorder that affects their decision-making capability

Where a person is a risk to public health from a serious communicable disease.

Unrelated physical disorders still require the person to consent to treatment where they have capacity.

Patients who lack capacity, either through pre-existing conditions or through their being unconscious as a result of an acute illness or accident, should be treated in their best interests adopting the doctrine of necessity. In an emergency, a patient may be treated without consent under the doctrine of necessity, as long as there is a necessity to act when it is not practicable to communicate with the patient and that the action taken is no more than is immediately necessary in the best interests of the patient. This common law approach has been enshrined within the Mental Capacity Act 2005, and Chapter 7: Legislation Relating to Mental Capacity focuses on patients whose capacity is diminished. In such cases, consent can be considered to be ‘implied’.

The notion of ‘immediately necessary’ is not often a challenge for paramedics, where the extent and scope of their treatment will be limited to such interventions. Challenges in respect of consent and, more often, the refusal of consent, tend to arise later in the hospital setting where additional information and options become available. An example of such a situation is that of Re AK (Medical Treatment: Consent) [2001]. In this case, it was known that AK had motor neurone disease and that this degenerative disease would eventually result in his being unable to communicate or to move at all. An advance decision was put in place which specified that AK’s life support ventilator be switched off two weeks after he lost the ability to communicate.

The challenges associated with advance decisions will be explored again in Chapter 9: A Note on the Refusal of Blood Products, with those related to end-of-life decisions considered in Chapter 13: Law and Ethics of Palliative Medicine and End-of-Life Care.

Consent and Mental Capacity

Mental capacity legislation across the UK is discussed in Chapter 11: Legislation Relating to Mental Health; it is, however, important to briefly outline where consent and mental capacity legislation overlap.

The Mental Capacity Act 2005 (for England and Wales) makes it clear that a person is presumed competent, with an ability to consent, until proven otherwise. If they cannot consent, a decision can be made in their best interests on their behalf. Section 27 within the Act lists some things that cannot be consented to on behalf of a person lacking capacity – however, it is unlikely that a paramedic in any role would be required to be involved with these items.

Part 5 of the Adults with Incapacity (Scotland) Act 2000 allows treatment to be given to safeguard or promote the physical and mental health of an adult who is unable to consent. Special provisions apply where others (such as those with a power of attorney) have been appointed under the Act with powers relating to medical treatment. This Act also permits research involving an adult incapable of giving consent, but only under strict guidelines.

In Northern Ireland, the treatment of a patient lacking capacity is governed by the Mental Capacity Act (Northern Ireland) 2016. Rather than providing legal powers to act, the Act is framed to protect the individual (such as a paramedic) from both civil and criminal liability when carrying out an act in the patient’s best interests after determining that the patient lacks capacity to make a decision, and so cannot consent. In general, this legislation outlines additional safeguards that are required to be in place before a defined intervention is implemented.

What Can Happen If Appropriate Consent Is Not Gained?

There are some potentially misleading terms associated with consent, for example when ‘informed consent’ is discussed as being different from ‘implied consent’. In the context of inserting an intravenous cannula, for example, it is sometimes considered that the fact that a patient presented their arm when asked to do so represents ‘implied consent’ to the procedure.

Any form of consent must be valid, based on the three principles previously outlined. In cases where a patient has capacity, it could be argued that the paramedic saying, ‘I just need to pop a needle into your vein’, and the patient presenting their arm does not constitute gaining appropriate consent. The consent ‘implied’ by the presentation of their arm does not represent an understanding of the potential risks associated with the procedure, or the risks of not having the procedure.

In the absence of a discussion regarding the clinical requirement to administer a drug by the intravenous route, the act of cannulation could be seen as an act of battery. Whether or not such an allegation arises depends to a large degree on the outcome of the procedure. If the patient were to develop an infection at the venepuncture site, and suffer harm as a result, then there may be a case for a claim in negligence.

Consent must, by definition, be informed. Consent without information is not valid. The level of information that is required does, however, differ depending on both the intervention and the patient. In all cases of conscious adults with capacity, the aim should be to gain appropriately informed consent for any assessment or intervention. Specific consent does not normally need to be sought in order to ask clinical questions and gain a history, with the responses of the patient effectively demonstrating consent to participate in the dialogue. In patients who are refusing to answer questions, the importance of their responding, from a clinical perspective, should be shared with the patient to ensure that they are fully aware of the consequences of not giving the information required to make a sound clinical decision in their treatment.

Consent and Criminal Law

Although it was previously suggested that the gaining of consent can protect against prosecution for assault or battery, it does not offer a defence against the infliction of actual or grievous bodily harm. This is an area that will generally fall outside the remit of the paramedic or ambulance clinician, whose invasive procedures are minimal, but is, rather, aimed at surgeons who undertake much more invasive procedures. For public interest reasons, such procedures are more often seen to sit outside of the criminal law and are accepted as being legally undertaken and termed ‘reasonable surgical interference’ (Attorney General’s Reference No. 6 of 1980) [1981]. It is, however, sometimes found that the ‘surgical interference’ undertaken is not considered ‘reasonable’ (Devi v. West Midlands RHS [1980]). The limitations of the use of consent as a more general, non-medical, defence are based on cases involving severe sadomasochistic practices where causing actual bodily harm is still considered an offence despite the ‘victim’s’ apparent consent to such acts, such as in R v. Brown [1993].

Devi v. West Midlands RHS [1980]

Ms Devi was a 29-year-old female who consented to undergo an abdominal operation. This was to repair a perforated uterus, which had been punctured following complications after the birth of her fourth child. During the operation, the surgeon undertook a hysterectomy, believing it was in Ms Devi’s best interests to do so. The Court found the surgeon liable for battery, as there was no consent given for the removal of the uterus.

Consent and Civil Law

Gaining consent broadly prevents a clinician from being liable in the civil courts for the tort of battery. This means that, provided the patient consented to treatment, there can be no possibility of an action to recover damages for ‘unlawful touching’. It does not, however, mean that there cannot be a claim in negligence if the consent given, or withheld, is found to have not been sufficiently informed, as differentiated in the case of Chatterton v. Gerson [1981].

Chatterton v. Gerson [1981]

Mrs Chatterton underwent a hernia operation, a result of which was a trapped nerve resulting in severe pain. A pain specialist, Dr Gerson, performed an operation to relieve the pain, but this resulted in permanent immobility of her right leg. Mrs Chatterton said that she should have been informed of this risk and claimed in battery. It was held that she had been informed in broad terms of the nature of the procedure, that is she had been informed and consented to an operation to her right leg. The fact that she may not have been informed of the specific risks of paralysis to her leg could not amount to battery, but any claim would have to be made in negligence.

In cases concerning paramedics, it is commonly alleged that the attending clinician negligently failed to appropriately inform the patient of the possible adverse outcomes of refusing transport to hospital and subsequent assessment and treatment. The breach of duty is more often found to lie in the clinical decision-making process of the paramedic, in that they did not recognise the potential adverse outcomes of a presenting complaint, rather than the position in the majority of claims made against surgeons where they were aware of the risks but failed to disclose them (see Chester v. Afshar [2004]). Chapter 4: Clinical Negligence is dedicated to exploring clinical negligence in greater depth.

Chester v. Afshar [2004]

The claimant, Ms Chester, was left partially paralysed following surgery for lumbar disc protrusion. Paralysis was a foreseeable but unavoidable risk of the surgery, with a risk of between one and two per cent. Dr Afshar, the surgeon in the case, had failed to warn Ms Chester of this particular risk. The House of Lords concluded that while failure to warn of this risk was not a direct cause of the injury, it amounted to negligence. The comments made by Lord Bingham in the judgment appear to go beyond the Bolam test and lay the foundations for the later findings in Montgomery: ‘a surgeon owes a general duty to a patient to warn him or her in general terms of possible serious risks involved in the procedure…In modern law medical paternalism no longer rules and a patient has a prima facie right to be informed by a surgeon of a small, but well-established, risk of serious injury as a result of surgery.’

What Form Should Consent Take?

Consent should be considered as a process, rather than a one-off event: patients may change their minds, or consent to one procedure, but not another. It is important to remember that consenting to, or requesting, a specific aspect of care or treatment does not imply consent to any other aspect of care.

The process of gaining of consent is rarely recorded in writing, unless for specific surgical procedures. More often, it is a refusal of consent that is recorded on clinical documentation. There are very rarely any cases brought against ambulance clinicians or paramedics on the basis of consent where an assessment or treatment is actually carried out. The vast majority of litigation cases involve consent in the context of an absence of information being shared with the patient in order for them to make an informed decision regarding their consent to a particular treatment pathway.

Refusal of Consent to Treatment

Some cases are brought against paramedics where the nature of the information that they have given the patient leads that patient to ‘refuse’ consent (such as consent to transport to hospital) rather than a refusal of consent to assessment and treatment. Sometimes, the information that sways a patient’s decision is related to perceptions of lengthy waiting times at hospital. While it may be appropriate to share such information, it is always the responsibility of the paramedic to appropriately inform their patient about the clinical ramifications of any decision to refuse treatment or further investigations.

It must be remembered that the patient is not a clinician and is not, therefore, in a position to make a clinical judgement. Cases where a paramedic starts a sentence with ‘We could take you to hospital if you want, but …’ are wholly inappropriate. If there is a clinical need for a patient to attend hospital, or to be referred to an alternative care pathway, then this is the information that must be shared. It is rare that anyone would want to go to hospital when it is not necessary.

A signature is only evidence that the patient has signed the form. It is not proof of valid consent or informed refusal.

If a patient is refusing treatment or transport, ensure that the information shared with them is accurately and fully recorded on any patient documentation.

Where possible, ensure that your discussions with the patient are witnessed by a third party, whose details should be recorded on the appropriate documentation.

Refusal to consent to transport to hospital should be distinguished from refusal to receive treatment, and also from refusal ‘against advice’. Where the advice of the paramedic is that the patient attend hospital, then that information, and the rationale behind it must be clearly articulated to the patient and recorded within documentation records.

Power of Entry

Under current legislation, the Fire and Rescue Service may force entry to property under Section 44 Fire and Rescue Services Act 2004 and the Police likewise under Section 17 Police and Criminal Evidence Act 1984 in order to ‘save life or limb’. Despite its raison d’etre, the Ambulance Service does not have the protection of such legislation, and may attend an emergency call only to find they are unable to access a patient in a secure premise. The Ambulance Service must then request the attendance of the Fire Service or Police (depending on provisions in the local area) to exercise its power of entry under their relevant legislation.

Access to Medical Records

Subject to some exceptions (listed in Box 6.1), patients with capacity have a right to access their own health records under the General Data Protection Regulation and UK Data Protection Act 2018 via a subject access request (SAR). It is not necessary for patients to give reasons as to why they wish to access their records, and patients may also authorise a third party, such as a solicitor, to do so on their behalf (British Medical Association, 2020).

Box 6.1 Exemptions for disclosure of medical records

Information can generally be treated as exempt from disclosure and should not be disclosed if:

It is likely to cause serious physical or mental harm to the patient or another person.

It relates to a third party who has not given consent for disclosure (where that third party is not a health professional who has cared for the patient) and after taking into account the balance between the duty of confidentiality to the third party and the right of access of the applicant, the data controller concludes it is reasonable to withhold third party information.

It is requested by a third party and, the patient had asked that the information be kept confidential, or the records are subject to legal professional privilege or, in Scotland, the records are subject to confidentiality as between client and professional legal advisor. This may arise in the case of an independent medical report written for the purpose of litigation. In such cases, the information will be exempt if after considering the third party’s right to access and the patient’s right to confidentiality, the data controller reasonably concludes that confidentiality should prevail.

It is restricted by order of the courts.

It relates to the keeping or using of gametes or embryos or pertains to an individual being born as a result of in vitro fertilisation.

In the case of children’s records, disclosure is prohibited by law, e.g. Adoption records.

(British Medical Association, 2020, p. 6).

Solicitors must provide the patient’s written consent during request for access, and health professionals releasing information to solicitors acting for their patients should ensure that they have this consent. The consent must cover the nature and extent of the information to be disclosed under the SAR (for example, past medical history), and who might have access to it as part of the legal proceedings. Where there is any doubt, health professionals should confirm with the patient before disclosing the information. Should the patient refuse, the solicitor may apply for a court order requiring disclosure of the information.

Rights of access are not confined to health records held by NHS bodies. They apply equally to the private health sector and to health professionals’ private practice records. Information relating to the disclosure of health information by children is outlined in Chapter 8: Legal and Ethical Treatment of Children.

Given their close working relationship in the out-of-hospital space, paramedics may be in a position where the police request medical records from them. If the police do not have a court order or warrant, they can ask for a patient’s health records to be disclosed voluntarily under Schedule 1, Paragraph 10 of the Data Protection Act 2018. However, while health professionals have the power to disclose the records to the police, there is no obligation to do so. In such cases, health professionals may only disclose information where the patient has given consent, or there is an overriding public interest to prevent a serious threat to public health, national security, the life of the individual or a third party, or to prevent or detect serious crime (as outlined in the Data Protection Act 2018). If paramedics are unsure regarding such disclosure, they should seek advice from their employer prior to any disclosure of patient medical records.

Summary

The gaining of consent from patients is a fundamental principle of healthcare. Although there may be challenges regarding the degree of information which should be shared to meet the expectations of the Courts, the role of the paramedic is such that they are unlikely to fall foul of the law based solely on a matter of consent.

You are a paramedic working in a minor injury unit. Your patient is a sixty-four-year-old who lives alone. Their past medical history includes a stroke two years ago and atrial fibrillation, for which they take rivaroxaban. The patient tells you they were walking through their kitchen when they tripped and fell to the floor, hitting their head on the edge of the fireplace. They are a little shaken and have a 2.5 cm haematoma to the left temple. They did not lose consciousness and have no symptoms of a head injury. They did not want to attend the emergency department, which is fifteen miles away.

You inform the patient that while it is up to them, you would recommend that anyone who hits their head should go and get checked over in the emergency department to be on the ‘safe side’. You do not doubt the patient’s capacity to make this decision for themself.

After returning home, the patient’s friend visits later that day and finds the patient unconscious in a collapsed state on the floor. The patient is taken to hospital where they later die as a result of a subdural haemorrhage.

Was the patient’s refusal of consent valid?

Considering the three requirements of valid consent, the patient had capacity to make the decision and the decision was made voluntarily. However, they were not sufficiently informed to make a decision.

Based on the patient’s own circumstances, the general advice that minor head injuries do not require hospital assessment does not apply. Although the head injury is apparently minor, they are on an anticoagulant drug which increases their risk of intracranial haemorrhage, and this cannot be excluded outside of the hospital.

The matter of an invalid refusal of consent may apply if there was awareness of this increased risk, but it was not disclosed. It is more likely that the risk was not considered and clinical decision making fell below the reasonable standard expected of a paramedic, resulting in a breach of duty of care.

What information should be shared with the patient to ensure that the refusal is valid?

It is most important that the patient knows that their presentation is potentially life-threatening. This should be set out in clear and simple terms which the patient can understand. The implications of not attending hospital, and the nature of any potential deterioration, should be explained. The method of treatment that the hospital may undertake should be discussed along with the potential that this treatment would have to successfully treat the patient’s condition. Clearly, only broad information can be given in this regard as you cannot be expected to be fully conversant with all the risks associated with interventions in a setting outside that of which you work within.

It should also be clear what the patient is refusing: travel to hospital or treatment (or both). In the scenario, the patient is refusing to go to another hospital. This is different from refusing treatment. It may be the case that the patient wants to be treated for the presentation but has reservations about travelling to hospital. In some cases, this is due to something as simple as worrying about a pet who will be left alone if the patient is conveyed to hospital. Thoroughly exploring the patient’s situation and gathering as much information as possible, both clinical and otherwise, will enable you to share sufficient, appropriate information to support the patient’s decision making.

If, having shared all of this information, the patient still refuses to attend hospital, then all of the information shared must be documented and local procedures for refusal of escalation against advice adhered to.

Recommended Reading

Lynch J (2016). Consent to Treatment. London: CRC Press.

References

British Medical Association (2020). Access to health records: Updated to reflect the General Data Protection Regulation and Data Protection Act 2018. Available at: https://www.bma.org.uk/media/2821/bma-access-to-health-records-june-20.pdf (accessed 28 June 2023).

Chan SW et al. (2017). Montgomery and informed consent: Where are we now? British Medical Journal, 357: j2224.

Gillon R (2007). Principles of Health Care Ethics. 2nd edn. Chichester: John Wiley & Sons.

General Medical Council (2020). Guidance on Professional Standards and Ethics for Doctors: Decision Making and Consent. Available at: https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors---decision-making-and-consent-english_pdf-84191055.pdf (accessed 28 June 2023).

Heywood R (2015). Litigating labour. Common Law World Review, 44(1): 28–50.

Chapter 7

Legislation Relating to Mental Capacity

Edd Bartlett

What good is it making someone safe if it only makes them miserable?

Munby J (as he then was) in Local Authority X v. MM & Anor (No. 1) [2007] at [120]

Introduction

It is crucial that paramedics are able to competently assess mental capacity and, where they consider a person to not be capacitous, provide care and treatment in accordance with the law as it applies in their respective jurisdiction.

The importance of knowing when to undertake a mental capacity assessment, record the outcome of that assessment in the medical records, and provide treatment in the person’s best interests if they are found to lack capacity, is demonstrated by the Prevention of Future Deaths Report issued by HM Senior Coroner David Reid (2022) following the inquest relating to the death of Emily Caldicott. This inquest was in relation to a death on a mental health in-patient unit, but the learning applies to all areas of practice. From the information provided in the Coroner’s report, it appears the staff on duty did not understand the time-specific nature of capacity assessments and that treatment can be provided (using restraint if necessary and proportionate to the likelihood and seriousness of harm) in a person’s best interests. The Coroner recorded that:

… the jury found that if an adequate assessment of Emily’s capacity had taken place, she would have been given IM Lorazepam ‘in best interests’, that this would have quickly relieved her anxiety and distress, and that her death would probably have been prevented. ... Although staff … were undoubtedly having to deal with a very difficult situation in this case, I am concerned that if such a decision has to be made in similar circumstances in the future, staff may not apply the correct test under the Mental Capacity Act 2005, and there is therefore a risk of future deaths occurring.

The Care Quality Commission (CQC) have also been reported to be ‘clamp[ing] down’ on mental capacity, with an NHS Trust being fined £8000 via criminal enforcement in October 2022 for breach of Regulation 11 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and failing to comply with the Mental Capacity Act 2005 (CQC, 2022a; Weatherill, Woods and Dandridge, 2022).

Some readers of this chapter might be frustrated by the paucity of reference to case law from Scotland and Northern Ireland. Due to these counties being smaller than England and Wales, there are fewer court cases being bought to enable lawyers to establish what the law is (Patrick and Stavert, 2016). Cases heard in England and Wales, however, have persuasive authority in Scotland and Northern Ireland and are reported to generally be followed by the Courts (General Medical Council (GMC) 2020a; Patrick and Stavert, 2016).

This chapter will provide an overview of the principle of autonomy and the common law before setting out the law that covers decision making in this area for England and Wales, Scotland and Northern Ireland.

Autonomy and the Common Law

Autonomy

The right to autonomy is considered a core right in medical ethics, obtaining consent is therefore essential before providing any medical treatment. It has long been recognised by medical ethicists that even if a patient is making an unwise decision, this is not in itself a good reason for paternalistic interference (Harris, 1985). In order for a clinician to obtain valid consent from a patient for any treatment or intervention, the patient must be fully informed, free from undue influence and have capacity to make that decision, as outlined in Chapter 6: Consent. If the patient is eighteen or over, found to be able to consent and they choose not to, their decision must be respected. The law relating to sixteen- and seventeen-year-olds is more complex, as a capacitous refusal of treatment can be overridden by the Courts, this is discussed in Chapter 8: Legal and Ethical Treatment of Children.

Medical Treatment

The case of Re C (Adult: Refusal of Treatment) [1994] set a precedent in common law that a person must not be treated as being unable to make a decision to refuse medical treatment simply because they make an unwise decision. It is the approach used in Re C that has influenced the statutory framework for assessing capacity outlined in the Mental Capacity Act 2005 and still guides the approach to assessing capacity in the Scottish and Northern Ireland jurisdictions, where the common law still applies (British Medical Association, 2020; Patrick and Stavert, 2016).

Re C (Adult: Refusal of Treatment) [1994]

The Decision

Amputation of a gangrenous foot.

The Patient

C was a patient at Broadmoor and suffered from chronic paranoid schizophrenia.

Assessment

C’s general capacity was not impaired enough by his illness to prevent him from being able to understand the nature, purpose and effects of the treatment.

Dame Elizabeth Butler Sloss noted at p. 437 that:

A person lacks capacity if some impairment or disturbance of mental functioning renders the person unable to make a decision whether to consent to or to refuse treatment. That inability to make a decision will occur when:

a) the person is unable to comprehend and retain the information which is material to the decision, especially as to the likely consequences of having or not having the treatment in question;

b) the patient is unable to use the information and weigh it in the balance as part of the process of arriving at a decision.

C understood that the doctors thought he would die without treatment.

Outcome

C accepted only conservative treatment, from which his foot made a recovery.

Re MB (Caesarean Section) [1997] related to a patient who needed a caesarean section and withdrew her consent for this at the last minute due to needle phobia. The Court held that people ‘who would normally have … capacity may be deprived of it or have it reduced by reason of temporary factors, such as unconsciousness or confusion or other effects of shock, severe fatigue, pain or drugs being used in their treatment’ (Re MB (Caesarean Section) [1997] at [18]).

The High Court has also held in Re B (Adult: Refusal of Medical Treatment) [2002] at [94] that ‘unless the gravity of the illness has affected the patient’s capacity, a seriously disabled patient has the same rights as a fit person to respect for personal autonomy’.

The patient’s right to refuse treatment or not be subjected to excessive force or coercion if they are being treated in their best interests has been given further weight by the Human Rights Act 1998, in particular Article 8 (the right to respect for private and family life).

Restraint

The common law also provides for the restraint of people of unsound mind where there is no immediate legal authority available (for example mental health legislation). In Black v. Forsey [1988] it was found that the Mental Health (Scotland) Act 1984 provided exhaustive powers of detention to hospital authorities, with common law powers implicitly removed. However, this did not prevent a private individual from detaining a person of unsound mind who is a risk to themselves or others and where there is presence of mental disorder and necessity of detention (College of Policing, 2021). Lord Griffiths noted that the power is confined to:

imposing temporary restraint on a lunatic¹ who has run amok and is a manifest danger to himself or others – a state of affairs as obvious to a layman as to a doctor … confined to the short period necessary before the lunatic can be handed over to a proper authority.

This was confirmed by R. v. Bournewood NHS Trust, Ex p. L [1998] at [302], where Lord Goff noted:

the common law permit[s] the detention of those who were a danger, or potential danger, to themselves or others, in so far as this was shown to be necessary.

Finally, there is also a ‘general common law power to take such steps as are necessary and proportionate to protect others from immediate risk or significant harm … whether or not the person lacks the capacity to make decisions for [themselves]’ (R (on the application of Munjaz) v. Mersey Care NHS Trust [2003] at [46]). Jones (2021) considers this could extend to the use of sedation in an emergency, where this was used to restrain the person from causing harm to others.

England and Wales

The Mental Capacity Act 2005 was enacted in 2007 and sets out the legal framework for assessing whether a patient has the capacity to make a specific decision and making decisions on the behalf of patients found to lack capacity (Office of the Public Guardian, 2013). It mandates that there should be an initial presumption of capacity for all those over the age of 16 (Heywood, 2014).

In 2015, the House of Lords published its report on whether the Mental Capacity Act 2005 was being utilised as Parliament intended. It found that: ‘capacity assessments are not often carried out [and] when they are, the quality is often poor’ (House of Lords, 2015, p. 8). The first national review of Safeguarding Adult Reviews completed between April 2017 and March 2019 inclusive continues to echo these concerns, noting that ‘[a]ttention to mental capacity was one of the most frequently noted deficiencies in direct practice in the SARs in this analysis, with concerns about how assessment, best interests and deprivation of liberty were addressed’ (Preston-Shoot et al., 2020, p. 4–5).

Even if a paramedic requires assistance to complete the capacity assessment from a more senior paramedic or another professional, they cannot delegate responsibility for assessing capacity to that person (39 Essex Chambers, 2022). If a paramedic does not reasonably believe that, on the balance of probabilities, a patient lacks capacity and performs treatment anyway, the defence provided in Section 5 of the Mental Capacity Act 2005 will not be available to them for any subsequent civil or criminal claims brought against them (39 Essex Chambers, 2022).

Assessing Capacity

When conducting a capacity assessment, the five statutory principles set out in Section 1 of the Mental Capacity Act 2005 should be at the forefront of the minds of those involved. These are:

1.A person must be assumed to have capacity unless it is established that they lack capacity.

2.A person is not to be treated as unable to make a decision unless all practicable steps to help them to do so have been taken without success.

3.A person is not to be treated as unable to make a decision merely because they make an unwise decision.

4.An act done, or decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in their best interests.

The Principles (Mental Capacity Act 2005, Section 1)

Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.

A capacity assessment should be considered for any patient over the age of 16 who is making a specific decision, where there is a concern that the patient might lack capacity to make that decision (Jones and Piffaretti, 2018).

While paramedics must always have a reason why they are undertaking a capacity assessment, they must also be prepared to justify their decision making where an assessment is not undertaken (39 Essex Chambers, 2022). In particular it is essential that paramedics are aware that a formal capacity assessment should be undertaken and fully documented where a patient is making ‘significant, complex or controversial decisions, decisions which would involve placing the incapacitated person at risk, or where the mental capacity of the person is disputed’ (Jones and Piffaretti, 2018, p. 27). Where a decision of this nature is being made it is crucial that the assessment is fully documented, even where the outcome is that a person has capacity.

It is often advised that the two stages of the capacity assessment set out in Sections 2 and 3 of the Mental Capacity Act 2005 are to be completed in the order they appear; this was indeed the approach set out in the first edition of this work and the position set out in the Mental Capacity Act 2005 Code of Practice (Office of the Public Guardian, 2013). However, the Courts have now made it clear that this is not the correct approach and that, in fact, taking this approach can have dangers associated with it, as demonstrated by the comments of Macfarlane LJ in PC v. City of York Council [2013] at [58–59].

The three-stage approach set out below is recommended in the excellent guidance document ‘Carrying Out and Recording Capacity Assessments’ (39 Essex Chambers, 2022):

1.Is the person unable to make a decision? If so:

2.Is there an impairment or disturbance in the functioning of the person’s mind or brain? If so:

3.Is there a causal connection between being unable to make a decision and the ‘impairment of, or a disturbance in the functioning of, the mind or brain’.

This approach has recently been endorsed by the Supreme Court in A Local Authority v. JB [2021], and it has been recommended that capacity assessment forms based on the ‘two-stage’ test contained in the Mental Capacity Act 2005 Code of Practice test should be reviewed to direct the assessor to consider functional ability first. It is also reflected in the draft Mental Capacity Act 2005 Code of Practice that was published for consultation in March 2022 (His Majesty’s Government, 2022). The three-stage approach to assessing capacity is broken down further next.

Stage 1: Is the Person Unable to Make a Decision?

The first stage is to establish whether the person is unable to do one or more of the things set out in Section 3(1) of the Mental Capacity Act 2005 and are therefore unable to make a decision. These are:

Understand the information relevant to the decision

Retain that information

Use or weigh that information as part of the process of making the decision

Communicate their decision (whether by talking, using sign language or any other means).

This is referred to as the ‘functional test’. An understanding of how each of the steps should be approached is essential to good documentation and ensuring the assessment is correctly completed. The threshold for finding that a person is able to do each of the things set out in Section 3(1) of the Mental Capacity Act 2005 will be higher for a serious decision or one that could put them at risk, the more complex or serious a decision is the more robust the assessment and its documentation should be.

Understand the Information They Have Been Given That Is Relevant to the Decision They Are Making

The person must be given the opportunity to understand the ‘salient points’ of the decision they are being asked to make; they do not need to be able to ‘give weight to every consideration that would otherwise be utilised in formulating a decision in [their] best interests’ (LBL v. RYJ [2010] at [58]). It is also important that the paramedic does not start from a ‘blank canvas’; the person whose capacity is being assessed ‘must be presented with detailed options so their capacity to weigh up those options can be fairly assessed’ (CC v. KK [2012] at [68]).

However, the level of understanding does not have to be that of the paramedic or an expert; instead, they should be able to demonstrate a ‘broad, general understanding of the kind that is expected from the population at large’ (Heart of England NHS Trust v. JB [2014] at [25]).

The Mental Capacity Act 2005 Code of Practice advises that relevant information the person should be able to demonstrate an understanding of includes:

The nature of the decision

The reason why the decision is needed

The likely effects of deciding one way or another, or making no decision at all.

(Office of the Public Guardian, 2013, p. 46)

Johnston KC and Roper KC (2022) expand on this suggesting that, depending on the proposed treatment and risks, it is likely to be sufficient if the patient can broadly understand:

The nature of diagnosis and prognosis

The nature and purpose of the proposed treatment

The anticipated benefits of and potential risks associated with the treatment

The risks and benefits associated with not having the proposed treatment

Any alternative treatment options and the risks and benefits of having those.

The information that has been shared with the person and their ability to understand it should be documented in the medical records; this is particularly important where the assessment is for a decision that might have serious consequences or put the person at risk. In these situations, it may be necessary for the paramedic to seek assistance from another professional, or information from a reliable source, to allow them to ensure the person is receiving all the relevant information they need to make a decision.

The information should be shared with the person in an accessible way, this could include ‘simple language, sign language, visual representations, computer support or any other means’ (Office of the Public Guardian, 2013).

Retain That Information Long Enough to Make a Decision

The Mental Capacity Act 2005 and the Mental Capacity Act 2005 Code of Practice are very clear that if a person is only able to retain information for a short while, they should not automatically be assumed to lack capacity (Office of the Public Guardian, 2013; Mental Capacity Act 2005, Section 3(3)).

An example of a person being found to be unable to retain information for a sufficient period of time to make a decision can be found in Mental Health Trust v. DD (Therapeutic Sterilisation) [2015] at [69]:

The other experts concur that only in limited respects does DD appear to understand that a further pregnancy may cause damage to her (specifically to her uterine wall); her basic and limited understanding of this is not consistently maintained, or retained.

Use or Weigh up the Information They Have Been Given as Part of Their Coming to Their Decision

Assessing a person’s ability to use or weigh information is one of the most complex parts of the capacity assessment. It is essential that careful consideration is given to how the patient is able to use the information they have been provided and weigh it up to come to a decision. There are a number of examples of how this is to be applied in case law; some of these pre-date the Mental Capacity Act 2005, but the principles still apply today.

One of the most frequently cited cases is Re MB (Caesarean Section) [1997]. MB was pregnant and was informed she may require a caesarean; after consenting to this, she refused to be given the necessary general anaesthetic due to a fear of needles. The hospital sought a declaration that it would be lawful for them to perform the operation, including delivering the anaesthetic using needles if required. MB appealed; however, it was dismissed. The Court found that due to her fear and panic, she was unable to use and weigh up the information relating to the risk to her and her baby against her fear of needles. She therefore lacked capacity to refuse the caesarean section. In Re T (Adult: Refusal of Medical Treatment) [1993] it was noted that a person might also be found to be so exhausted or in so much pain as to lack capacity.

More recent cases include A Local Authority v. E & Others [2012]. This is an extreme case where the local authority sought to protect the position of E, who ‘suffer[ed] from (1) severe anorexia nervosa, (2) unstable personality disorder, borderline subtype, (3) alcohol dependence syndrome, (4) opiate dependence, and (5) the debilitating and lifelong physical consequences of long-term malnutrition’ (at [23]). ‘She was refusing to eat, and was taking only a small amount of water. She was being looked after in a community hospital under a palliative care regime whose purpose was to allow her to die in comfort’ (at [1]). Jackson J found that E lacked capacity to make decisions about her care and treatment (and subsequently that it was in her best interests to receive treatment), in doing so he noted that:

48. There is no doubt that E has an impairment of, or a disturbance in the functioning of, the mind or brain in the form of her anorexia. Equally it is clear that in terms of [Mental Capacity Act] s. 3(1) she can understand and retain the information relevant to the treatment decision and can communicate her decision.

49. However, there is strong evidence that E’s obsessive fear of weight gain makes her incapable of weighing the advantages and disadvantages of eating in any meaningful way. For E, the compulsion to prevent calories entering her system has become the card that trumps all others. The need not to gain weight overpowers all other thoughts. By way of example, in August 2011, she was described as smiling and laughing during a conversation, but when the question of weight gain and the achievement of a BMI of 16 was mentioned, she began to cry.

This case is a good example of a person’s mental health preventing them from being able to effectively use and weigh information. Where paramedics are faced with a person who is presenting with a confirmed, or likely, mental health concern that they are not familiar with, it is advisable that where the person’s ability to use and weigh information is borderline or unclear, assistance is sought from a person qualified in mental healthcare; support is normally available in and out of hours via the local mental health NHS Trust and paramedics should ensure they are familiar with services locally available to them.

Communicate Their Decision in Any Way

The person should be able to communicate their decision; the crucial consideration here is that they are able to do this in any way. This means that where a person is unable to verbally communicate their decision to the paramedic in a language that they can understand, or their ability to communicate information is reduced or restricted to ‘yes’ or ‘no’ answers, steps must be taken to facilitate communication of their decision. This could include the use of a translator, communication board, and any other methods of communication that person uses; it will often be helpful to make enquiries of people who know them best to establish the best methods of communication. Paramedics must ensure that all practical steps have been taken to help the person to communicate their decision (Mental Capacity Act 2005, Section 1(3)).

Where a person has already been unable to fulfil one or more of the other things set out in Section 3(1) of the Mental Capacity Act 2005, it is still important that the decision the person is communicating to you is recorded; piecemeal completion of the assessment is not advised. Recording the person’s decision is particularly important as their wishes and feelings must be taken into consideration if they are found to lack capacity and a best interests decision is subsequently made on their behalf.

Stage 2: Is There an Impairment or Disturbance in the Functioning of the Person’s Mind or Brain?

The diagnostic test is set out in Section 2(1) of the Mental Capacity Act 2005. Where there is an ‘impairment of, or a disturbance in the functioning of, the mind or brain’, the diagnostic test is satisfied.

The Mental Capacity Act 2005 Code of Practice gives examples of what might cause an impairment of the mind or brain, including dementia, some forms of mental illness, symptoms of alcohol and drug use, significant learning difficulties, concussion, and brain damage (Office of the Public Guardian, 2013). The impairment or disturbance does not need to be a diagnosed medical condition or considered to be a medical condition at all.

Stage 3: Is There a Causal Connection Between Being Unable to Make a Decision and the ‘Impairment of, or a Disturbance in the Functioning of, the Mind or Brain’?

If a person fails the first and second stages of the test the assessor must then be satisfied that the person is unable to make the decision because of the impairment of, or disturbance in the functioning of, their mind or brain that has been identified in the second stage of the test. This is often referred to as ‘the causative nexus’. Once all three stages of the test are satisfied the person will have been found to lack capacity to make that specific decision at that material time.

The Burden of Proof

It is important to note that the Mental Capacity Act 2005 does not ask for certainty that the patient lacks capacity, but, instead, that the person carrying out the assessment has a reasonable belief that the patient lacks capacity on the balance of probabilities (more than 50%, or more likely than not). The clinician must be able to provide reasons for this in their documentation. Good documentation is essential, as this is what will be referred to if the capacity assessment is ever called into question.

A 999 call comes in to you at 23:30 at the start of a bank holiday weekend for an 86-year-old patient who has had a period of unresponsiveness and unilateral weakness. According to their daughter, this lasted for about 15 minutes and following your arrival, the patient has returned to their normal self. You assess the patient and note that they are hypertensive. Their daughter says that the patient is due to have a ‘memory assessment’; she thinks this is for concerns that the patient has some cognitive decline.

You are concerned that the patient is at risk of having a stroke, calculating their ABCD2 score as five (moderate risk). You advise the patient that it would be a good idea to go to the emergency department for further assessment and medication review, particularly as they are already on anticoagulation treatment (National Institute for Health and Care Excellence (NICE), 2017).

The patient states that while they appreciate your concerns and acknowledge that there would be risks to not being taken to the emergency department, they would prefer to stay at home. The patient is aware that they could have a stroke and that there is a risk of permanent disability and potentially premature death; however, the patient states that they are fed up with hospital and that they do not want to go. Instead, the patient will let their GP know next week and they can review the patient’s medication; the daughter will stay with the patient and will call 999 if they have any further symptoms.

Deciding If an Assessment Needs to Be Completed

It is important that you start from the rebuttable presumption that the patient has capacity; however, the decision they are making could be considered to be significant and also potentially serious, as there is a risk they could have another stroke. Therefore, you should complete a capacity assessment both to protect the patient and to ensure that they have capacity to make what some might perceive as an ‘unwise’ decision, and to protect you should their decision making be subject to scrutiny in the future.

Identifying the Salient Information

Before you undertake an assessment, you need to identify what salient (relevant) information applies to the decision.

In the case of this patient, this is likely to include the risks of not going to hospital, that the patient may have a stroke and that they may suffer permanent disability and premature death as a result of declining conveyance to the emergency department.

The Assessment

Stage 1: Applying the Functional Test to the Patient

This is the test that establishes whether the patient is able to make the specific decision to stay at home and not go to hospital. If the patient is found to be unable to do any one of the following – understand, use and weigh, retain or communicate information – the diagnostic test will then need to be considered. This will establish if the patient has an impairment or disturbance in the functioning of the mind or brain, and is unable to make the decision because of that impairment or disturbance.

In order to apply the functional test, it is crucial that you are clear on what decision you are asking the patient to make and how significant the decision is. The threshold is higher for decisions that could be life-threatening or life-changing; for example, the decision to have sugar in your tea is not as significant as the decision to decline conveyance to hospital when significant changes have been found on your ECG. It is also important that you are able to give the patient sufficient information in order for them to make an informed decision and weigh up that information as part of the decision-making process.

Understand

The patient must be able to understand the relevant information as to why you want them to go to hospital. The level of understanding does not have to be that of a paramedic or an expert; instead, they should be able to demonstrate a broad, general understanding of the kind that is expected from the population at large (Heart of England NHS Trust v. JB [2014]).

In the case of this patient, this is a broad understanding of the risks of not going to hospital, that they may have a stroke and that they may suffer permanent disability and premature death as a result of declining conveyance to the emergency department.

Retain

The patient must be able to retain this information for long enough to be able to use it and weigh it up as part of the decision-making process. The Mental Capacity Act 2005 and its Code of Practice are very clear that if a person is only able to retain information for a short while, they should not automatically be assumed to lack capacity (Office of the Public Guardian, 2013; Section 3(3) of the Mental Capacity Act 2005).

Use and Weigh

To demonstrate that the patient is able to use and weigh the information that they have understood and are retaining, they must be able to apply it to the decision they are making. Remember the example of Re MB; this was a good example of someone being unable to use and weigh up information as part of their decision-making process.

This patient is able to demonstrate that they weighed up their previous experiences at hospital with their preference to stay at home. It is essential that they are able to demonstrate that they are weighing up the risks, such as significant disability and premature death, as part of their decision making; if the patient is convinced that there is no risk to staying at home, you should be concerned about their ability to use and weigh up information.

Communicate

The patient has demonstrated they are able to verbally communicate their decision.

Stage 2: Applying the Diagnostic Test to the Patient

You will then need to consider if the patient has an impairment of or a disturbance in the functioning of the mind or brain? It is important to note that this patient has no formal diagnosis of dementia or cognitive impairment; they are only due for an assessment. As such, you should not jump to any conclusions about the outcome of the diagnostic test.

The diagnostic test does not require a formal diagnosis to support the decision that the person fails the test, although being able to document a condition such as dementia or a learning disability will make establishing an impairment of, or a disturbance in the functioning of, the mind or brain easier. It is crucial that this is not interpreted as meaning that the person cannot make the decision – a person can only be found to lack capacity if they are found to be unable to make a decision and this is because of an impairment of or a disturbance in the functioning of the mind or brain.

As the patient does not have a formal diagnosis that could be recorded as the reason for concluding that they have failed the diagnostic test, you must document what leads you to believe that the patient has an impairment of or a disturbance in the functioning of the mind or brain. In this patient’s case, this could be that there have been concerns about their cognition and memory, or that they have just had a neurological event. Other things could be the ingestion of alcohol or any other substances that affect cognition, fatigue, pain or trauma (this is not an exhaustive list).

Stage 3: The Causative Nexus

Finally, you must decide if there is a causal connection between the patient being unable to make a decision (if that is the conclusion they reach) and an impairment of, or a disturbance in the functioning of, their mind or brain. If, on the balance of probabilities, the patient is unable to make the decision because of an impairment of, or a disturbance in the functioning of, their mind or brain, the paramedic can conclude that the patient lacks capacity to make the decision and will need to make a decision in their best interests.

Concluding the Assessment

You should briefly summarise your conclusions at the end of your assessment.

Different Decisions

It is also important that where more than one decision is being made, separate assessments are completed for each decision; this is demonstrated by A NHS Foundation Trust v. Ms X [2014] and has recently been reinforced by AMDC v. AG [2020]. In the matter of Ms X, she suffered from anorexia and alcohol dependency. She was found to have capacity in relation to her alcohol consumption, but was found to lack capacity in relation to anorexia and associated conditions. In AMDC v. AG at [24] it was found that the expert’s capacity assessment was lacking on the basis that it ‘had been reached on a broad-brush basis rather than by reference to each decision under consideration’.

Fluctuating Capacity

Where a person’s capacity to make decisions fluctuates, consideration needs to be given to the nature of the decision(s) that need to be made and the person’s individual presentation. The Draft Mental Capacity Act 2005 Code of Practice, recent case law and academic commentary suggest it is appropriate to approach fluctuating capacity in two ways (Ruck Keene, 2022a; His Majesty’s Government, 2022; Curtice, 2020; RB Greenwich v. CDM [2019]).

One-off Decisions

Where a decision is a one-off decision, it should be addressed in isolation. Consideration should be given as to whether the assessment can safely be delayed until the person regains decision-making capacity.

If the decision cannot wait, the minimum action necessary should be taken to keep the person safe until they regain decision-making capacity. This would normally include any appropriate transfer to the emergency department to allow for appropriate investigations and treatment, the best interests decision-making process set out later in this chapter must be followed (Ruck Keene, 2022a).

When the person regains capacity, their decision should be clearly recorded. It may also be appropriate to establish and record what their wishes are if they lack capacity in the future (Ruck Keene, 2022a).

Repeated Decisions

When a decision needs to be repeated over a period of time, it will usually be appropriate to take a broad view as to the ‘material time’ for the purpose of Section 2(1) of the Mental Capacity Act 2005 (Ruck Keene, 2022a).

On this approach, if there are only small periods of time that the person has capacity to make decisions, it will usually be appropriate to proceed on the basis the person lacks capacity. This is particularly so when the consequences of a decision are serious and a person only has capacity to make that decision for limited periods of time (His Majesty’s Government, 2022; Ruck Keene, 2022a).

An example of such a decision is the management of diabetes. This was addressed by the Court of Protection in RB Greenwich where it was noted by Newton J at [48] that:

… on the assessment of capacity to make decisions about diabetes management, in all its health consequences, the matter is a global decision, arising from the inter dependence of diet; testing her blood glucose and ketone levels; administration of insulin; and, admission to hospital when necessary in the light of blood glucose levels.

When this approach is taken care must be taken to keep the person’s decision making under review and reassess, when indicated, that the balance has not tipped such that the person has capacity to make the relevant decision(s) more often than not (Ruck Keene, 2022a).

It is also very important that the person’s wishes and feelings are given ‘particular regard’ at times when the person is demonstrating that they are closer to being able to make a decision than they are at other times (Ruck Keene, 2022a).

Best Interests Assessments and Decisions

Following a capacity assessment, the patient may be found to lack capacity to make the decision. This means that any decision that a person has been found to lack capacity to make must be made in their best interests, unless the impairment of, or disturbance in, the functioning of the mind or brain is temporary, and the decision can wait until they regain capacity (Mental Capacity Act 2005).

This is in accordance with the fourth principle of the Mental Capacity Act 2005: ‘an act done, or decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests’ (Section 1(5), Mental Capacity Act 2005). One of the few exceptions to this is where the patient has made an advance decision for the refusal of life-sustaining treatment and is not detainable for treatment under the Mental Health Act 1983; this will be covered later in this chapter.

The fifth principle of the Mental Capacity Act 2005 must also be followed when making a best interests decision: ‘before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action’ (Section 1(6), Mental Capacity Act 2005).

Only if a decision is made that is in the patient’s best interests will the paramedic be protected from the tort of battery (unlawfully touching the person or providing treatment without consent) (Section 5(1), Mental Capacity Act 2005); however, they are not protected from civil or criminal liability resulting from negligence (Section 5(3), Mental Capacity Act 2005). The Mental Capacity Act 2005 offers guidance on how a best interests decision should be made in Section 4, with guidance offered within the Code.

A best interests decision must be documented and include the following information:

How the decision about the person’s best interests was reached

What the reasons for reaching the decision were

Who was consulted to help work out best interests

What particular factors were taken into account.

(Office of the Public Guardian, 2013)

When making a best interests decision for a person, the paramedic must always have Section 4(4), (6) and (7) of the Act in mind.

Best Interests (Section 4(4), (6) and (7) of the Mental Capacity Act 2005

[They] must, so far as reasonably practicable, permit and encourage the person to participate, or to improve [their] ability to participate, as fully as possible in any act done for [them] and any decision affecting [them].

(6) [They] must consider, so far as is reasonably ascertainable —

a) the person’s past and present wishes and feelings (and, in particular, any relevant written statement made by [them] when [they] had capacity),

b) the beliefs and values that would be likely to influence [their] decision if [they] had capacity, and

c) the other factors that [they] would be likely to consider if [they] were able to do so.

(7) [They] must take into account, if it is practicable and appropriate to consult them, the views of —

a) anyone named by the person as someone to be consulted on the matter in question or on matters of that kind,

b) anyone engaged in caring for the person or interested in [their] welfare,

c) any donee of a lasting power of attorney granted by the person, and

d) any deputy appointed for the person by the court,

as to what would be in the person’s best interests and, in particular, as to the matters mentioned in subsection (6).

The person’s past and present wishes and feelings must be given significant weight when a best interests decision is being made. These can be established by the assessor by consulting with anyone outlined in Section 4(7). There has been a significant move away from a paternalistic approach, where best interests decisions are made on the basis of what is considered to be in the patient’s medical best interests.

Where there is a dispute about a person lacking capacity or whether a treatment is in their best interests, and this cannot be resolved, the case can be considered by the Court of Protection. It is particularly important to consider an application to the Court of Protection if there is a dispute about a person’s capacity or best interests where the repercussions of the decision could be serious (for example, resulting in serious harm or death). If you think an application to the Court of Protection might be required, this should be escalated as per your organisations processes, in very urgent or emergency situations applications can be made, and the Court can sit, out of normal working hours. The Court of Protection covers:

Making declarations on capacity (for example where there is a dispute)

Making a determination as to the patient’s best interests

The authorisation of deprivation of liberty

Matters relating to lasting powers of attorney

Decisions for people who lack capacity about their welfare or finance.

The extent to which the patient’s wishes and feelings are taken into account by the Court of Protection is demonstrated well by the case of Wye Valley NHS Trust v. Mr B [2015]. This case is also a good example of a decision that amounts to serious medical treatment and therefore requires an application to the Court of Protection.

Wye Valley NHS Trust v. Mr B [2015]

The Decision

Amputation of a leg.

The Patient

Mr B had a history of mental illness and Type 2 diabetes, which had resulted in a foot ulcer becoming infected. The infection eventually spread to the bone and the hospital considered that amputation of the leg was required to prevent imminent death.

Assessment

The judge, Peter Jackson J, gave the following rationale for believing on the balance of probabilities that Mr B lacked capacity:

Based on the following evidence, I am satisfied that Mr B does not have the capacity to make treatment decisions about his foot:

1. He suffers from persistent and treatment-resistant Schizoaffective Disorder, otherwise known as Bipolar Affective Disorder with Psychotic Symptoms.

2. In consequence, he experiences auditory hallucinations that tell him whether or not to take his medication: ‘if the Lord says it’s no, it’s no.’ Although he did not make a similar connection when speaking about amputation to Dr Glover or to me, he told Ms Chapman that because the Lord does not want him to have his leg taken off, he is not doing it.

3. He does not understand the reality of his injury. Asked how things would go if he did not have the operation, he told me that his leg would get better with proper care and if he was allowed to use it.

4. He also mistrusts the doctors to the extent that he expressed the fear that if they put him to sleep for the operation, they could do anything. He did not seem reassured by my telling him that they would not go beyond treatment that the court permitted.

5. Whenever anyone speaks to Mr B about treatment for his leg, he becomes agitated and will shut down the conversation so that the pros and cons of the various options cannot be further discussed (para 34).

Best Interests Supporting Information

Peter Jackson J considered Mr B’s wishes and feelings to be so significant in his decision making that he went to visit Mr B.

A number of statements that Mr B made strongly influenced Peter Jackson J’s decision. These included the following:

I don’t want an operation.

I’m not afraid of dying, I know where I’m going. The angels have told me I am going to heaven. I have no regrets. It would be a better life than this.

I don’t want to go into a nursing home, [my partner] died there.

I don’t want my leg tampered with. I know the seriousness, I just want them to continue what they’re doing.

I don’t want it. I’m not afraid of death. I don’t want interference. Even if I’m going to die, I don’t want the operation.

All this was said with great seriousness, and in saying it, Mr B did not appear to be showing florid psychiatric symptoms or to be unduly affected by toxic infection (para 37(1)).

Peter Jackson J also took into consideration the impact that having the operation would have on Mr B’s quality of life following the operation and the likelihood that the amputated limb would serve as a constant reminder that his and (Mr B believes) the Lord’s wishes had not been respected (para 37(4)).

Best Interests Decision

Peter Jackson J highlighted that the absence of capacity did not mean that Mr B was no longer protected by the European Convention on Human Rights (the Convention) as per the Human Rights Act 1998. In this case, Peter Jackson J considered that Article 2 (the right to life), Article 5 (the right to not be subject to inhuman or degrading treatment) and Article 9 (the right to freedom of religion) were engaged.

It was decided that it was in Mr B’s best interests to not receive the treatment. Peter Jackson J concluded:

I am quite sure that it would not be in Mr B’s best interests to take away his little remaining independence and dignity in order to replace it with a future for which he understandably has no appetite and which could only be achieved after a traumatic and uncertain struggle that he and no one else would have to endure. There is a difference between fighting on someone’s behalf and just fighting them. Enforcing treatment in this case would surely be the latter (para 45).

Best Interests in Practice

When making a decision in a patient’s best interests, the paramedic is protected from the tort of battery (unlawfully touching the person or providing treatment without consent) as long as they have met the criteria set out in Section 5(1) of the Mental Capacity Act 2005:

Reasonable steps have been taken to establish if the person lacks capacity; and

The clinician reasonably believes that the person lacks capacity and that the treatment or intervention that they are considering is in the person’s best interests.

So, for example, if the patient lacks capacity and is compliant with treatment being planned (or is unconscious), under Section 5 of the Mental Capacity Act 2005, clinicians can treat them in their best interests. If the patient is resisting and restraint is required, a further two criteria must be met (which are discussed later in the chapter).

The paramedic will also need to consider if there is an advance decision to refuse treatment that applies to the decision and therefore must be followed, or an alternative person with decision-making authority, such as a Lasting Power of Attorney for Health and Welfare, or a Court Appointed Deputy; these are expanded in Chapter 13: Law and Ethics of Palliative Medicine and End-of-Life Care.

Best Interests and Life-limiting Conditions

There may be situations where you believe that providing your patient with treatment is not in their best interests. On these occasions, it is important to remember that the starting presumption should always be strongly that it is in the patient’s best interests to stay alive (Aintree University Hospitals NHS Foundation Trust v. James [2013] UKSC 67, para 35). As long as the decision-making process set out by the Mental Capacity Act 2005 and demonstrated by the court in Wye Valley NHS Trust v. Mr B [2015] is followed, the decision will be made in the patient’s best interests.

It is also important to consider Section 4(5) of the Mental Capacity Act 2005: ‘where the determination relates to life-sustaining treatment [they] must not, in considering whether the treatment is in the best interests of the person concerned, be motivated by a desire to bring about [their] death.’ This section ensures that the Mental Capacity Act 2005 cannot be used as a back door to euthanasia.

In practice, paramedics will almost certainly find themselves in a situation where they have a duty of care for a patient who lacks capacity and their holistic best interests do not match what treatment protocols or policies suggest is in the patient’s medical best interests, for example, treatment guidance based on national early warning scores.

An example of this would be a patient who is believed to be at the end of their life. A holistic assessment may reveal that interventions to reverse sepsis are unlikely to be effective, the patient may also be frail, and their family may oppose them being acutely admitted to hospital. You could reasonably come to the conclusion that treatment and acute admission are not in the patient’s best interests, even though it is likely that sepsis will result in their death. Such a decision would be best supported by advanced care planning documentation, such as a ReSPECT form or treatment escalation plan.

Any decision like this is best made as a shared decision and guidance from experts, such as hospice staff, should be sought where possible. It is also important to make sure that contingencies are in place should the patient deteriorate and suffer discomfort or distress. Chapter 13: Law and Ethics of Palliative Medicine and End-of-Life Care Research looks at this in more detail.

Serious Medical Treatment

In some circumstances treatment that is proposed in a person’s best interests might amount to serious medical treatment (SMT). In these circumstances an application to the Court of Protection might be required to authorise treatment that is considered to be SMT, where the following criteria are met (Serious Medical Treatment Guidance [2020] EWCOP 2):

1.If the decision is finely balanced, or

2.If there is a difference of medical opinion, or

3.If there is a lack of agreement as to a proposed course of action from those with an interest in the person’s welfare, or

4.If there is a potential conflict of interest on the part of those involved in the decision-making process, or

5.If there would be a serious interference with the person’s rights under the European Convention on Human Rights.

Where SMT is being considered, there is a duty to appoint an Independent Mental Capacity Advocate (IMCA) if there is no-one appropriate to consult about whether the decision is in the person’s best interests, other than paid care staff (Department of Health, 2015).

While it is impossible to set out all the procedures that might be considered to amount to ‘serious medical treatment’, the Mental Capacity Act Code of Practice suggests that the following might be considered serious (Department of Health, 2015):

Chemotherapy and surgery for cancer

Electro-convulsive therapy

Therapeutic sterilisation

Major surgery (such as open-heart surgery or brain/neuro-surgery)

Major amputations (for example, loss of an arm or leg)

Treatments which will result in permanent loss of hearing or sight

Withholding or stopping artificial nutrition and hydration

Termination of pregnancy.

In an emergency, where there is not time to seek authorisation from the Court, or if an emergency arises while an application to Court is being made, treatment should be provided in the patient’s best interests. It is unlikely that paramedics working in a traditional frontline ambulance setting will come across a situation where a Court application needs to be sought by the ambulance service.

Restraint

Just because it has been decided that a proposed treatment is in a person’s best interests, this does not mean the patient will accept the professional’s decision and, in some situations, this may result in them refusing to comply. Such situations are often resolved through good communication and explanation, but sometimes this is not possible or practicable. In such situations, the patient may need to be restrained.

Section 6 of the Mental Capacity Act 2005 outlines when it is acceptable to restrain a person for the purposes of care or treatment. It is very important to recognise that restraint includes both using force and threatening to use force when the person is resisting care or treatment; it also includes restricting the person’s liberty of movement, whether or not they resist (Section 6(4)). Restraint may only be used if the following four conditions are met:

1.Reasonable steps have been taken to establish if the person lacks capacity.

2.The clinician reasonably believes that the person lacks capacity and that the treatment or intervention that they are considering restraining the person to perform is in the person’s best interests.

3.The clinician reasonably believes the treatment or intervention they are considering restraining the person in order to perform is necessary to prevent harm to that person.

4.The restraint is a proportionate response to the likelihood of the person the clinician is restraining suffering harm and how serious that harm is likely to be (Sections 5(1) and 6(2)–(3) of the Mental Capacity Act 2005).

Proportionality and what is the least restrictive option are the key considerations that should be in the paramedic’s mind. Is the intervention proportionate to the risk to this patient’s well-being? Is it the least restrictive option? An example of where restraint is acceptable is a patient with sepsis who is combative, clearly extremely confused, unwell, has no indication of past wishes and feelings that suggest they would not want to receive treatment, and treatment is not futile. Using a blanket wrap and carry chair to restrain the patient and remove them from their property is a proportionate intervention to the risk of them dying from sepsis.

Conversely, consider a patient with dementia who has a laceration that would benefit from sutures. The decision is made that it is in their best interests to be taken to hospital for treatment, but when they are asked to come to hospital, they get very agitated and upset. It is unlikely that using restraint to take the patient to the emergency department is the least restrictive option; conservative treatment with a bandage may be appropriate, combined with a referral to the district nurses the following day for wound care.

Paramedics working with patients on a Mental Health Unit must ensure they are familiar with the Mental Health Units (Use of Force) Act 2018 and its associated Statutory Guidance (Department of Health and Social Care, 2021). The guidance notes, not exhaustively, that the following environments (where paramedics would more traditionally be expected to work) are considered not to be covered by the Mental Health Units (Use of Force) Act 2018:

Accident and emergency departments of emergency departments

Section 135 and 136 suites that are outside of a mental health unit

Outpatient departments or clinics

Mental health transport vehicles.

Section 6(5) of the Mental Health Units (Use of Force) Act 2018 provides information that must be recorded where restraint is used on a Mental Health Unit. While some of it may not be relevant (or possible to establish), it is a useful guide as to what should be considered when documenting use of force in any setting (particularly the prehospital environment):

The reason for the use of force

The place, date and duration of the use of force

The type or types of force used on the patient

Whether the type or types of force used on the patient formed part of the patient’s care plan

Name of the patient on whom force was used

A description of how force was used

The patient’s consistent identifier

The name and job title of any member of staff who used force on the patient

The reason any person who was not a member of staff in the mental health unit was involved in the use of force on the patient

The patient’s mental disorder (if known)

The relevant characteristics of the patient (if known)

Whether the patient has a learning disability or autistic spectrum disorders

A description of the outcome of the use of force

Whether the patient died or suffered any serious injury as a result of the use of force

Any efforts made to avoid the need to use force on the patient

Whether a notification regarding the use of force was sent to the person or persons (if any) to be notified under the patient’s care plan.

A 999 call comes in at 16:30 for a 75-year-old patient whose daughter has come to see them, as she does every Sunday. Normally the patient is able to answer the door and let their daughter in; however, on this occasion, the patient has not answered the door and the daughter has had to use the key safe to gain entry to the property. She finds the patient sitting in the living room. The patient is unkempt and has an odour that suggests they have not been managing their personal care. The patient is also very confused, thinking it is Friday morning and querying why their daughter has come to visit.

You are dispatched to the address and on arrival you are concerned that the patient has an infection; they are pyrexic, tachycardic and slightly hypotensive, and are also unable to get out of their chair independently. The patient’s daughter reports that this is very unusual and she is very concerned. You advise the patient that they may need to attend hospital; the patient tells you to get lost and lashes out at you.

A capacity assessment is completed and it is clear that the patient lacks capacity. Their daughter is also surprised that they are refusing treatment as they ‘normally do whatever the doctor says; this is very out of character’. You think that the patient needs to attend hospital for assessment and possibly intravenous antibiotics. There are no less restrictive options available that are appropriate and the patient is not likely to regain capacity without treatment. There is also no lasting power of attorney, written statement of wishes or advance decision to refuse treatment.

Following your decision that it is in the patient’s best interests to attend hospital, you decide to use a blanket wrap to restrain the patient and prevent them from lashing out. You use the carry chair and two blankets to restrain the patient and remove them from the property; you then transfer the patient onto the stretcher. Once in the ambulance, you review the situation and see if the patient still needs to be restrained. They are still very agitated, so you decide it is appropriate to continue to restrain the patient until you get to hospital.

When completing your paperwork, you ensure that you document the capacity assessment, best interests assessment and that you restrained the patient, including the review of that restraint once they were in the ambulance.

Documenting the Patient’s Best Interests Assessment

When documenting the patient’s best interests assessment, it is important that you demonstrate that you have followed the statutory framework for assessing best interests. You should document:

That the decision cannot wait because the patient is not going to regain capacity

That there is no advance statement or advance decision to refuse treatment available that refers to the decision

Who you have consulted to assist you with making the decision (in this example, the patient’s daughter)

If there is a lasting power of attorney for health or welfare and if they have been consulted (if they have not been contacted, document why this is the case – a reasonable attempt should be made to contact them)

That there is no appropriate less restrictive option available.

It is also recommended that as much of the relevant information that can be obtained as set out in Section 6(5) of the Mental Health Units (Use of Force) Act 2018 is recorded.

Deprivation of Liberty

In some circumstances restraint, or restrictions, that form part of a patient’s care or treatment will be so significant that they amount to a deprivation of liberty. In these circumstances Article 5 of the European Convention on Human Rights (ECHR) is engaged and the restraint or restrictions must be implemented in accordance with a procedure prescribed by law. Sections 5 and 6 of the Mental Capacity Act do not provide for restraint or restrictions that amount to a deprivation of liberty (Mental Capacity Act 2005, Section 1) and additional steps must be taken for the deprivation of liberty to be lawful.

Article 5, European Convention on Human Rights

(Human Rights Act 1998, Schedule 1)

1. Everyone has the right to liberty and security of person. No one shall be deprived of his liberty save in the following cases and in accordance with a procedure prescribed by law:

[…] the lawful detention of persons for the prevention of the spreading of infectious diseases, of persons of unsound mind, alcoholics or drug addicts or vagrants;

[…]

4. Everyone who is deprived of his liberty by arrest or detention shall be entitled to take proceedings by which the lawfulness of his detention shall be decided speedily by a court and his release ordered if the detention is not lawful.

5. Everyone who has been the victim of arrest or detention in contravention of the provisions of this Article shall have an enforceable right to compensation.

At the time of writing, the Mental Capacity (Amendment) Act 2019 is yet to come into force, and the new Mental Capacity Act Code of Practice has not been published. Clinicians therefore need to be mindful that the processes for authorising a deprivation of liberty will be changing.

Definition of Deprivation of Liberty

There are three elements that need to be present for a deprivation of liberty to arise; these are the objective element, the subjective element and state imputability element (Law Society, 2015). The last two elements are generally relatively straightforward to establish. The subjective element is that there is no consent, where the Mental Capacity Act 2005 applies this will be because the person has been assessed as lacking capacity to consent to the deprivation of liberty (Mughal and Richards, 2022). The state imputability element is that the deprivation of liberty is either directly, or indirectly, the state’s responsibility (for example, provided, or funded, by an NHS Trust).

The objective element is more complex and requires careful consideration of the circumstances and how they apply to a particular person. The difference between what amounts to restraint where Sections 5 and 6 of the Mental Capacity Act 2005 can be relied upon and deprivation of liberty that requires a formal legal process to be followed is one of degree and intensity, not one of nature or substance (Law Society, 2015). This means that what is considered to amount to a deprivation of liberty in one set of circumstances (for example, in terms of the level of restriction used and duration of those restrictions) might not be in another set of circumstances.

Paramedics will therefore need to consider the type, duration, effect, manner of implementation, degree or intensity of the restriction(s). If it is considered the person might be deprived of their liberty, it then needs to be considered whether the person is under constant supervision and not free to leave; this is known as the acid test (Mughal and Richards, 2022).

For paramedics working in a traditional frontline ambulance setting it will be relatively unusual for any restrictions used to convey a patient to hospital for care and treatment to amount to a deprivation of liberty. The Mental Capacity Act Deprivation of Liberty Safeguards Code of Practice states that (Ministry of Justice, 2008):

in a very few cases, there may be exceptional circumstances where taking a person to a hospital or a care home amounts to a deprivation of liberty, for example where it is necessary to do more than persuade or restrain the person for the purpose of transportation, or where the journey is exceptionally long.

It is the author’s view that it is highly unlikely restraining a patient in an emergency, where this has been assessed as being both necessary and proportionate to their risk of suffering harm, and the seriousness of that harm, for the purpose of conveyance to hospital for assessment or treatment will amount to a deprivation of liberty in the prehospital setting.

In any exceptional cases where the restraint required does amount to a deprivation of liberty, and Subsections 4(3)–(5) of the Mental Capacity Act 2005 do not apply (this is where a Court Order has been obtained authorising the deprivation of liberty, or a Deprivation of Liberty Safeguards authorisation is in place), Paramedics will be exempted from the prohibition of depriving a person of their liberty set out at Section 4A of the Mental Capacity Act 2005, where Section 4B of the Mental Capacity Act 2005 applies.

This section does present healthcare professionals with some difficulty, as it is currently worded so that it only applies ‘while a decision as respects any relevant issue is sought from the court’; staff therefore should take legal advice and steps to make an application to court before the person is deprived of their liberty. This issue will be resolved when the Mental Capacity (Amendment) Act 2019 comes into force, as this will provide at Section 4B(6)(b) for deprivation of liberty in an emergency in the absence of this requirement.

In a situation where there is a risk of serious harm or death to the patient, or another person, unless the person is imminently transported to hospital, and it is not practical to instigate the steps required to take the matter to court (and therefore it cannot be said that a decision is being sought from the court), it is the author’s opinion that it is likely that staff will be protected by common law and/or the overarching right to life provided by Article 2 of the ECHR (Human Rights Act 1998, Section 6; Jones, 2021). If, when the dust has settled, the view is taken that procedurally things should have been done differently, courts and regulatory bodies will be more concerned about the consideration that has been given to ensuring steps taken are necessary and proportionate to the seriousness and likelihood of harm (39 Essex Chambers, 2019).

The case of ZH v. Commissioner of Police for the Metropolis [2012] provides a good example a situation where restraint was considered not only not necessary or proportionate to the risk of harm, but also to amount to a deprivation of liberty – even though it only lasted for around 40 minutes.

ZH v. Commissioner of Police for the Metropolis [2012]

ZH was a severely autistic, epileptic 19-year-old man who went on a school visit to a swimming pool, became fixated with the water and would not move from the water’s edge. The police were called and when an officer touched him on his back, he jumped into the water, fully clothed. The police physically pulled him out of the water, put on handcuffs and leg restraints, and put him in the cage in the back of a police van for around 40 minutes.

The Court found that the defence in Sections 5 and 6 of the Mental Capacity Act 2005 could not be relied upon by the police, because the restraint was not proportionate to the likelihood and seriousness of ZH suffering harm. Further, the restraint was so excessive, it amounted to a deprivation of liberty. The police were held liable for assault, false imprisonment and for breaches of human rights, with £28,250 in damages being awarded to the claimant.

The Judge concluded:

162. This case is another example of the difficult role the police are often called upon to play. None of them were fully aware of the features of autism, what problems it presented and how it should best be dealt with in a situation such as occurred at the Acton swimming baths. They were called to the scene by a misleading message about ZH’s behaviour, and on arrival perceived the need to take control and be seen to be taking steps to deal with the situation. What was called for was for one officer to take charge and inform herself of the situation, as fully as the circumstances permitted so as to be able to decide on the best course of action to take. That did not happen: their responses were over-hasty and ill-informed, and after ZH had gone into the pool matters escalated to the point where a wholly inappropriate restraint of an epileptic autistic boy took place. They did not consult properly with the carer who was present when they arrived, even if he was not as proactive as he might have been in informing them of what was happening, what needed to be done and what needed to be avoided.

163. The opportunities to take stock, before ZH went into the pool and whilst he was in it, were not taken. All of those involved in this incident were acting as they genuinely thought best, whether pool staff, carers or police, and it is clear to me, having listened to their evidence, that all have been to some extent emotionally affected by the events of that day. Whilst I am clear in my conclusion that the case against the police is established, I am equally clear in concluding that no one involved was at any time acting in an ill-intentioned way towards a disabled person.

164. The case highlights the need for there to be an awareness of the disability of autism within the public services. It is to be hoped that this sad case will help bring that about.

The Deprivation of Liberty Safeguards

The Deprivation of Liberty Safeguards (DoLS) are the procedure prescribed by law that was added to the Mental Capacity Act 2005 by the Mental Health Act 2007 in an attempt to establish compliance with Article 5 ECHR. DoLS only apply to Hospital and Care Home settings and patients over the age of 18 (Mental Capacity Act 2005, Schedule A1, 1(2)).

If a deprivation of liberty needs to be authorised for a community setting (for example, where a person has a package of care in their own home that amounts to a deprivation of liberty), or a transfer where Section 4B of the Mental Capacity Act 2005 does not apply, or a person under the age of 18, this will need to be done by the Court of Protection pursuant to Section 15 of the Mental Capacity Act 2005, or for the deprivation of liberty of a person under the age of 16 using the inherent jurisdiction of the High Court (CQC, 2022b).

Following a judgement known colloquially as Cheshire West in 2014, which widened the scope of what is legally considered to be a deprivation of liberty (P (by his litigation friend the Official Solicitor) (Appellant) v. Cheshire West and Chester Council and another (Respondents) P and Q (by their litigation friend, the Official Solicitor) (Appellants) v. Surrey County Council (Respondent) [2014]), there was a substantial increase in DoLS applications. This has led to significant delays and many people being deprived of their liberty with no legal authority in place – therefore in breach of Article 5 ECHR (Mughal and Richards, 2022).

This chapter does not cover the practical elements of instigating the Deprivation of Liberty Safeguards; for more information the Law Society (2015) have produced a helpful guide to the deprivation of liberty safeguards.

A Note on the Liberty Protection Safeguards

In response to the delays caused by Cheshire West, general criticism of DoLS for being unnecessarily bureaucratic, and DoLS not being applicable to deprivation of liberty outside the hospital or care home setting the Government has legislated for a new process to deprive people of their liberty, known as the Liberty Protection Safeguards (LPS).

The LPS process is set out in the Mental Capacity (Amendment) Act 2019, and when this comes into force the amendments it has made to the Mental Capacity Act 2005 will apply. This will mean there will be changes to parts of the Mental Capacity Act 2005, including Section 4B.

The LPS will introduce some significant changes to the way the deprivation of liberty for people who lack capacity is authorised. A very brief summary of some of the key changes are that the LPS will be applicable to people aged sixteen and over deprived of their liberty in community settings as well as hospitals and care homes. LPS also moves the responsibility for authorising the deprivation of liberty in the hospital setting from the local authority to the hospital.

The Interface between the Mental Capacity Act 2005 and Mental Health Act 1983

Paramedics attending patients experiencing a mental health crisis may feel that conveyance to either the emergency department or a place of safety is required. Just like other patient cohorts, mental health patients may decline treatment or conveyance; such patients are referred to hereafter as an ‘objecting patient’. Sometimes it will be appropriate to respect the person’s wishes and not provide them with any treatment or conveyance, in these circumstances the risk assessment that has led the paramedic to this conclusion should be carefully documented. On other occasions, it may be that providing treatment, conveyance for treatment or conveyance to a place of safety in the absence of patient’s consent is appropriate; however, this must be done using the correct legal framework and therefore an understanding of the legislative frameworks that relate to mental health patients is essential.

The Mental Health Act 1983 allows a more paternalistic approach towards patients with mental disorders than the wider population – for example, mental health patients are one of the only patient groups that can be detained for assessment or treatment without their consent. This is often colloquially referred to as a person being ‘sectioned’. However, the Mental Health Act 1983 Code of Practice states:

The fact that someone has a mental disorder is never sufficient grounds for any compulsory measure to be taken under the [Mental Health] Act. Compulsory measures are permitted only where specific criteria about the potential consequences of a person’s mental disorder are met. There are many forms of mental disorder which are unlikely to call for compulsory measures.

(Department of Health, 2015, 2.6)

What the Mental Health Act 1983 Code of Practice is essentially saying here is that it is not appropriate to use the sectioning powers of the Mental Health Act 1983 just because a patient is suffering a mental disorder. As with the Mental Capacity Act 2005, the interventions must be proportionate to the patient’s presentation.

Paramedics will often encounter people presenting with exacerbations of their mental health; some may have a pre-existing diagnosis and for others this might be the first time they have called a healthcare professional, or had one called for them, to assist them with their mental health. Where assessment and treatment for a mental health problem is to be compelled (because the person is refusing to engage with the proposed plan), this most often done using the Mental Health Act 1983. Paramedics will most often experience this where the police detain people in public places under Section 136 of the Mental Health Act 1983, or where a warrant under Section 135 of the Mental Health Act 1983 has been obtained; these are covered in more detail in Chapter 11: Legislation Relating to Mental Health.

The Mental Capacity Act 2005 can be used where a person is presenting with a mental health problem; however, this should generally only be where a person is assessed as lacking capacity for the treatment of physical health concerns (for example, treatment following an overdose or treatment for bleeding following self-harm), or where there is a risk of harm that justifies intervention in the person’s best interests and there is not time to make arrangements under the Mental Health Act 1983.

Where a person assessed as having capacity to refuse treatment for a physical health problem that is caused by a symptom or manifestation of their mental health condition (for example, a person with a mental health condition who has capacity and is refusing treatment following an overdose), treatment can still be provided if they are detained under the Mental Health Act 1983 pursuant to Section 63. The authority for this is set out by Hoffmann LJ in B v. Croydon Health Authority [1995] 1 All E.R. 683 at [687–688]:

It would seem to me strange if a hospital could, without the patient’s consent, give him treatment directed to alleviating a psychopathic disorder showing itself in suicidal tendencies, but not without such consent be able to treat the consequences of a suicide attempt.

This approach has been re-affirmed in Nottinghamshire Healthcare NHS Trust v. RC [2014] EWHC 1317 (COP) at [31], where Motstyn J. stated:

It cannot be disputed that the act of self harming, the slashing open of the brachial artery, is a symptom or manifestation of the underlying personality disorder. Therefore to treat the wound in any way is to treat the manifestation or symptom of the underlying disorder. So, indisputably, to suture the wound would be squarely within Section 63. As would be the administration of a course of antibiotics to prevent infection.

Such treatment would be provided under Part 4 of the Mental Health Act 1983 and would require specific criteria to be met.

Therefore, where paramedics encounter a patient who has capacity and requires treatment for a physical health condition that is a symptom or manifestation of (caused by) their underlying mental health condition, they should consider if an application for detention under the Mental Health Act 1983 should be made. The same approach would apply where the person has an advanced decision to refuse treatment, as this only puts a person in the same position as a person with capacity (Jones and Piffaretti, 2018). Discussion with an approved mental health practitioner or healthcare professional with expertise in mental health is recommended in circumstances where this arises.

Assessment and treatment can be provided for illness or injury that is in the best interests of a person suffering from a mental disorder, as long as they lack capacity and, where restraint is required, it is necessary and proportionate to the likelihood and seriousness of the person suffering harm. What the Mental Capacity Act 2005 cannot be used for, however, is a shortcut to avoid sectioning under the Mental Health Act 1983 for assessment or treatment in hospital for a mental disorder (R (Sessay) v. SLAM and Commissioner of the Police for the Metropolis [2011]).

R (Sessay) v. SLAM and Commissioner of the Police for the Metropolis [2011]

Background

The police were called regarding concerns about the way in which the claimant (S) had been caring for her child. Upon arrival, the two officers who attended were concerned for S’s mental well-being and, considering her to be mentally disordered, took her to hospital under Section 5 of the Mental Capacity Act 2005. Upon arrival, S was left in the 136 suite because the staff believed her to be under Section 136 of the Mental Health Act 1983; she was detained for 13 hours while an application for admission under Section 2 of the Mental Health Act 1983 was made. The Court held that she had been deprived of her liberty/falsely imprisoned, in breach of Article 5 of the European Convention on Human Rights. It was considered that there is a ‘complete statutory code covering persons in [S’s] … position’: for the purposes of an emergency situation, where the person needed admission for assessment, Sections 2, 4 and 135 of the Mental Health Act 1983 should be used.

The Judgment

In our judgment:

Part II of the Mental Health Act 1983 provides a comprehensive code for compulsory admission to hospital for non-compliant incapacitated patients such as the Claimant. The common law principle of necessity does not apply in this context.

The Claimant’s detention at the hospital on 7 August 2010 was unlawful and in breach of her rights under Article 5 ECHR. The Claimant is entitled to a declaration to this effect, together with damages for breach of Article 5 and for false imprisonment to be assessed, if not agreed (para 59).

Application to Paramedic Practice

Based on the facts given, S had no pressing medical need secondary to her mental disorder which meant that the use of Sections 5 and 6 of the Mental Capacity Act 2005 was appropriate. The police should have got in contact with an approved mental health professional (AMHP), who would have been able to consider if admission under section was appropriate and organise the appropriate section.

The Mental Health Act 1983 Code of Practice gives guidance on when an application for detention (sectioning) of a patient might be appropriate (Department of Health, 2015).

In situations where it is believed that a mentally disordered patient is in need of detention (sectioning), it is advisable to contact the social services Emergency Duty Team, or equivalent, and ask to speak to the duty AMHP. In an emergency, and where the person is in a public place, the police may also be able to use their powers under Section 136 Mental Health Act 1983.

While the assessment and application for detention under the Mental Health Act 1983 is arranged a person can be prevented from leaving, providing there is no undue delay in arranging this (R (Sessay) v. SLAM and Commissioner of the Police for the Metropolis [2011] at [57]; Jones, 2021). In this situation if the person lacks capacity, it is likely the defence in Sections 5 and 6 of the Mental Capacity Act 2005 would apply, providing actions taken are necessary and proportionate to the likelihood and seriousness of the person suffering harm. Even if the person was considered to have capacity there would still likely be a common law defence available where actions to detain a person while a Mental Health Act assessment was arranged were considered necessary because they were considered to be a danger (or potential danger) to themselves or others (R v. Bournewood NHS Trust, Ex p. L [1998]; Jones, 2021).

It is essential that paramedics recognise that the restraint, detention or deprivation of liberty of someone suffering from a mental disorder is always a potential breach of their human rights unless it is done within the appropriate legal framework. Even then, it is essential that the principles of the Mental Capacity Act 2005 and the overarching principles outlined in the Mental Health Act 1983 Code of Practice are taken into consideration, and that the least restrictive option is always sought, with restraint, detention or deprivation of liberty always treated as the last option (Mental Capacity Act 2005, Section 1; Department of Health, 2015).

Northern Ireland

In Northern Ireland, the Mental Capacity Act (Northern Ireland) 2016 is being implemented in phases, with the Mental Capacity (2016 Act) (Commencement No.1) Order (NI) 2019 (Commencement No.1 Order) detailing the specific provisions that have been commenced in Phase One (Department of Health (NI), 2022b). Part 2 of the schedule to Commencement No. 1 Order sets out that sections 1–8 Mental Capacity Act (Northern Ireland) 2016 (dealing with the principles, including capacity assessment and best interests) came into operation ‘only in so far as it relates to an act that is a deprivation of liberty, research, offences or the power to make regulations about dealing with money and valuables’.

The authority for provision of treatment to those who are unable to consent, and much other decision making, therefore continues to be covered by the common law and Mental Health (Northern Ireland) Order 1986 (Ruck Keene, 2022b). The Department of Health (NI) (2022a) guidance on consent for examination, treatment or care is currently under review, with professionals being advised to ‘consult their relevant professional bodies for the most up to date advice’.

Assessing Mental Capacity

The approach to assessing Mental Capacity in Northern Ireland is currently governed by the common law, and guidance on the ‘Form 4 Adults who are unable to consent to examination, treatment or care’ (Department of Health (NI), 2004) (currently under review) sets out the test clinicians should apply in a very similar way to Re C.

While the Northern Ireland Assembly work towards full implementation of the Mental Capacity Act (Northern Ireland) 2016 there is a paucity of current guidance on how the assessment of capacity should be approached in Northern Ireland (BMA, 2020; Department of Health (NI), 2022a). The GMC (2022) guidance on assessing capacity notes that requirements ‘can differ from country to country but by following the principles in our decision making and consent guidance you’ll always be in line with the law’.

General Medical Council (2020b)

The Seven Principles of Decision Making and Consent

1. All patients have the right to be involved in decisions about their treatment and care and be supported to make informed decisions if they are able.

2. Decision making is an ongoing process focused on meaningful dialogue: the exchange of relevant information specific to the individual patient.

3. All patients have the right to be listened to, and to be given the information they need to make a decision and the time and support they need to understand it.

4. [Clinicians] must try to find out what matters to patients so they can share relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option to take no action.

5. [Clinicians] must start from the presumption that all adult patients have capacity to make decisions about their treatment and care. A patient can only be judged to lack capacity to make a specific decision at a specific time, and only after assessment in line with legal requirements.

6. The choice of treatment or care for patients who lack capacity must be of overall benefit to them, and decisions should be made in consultation with those who are close to them or advocating for them.

7. Patients whose right to consent is affected by law should be supported to be involved in the decision-making process, and to exercise choice if possible.

Until Sections 1–8 Mental Capacity Act (Northern Ireland) 2016 come into force for all assessments (not just those relating to deprivation of liberty), it would seem appropriate for staff in Northern Ireland to adopt an approach to assessing capacity along the same lines as that set out in the guidance for England and Wales (Department of Health (NI), 2022a).

Assessing Best Interests

As with the assessment of capacity, until the relevant sections of the Mental Capacity Act (Northern Ireland) 2016 come into force, the assessment of what is in the best interests of a patient falls to common law and clinical guidance. The ‘Form 4 Adults who are unable to consent to examination, treatment or care’ (Department of Health (NI), 2004) (currently under review) sets out that:

An adult’s best interests are not limited to their best medical interests. Other factors which form part of the best interests decision include:

The wishes and beliefs of the adult when competent

Their current wishes

Their general well-being

Their spiritual and religious welfare.

It would again seem appropriate for staff in Northern Ireland to adopt an approach to assessing best interests along the same lines as that set out in the guidance for England and Wales (Department of Health (NI), 2022a).

Where there are doubts about the person’s capacity or best interests’ approval can be sought from the High Court.

The Mental Capacity Act (Northern Ireland) 2016

The Department of Health (NI) (2022c) describe the Mental Capacity Act (Northern Ireland) 2016 as:

a ground-breaking piece of legislation that, when fully commenced, will fuse together mental capacity and mental health law for those aged 16 years old and over within a single piece of legislation, as recommended by the Bamford Review of Mental Health and Learning Disability.

The Mental Capacity Act (Northern Ireland) 2016 adopts an approach along the lines of those recommended by Szmukler (2019) – set out in more detail later in the chapter – and when fully in force will represent one of the most progressive recent innovations in European mental health legislation, fusing mental capacity and mental health legislation in one Act (Kelly, 2016).

The Mental Capacity Act (Northern Ireland) 2016, at Section 3(1), sets out a very similar description of ‘lacks capacity’ to the Mental Capacity Act 2005:

a person who is 16 or over lacks capacity in relation to a matter if, at the material time, the person is unable to make a decision for himself or herself about the matter … because of an impairment of, or a disturbance in the functioning of, the mind or brain.

The definition of incapacity in the Mental Capacity Act (Northern Ireland) 2016, at Section 4(1) is also very similar to that set out in the Mental Capacity Act 2005:

a person is ‘unable to make a decision’ for himself or herself about a matter if the person –

(a) is not able to understand the information relevant to the decision;

(b)is not able to retain that information for the time required to make the decision;

(c)is not able to appreciate the relevance of that information and to use and weigh that information as part of the process of making the decision; or

(d)is not able to communicate his or her decision (whether by talking, using sign language or any other means) …

The key difference between this and other definitions of incapacity is the use of the word ‘appreciate’. When this Act was consulted upon, prior to its implementation, consideration was given to the importance of moving a decision about capacity from a purely cognitive test. The consultation document gives as an example: ‘a person whose insight is distorted by their illness or a person suffering from delusional thinking as a result of their illness may not, therefore, meet this element of the test’ (Department of Health, Social Services and Public Safely, 2014 p. 13).

Kelly (2016 pp. 72–73) contests the significance of the inclusion of ‘appreciate’, noting that it is an ‘extremely subtle purported difference between the definition in Northern Ireland and that in England and Wales’; concluding that the ‘difference between the two positions appears vanishingly subtle in theory, let alone in clinical practice’.

In relation to best interests, the test is again broadly similar to that set out in the Mental Capacity Act 2005. It is set out in Section 7 Mental Capacity Act (Northern Ireland) 2016 and instructs that a person assessing what is in the patient’s best interests must ‘so far as practicable, encourage and help [the patient] to participate as fully as possible in the determination of what would be in [the patient’s]’s best interests’ and must:

Consider whether it is likely that the patient will at some time have capacity in relation to the matter in question; and if it appears likely that the patient will, when that is likely to be.

Have special regard to (so far as they are reasonably ascertainable):

The patient’s past and present wishes and feelings (and, in particular, any relevant written statement made by the patient when they had capacity);

the beliefs and values that would be likely to influence the patient’s decision if the patient had capacity; and

the other factors that the patient would be likely to consider if able to do so.

So far as it is practicable and appropriate to do so, consult the relevant people (listed in Section 7(11) Mental Capacity Act (Northern Ireland) 2016) about what would be in the patient’s best interests; and

Take into account the views of those people (so far as ascertained from that consultation or otherwise) about what would be in P’s best interests and in particular about those matters.

The principle of the least restrictive option also applies (Section 7(8) Mental Capacity Act (Northern Ireland) 2016) and the requirement not to be motivated by a desire to bring about P’s death where the matter relates to life-sustaining treatment (Section 7(10) Mental Capacity Act (Northern Ireland) 2016). There is also a requirement to have regard to whether failure to do the act is likely to result in harm to other persons with resulting harm to the patient (Section 7(9)).

At the time of writing, it is unclear when these, and the many other provisions in the Mental Capacity Act (Northern Ireland) 2016, will come into force.

Scotland

In Scotland, the decision-making framework for patients who lack capacity is detailed within the Adults with Incapacity (Scotland) Act 2000, with the Mental Health (Care and Treatment) (Scotland) Act 2003 providing information about those with mental health problems. The Adults with Incapacity (Scotland) Act 2000 provides the legal framework for decision making with regard to adults who lack capacity in Scotland in relation to welfare, property, financial affairs and medical treatment. The Adults with Incapacity: Code of Practice for Medical Practitioners (Scottish Government, 2010) provides clinicians with guidance on how to apply the Adults with Incapacity (Scotland) Act 2000 to practice.

The Adults with Incapacity (Scotland) Act 2000 defines incapacity as occurring when a person aged 16 years or over is incapable of doing one or more of the following: acting, or making decisions, or communicating decisions, or understanding decisions, or retaining the memory of decisions by reason of mental disorder or of inability to communicate because of physical disability (but a person shall not fall within this definition by reason only of a lack or deficiency in a faculty of communication if that lack or deficiency can be made good by human or mechanical aid (whether of an interpretative nature or otherwise)) (Adults with Incapacity (Scotland) Act 2000, Section 6).

Statutory Principles

The Adults with Incapacity (Scotland) Act 2000 is underpinned by principles that anyone taking action under the Act must apply when deciding which measure will be the most suitable for meeting the needs of the individual. The principles must also be used whenever decisions need to be made on behalf of the adult.

Principle 1: Benefit

Any action or decisions taken must benefit the adult, and only be taken when that benefit cannot reasonably be achieved without it. In G v. West Lothian Council [2014] it was suggested by the sheriff that ‘benefit’ was the overarching principle of the Adults with Incapacity (Scotland) Act 2000; however, Patrick and Stavert (2016) dispute this, noting that it is not reflected in the Adults with Incapacity (Scotland) Act 2000 and does not reflect the promotion of autonomy of adults in Article 12 of the United Nations Convention on the Rights of Persons with Disabilities (United Nations, 2006).

Principle 2: Least Restrictive Option

Any decision should be the minimum necessary to achieve the purpose. It should be the option that restricts the person’s freedom as little as possible.

Principle 3: Taking into Account the Patient’s Wishes

In deciding if an action or decision is to be made, and what that should be, account must be taken of the present and past wishes and feelings of the person, as far as this may be ascertained. Further to this, the adult should be offered appropriate assistance to communicate his or her views.

Principle 4: Consultation with Relevant Others

The decision maker should take account of the views of others with an interest in the person’s welfare. This could be the nearest relative, the primary carer of the adult, their named person, guardian or attorney with powers relating to the proposed intervention, or any person whom the Sheriff has directed.

Principle 5: Encouraging the Adult

Any guardian, attorney or manager of an establishment exercising functions under this Act should encourage the adult to exercise whatever skills they have concerning property, financial affairs or personal welfare as the case may be and to develop new such skills, in so far as it is reasonable and practicable to do so.

Assessing Mental Capacity

The Adults with Incapacity (Scotland) Act 2000 only deals with the effect of incapacity, it does not deal with assessing capacity, for this the common law continues to apply (Patrick and Stavert, 2016). Most of the case law on this subject comes from England and Wales, and Patrick and Stavert (2016) note that there is no reason to think the law in Scotland would be different, citing the British Medical Association’s (BMA’s) heavy reliance on these cases (BMA, 2009).

The starting point for assessing someone’s capacity to make a particular decision is always the assumption that the individual has capacity. When assessing capacity, the higher the level of risk, the greater the level of competence the person will need to demonstrate. For decisions that pose a significant risk – such as rejecting medical advice – a higher standard may be required (Patrick and Stavert, 2016).

A person is considered to be incapable (lack capacity) for the purposes of Adults with Incapacity (Scotland) Act 2000 if they are (Patrick and Stavert, 2016):

unable to take a relevant decision because of mental disorder (or cannot communicate because of physical disability; this could apply to someone who is unconscious following an accident or a stroke as well as to someone with communication difficulties.

For medical treatment decisions Patrick and Stavert (2016) recommend the following approach based on the framework set out in Section 3 of the Mental Capacity Act 2005; it is likely much of the information relating to the functional test in England and Wales would also be applicable to the assessment of incapacity.

Ability to Understand the Decision

The person needs to be able to understand what the treatment is, why it is being proposed and the nature, purpose, principle benefits and likely effects of the treatment (Mental Welfare Commission, 2022). They also need to understand the alternatives, and risks associated with not having it (Mental Welfare Commission, 2022).

Only a broad understanding is required (although note the previous comments about significant risks); the example given by Patrick and Stavert (2016) is that a person might be able to understand routine procedures, but not weigh up risks and benefits of complex procedures. What the principles require is that the person is assisted in making as many medical decisions as they can, and where necessary more complex decisions are then made in their benefit.

Memory of Decision

If a person’s short-term memory is poor, it does not necessarily mean they cannot make a decision, although it might mean they are unable to retain information for enough time to make the decision.

Patrick and Stavert (2016) note that professionals working with those with dementia sometimes use consistency of decision making as a tool for assessing capacity in those with dementia, where a person does not remember the question but consistently gives the same answer, it is considered reasonable to respect this. The guidance given by the Scottish Government (2008) is slightly different, using an example where the person does not remember being asked the question in a previous discussion, but provides the same response.

Ability to Weigh up Information

This relates to the person’s ability to weigh information in the balance. A person’s illness may cause them to be able to understand information provided to them, but twist and distort the information, or discount aspects that do not suit them, or they may simply not believe what the clinician tells them. In these situations, a person cannot be said to be able to weigh up the information given to them (Patrick and Stavert, 2016).

Making a Free Choice

It is the author’s view that much of the commentary given by Patrick and Stavert (2016) on assessing the person’s ability to make a free choice would be considered under the ‘use and weigh’ limb of the Mental Capacity Act 2005 functional test. However, Patrick and Stavert (2016, 7.11) do make the distinction between an ability to understand and retain information and being able to weigh up the risks, and being ‘truly … able to take the decision’.

Examples are given from case law of a person being found to be unable to make a free choice because of compulsion to refuse treatment caused by anorexia (Re W (A Minor) (Medical Treatment) [1992]), or a person with a personality disorder being unable to break out of the routine of punishing themselves (B v. Croydon Health Authority [1995]), or a person being unduly suggestible due to mental illness, learning disability, pain or distress (Re T (Adult: Refusal of Medical Treatment) [1993]).

Inability to Communicate Decision

Where a person is unable to communicate their decision, even with assistance, they can be found to lack capacity. A person should not be found to lack capacity just because those who are assessing their capacity have failed in their communication skills, and efforts must be made to maximise their capacity (Patrick and Stavert, 2016). However, where steps to maximise a person’s capacity cannot be taken due to the need to provide emergency treatment, this should be provided and their capacity re-assessed when the treatment required to resolve the emergency has been provided.

Emergencies

The Adults with Incapacity (Scotland) Act 2000 maintains that where a person is unable to consent to treatment in an emergency, treatment can be given under the common law ‘principle of necessity’ (Mental Welfare Commission for Scotland, 2022; Patrick and Stavert, 2016; Scottish Government, 2010). The Adults with Incapacity (Scotland) Act 2000 Code is clear that ‘it would be contrary to good practice to risk prejudice to a patient’s health through any delay in providing necessary treatment, in order to give effect to the procedures under Part 5 of the Act’ (see ‘Treatment Under Part 5’).

The Adults with Incapacity (Scotland) Act 2000 Code recognises that it sometimes might not be easy to delineate what constitutes an ‘emergency’, and that this will vary from speciality to speciality (Scottish Government, 2010). The Mental Welfare Commission for Scotland (2022) advise that where treatment is required ‘for the preservation of the life of the adult or the prevention of serious deterioration in the adult’s medical condition’, this can be given under the common law principle of necessity. Paramedics should also be mindful of their duty to preserve life under Section 6(1) of the Human Rights Act 1998, which enshrines in United Kingdom (UK) law the right to life that is provided by Article 2 of the European Convention on Human Rights.

In an emergency therefore paramedics can do what is reasonably required in the person’s best interests (Re F (Mental Patient: Sterilisation) [1990]; Scottish Law Commission, 1995). This would apply where such treatment was immediately required to ‘improve or stop a deterioration in physical or mental health’ (Patrick and Stavert, 2016).

If the person is able to consent and refuses treatment, it cannot be provided (unless the Mental Health (Care and Treatment) (Scotland) Act 2003 could be used) (Patrick and Stavert, 2016).

A 19-year-old patient who was involved in a road traffic accident has been brought into the emergency department and is unconscious. The patient has sustained potentially life-threatening injuries, all of which require urgent attention.

The patient lacks capacity, as they are unable to understand or communicate due to their head injury. It would not be prudent to wait to see whether they regain consciousness and assess their capacity before treating them. Under common law, practitioners have a duty of care in an emergency to take necessary action to safeguard a person who is unable to consent and without treatment would come to significant harm. In this case, what is required is clear documentation within the case notes of the treatment given and why it was required under common law (Mental Welfare Commission for Scotland, 2021).

Advance Choices

While statutory recognition is given to advance refusal of treatment in England and Wales (Mental Capacity Act 2005, Sections 24–26), the Adults with Incapacity (Scotland) Act 2000 does not specifically deal with making advance choices (Patrick and Stavert, 2016). Patrick and Stavert (2016) note that the House of Lords recognised their validity in Airedale NHS Trust v. Bland [1993] AC 789 HL at [860 and 866], and as the Scottish Parliament did not intend to alter the common law on advance refusals take the view that, ‘in so far as they were valid prior to the Adults with Incapacity (Scotland) Act 2000 … they should remain valid’.

However, due to Scotland being a small country, not many court cases are brought forward to enable lawyers to establish what the law is, meaning there is considerable uncertainty in this area of law (Patrick and Stavert, 2016), and while commentators believe an advance decision to refuse medical treatment may have legal effect in Scotland, no one can be sure (McKay et al., 2022). The Scottish Law Society have called for legislative provision for ‘advance choices’ to provide clarity and certainty on this issue (Law Society of Scotland, 2022).

Treatment Under Part 5

Unlike the Mental Capacity Act 2005, the AWI Act does not make specific reference to ‘best interests’, as this was felt to be vague and not attribute sufficient weight to the views of the adult (Edwardson and Baruah, 2018). Although the third general principle set out in Section 1(4) of the AWI Act provides a list of what should be taken into account when determining whether an intervention should be made.

Instead of a ‘best interests’ approach, the AWI Act provides a ‘general authority’ to treat a patient under ‘Part 5’ of the Act as long as they have been assessed to lack mental capacity and a Section 47 medical treatment certificate has been completed; this must be completed by a registered medical practitioner, or a dental practitioner, ophthalmic optician or registered nurse who has undergone the necessary training (Mental Welfare Commission for Scotland, 2021).

The certificate can authorise treatment for up to a year, or three years in circumstances where the patient has a severe or profound learning disability, or severe dementia, or severe neurological disorder; no curative treatment is available; and their capacity is unlikely to improve (Mental Welfare Commission for Scotland, 2021). Only registered medical practitioners can complete a Section 47 certificate that authorises treatment to be provided by other healthcare professionals, either under their instructions or with their agreement (Mental Welfare Commission for Scotland, 2021).

There are also some treatments that Section 47 certificates cannot authorise and have to be approved by the Court of Session, these include neurosurgery for mental disorder, sterilisation where there is no serious malfunction or disease of the reproductive organs, and surgical implantation of hormones for the purpose of reducing sex drive.

Figure 7.1 provides guidance on what legal authority can be relied upon, or should be obtained, before providing medical treatment to adults who lack capacity in Scotland (Scottish Government, 2021).

Figure 7.1 Adults with Incapacity (Scotland) Act 2000, Part 5: Medical treatment flowchart.

Source: Scottish Government (2021). Open Government License.

Welfare Attorneys and Welfare Guardians

In Scotland, a person aged sixteen or over can make a power of attorney if they are mentally capable of doing so. This gives authority to another person to support the person, or act on their behalf where necessary, in relation to finance, property and/or health and welfare when they are no longer able to make decisions themselves (Scottish Independent Advocacy Alliance (SIAA), 2021). This chapter will only cover welfare power of attorney, which applies to health and welfare matters; it will not cover continuing power of attorney, which applies to property and finance. Should the person wish, they can appoint multiple attorneys. They can also stipulate if they would like them to act jointly (where they have to work together), jointly and severally (where they can work individually) or a mix (where they have to work together for some decisions, but can make others independently) (SIAA, 2021). Welfare powers only start when the person is incapable.

Where a person has lost capacity, needs someone to support them, or act on their behalf, in relation to making decisions, and does not have an attorney, a guardian can be appointed by making an application to the Sheriff court closest to where the person lives (SIAA, 2021). Where there is no one to make the application, but one is required, the Local Authority will make the application; generally the Chief Social Work Officer is then appointed as welfare guardian, although the authority is usually delegated to a local social worker (SIAA, 2021).

An attorney or guardian has the following obligations (SIAA, 2021, p. 15):

In short, to put the incapable person at the centre of their thinking

To act with honesty and integrity

To owe a duty of care to the person, which means applying a standard of care and skill

To support the person to make their own decisions whenever possible

If this is not possible, to make the decision that the person would most likely have made for themselves

To only make decisions that they have authority to make

To act in accordance with the principles of the Adults with Incapacity (Scotland) Act 2000

To be aware of, and have regard, to the Adults with Incapacity (Scotland) Act 2000 Code of Practice

To maintain records of their actions

To comply with any orders of the Public Guardian and of the Court.

Use of Force and Restraint

The provisions for using restraint or force to provide treatment are set out in more detail in the Mental Welfare Commission (2022) document Right to Treat?. Only a summary of the relevant provisions is provided here.

Where treatment is immediately necessary to save life or prevent a serious deterioration, this can be given immediately under the common law principle of necessity; once this has been done, the situation should then be reassessed (Mental Welfare Commission, 2022).

Where force is necessary in the short to medium term, but cannot wait for Court authorisation, a certificate of incapacity under Section 47 of the Adults with Incapacity (Scotland) Act 2000 should be obtained. Force can be used only ‘where immediately necessary and only for as long as is necessary’ (Adults with Incapacity (Scotland) Act 2000, Section 47(7)(a)), and the paramedic should clearly document why force was necessary. If the use of force is likely to be needed on an ongoing basis application for a welfare intervention order or welfare guardianship should be considered (Mental Welfare Commission, 2022).

If the treatment can wait for a Court authorisation, advice should be sought on the process for obtaining this. Where the treatment is for a physical disorder that is a direct cause of consequence of a mental disorder and the person is subject to treatment under the Mental Health (Care and Treatment) (Scotland) Act 2003, it can be provided under this authority (Mental Welfare Commission, 2022).

The Mental Welfare Commission (2022) provide a useful flowchart to assist professionals in situations where a person with an apparent mental disorder needs treatment for a physical disorder but is refusing to attend hospital. This and the accompanying guidance notes (referred to by numbers in brackets) can be seen in Figure 7.2.

Figure 7.2 Flowchart and guidance notes (p. 152) for situations where a person with an apparent mental disorder needs treatment for a physical disorder but is refusing to attend hospital.

Source: Mental Welfare Commission (2022, p. 34)

Guidance Notes

1. This is explored in the Mental Welfare Commission’s Consent to Treatment (2018): a guide for mental health practitioners (2017).

2. A medical practitioner should assess capacity. Definition of incapacity (AWI Act): incapacity means being incapable of acting, or making decisions, or communicating decisions, or retaining the memory of decisions by reason of mental disorder or inability to communicate due to physical disorder.

3. For example:

a. Person has taken an overdose, is becoming drowsy and is in serious danger if not treated immediately.

b. Person has acute chest pain possibly a myocardial infarction and needs immediate hospital attention.

3. Practitioner should discuss this with ambulance staff to ensure that everyone understands and agrees the necessity for immediate treatment. Once in hospital, a person who lacks capacity can be treated under Part 5 of the AWI Act. The medical practitioner completes a certificate of incapacity under Section 47. This certificate does not authorise force or detention unless it is immediately necessary and only for as long as is necessary.

4. An approved medical practitioner and a mental health officer should be contacted. Emergency detention should only be considered if both cannot attend within a safe timescale.

5. Mental Health Officer applies to the Sheriff for a warrant. If urgent, [they] can apply to a Justice of the Peace

Presently, the AWI (Scotland) Act 2000 and associated codes of practice are unclear on the correct procedure to follow for non-urgent physical health interventions that the adult with incapacity actively resists. The best advice is to apply for welfare guardianship – the Sheriff may take the view that, on the basis of this application, an intervention order will suffice.

An Alternative Approach

There have been criticisms of legislation that separate mental capacity and mental health. For example, in England and Wales, the Mental Capacity Act 2005 is considered by some not to have sufficient safeguards built in for the use of restraint or force, and the Mental Health Act 1983 is considered by some to discriminate against those with mental disorders and to be at odds with the United Nations Convention on the Right of Persons with Disabilities (United Nations, 2006; Hale, 2017). This is because the legislation does not allow those with a mental disorder to enjoy the same rights as those with a physical disorder. It is also often considered that the way the two pieces of legislation interact with each other is unnecessarily complex.

The justification for this disparity between the respect for autonomy and rights of those with mental and physical health disorders is the risk of harm. Broadly, if a person has a mental disorder and is a risk to themselves or others, this could be sufficient justification for detention and involuntary treatment (Szmukler, 2019). This is supported by Article 5(1)(e) of the European Convention on Human Rights. In practice, this means that those with a mental disorder may be given treatment even when they retain the capacity to refuse.

There is sometimes a nervousness about the use of force to treat a patient in the absence of a clear statutory authority, such as the Mental Health Act 1983 (that is, formally sectioning a patient for assessment or treatment). This nervousness may mean that a patient refusing treatment who lacks capacity does not receive treatment that is in their best interests because it is easier to treat them with a presumption of capacity and capacitous refusal of treatment (Szmukler, 2019). It also means that in some circumstances, the Mental Health Act 1983 may be used inappropriately for those who lack capacity, do not have a mental disorder of a ‘traditional nature’, but require force in order to be given treatment (Szmukler, 2019).

The ‘Fusion’ Approach

Szmukler (2019) offers a case for a new law that would not discriminate against those with mental disorder. He suggests a move towards a new ‘fusion’ approach, a generic law that combines legislation relating to mental health and mental capacity. This would create a capacity-based law that combines the emphasis of autonomy that is central to the Mental Capacity Act 2005 with the clearly regulated use of detention and force found in the Mental Health Act 1983.

The proposed law has similar core principles to the Mental Capacity Act 2005 and borrows heavily from its diagnostic and functional tests; the definition of ‘best interests’ is also similar to the Mental Capacity Act 2005, but with a stronger emphasis on the participation of the person in making the decision (Szmuckler, 2019).

Where a person is objecting to treatment, the fusion law demands that a set of conditions are met. If any of the conditions are no longer met, the person must be discharged. The conditions are:

The person has an impairment or dysfunction of the mind

The person lacks capacity to make a decision about his or her care or treatment

The person needs care or treatment in his or her best interests

The person objects to the proposed care or treatment

The proposed objective cannot be achieved in a less restrictive fashion.

(Szmuckler, 2019, p. 90)

In an emergency, paramedics (and other professionals), with a reasonable belief that a person lacks capacity would be able to intervene and take the person to an appropriate place for assessment (Szmuckler, 2019). The following would then be instigated:

1.An emergency assessment, including capacity assessment, and an immediately required treatment period would follow, lasting only 24 hours (second opinion and consultation with those involved in best interests decision making would be required for an extension of this).

2.If it was decided that further involuntary treatment was required, a care plan would be made and shared with the patient, and treatment would continue for up to 28 days.

3.If the involuntary treatment was required for more than 28 days, this would be authorised by a tribunal.

Involuntary treatment could also be provided to those lacking capacity for the protection of others; this would be subject to it being in the patient’s best interests (for example, where they are being aggressive towards someone they love and to whom they are not normally aggressive) or where treatment in the patient’s best interests caused a risk to others (for example, being aggressive towards other in-patients) (Szmuckler, 2019).

Szmuckler’s ‘fusion law’ proposal would also apply to offenders (those in the criminal justice system) with an impairment in their mental functioning; however, this will not be discussed here.

If implemented, the fusion law proposal would provide paramedics and other healthcare professionals with a clear statutory framework to work within and would remove some of the challenges faced by the emergency services when working with the cognitively impaired, such as the previously discussed ‘Sessay problem’ (R (Sessay) v. SLAM and Commissioner of the Police for the Metropolis [2011]).

Summary

Although there are different statutory frameworks across the UK for the assessment of capacity and making decisions for those who lack capacity, they all adopt a similar general approach. Central to legislation is the promotion of autonomy, with case law continuing to emphasise this by attributing increasing weight to the person’s past wishes and feelings when they lack capacity. Mental capacity legislation is not perfect and it has been argued that it fails to provide adequate safeguards that are found in other pieces of legislation which authorise involuntary treatment, such as mental health legislation.

A ‘fusion law’ is considered likely to reduce discrimination against those with mental disorders and provide safeguards to ensure that involuntary treatment is not given arbitrarily. It will be interesting to see if this is true when the Mental Capacity Act (Northern Ireland) 2016 comes fully into force.

Capacity is specific to the material time a specific decision is being made.

Where a person may regain capacity, you should always ensure that the decision cannot wait until they do, and that treatment provided is the least necessary to keep the person safe until they regain capacity.

It is essential to clearly document your capacity assessment, any decision making about providing treatment and the rationale for any restraint used.

How detailed your documentation needs to be will depend on, and should be proportionate to, the seriousness of the decision that is to be made.

Recommended Reading

England and Wales

39 Essex Chambers (2022a). Mental Capacity Guidance Notes. Available at: https://www.39essex.com/tag/mental-capacity-guidance-notes/ (accessed 29 June 2023).

Beale C et al. (2023). Mental capacity in practice part 1: how do we really assess capacity? British Journal of Psychiatry Advances: 1–9.

Beale C et al. (2023). Mental capacity in practice part 2: capacity and the suicidal patient, British Journal of Psychiatry Advances: 1–10.

Farmer T (2020). Grandpa on a Skateboard: The Practicalities of Assessing Mental Capacity and Unwise Decisions. 3rd edn. Gorleston: Rethink Press.

Hallett N (2023). Assessing mental capacity: tensions, values and duties, British Journal of Psychiatry Advances: 1–3.

Jones R and Piffaretti E (2018). Mental Capacity Act Manual. 8th edn. London: Sweet & Maxwell.

Mughal AF and Richards S (2022). Deprivation of Liberty Safeguards (DoLS) Handbook. 2nd edn. London: BooksWise.

Ruck Keene A (2019). ‘Liberty Protection Safeguards resources’, Mental Capacity Law and Policy. Available at: https://www.mentalcapacitylawandpolicy.org.uk/resources-2/liberty-protection-safeguards-resources/ (accessed 17 July 2023).

Northern Ireland

Kelly B (2016). Mental Illness, Human Rights and the Law. London: Royal College of Psychologists.

Scotland

McKay C et al. (2022). Scottish Mental Health Law Review: Final Report. Edinburgh: Scottish Government.

Mental Welfare Commission for Scotland (2022). Right to treat? Delivering physical healthcare to people who lack capacity and refuse or resist treatment. Good practice guide. Available at: https://www.mwcscot.org.uk/sites/default/files/2022-08/RightToTreat-Guide-February2022.pdf (accessed 29 June 2023).

Patrick H and Stavert J (2016). Mental Health, Incapacity and the Law in Scotland. London: Bloomsbury Professional.

References

39 Essex Chambers (2019). Deprivation of Liberty in the Hospital Setting. Available at: https://www.39essex.com/mental-capacity-guidance-note-deprivation-liberty-hospital-setting/ (accessed 29 June 2023).

39 Essex Chambers (2022). Carrying out and recording capacity assessments. Available at: https://www.39essex.com/mental-capacity-guidance-note-brief-guide-carrying-capacity-assessments/ (accessed 29 June 2023).

British Medical Association (BMA) (2009). Medical treatment for adults with incapacity. Guidance on ethical and medico-legal issues in Scotland. Available at: https://www.bma.org.uk/media/1190/bma-guidance-about-medical-treatment-for-adults-with-incapacity-in-scotland.pdf (accessed 29 June 2023).

British Medical Association (BMA) (2020). Adults with incapacity in Scotland and Northern Ireland. Available at: https://www.bma.org.uk/advice-and-support/ethics/adults-who-lack-capacity/adults-with-incapacity-in-scotland-and-northern-ireland (accessed 29 June 2023).

Care Quality Commission (CQC) (2022a). University Hospitals Birmingham NHS Foundation Trust pays fixed penalties of £8,000 for failures around consent. Available at: https://www.cqc.org.uk/press-release/university-hospitals-birmingham-nhs-foundation-trust-pays-fixed-penalties-ps8000?fbclid=IwAR3xLPn17K04AhJuzuKJLRlX6rNwnQLQS5L_tHMIAGQ3OLCt9UO_pzQpWdw (accessed 29 June 2023).

Care Quality Commission (CQC) (2022b). Outcome of an application to deprive a person of their liberty (DoLS) – notification form. Available at: https://www.cqc.org.uk/guidance-providers/notifications/application-deprive-person-their-liberty-dols-notification-form (accessed 29 June 2023).

College of Policing (2021). Memorandum of Understanding – The Police Use of Restraint in Mental Health & Learning Disability Settings. Available at: https://rcem.ac.uk/wp-content/uploads/2021/11/Police_Use_of_Restraint_in_Mental_Health_and_LD_Settings.pdf (accessed 16 July 2023).

Curtice M (2020). Fluctuating capacity: The concept of micro- and macro-decisions. British Journal of Psychiatry Advances, 26(4): 238–244.

Department of Health (2015). Mental Health Act 1983: Code of Practice. London: The Stationery Office.

Department of Health and Social Care (2021). Mental Health Units (Use of Force) Act 2018: statutory guidance for NHS organisations in England, and police forces in England and Wales. Available at: https://www.gov.uk/government/publications/mental-health-units-use-of-force-act-2018/mental-health-units-use-of-force-act-2018-statutory-guidance-for-nhs-organisations-in-england-and-police-forces-in-england-and-wales (accessed 29 June 2023).

Department of Health (NI) (2004). Form 4: Adults Who Are Unable To Consent To Examination, Treatment Or Care. Available at: https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/consent-form-4.pdf (accessed 16 July 2023).

Department of Health (NI) (2022a). Consent for examination, treatment or care. Available at: https://www.health-ni.gov.uk/articles/consent-examination-treatment-or-care (accessed 29 June 2023).

Department of Health (NI) (2022b). Mental Capacity Act Legislation. Available at: https://www.health-ni.gov.uk/mental-capacity-act-legislation (accessed 29 June 2023).

Department of Health (NI) (2022c). Mental Capacity Act Background. Available at: https://www.health-ni.gov.uk/mental-capacity-act-background (accessed 29 June 2023).

Department of Health, Social Services and Public Safety (2014). Draft Mental Capacity Bill (Nl): Consultation Document. Available at: https://www.health-ni.gov.uk/sites/default/files/consultations/dhssps/mental-capacity-consultation-document.pdf (accessed 29 June 2023).

Edwardson S and Baruah R (2018). Scots law and its relevance to anaesthesia, critical care, and pain medicine. British Journal of Anaesthesia Education, 18(6): 178–184.

General Medical Council (GMC) (2020a). Factsheet: Key legislation and case law relating to decision making and consent. Available at: https://www.gmc-uk.org/-/media/documents/factsheet---key-legislation-and-case-law-relating-to-decision-making-and-consent-84176182.pdf (accessed 29 June 2023).

General Medical Council (GMC) (2020b). Decision Making and Consent. Available at: https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors---decision-making-and-consent-english_pdf-84191055.pdf (accessed 29 June 2023).

General Medical Council (GMC) (2022). Mental Capacity. Available at: https://www.gmc-uk.org/ethical-guidance/ethical-hub/mental-capacity (accessed 29 June 2023).

Hale B (2017). Mental Health Law. London: Sweet & Maxwell.

Harris J (1985). The Value of Life: An Introduction to Medical Ethics. London: Routledge.

Heywood R (2014). Revisiting advanced decision making under the Mental Capacity Act 2005: a tale of mixed messages. Medical Law Review, 23(1): 88–102.

His Majesty’s Government (2022). Mental Capacity Act 2005 Code of Practice Including the Liberty Protection Safeguards (Draft). London: His Majesty’s Government.

House of Lords (2015). Mental Capacity Act 2005: Post-legislative Scrutiny. London: The Stationery Office.

Johnston C, KC and Roper S, KC (2022) Medical Treatment: Decisions and the Law. London: Bloomsbury Publishing.

Jones R and Piffaretti E (2018). Mental Capacity Act Manual. 8th edn. London: Sweet & Maxwell.

Jones R (2021). Mental Health Act Manual. London: Sweet & Maxwell.

Kelly B (2016). Mental Illness, Human Rights and the Law. London: Royal College of Psychologists.

Law Society (2015). Deprivation of Liberty Safeguards: A Practical Guide. https://www.lawsociety.org.uk/topics/private-client/deprivation-of-liberty-safeguards-a-practical-guide (accessed 29 June 2023).

Law Society of Scotland (2022). Advance choices, and medical decision-making in intensive care situations. Available at: https://www.lawscot.org.uk/media/372888/22-05-19-adwg-report-final.pdf (accessed 29 June 2023).

Mental Welfare Commission for Scotland (2018). Consent to treatment: A guide for mental health practitioners. Available at: https://www.mwcscot.org.uk/sites/default/files/2019-06/consent_to_treatment_2018.pdf (accessed 29 June 2023).

McKay C et al. (2022). Scottish Mental Health Law Review: Final Report. Edinburgh: Scottish Government.

Ministry of Justice (2008). Mental Capacity Act 2005 Deprivation of Liberty Safeguards Code of Practice to supplement the main Mental Capacity Act 2005 Code of Practice. London: The Stationary Office.

Mughal AF and Richards S (2022). Deprivation of Liberty Safeguards (DoLS) Handbook. 2nd edn. London: BooksWise.

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Office of the Public Guardian (2013). Mental Capacity Act Code of Practice. London: The Stationery Office.

Patrick H and Stavert J (2016). Mental Health, Incapacity and the Law in Scotland. London: Bloomsbury Professional.

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Weatherill G, Woods S and Dandridge H (2022). CQC clamps down on mental capacity. Available at: https://www.dacbeachcroft.com/en/gb/articles/2022/october/cqc-clamps-down-on-mental-capacity/ (accessed 29 June 2023).

¹ We note that this is archaic language and, sadly, a product of its time.

Chapter 8

Legal and Ethical Treatment of Children

Will Broughton and Georgette Eaton

It was once said that the moral test of government is how that government treats those who are in the dawn of life, the children ...

Hubert Humphrey

Introduction

Other than inclusion as subject matter within the undergraduate curriculum, the Health and Care Professions Council (HCPC) offers no specific advice regarding children, and neither do the College of Paramedics (College of Paramedics, 2019). With those aged 0–14 estimated to make up just 17.68% of the total population of the United Kingdom (UK) (World Bank, 2021), it could be observed that an ageing UK population has almost put children off the agenda. However, paramedics caring for children and young people have several ethical and legal obligations with which they should be familiar, and these are often outlined in best practice guidance, statute and case law.

Where children are involved, there is a human notion to make ‘best’ moral decisions. However, one of the most interesting ethical arguments involving a child is in Ursula Le Guin’s The Ones Who Walk Away from Omelas (1973). This tells the story of a utopian city (Omelas), which is a city of happiness of aspirant utilitarian proportions, with indications that it is free from war, conflict and depravity. However, this constant state of prosperity depends on one thing: the never-ending misery of a single child who is kept in perpetual filth, darkness and misery. The story recounts that once citizens are old enough to know the truth, though initially shocked and disgusted, most accept this one injustice secures the happiness of the rest of the city. Their happiness ultimately comes from their willingness to sacrifice one human (a child) for the benefit of the rest. Ultimately, they reject guilt. Yet, even if utilitarianism could lead to such a city of happiness, most readers would outline that it would be morally wrong to violate the rights of an innocent child, even if this secures the happiness of the multitude. Perhaps this is why some of the population in the story walk away from the city of happiness in pursuit of justice, which they would value more than their own joy. Yet, what if this was an adult? Would the same human notion regarding moral decision making apply?

The role of children in medical law frequently sparks contentious debates and gives rise to ethical quandaries. The recent Charlie Gard case, along with the use of social media during this legal battle, serves as a vivid illustration of the challenges confronting healthcare professionals in the treatment of children (Yates and Gard v. Great Ormond Street Hospital for Children NHS Foundation Trust [2017]). This is far from an easy subject for any paramedic, regardless of their education or experience. When paramedics encounter these difficult situations they should be reassured by the publications that are in place to support them, but must also seek guidance from those who know the publications, and the law, in detail.

When making decisions about the healthcare of children and young people, there are several essential principles outlined by the British Medical Association (BMA) (2021, p. 2):

All children and young people can expect the following:

To be kept as fully informed as they wish, and as is possible, about their care and treatment

Health professionals to act as advocates

To have their views and wishes sought and taken into account as part of promoting their welfare in the widest possible sense

To be the individual who consents to assessment or treatment when they are competent and wish to do so

To be encouraged to take decisions in collaboration with other family members, especially parents, if this is feasible

To be able to expect that information provided will remain confidential unless there are exceptional reasons that require confidentiality to be breached.

This chapter will set out some key pieces of guidance, legislation, case law and statute that professionals should be familiar with to practice safely. It includes profession-specific guidance for clinical practice. These should be read in conjunction with the further reading that has been identified, which serves as a point of reference for those interested in the law and ethics related to paediatric paramedic practice.

The Rights and Interests of Children

Within the UK, there are several main Acts that govern the legal rights of children and exist to protect their interests.

England and Wales

The Children Act 1989

This allocates duties to parents, local authorities, courts and other agencies in the UK to ensure that the welfare of children is promoted, and they are safeguarded as appropriate. The Act outlines that the child’s welfare is of paramount importance and that the views of the child must be respected.

This Act centres on the idea that children are best cared for within their own families, but it also makes provisions for those who cannot cooperate with statutory bodies. It outlines exactly who would have parental responsibility or guardianship of the child, and allows anyone with parental responsibility to act alone – so decisions may be based on one parent.

Although mostly aimed at court decisions for care, this Act produces a list of general principles that are pertinent to clinical practice, to maximally promote and protect the child’s general welfare and ensure any actions are in their best interests. The following should be considered:

The wishes and feelings of the child

The education, emotional and educational needs of the child

The effect on the child of any change in circumstances

Any harm which the child is a risk of suffering or has suffered

How capable the child’s parents or guardians are in meeting the child’s needs

The relevant characteristics of the child, including their age, gender and background.

The Children Act 2004

This Act supplemented the 1989 Act and reinforced the message that all organisations working with children have a duty in helping safeguard and promote the welfare of children.

Family Law Reform Act 1969

This is largely concerned with law relating to the age of majority (where a person shall attain full age on becoming 18 years old), the property rights of illegitimate children, the provision of blood tests to confirm paternity and other provisions in connection with registration of the birth of an illegitimate child. The Act also makes it quite clear that those who are aged 16–17 years have the same legal ability to consent to any medical, surgical or dental treatment as anyone above the age of 18, without the consent from their parent or guardian.

Northern Ireland

The Children (Northern Ireland) Order 1995

This is the principal statute governing the care, upbringing and protection of children in Northern Ireland. It affects all those who work with and care for children, whether parents, paid carers or volunteers. The Order brought together most of the ‘public’ and ‘private’ law relating to children in a single statutory framework along the lines of the Children Act 1989 in England and Wales. The legislative framework for Northern Ireland’s child protection system is set out in this Act.

The Children’s Services Co-operation Act (Northern Ireland) 2015 builds on this and requires public authorities (including health services) to cooperate in contributing to the well-being of children and young people, in the areas of:

Physical and mental health

Enjoyment of play and leisure

Learning and achievement

Living conditions, rights and economic well-being.

Age of Majority Act (Northern Ireland) 1969

Under Section 4 of the Age of Majority Act (Northern Ireland) 1969, patients aged 16 or 17 can provide consent to their own medical care if they are deemed to be capable of making informed decisions.

Scotland

Children (Scotland) Act 1995

Mothers and married fathers have automatic parental responsibilities and rights (Section 3). Unmarried fathers can acquire parental responsibilities and rights by entering into an agreement with the mother or by application to the court. Regarding children born on or after 4 May 2006, fathers who register the birth jointly with the mother will also acquire parental responsibilities and rights.

Law Reform (Parent and Child) (Scotland) Act 1986

When parents separate or divorce, or indeed have always lived apart, much of the legal framework relevant to their parenting issues can be found in this Act. Importantly, this Act expresses that the child has a right to have any views he or she wishes to express taken into account, in light of the child’s age and maturity in regard to whom the child lives with.

Age of Legal Capacity (Scotland) Act 1991 (the ‘Scottish Act’)

Under the ‘Scottish Act’, the age of majority (adulthood) is considered to be 16 years. Also outlined within the Act are certain circumstances in which a person under the age of 16 years is deemed to have the capacity to consent to any dental, medical or surgical procedure. This is with the proviso that they are capable of understanding the nature and consequences of the proposed intervention.

Parental Responsibility

In England, Wales and Northern Ireland, parental responsibilities may be exercised until a young person reaches 18 years.

In Scotland, only the aspect of parental responsibilities concerned with the giving of ‘guidance’ endures until 18 years – guidance meaning the provision of advice. The rest is lost when the young person reaches 16 years, although some may be lost before this if the child attains legal capacity to act on their own behalf.

Throughout the United Kingdom (UK), a mother will automatically gain parental responsibility at birth. The parental responsibility held by others will vary according to the place of birth and when the birth is registered:

In England and Wales, a father would have parental responsibility if he is married to the child’s mother when the child is born or if they have jointly adopted the child. If married parents later divorce, they both still retain parental responsibility. For unmarried parents, they must either jointly register the birth (from 1 December 2003), put in place a parental responsibility agreement with the mother or obtain a parental responsibility order from a court.

In Scotland, a father has parental responsibility if he is married to the mother when the child is conceived, or they become married at any point from conception. An unmarried father must be named on the birth certificate to gain parental responsibility (from 4 May 2006).

In Northern Ireland, a father has parental responsibility if he is married to the mother at the time of the child’s birth. If a father marries the mother after the birth, he will still have parental responsibility if he lives in Northern Ireland at the time of the marriage. An unmarried father has parental responsibility if he’s named, or becomes named, on the child’s birth certificate (from 15 April 2002).

Same-sex partners will both have parental responsibility if they were civil partners or are married at the time of donor insemination or fertility treatment. For same-sex partners who are not civil partners or married, the second parent may obtain parental responsibility by applying to the court if a parental agreement was made or by becoming a civil partner/husband/wife of the other parent and making a parental responsibility agreement or jointly registering the birth.

For a child born under a surrogacy arrangement, parental responsibility will lie with the surrogate mother and her husband, if she is married or in a civil partnership, until the intended parents either obtain a parental order from a court under the Human Fertilisation and Embryology Act 1990 or adopt the child.

Consent

A child or young person is defined as a person under the age of 16 years in Scotland and 18 years in England, Wales and Northern Ireland. Capacity to consent to medical treatment for children aged 16–17 years is presumed within each nation of the UK, unless the patient does not pass the assessment outlined by the Mental Capacity Act 2005 (in England and Wales), Adults with Incapacity (Scotland) Act 2000 or the Mental Capacity Act (Northern Ireland) 2016.

The BMA (2021) toolkit offers guidance for those with parental responsibility, as well as guidance on assessing competence of children and the capacity of children and young people when making decisions about their admission and/or treatment.

To give consent to medical treatment of a child or young person, that person must be:

A competent child or young person, giving consent for their own care

A parent or other person or agency with parental responsibility where the decision is in the best interests of the child

A court

An appointed proxy (in Scotland where the patient is over 16 and unable to make decisions for themself)

A person caring for a child, for example a grandparent or child minder, may do what is reasonable in the circumstances to safeguard or promote the child’s welfare.

(BMA, 2021; Royal College of Nursing (RCN), 2017)

Despite extensive legal guidance, there is no discussion concerning capacity of children under the age of 16, or capacity for the refusal of treatment. Those decisions are governed by common law.

Competence

In England, Scotland, Wales and Northern Ireland, all people aged 16 and over are presumed in law to be competent to give their consent to medical treatment. For a young person under the age of 16 to be competent, they should have:

The ability to understand that there is a choice and that choices have consequences

The ability to weigh the information and arrive at a decision

A willingness to make a choice (including the choice that someone else should make the decision)

An understanding of the nature and purpose of the proposed intervention

An understanding of the proposed intervention’s risks and side effects

An understanding of the alternatives to the proposed intervention, and the risks attached to them

Freedom from undue pressure.

Perhaps the most notorious aspect of law within the UK associated with children is that of Gillick and Fraser. It is important to note that these are related, but not interchangeable, terms.

Gillick Competence and Fraser Guidelines

Gillick competence refers to the assessment that could be made in regard to whether a child under the age of 16 has the capacity to consent to treatment without parental or guardian consent. This is relevant in England, Wales and Northern Ireland.

This was a landmark decision which raised several complex legal issues. The House of Lords were called upon to resolve the extent of the parental right to control a minor and when, and indeed whether, such a minor could receive contraceptive advice or consent to medical treatment, against the wishes or knowledge of their parents. Finally, it fell to be determined whether a doctor, in exercising their clinical duty, would be guilty of a criminal offence by providing contraception or advice to underage patients.

As Gillick was decided in the House of Lords, its authority extends to the whole of the UK. However, subsequent Scottish law has superseded Gillick with the enactment of the Age of Legal Capacity (Scotland) Act 1991 (the ‘Scottish Act’).

Gillick v. West Norfolk & Wisbeck Area Health Authority [1985]

Facts of the Case

Mrs Gillick was a mother of (at that time) four children and raised concern about guidance issued by the Department of Health and Social Security surrounding the provision of contraceptive advice and treatment for a girl under the age of 16 when, at that age, the girl could not lawfully consent to intercourse. Mrs Gillick sought a declaration from the court that the Department’s guidance was unlawful as it adversely interfered with parental rights and duties.

The Judgment

The application for a declaration was dismissed. Parental rights, as such, did not exist, except insofar as necessary to safeguard the best interests of a minor. In some circumstances a minor would be able to give consent in their own right, without the knowledge or approval of their parents. The test proposed by Lord Scarman posits that a minor will be able to consent to treatment if they demonstrate ‘sufficient understanding and intelligence to understand fully what is proposed’ ([1986] AC 112, 187[D]). The test is now often referred to as ‘Gillick competence’ and is an integral aspect of medical law.

‘Fraser guidelines’ is in reference to Lord Fraser’s involvement with the Gillick case. He commented on the responsibility of doctors to ensure adequate capacity of children specifically receiving contraceptive advice and prescriptions.

Lord Fraser stated that a doctor could proceed to give advice and treatment ‘… provided they are satisfied with the following criteria:

1.That the girl (although under the age of 16) will understand his advice;

2.That [they] cannot persuade her to inform her parents or to allow [them] to inform the parents that she is seeking contraceptive advice;

3.That she is very likely to continue having sexual intercourse with or without contraceptive treatment;

4.That unless she receives contraceptive advice or treatment her physical or mental health are both likely to suffer;

5.That her best interests require [them] to give her contraceptive advice, treatment or both without the parental consent.’

These guidelines are accepted by the Department of Health in England, Wales and Northern Ireland. There is no specific government guidance from Scotland.

It is important to note that Fraser does not comment on the capacity of children for any other treatment or procedure than for those specifically receiving contraceptive advice and prescriptions.

Since these rulings, Gillick competence and Fraser guidelines have become interchangeable terms across medical communities as a means of assessing competence in children. This is, as we can see, incorrect. Wheeler (2006) argues that if Gillick became completely incorporated into Fraser, the detailed assessment of the child’s capacity provided by the original case would be lost. Likewise, if Fraser became completely synonymous with Gillick, Lord Fraser’s comments on the particular clinical problem of contraceptives in girls under the age of 16 would be lost in the generalities of children’s capacity.

Although the focus in Gillick was the provision of contraceptive treatment, the principles of this have applied to the consent of minors for other forms of treatment and is a widely used test of competence for decision making in young people. Gillick was unsuccessfully challenged in R (Axon) v. Secretary of State for Health [2006], where guidance for abortion under the age of 16 from the Department of Health was challenged by parents.

Over a decade later, Cobb J in S (Child as Parent – Adoption – Consent) [2017] EWHC 2729 (Fam) passed judgement on competency relating to a child under 16 and capacity to consent to an adoption order. While many elements relate specifically to the adoption order, there are two key sections of this judgement that paramedics may need to be cognisant of in their practice:

‘(i) The test of competence for decision making of a young person is that set out in the House of Lords decision of Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 WLR 830, [1986] 1 AC 112 (‘Gillick’) (‘a sufficient understanding and intelligence to enable him or her to understand fully what is proposed’); in this regard, the child should be able to:

a)Understand the nature and implications of the decision and the process of implementing that decision;

b)Understand the implications of not pursuing the decision;

c)Retain the information long enough for the decision-making process to take place;

d)Be of sufficient intelligence and maturity to weigh up the information and arrive at a decision;

e)Be able to communicate that decision.

(ii) The determination of a child’s competence must be decision-specific and child-specific; it is necessary to consider the specific factual context when evaluating competence.’

The determination of sufficient intelligence and maturity may not be something that can be established by a paramedic; indeed, this will require the input of a clinical psychologist (or similar) to provide a view relating to specific decisions. That said, there are situations in which a paramedic will need to determine competence of a child to proceed with medical treatment. In those circumstances, it would be wise for the paramedic to be aware of the five steps outlined by Cobb J and apply the principle of best interests decision making dependant on the prevailing circumstances. Where possible, this should be a shared decision with the child or young person and demonstrate good professional judgement in determining what information is relevant to the specific child, to make a specific decision.

Disclosure of Health Information

In England, Wales and Northern Ireland, it is reasonable to presume that children aged 12 and over have the competence to give or withhold their consent to the disclosure of personal health information and, in Scotland, anyone aged 12 or over is legally presumed to have such competence. Younger children may also be competent to make decisions regarding the control of their health information, and this would depend on the assessment of their competence (BMA, 2021). Paramedics should respect the child’s wishes if they do not want their parents or guardians to know about some or all aspects of their healthcare, unless there are convincing reasons to the contrary, for example requiring child protection. Paramedics should encourage the child to involve parents or guardians, particularly for important or potentially life-changing decisions.

Children Less Than 16 Years Who Are Not Gillick Competent

The Children Act 1989 outlines that consent for treatment of non-Gillick competent children is by parents or those with parental responsibility. Parental responsibility is defined in the Act as compromising the authority, duties, rights, responsibilities and powers which parents have in relation to their children. This also includes consent to medical treatment on behalf of the child. Parental responsibility may be acquired by relatives, guardians, local authorities or the court.

Normally, the consent of one person with parental responsibility will suffice for the purpose of medical treatment. This is outlined in Re R (A Minor) (Wardship: Consent to Treatment) [1992], where the Court of Appeal demonstrated that a Gillick competent adolescent had the ability to consent to treatment, though should the adolescent refuse the treatment, consent can be given by someone else who had parental responsibility over the child, such as the Court. Essentially, refusal by a Gillick competent child may be over-ridden if consent for treatment is obtained from a valid source.

16- to 17-year-olds Who Lack Mental Capacity

There may also be occasions when a 16- or 17-year-old, who would usually be presumed to be competent to make decisions, may lack mental capacity or may become incapacitated.

In England and Wales, the Mental Capacity Act 2005 outlines the principle that any decision or action taken must be in the best interests of the 16- or 17-year-old who lacks capacity. However, there are some provisions in the Act that do not apply to 16- or 17-year olds:

They cannot make a Lasting Power of Attorney (LPA)

They cannot make an advance decision to refuse medical treatment

The Court of Protection cannot make a statutory will.

In Scotland, the Adults with Incapacity (Scotland) Act 2000 sets out the framework for regulating intervention in the affairs of adults (people over 16) who have impaired capacity. It allows people over the age of 16 who have capacity to appoint a welfare attorney to make health and personal welfare decisions once capacity is lost. The Court of Session may also appoint a deputy to make these decisions.

In Northern Ireland, treatment can be provided in the young person’s best interests if a parent cannot be contacted, although healthcare professionals should seek additional legal advice if applying for non-emergency interventions (General Medical Council (GMC), 2020). There are also plans to introduce new legislation relating to both mental health and mental capacity in Northern Ireland; however, there are currently no publications concerning this.

Refusal of Treatment

Just because a child or young person is able to consent and demonstrate competence, does not necessarily allow the right to refuse treatment. In England, Wales and Northern Ireland a competent refusal can be overruled by a Court or a person with parental responsibility.

In Re R (A Minor) (Wardship: Consent to Treatment) [1992], the British Court of Appeal held that a 15-year-old girl who suffered from serious episodes of mental illness and suicidal behaviour lacked the competence to give or withhold her consent to anti-psychotic drug treatment. Although between episodes of illness the girl had once indicated that she would refuse the drug therapy, the court determined that the fluctuating nature of her illness rendered her incompetent to give or withhold consent. The girl was not Gillick competent because she had not reached sufficient understanding and intelligence to be capable of making up her own mind on the matter requiring decision. Regardless of the issue of competence, the court was able to override the girl’s decision by exercising its wardship jurisdiction.

In Re W (A Minor) (Medical Treatment: Court Justification) [1993], the English Court of Appeal ordered that a 16-year-old girl under the care of the local authority suffering with anorexia nervosa be transferred against her will to a hospital specialising in eating disorders. Her argument was the presumption of capacity under the Family Law Reform Act 1969 that allowed refusal of treatment, the same as that for an adult. The claim was unsuccessful, and the court further held that the Family Law Reform Act 1969 is inapplicable to the issue of whether a 16-year-old minor has the absolute right to refuse medical treatment.

These cases founded a ‘conventional wisdom’ that where the consequence of the child’s decision is likely to be serious risk to health or death, even if a child is Gillick competent, or has reached the age of 16 and comes within the ambit of the Family Law Reform Act 1969, the child’s decision (which may be refusal of treatment or wish for treatment) can be rejected by the courts in exercise of its wardship (parens patriae) jurisdiction. Generally, the graver the decision, the greater the capacity required in order to make that decision. No doubt, if a child is Gillick competent, their wishes, feelings and decision will carry significantly more weight than those of a child who is not Gillick competent, but that does not mean the Gillick competent child’s decision is determinative in all circumstances. Despite more recent cases questioning this conventional wisdom (Re X (A Child) (No 2): An NHS Trust v. X [2021]), this has been considered to remain ‘good law’, and ultimately any change in the law regarding this ‘is a matter for Parliament, not the courts’.

And what of refusal by the parents? Prevailing law across the UK regarding parental treatment refusal on religious grounds remains unchallenged: parents who fail to obtain medical treatment for their children are subject to criminal liability even if their refusal is religiously based. Cases that relate to such decisions are outlined in Chapter 9: A Note on the Refusal of Blood Products, where lifesaving blood transfusions were refused by children who were Jehovah’s Witnesses (Re A (A Minor) (Wardship: Medical Treatment) [1993]; Re S (A Minor) (Consent to Medical Treatment) [1994]; Re L (Medical Treatment: Gillick Competency) [1998]).

You are a critical care paramedic working for a Welsh Helicopter Emergency Medical Service (HEMS). You are dispatched to a multiple vehicle road traffic collision in one of the valleys. Various resources are already on scene, and you are requested to attend a 12-year-old patient who has sustained a complete amputation above the right knee, and partial amputation above the left knee. The two other people in the car are fatalities. On your arrival, two tourniquets have already been applied to each leg alongside haemostatic gauze, but the right leg continues to bleed. The patient is conscious but haemodynamically compromised and in pain. On handover from the paramedic on scene, you are told that he is refusing all treatment, and will only accept analgesia.

What do you do?

There is no ‘emergency privilege’ that permits paramedics to treat competent patients with emergency conditions who refuse treatment, but how does one assess an injured child’s decision-making capacity to refuse treatment? Medical decision-making capacity is present when the patient can understand information about the medical condition and its consequences, to reason and deliberate about the choice available, to make a choice consistent with their values and goals, to communicate this choice to the physician, and to maintain this choice consistently over time. This is as true for children, as it is for adults.

When considering the case law mentioned earlier in this chapter, where children have refused medical treatment, these cases had the luxury of time, even if somewhat pressured; these decisions were not in the same context as this case. In such a situation, there are limitations in determining the decision-making capacity of the child. When faced with medical emergencies requiring urgent action and decision making, paramedics do not have the luxury of time to consult an ethics committee, legal counsel or psychiatric professionals. Truly urgent situations are by definition time limited. The culture of emergency medicine is to preserve life at all costs. In the immediacy of illness and injury, survivability and outcome cannot be predicted. Consequently, it is typical for paramedics to ‘err on the side of life’.

Consent in an Emergency

In an emergency, where consent is unavailable (for example, when the patient is unable to communicate their wishes and where nobody with parental responsibility is available), it is legally and ethically appropriate for health professionals to proceed with treatment necessary to preserve the life, health or well-being of the patient. In extreme situations, health professionals are advised to take all essential steps to stabilise the patient.

An emergency is best described as a situation where the requirement for treatment is so pressing that there is not time to refer the matter to court.

However, as outlined in E & F (Minors: Blood Transfusion) [2021], healthcare professionals should be cautious in relying upon their ‘emergency powers’ in the preservation of life, especially in relation to the administration of blood products to a capacitous child who has refused them.

Legal advice may be needed once emergency action has been taken, and care should be taken to document every conversation and action that took place following a decision to proceed without consent.

Accessing Medical Records

Where a child is competent, they are entitled to access their medical records via a subject access request (SAR). It is unlikely that paramedics will be in the decision-making position regarding SARs for children’s medical records; however, it is important to appreciate how these requests are managed.

As previously outlined, in Scotland anyone aged 12 or over is legally presumed to have such competence and in England, Northern Ireland and Wales, children aged over 16 years are presumed to be competent.

Children under the age of 16 in England, Northern Ireland and Wales must demonstrate that they have sufficient understanding of the request in order to make (or consent to) an SAR. However, it is generally expected that children who are aged 12 or over will have the competence to give, or withhold, their consent to the release of information from their health records (BMA, 2020).

When assessing a child’s competence, it is vital that the explanation given regarding the request is suitable for their age. Where a child is considered capable of making decisions about access to their medical record, the consent of the child must be sought before a parent or other third party can be given access via an SAR (BMA, 2020). Where a child lacks competency to understand the nature of their SAR application, the holder of the record is entitled to refuse to comply with the SAR.

Parents may access their children’s records if this is not contrary to a child’s best interests or a competent child’s wishes. For children under 18, or in Scotland under 16, any person with parental responsibility may apply for access to the records.

However, not all parents will have parental responsibility. Both biological parents have parental responsibility for children born after 1 December 2003 (England and Wales), 15 April 2002 (Northern Ireland) and 4 May 2006 (Scotland), if they are both registered on a child’s birth certificate. For children born before these dates, if the parents were married at the time of the child’s birth both parents will automatically have parental responsibility. For children born before these dates, if the parents have never been married, only the mother automatically has parental responsibility, but the father may acquire that status by application.

How would you handle the request for medical records from a competent child over the age of 12 in Scotland, whose parents do not wish them to access records due to a known family genetic issue (for example, Huntington’s disease)?

Neither parent loses parental responsibility on divorce. Where more than one person has parental responsibility, each may independently exercise rights of access. Indeed, there is no obligation to inform the other parent if access has been sought by one parent. Where a child has been formally adopted, the adoptive parents are the child’s legal parents and automatically acquire parental responsibility.

Parental and Medical Disagreement

On occasion, parents and medical professionals will disagree regarding the treatment of children. This may be down to conflicting cultural or religious expectations, different values concerning the concept of life or simply down to a lack of understanding from both sides. Although such a difference of opinion is not rare, usually a solution can easily be found.

Generally, as demonstrated in Re B (A Minor) (Wardship: Medical Treatment) [1990], the courts are willing to override parental refusal if the treatment is considered in the best interests of the child. As with Re A (Children) (Conjoined Twins: Surgical Separation) [2001], even if the views of the parents are considered sincere and reasonable, the court outlined the principle that parental views are not necessarily determinative. However, in Glass v. UK [2004] the European Court of Human Rights (ECHR) confirmed that disputes about best interests decisions between those with parental responsibility and medical staff required referral to the court for adjudication. In this case, where the doctor’s actions had bypassed parental consent, a violation of Article 8, ‘a right to family life’ was held and the hospital had a duty to involve the patient in decisions relating to their treatment.

The court also tends to favour decisions that preserve life, although in Re T (A Minor) (Wardship: Medical Treatment) [1997] it was held that a loving parents’ decision not to treat a child who suffered from a life-threatening disease was not to be interfered with, as they have made an assessment of what is in their child’s best interests.

Disagreements regarding continued treatment of children is also present. In Re Wyatt (A Child) (Medical Treatment: Continuation of Order) [2005] considerable weight was given to the medical evidence to withdraw treatment from the child, Charlotte Wyatt, against the wishes of her parents.

The recent case of Yates and Gard v. Great Ormond Street Hospital for Children NHS Foundation Trust [2017] was a powerful example of a parents wish to offer their child every opportunity for medical treatment despite the advice of medical professionals. The case was complex and went through multiple legal challenges including the ECHR, before The Honourable Justice Francis gave a final ruling in July 2017, that ‘Charlie’s life cannot be improved and that the only remaining course is for him to be given palliative care and to permit him to die with dignity’. Ultimately, the decision was made in the best interests of the child but demonstrates the possibility, as well as the ramifications of legal challenge when there is disagreement between parents and medical professionals. The UK saw another complex case in 2018, James and Evans v. Alder Hey Children’s NHS Foundation Trust [2018]. This case endured a lengthy legal challenge and saw a great deal of media attention. In Yates and Gard v Great Ormond Street Hospital for Children NHS Foundation Trust [2017], McFarlane LJ observed: ‘as the authorities to which I have already made reference underline again and again, the sole principle is that the best interests of the child must prevail and that must apply even to cases where parents, for the best of motives, hold on to some alternative view’. What both cases are able to demonstrate is that medical professionals and parents are entitled to challenge the views of one another in respect of the care of a child. When, despite the process of mediation, no consensus is able to be reached the matter should then be referred to the courts for a final decision.

Confidentiality

In medical law, children can be a challenging group as much of the legislation does not necessarily relate directly to them (Waller, 2011), and the legal definition of a child is different between Scotland and England, Northern Ireland and Wales.

One issue that arises in respect to children and confidentiality is whether parents have a right to be informed about medical details relating to their child, and that children may withhold sensitive information from their parents or carers. In R (Axon) v. Secretary of State for Health [2006], Mrs Axon unsuccessfully challenged guidance for abortion under the age of 16 from the Department of Health. She also highlighted that parents should be informed when advice concerning sexual matters was given to children.

The common law is clearer in this by stating that the mature minor’s right to confidentiality is permitted when it is deemed in their best interests (Gillick v Norfolk and Wisbech Area Health Authority [1986]). The court held that Gillick competent children have the same rights to confidentiality as adults. Following this case, it appears that if a child is not Gillick competent, then parents should be informed unless there is a robust reason for not doing so. This may well then come down to the ethical standpoint of the clinician in the situation that this occurs in. Despite this, there continues to be a duty placed upon the clinician to attempt to persuade the child to inform those who hold parental responsibility, or even allow them to make contact with the parents themselves.

A breach of confidentiality may also be justified in order to protect children from abuse, as outlined in A County Council v. SB [2010] (GMC, 2012).

Mental Ill Health in Children

An estimated 13% of children aged 5–19 years in England have a mental health disorder (The Lancet, 2020), though this number is likely to be far higher. A particular problem of cases concerning children with mental ill health is the interplay between mental capacity and mental health legislation.

In England, the use of Sections within the Mental Health Act 1983 is not age restricted. Therefore, if a child is detained under the Mental Health Act 1983, there is a duty to ensure that the environment is suitable for their age and needs. It is important that a Child and Adolescent Mental Health Services (CAMHS) assessment is carried out at the earliest opportunity, and the child should be in an environment that facilitates this. This must never be a police station. There is similar guidance within the Mental Health (Wales) Measure 2010.

Section 2 of the Mental Health (Scotland) Act 2015 makes specific provisions to safeguard the welfare of any child under the age of 18. Section 2 requires that any functions under the Act in relation to a child with a mental disorder should be carried out in the way that best secures the welfare of the child. In particular it is necessary to take into account:

The wishes and feelings of the child alongside the views of any carers

The carer’s needs and any circumstances which are considered relevant to the discharge of the child

Where the child is or has been subject to detention or compulsory treatment order, the importance of providing appropriate services to that child

The importance of the function being discharged in the manner that appears to involve the minimum restriction on the freedom of the child as is necessary in the circumstances.

Within Northern Ireland, children are not within the scope of the Mental Capacity (NI) Act 2016, the newest mental health legislation, and therefore the Mental Health (Northern Ireland) Order 1986 remains the main legislation for children under the age of 16. Purely on the basis of age, under 16s will not be able to access the range of protections and safeguards outlined in the Mental Capacity (NI) Act 2016, which is afforded to those over the age of 16 who lack capacity as a result of mental illness or disability. For those aged 16–17, the Mental Capacity (NI) Act 2016 operates alongside the Children (Northern Ireland) Order 1995, and additional safeguards are planned to be put in place, with proposed calls to review the impact of the mental health legislation on children within Northern Ireland (Northern Ireland Commissioner for Children and Young People, 2017). The government has indicated that their intention is that there will eventually be legislation for those under 16, but at present, this is some way off. The Children (Northern Ireland) Order 1995 also has provision for a court to direct a parent or guardian to bring a child or young person to hospital for assessment of their mental disorder and, if necessary, for treatment (Guidelines and Audit Implementation Network, 2011).

Organ Donation

Chapter 10: The Role of Organ and Tissue Donation and the Paramedic Profession gives an introduction on the use of uncontrolled donation after circulatory death, and therefore a brief mention regarding organ donation in respect of children is felt pertinent. This concept presents many ethical decisions and conflicts of interest, but an overview of the law in respect to organ donation may assist with this understanding.

Section 2 of the Human Tissue Act 2004 provides that Gillick competent children (under 18 years of age) can give appropriate consent to donate organs. If the child lacks capacity, or does not wish to make a decision, Section 2(3) outlines how consent can be given by a person with parental responsibility. However, it is the notion of appropriate consent that is considered important, as this is considered insufficient without court approval. The court’s paramount consideration is the welfare of the donor over that of the recipient (Paragraph A11) and children can be considered as living donors in very rare circumstances. In Hart v. Brown [1972] the court found that the donor’s psychological benefit (namely her sister’s survival and companionship) was sufficient to allow sibling-to-sibling organ donation.

Foetal Rights

There is a lot of legal contention and ethical debate concerning abortion and pre-natal life, which is largely outside of the scope of this book. However, it is worth clarifying foetal rights. A foetus has no legal personality, or legal status until it is born and exists independent of its mother (Paton v. British Pregnancy Advisory Service [1978]). Even if the foetus did have a right to life under Article 2 of the European Convention on Human Rights (which the court refused to assert in Paton v. UK [1980]), this right would be constrained in the event of the life of the pregnant mother being in jeopardy. This also means that pregnant women with capacity have a right to refuse medical treatment, and these are not outweighed by any rights of the foetus, even if viable (St George’s Healthcare Trust v. S [1998]). This was also confirmed in Attorney General’s Reference (No 3 of 1994) [1997], which found that the foetus has no independent legal personality until birth. This is further outlined in Vo v. France [2004], where the ECHR found no consensus on the moral status of the foetus, and so the extent of the right to life of the foetus under Article 2 remains undefined.

Use of a Chaperone

When a paramedic is required to treat a child, in most cases, a parent or carer will be present and can act as a chaperone for the child or young person. However, given the diverse roles paramedics may work in, many of which include emergency and unscheduled care, it is possible that you will be called to examine a child who may be alone or with other children. A competent child or young person may also state that they do not wish for a parent or carer to be present.

Employing organisations should have a chaperone policy and this should be made available to staff and patients. A patient may request a chaperone and as a medical professional you should be able to offer a chaperone when appropriate. However, if offered, a patient also has a right to decline the presence of a chaperone.

The HCPC do not provide any guidance relating to use of chaperones. The GMC (2013) state that a chaperone should be a health professional and that the registrant must be satisfied that the chaperone will:

a. Be sensitive and respect the patient’s dignity and confidentiality

b. Reassure the patient if they show any signs of distress or discomfort

c. Be familiar with the procedures involved in a routine intimate examination

d. Stay for the whole examination and be able to see what the [doctor] is doing, if practical

e. Be prepared to raise concerns if the patient is concerned about the [doctor’s] behaviour or actions.

When considering paramedic practice, several issues arise. Paramedics may find themselves in lone working situations and be required to examine a child. While it is appropriate to use parents or carers, they are unlikely to meet points c, d, and e in the GMC guidance listed previously and be able to act as an impartial observer. Therefore, the registrant must consider if the examination is immediately required in order to make decisions about the care of a child or young person. Consideration should also be given to requesting the presence of an appropriately trained adult, alongside the parent or carer. If using a parent or carer, the examination or procedure should be explained so that they understand in advance what it is you will be doing (Medical Protection, 2016).

If a child or young person declines the presence of a chaperone, consider if it would be appropriate and necessary to continue. The fact that the patient has been examined without the presence of a chaperone should be recorded alongside a rationale for proceeding with the examination.

The use of chaperones is to protect the patient and the registrant. Paramedics should, wherever possible, ensure that an appropriately trained chaperone be present when examining a child or young person, particularly if that examination is of intimate areas.

You are a paramedic working in a rural urgent care centre. You are the only clinician in the building today and there is a (female) receptionist who is booking in patients. A 15-year-old boy presents with a friend complaining of severe pain in his left testicle which came on after being hit in the groin by his friend (also a 15-year-old male). The patient is booked in by the receptionist and you bring the child into your treatment room accompanied by the friend who hit him. The child is in severe discomfort and after confirming some basic details and medical history you offer some analgesia, which is accepted by the child. The history is suggestive of testicular torsion as there is recent trauma, followed by unilateral testicular pain that is severe and radiating into the abdomen. The receptionist has been trying to contact the child’s parents with the phone numbers provided, but there has been no answer.

You have requested an ambulance (40 minutes away) and have successfully referred to the paediatric surgeon at the local hospital, who agrees with your working diagnosis of torsion. As this case involves trauma, you would like to examine the area to rule out any injury that may require immediate attention.

How Will You Examine this Child?

Chaperone required: the other 15-year-old is not suitable and would not be an impartial observer or reliable witness.

The receptionist may be a suitable chaperone, but there are many things to consider; do they have the required training? Are they willing to act in this capacity? Are they available? Would the child be comfortable with a chaperone who is a different sex?

Is the examination going to affect the management of this patient? Potentially and, given the nature of the injury, it is appropriate to carry out an inspection and or examination of the area concerned. You could wait until the ambulance arrives, as then there will likely be another health professional who could act as the chaperone.

A final option to consider is that while the examination is indicated, the child could be given space to inspect the site themselves and let you know if there is any injury. If a suitable chaperone is not available and you do not believe the examination to be immediately required, then you could justify waiting until the child is in the care of the hospital team.

Clinical Holding and Use of Restraint to Provide Treatment

Clinical holding is not defined by any profession-specific guidance, but it is a recognised method of supporting a child with a painful procedure (RCN, 2010). Clinical, or therapeutic, holding is presented as a method that differs from restraint due to the degree of force required and the intention. What is not defined in the literature is what would constitute a painful procedure, and this creates some difficulty in being able to determine if ‘holding’ would be appropriate.

Consider the one-year-old child who is unwell with a fever and, despite your best intentions, will not let you measure their temperature. Is it appropriate to work with a parent, carer or colleague to ‘hold’ the child while an accurate temperature is recorded? This is a difficult situation to provide absolute clarity; however, looking from purely a clinical perspective, the temperature reading may influence your overall management of the child and therefore would be considered an essential observation. The child is not in a position to be able to give consent for holding, nor are they in a position to refuse any examination or intervention. A person with parental responsibility would be able to provide consent on their behalf and it would seem logical to involve that person in the procedure as much as it practicable. There is seldom a reason for a paramedic to be unable to document a complete set of vital signs measurements for any age of child and, regardless of age, a patient who is unable to give consent or is lacking in mental capacity must be treated according to their best interests. In summary, clinical holding is an appropriate technique to perform clinical assessment or urgently required interventions for a child or young person who is unable to give their consent. The use of clinical holding in paramedic practice should be supported by policy and guidance documents and registrants should have appropriate training.

In contrast to clinical holding, restraint should be used only when it is necessary to give essential treatment or to prevent a child from significantly injuring themselves or others. Once a decision has been made that it is lawful and ethically acceptable to override a refusal of treatment, the appropriate use of force and/or restraint may be used to provide that treatment. However, paramedics must look at the patient’s overall interests and whether imposing treatment is a proportionate interference given the expected benefits. Where possible, the decision to use restraint should be made in consultation with a team (be that other professionals, or senior colleagues that can provide advice).

Importantly, paramedics must consider if imposing treatment could damage the young person’s current and future relationships with healthcare providers and undermine trust in the medical profession. It is important for young people to understand that restraint of any form to provide treatment is used only as a last resort and not until other options for treatment have been explored. The child and the family must be offered continual support and information throughout the period of treatment.

If, after spending as much time as is practicable, it is impossible to persuade a child to cooperate with essential treatment, the clinician in charge of the patient’s care may decide that restraint is appropriate. Members of the health team should be given an opportunity to express their views and to participate in decision making, although ultimate responsibility rests with the clinician in charge of care. All staff require support and should not be asked to be involved in restraining a child without proper training.

Summary

Paediatric law is complex, as is the ethical decision making that surrounds it. Support should always be sought when dealing with challenging cases that may involve decisions around consent, capacity or disagreement between parents and medical professionals. The law, however, does provide very specific guidance to enable medical practitioners to undertake their role in delivering safe and effective healthcare to children and young people in a variety of circumstances. Despite being registered healthcare professionals, paramedics cannot be expected to have knowledge of each piece of legislation relating to the care of a child, but should know where to access this information, and how to use it during their clinical practice.

The legislation concerning children and young people is complex and may not always have the answer to your clinical scenario. Make sure you know how to access decision-making support in your area of practice.

Paramedics are likely to encounter children in emergency situations. If consent is not possible, do what is needed to stabilise the patient and act in their best interests. Legal guidance can be sought once emergency action has been taken.

Children and young people can be challenging to assess. They also may not appreciate how important it is for you to measure their vital signs. Use of distraction and clinical holding are appropriate techniques to enable effective assessment.

Recommended Reading

British Medical Association (BMA) (2016). Children and Young People Ethics Toolkit. Available at: https://www.bma.org.uk/advice/employment/ethics/children-and-young-people/children-and-young-peoples-ethics-tool-kit/1-basic-principles (accessed 30 June 2023).

General Medical Council (GMC) (2020). 0–18 years: Guidance for All Doctors. Available at: https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors---0-18-years---english-20200211_pdf-48903188.pdf (accessed 30 June 2023).

Le Guin U (1973). The Ones Who Walk Away from Omelas. Mankato: Creative Education.

References

British Medical Association (BMA) (2020). Access to health records: Updated to reflect the General Data Protection Regulation and Data Protection Act 2018. Available at: https://www.bma.org.uk/media/2821/bma-access-to-health-records-june-20.pdf (accessed 30 June 2023).

British Medical Association (BMA) (2021). Children and Young People Ethical Toolkit. Available at: https://www.bma.org.uk/media/4666/bma-children-and-young-people-ethics-toolkit-oct-2021.pdf (accessed 30 June 2023).

College of Paramedics (2019). Paramedic Curriculum Guidance. 5th edn. Bridgwater: College of Paramedics.

General Medical Council (GMC) (2012). Protecting Children and Young People. Available at: https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/protecting-children-and-young-people (accessed 30 June 2023).

General Medical Council (GMC) (2013). Intimate examinations and chaperones. Available at: https://www.gmc-uk.org/-/media/documents/maintaining-boundaries-intimate-examinations-and-chaperones_pdf-58835231.pdf (accessed 30 June 2023).

General Medical Council (GMC) (2020). 0–18 years: Guidance for All Doctors. Available at: https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors---0-18-years---english-20200211_pdf-48903188.pdf (accessed 30 June 2023).

Guidelines and Audit Implementation Network (2011). Guidelines on the Use of the Mental Health (Northern Ireland) Order 1986. Available at: https://www.rqia.org.uk/RQIA/files/4e/4ee9f634-be47-4398-afc9-906a20ff3198.pdf (accessed 30 June 2023).

The Lancet (2020). Child mental health services in England: A continuing crisis. The Lancet, 395(10222): 389.

Le Guin U (1973). The Ones Who Walk Away from Omelas. Mankato: Creative Education.

Medical Protection (2016). Chaperones. Available at: http://www.medicalprotection.org/uk/resources/factsheets/england/england-factsheets/uk-chaperones (accessed 30 June 2023).

Northern Ireland Commissioner for Children & Young People (2017). Advice to the Northern Ireland Executive on its Draft Children and Young People’s Strategy. Available at: https://dera.ioe.ac.uk/id/eprint/29386/ (accessed 11 October 2023).

Royal College of Nursing (RCN) (2010). Restrictive Physical Intervention and Therapeutic Holding for Children and Young People: Guidance for Nursing Staff. 3rd edn. London: Royal College of Nursing.

Royal College of Nursing (RCN) (2017). Principles of Consent: Guidance for Nursing Staff. London: Royal College of Nursing.

Waller L (2011). Ethics, law and paediatric medicine. Journal of Paediatrics and Child Health, 47: 620–623.

Wheeler R (2006). Gillick or Fraser? A plea for consistency over competence in children: Gillick and Fraser are not interchangeable. British Medical Journal, 332(7545): 807.

World Bank (2021). Children’s share of total population in the United Kingdom (UK) 2013–2060. Available at: https://tradingeconomics.com/united-kingdom/population-ages-0-14-percent-of-total-wb-data.html (accessed 30 June 2023).

Chapter 9

A Note on the Refusal of Blood Products

Simon Kersey and Georgette Eaton

Introduction

Consent to treatment can, in many circumstances, be a relatively straightforward process. However, the principles and issues involved are brought sharply into focus when a patient declines to consent to some aspect of a procedure or treatment that up until recent decades would have typically been viewed as a part of normal practice and therefore unquestioned. A striking example of this, and one that must cross the mind of many paramedics, is the patient who refuses allogeneic blood transfusion.

How can patient care be balanced with the need to comply with the relevant legal and ethical principles around consent in such a challenging situation? Of relevance here is the very first section of the Health and Care Professions Council’s (HCPC) Standards of conduct, performance and ethics guidance (2016):

1.1 You must treat service users and carers as individuals, respecting their privacy and dignity.

1.2 You must work in partnership with service users, involving them, where appropriate, in decisions about the care, treatment or other services to be provided.

Paramedics have long been patient advocates and pride themselves on the ability to work within a complex web of legal, ethical and moral boundaries. It can be stressful to care for someone who is seriously injured, while also modifying normal procedures because the patient refuses to consent to a familiar treatment option. Such stress could be compounded by a fear of giving offense by asking about personal religious beliefs or of litigation as a result of withholding indicated treatment.

The aims of this chapter are to inform clinicians regarding the legislative and ethical aspects regarding refusal of treatment, particularly in the context of blood products, and provide a framework for treatment. We will, therefore, consider first the clinical management strategies and subsequently the legal and bioethical aspects of caring for patients who refuse transfusion.

Context

The devastating public health consequences of transfusion-related morbidity and mortality have increased awareness among healthcare professionals and the general public of the inherent risks of blood transfusion (Triggle, 2019; The Penrose Inquiry, 2015). Blood is a biological product that cannot be made completely safe. Therefore, it is not unreasonable that some individuals may refuse blood-based products in their medical care.

Jehovah’s Witnesses

In the Bible, blood is a symbol of life (Leviticus 17:13, 14). Jehovah’s Witnesses hold that taking into their bodies the blood of another creature violates Biblical law (JW.org, 2022). Witnesses adhere to this deeply held core value even in circumstances where in the opinion of some clinicians, allogeneic transfusion is necessary to preserve life (Acts of Apostles 15:28, 29). This refusal of blood transfusion, however, does not equate to refusal of medical treatment. Jehovah’s Witnesses appreciate high-quality surgical and medical care. They value life and want to do whatever is reasonable and compatible with their beliefs to prolong it (Royal College of Surgeons of England, 2018).

Why might it be important to understand the basic beliefs and motivations of those who refuse medical treatment on religious grounds? What preconceived ideas might impact your delivery of patient-centred care?

Wider Population

It is not only Witnesses who seek treatment without blood transfusion. Medical researchers have previously reported that blood transfusions were considered to be generally harmful by 10.9% of non-Witness patients and 14.6% of non-Witness caregivers (Graw, 2018). Moreover, a recent large multicentre randomised controlled phase 3 trial in patients suffering major trauma and haemorrhagic shock in the United Kingdom (UK) (RePHILL trial) concluded that prehospital administration of packed red cells and lyophilised plasma (Lyo-Plas) was not superior to 0.9% sodium chloride (Crombie, 2022). Hence, the approach to consent and finding the optimal medical or surgical management that does not entail using allogeneic blood is of significance and value well beyond the Witness community. This chapter, however, will focus on the common example presented in regard to Witness patients, where faith and religious belief are central to the decision to refuse transfusion.

Therapeutic Strategies to Pre-empt Allogeneic Blood Transfusion

There is an extensive and ever-growing range of strategies to manage haemorrhage and anaemia without blood transfusion in various clinical settings. Patient blood management involves the timely, multidisciplinary application of evidence-based medical and surgical concepts aimed at screening for, diagnosing and appropriately treating anaemia. It also aims to minimise surgical, procedural and laboratory sampling blood losses, optimising haemostasis and managing coagulopathic bleeding throughout the care episode, and supporting the patient while appropriate treatment is initiated (Shander et al., 2022).

While such treatment approaches are outlined in clinical literature, this range of treatment choices by using a traffic light system in terms of acceptability is shown in Table 9.1.

These methodologies and steps closely mirror those that are widely recognised and used within the World Health Organization (WHO)-supported patient blood management (PBM) philosophy, which is defined thus:

It is a patient-centred, systematic, evidence-based approach to improve patient outcomes by managing a patient’s own blood through diagnosis and aetiology-specific treatment of anaemia and preserving the patient’s own blood by minimizing blood loss and bleeding, while promoting patient safety and empowerment.

(World Health Organization, 2021, p. 4)

Unsurprisingly, the principles and practical application of patient blood management initiatives first took place when assisting Jehovah’s Witness patients (Bolcato et al., 2021). However, patient blood management methodologies will often need to be applied earlier, more aggressively, and with greater multi-disciplinary input from the outset when the patient is one of Jehovah’s Witnesses or, if for other reasons, cannot be transfused (e.g., inventory shortages, alloimmunised patients). For example, intraoperative cell salvage is typically used to recover blood from the patient once blood loss exceeds or is expected to exceed 500 mL. However, in the Witness patient where the option to administer allogeneic blood transfusion does not exist, it would be good practice to have it available from the very start of a procedure.

Table 9.1 Traffic light system for patient blood management.

Refused

Potentially Acceptable

Acceptable

Whole blood

Red cells

White cells

Platelets

Plasma (including Lyoplas, Octaplas, FFP)

Preoperative autologous

Blood donation (predonation)

Cryoprecipitate

Fibrinogen concentrate

Prothrombin complex concentrate (PCC) (e.g., Octaplex®; Beriplex®)

Clotting factor concentrates

Human serum albumin (HSA) solution

Immune globulins

Recombinant activated factor VII (rFVIIa)

Systemic or topical haemostatic agents containing plasma derivatives

Haemoglobin-based oxygen carriers (HBOCs)

Antifibrinolytic agents (e.g., tranexamic acid, aprotinin)

Synthetic topical haemostatics (e.g., Celox™, Quickclot®, HemCon®)

Desmopressin

Intravenous iron

Erythropoiesis-stimulating agents (ESAs) (e.g., rHuEPO, darbepoietin)

Recombinant (synthetic) products

Non-haemoglobin-based oxygen therapeutics (when clinically available)

The choice of hospital or medical facility is also a consideration for prehospital paramedics. Major trauma centres typically have the capability to manage patients without blood transfusion.

Advance Decisions to Refuse Specific Medical Treatment

It is a core ethical and legal principle in Great Britain and Ireland that an adult with full mental capacity has an absolute right to refuse treatment. An adult patient with capacity can give consent to a procedure while withholding consent for specific aspects of management, such as the administration of blood components. For so long as the patient does not give that consent, the bar to the provision of that treatment is absolute. Treatment in the face of such a bar is unlawful and can give rise to both civil and criminal liability, as well as professional sanctions.

(Klein et al., 2018, p. 4)

This guideline, from the Association of Anaesthetists of Great Britain and Ireland, outlines that the patient is not required to present their rationale for refusal and there should be no coercion either by friends and supporters of the patient or by the medical professionals providing care.

When a patient is unconscious or otherwise lacking capacity but has completed a legally binding Advance Decision to Refuse Specific Medical Treatment (ADRT), the stipulations outlined in that document take effect. These are discussed in more detail in Chapter 13: Law and Ethics of Palliative Medicine and End-of-Life Care. However, not all ADRTs are for those nearing the end of their life or receiving palliative treatment. Figure 9.1 shows an example of the ADRT typically carried by Jehovah’s Witnesses. The folded, credit card-sized document is usually carried on their person. Scanned versions may be viewable via an electronic summary care record.

Figure 9.1 Example ADRT typically carried by Jehovah’s Witnesses.

Source: Reproduced with the permission of Hospital Information Services for Jehovah’s Witnesses (UK and Ireland).

It is important for paramedics to understand the following points in this document:

1. Name and date of birth. It contains an unequivocal statement that it is to apply even if life may be at risk.

2. Clearly states the refusal of whole blood and its primary blood components (that is, RBCs, WBCs, platelets and plasma).

3. This is vital for the treating team to check. If an individual chooses to refuse a particular product (e.g., certain plasma derivatives – the amber category of the chart in the ‘Context’ section of this chapter), they can record that refusal here and it holds the same weight as Point 2. If, however, the individual does not indicate anything additional here and no discussion is possible, then for the treating team, there is freedom to treat as clinically necessary outside of the primary components refused in Point 2.

4. The treating team may wish to contact the local Hospital Liaison Committee for Jehovah’s Witnesses (HLC). Of course, patient confidentiality is at the heart of good healthcare, but, when using this template, the patient has pre-authorised such dialogue. The Jehovah’s Witness community has a network of 36 HLCs across the UK (approximately 2,000 worldwide) to provide information to clinicians and offer support and pastoral care to Witness patients. They are trained volunteers who make themselves available 24/7, to answer questions from clinicians, support sick and injured patients at the bedside, and to promote an atmosphere of cooperation and understanding (Johnson-Arbor, 2022). Upon request, HLC representatives can call attention to relevant clinical information in the peer-reviewed medical literature or, in urgent situations, facilitate doctor-to-doctor consultation with senior clinicians in the UK or abroad who have considerable experience managing patients without blood transfusion. This includes medicine, surgery and paediatrics, as well as bioethics and law. HLCs are also actively involved in educational presentations to clinical teams and are available to assist with incident debriefs.

5. Signed in the presence of witnesses.

While ADRTs are a legally binding document, there has been one notable case where an ADRT was overruled. In Re PW (Jehovah’s Witness: Validity of Advance Decision) [2021], the Court of Protection ruled invalid an advance decision made 20 years previously by a Jehovah’s Witness who, at the time of the hearing, lacked capacity to make a decision about receiving a life-sustaining blood transfusion. In this case, the validity of the ADRT was questioned since PW had subsequently appointed health and welfare power of attorney in favour of her four children, without mentioning to them or including in the written LPA any preference or requirement not to receive blood transfusion or blood products. The judge, Poole J, identified that her actions at the time of granting the LPA were clearly inconsistent with the advance decision remaining her fixed decision, and so the more recent directions within the LPA would be followed – that would include life-sustaining treatment in the form of a blood transfusion.

This case outlines that advance decisions may well be ‘brittle’ – and it is extremely important that any advance decision includes a values statement so as to be able to guide decision making in the event that (as here) the decision is ultimately one made by reference to best interests, rather than simply loyally seeking to abide by the ADRT.

Emergency Treatment

Emergencies involving Witness patients may present a special ethical challenge, as there could be evidence that the patient is one of Jehovah’s Witnesses, but no ADRT can be located, even by family or friends. The common law doctrine of necessity, enabling treatment without capable consent and restraint, has now been codified by the Adults with Incapacity (Scotland) Act 2000, the Mental Capacity Act 2005 (England and Wales) and the Mental Capacity Act (Northern Ireland) 2016. Although capacity must be assumed, the degree of disability required to classify someone as lacking capacity should vary in proportion to the gravity of the decision required to be made. Thereby the threshold for pronouncing decision-making incapacity in life-threatening situations will be lower than in less critical situations, the test being that the clinician has a ‘reasonable belief’ of incapacity.

In emergency situations it will almost always be in the person’s best interests to give urgent treatment without delay.

The Association of Anaesthetists Guideline outlines the caution that:

‘Best interests’ encompasses not merely the patient’s clinical interests, but their wishes, feelings, beliefs and values: the purpose of any best interests decision is to make the decision that is right for that patient as an individual human being. Even where a patient has not made an explicit advance decision, if it is known that the patient would have refused to give consent to a specific treatment, it is likely that provision of that treatment would not be in the patient’s best interests, and therefore unlawful.

(Klein et al., 2018, p. 5)

One exception to this is when the healthcare staff giving treatment are satisfied that an advance decision to refuse treatment exists. Respecting the patient’s deeply held beliefs does not equate to failing the patient, even if members of the treating team would not personally have made the same choice.

The Rights and Interests of Children in Relation to Refusal of Blood Products

Chapter 8: Legal and Ethical Treatment of Children sets out in detail the geographical differences that exist within legislation across the UK concerning the rights and interests of children, and considers part of the issue in terms of a child’s refusal for medical treatment. However, notable cases have been laid before courts across the UK regarding the refusal of blood products in paediatric patients. Since these cases contribute towards the ‘conventional wisdom’ of Gillick-competent children outlined in Chapter 8, they are worthy of review here.

In an emergency, blood products can be administered in a life-sustaining situation or to prevent lasting disability without parental consent. However, legal permission for treatment in the face of parental refusal should be sought at the earliest available opportunity. Three seminal cases exist where lifesaving blood transfusions were refused by children who were Jehovah’s Witnesses (Re A (A Minor) (Wardship: Medical Treatment) [1993]; Re S (A Minor) (Consent to Medical Treatment) [1994]; Re L (medical Treatment: Gillick Competency) [1998]).

Re E (A Minor) (Wardship: Medical Treatment) [1993]

Re E, concerned a boy of 15¾ suffering from leukaemia, and was decided in wardship. Owing to his age, the relevance of Family Law Reform Act 1969, Section 8 was held not to apply. The essential conclusion of the judge, Ward J, was that E did not have sufficient understanding of ‘the process of dying’ in the way that he faced, and was accordingly not competent to refuse. Also noted was E’s conviction to die for his faith. Confirming wardship and authorising treatment for the welfare of the child, Ward concluded that although parents may martyr themselves, the ‘court should be very slow to allow an infant to martyr himself’. On attaining the age of 18 the young man was no longer a ward of court and decided to refuse further transfusions.

Re S (A Minor) (Consent to Medical Treatment) [1994]

Re S considered the case of a 15-year-old thalassaemic teen who wished to discontinue treatment involving the administration of blood transfusions. The matter was decided by Johnson J, who relied heavily on the conclusions of the doctor who had evaluated the mental condition and competence of the patient. The judge essentially held that the patient was sincere in her convictions but lacked maturity. He relied on the reasoning of Ward J in Re E. While the judge based his decision to authorise treatment on the power of the court to override a competent child’s refusal of treatment ‘in her best interests’, he also found that the patient was not Gillick-competent.

Re L (Medical Treatment: Gillick Competency) [1998]

This case concerned a 14-year-old who was held to be mature for her age and had suffered extensive and severe burns. The judge, Sir Stephen Brown P, described the girl and her family as ‘honest, sincere people’ and in terms did not question the sincerity of her beliefs. One basis for his decision to authorise blood was that the patient did not actually understand the full implications of her decision (not having been fully informed) rather than that she was not capable of understanding. The judge found that the patient was not Gillick-competent but also said that he would have made the same order even if his finding had been otherwise.

The issue with refusal of treatment is not the lack of rights for a child or young person to refuse, but rather that the refusal of consent by one holder of the rights (the child) is ineffectual against the willingness of another (court or parent) to consent. Especially, if this results in the competent minor having a more limited right of self-determination than the competent adult. Such a view is considered to be incompatible with Article 8 of the Human Rights Act 1998. In cases such as these, which concern strongly held religious beliefs, it is not the role of the court to pass any judgment on those beliefs and the starting point for the common law is respect for an individual’s religious principles, subject always to the paramount consideration of the child’s welfare (Ziebart, 2007).

Under the Children Act 1989 and the Children (Northern Ireland) Order 1995, an application can be made to the High Court for a Specific Issue Order (SIO) to authorise blood transfusion for a patient under the age of 18 (Re O (A Minor) (Medical Treatment) [1993]). However, in the setting of a seriously injured minor, such additional stress for the patient and parents can be avoided through the early involvement of senior consultants experienced in using transfusion-avoidance strategies, and the HLC (Re R (A Minor) (Blood Transfusion) [1993]). Such discussion can foster a spirit of cooperation and decision-making support (Klein et al, 2018).

In Scotland, the defining legislation postdates Gillick and presents a less nuanced position. Under the Adults with Incapacity (Scotland) Act 2000, the age of adulthood, and thus fully capable of both consent and refusal, is considered to be the 16th birthday. This Act also provides that, in certain circumstances, a person under the age of 16 years will be deemed to have capacity to consent to any surgical or medical treatment or procedure provided they are capable of understanding its nature and the possible consequences. Applications for a SIO can also be made under the Children (Scotland) Act 1995.

Competent Minors Who Refuse Blood

The likelihood that a Court will overturn a refusal to consent to treatment diminishes the closer the child is to the age of 18 (or 16 in Scotland).

A more recent case challenged the ‘conventional wisdom’ that no child has an absolute right to refuse medical treatment, even if the child is Gillick competent or, having reached the age of 16, is presumed to be Gillick competent pursuant to Section 8 of the Family Law Reform Act 1969, and whether the court, in the exercise of its wardship jurisdiction, can overrule that decision.

Re X (A Child) (No 2): An NHS Trust v X [2021]

X, a 15-year-old child, suffers from sickle cell syndrome and is a Jehovah’s Witness, as is her mother. On occasion, X was admitted to hospital in a crisis when, in the opinion of her treating clinicians, a top-up blood transfusion becomes an imperative necessity. There were two such crises in June and October 2020 when urgent applications had to be made to the court for declarations permitting top-up blood transfusions (Re X [2020] EWHC 1630 (Fam) and Re X [2020] EWHC 3003 (Fam)). As X had presented in crisis twice in a short space of time and having taken on board the views expressed by the court regarding the unsatisfactory nature of such serious applications being made on an urgent basis, the Trust sought a rolling two-year order to continue until X turns 18, authorising further top-up blood transfusions in the event of further serious deterioration in X’s condition.

X, who was declared to be Gillick competent and ‘mature and wise beyond her years’, outlined that she should be afforded the exclusive right to decide her own medical care in the same way as her peers aged 18 years and older. The challenge was unsuccessful, and the court held that Re R (A Minor) (Wardship: Consent to Treatment) [1992] and Re W (A Minor) (Medical Treatment: Courts Jurisdiction) [1993] remain good law.

Similarly, in E & F (Minors: Blood Transfusions) [2021], the Court of Appeal considered appeals brought by two young people, both Jehovah’s Witnesses who conscientiously reject blood transfusions. They appealed orders in which it was declared that, although they were Gillick competent to decide whether to consent to or refuse a blood transfusion, it would nevertheless be lawful for their doctors to administer blood in the course of an operation if that becomes necessary to prevent serious injury or death. Given that no crisis arose in either case, the declarations never formally came into effect. In this case, the key consideration was how the State, acting through the court, should exercise its power to overrule the capacitous decision of a mature minor, and in particular a young person aged 16 or 17. The central argument made on appeal was that there is a strong presumption in favour of a young person’s capacity and that decision should only be rebutted where, on the balance of probabilities, the decision would cause serious harm or death. It was wrong for the courts to intervene in these cases, because the risks were remote and the young persons’ decisions were ‘reasonable and safe ones’. These appeals were dismissed, favouring the greater imperative in the preservation of life, should this be compromised.

However, in this case, the Court made the following obiter comments (para 24):

Doctors undoubtedly have a power, and may have a duty, to act in an emergency to save life or prevent serious harm where a patient lacks capacity or cannot express a view, for example because of unconsciousness. However, we very much doubt that such a power exists in respect of treatment that has been foreseen and refused by a capacitous patient. It is doubtful whether such circumstances can properly be described as an emergency.

How does knowing the religious affiliation of a young patient affect your view of their medical choices?

Put simply, healthcare professionals need to be cautious in relying upon their ‘emergency powers’ in the preservation of life, especially in relation to the administration of blood products to a capacitous child who has refused them.

You are working alongside a team of other clinicians in the emergency department of an acute care hospital in North East England when an ambulance pre-alert arrives with a young patient who has been hit by a car while cycling to college. The patient has a suspected fractured pelvis, bilateral fractured femurs and suspected abdominal bleeding. Ambulance paramedics have tried to address the significant bleeding through the use of a haemostatic Celox™ dressing, a pelvic binder and the prompt administration of tranexamic acid (TXA). However, a rapid HemoCue® test reveals a haemoglobin level marginally below 60 g/L, and so you immediately call for a test to check the blood group so that a transfusion can be given ahead of the surgery that will surely be necessary.

A non-clinical member of the administrative team, overhearing the conversation, informs you that they recognise the patient and that they are known in the community as one of Jehovah’s Witnesses.

You put your request on hold, confirm this with the patient, who is conscious but struggling to understand all that is going on around them, and check their age. They are 17.

Where does that leave you now?

Is this a refusal of all medical treatment?

What options does the clinician have in these circumstances?

Ethical Considerations

Witnesses are often viewed with animosity or contempt, considered foolhardy and recklessly disregarding life, martyring themselves and their children (Ziebart, 2007). For Jehovah’s Witnesses of any age, refusal of blood transfusion is a ‘deeply-held core value’. These core values are developed over time. Jehovah’s Witnesses do not practice infant baptism and hold that Christian baptism is for those old enough to understand. Therefore, anyone (including minors) who wishes to become one of Jehovah’s Witnesses will spend many months, sometimes even years studying the Bible, before concluding that they wish to be baptised.

As much as it should be clear that a person with capacity has made the decision of their own reasoning and values, it is similarly important that the medical professional also does not aim to impose undue influence on a decision that is not in keeping with the patient’s own wishes and values. For clinicians, the ethical challenge is balancing their own view of best interests, the complex legal landscape, along with the principles of patient autonomy and self-determination.

A refusal of blood transfusion by a minor may not be legally binding but that does not mean it is a belief any less deeply held than that of an adult, nor any less absolute. As with any core belief linked to a person’s life and identity, the impact of a deliberate violation could be devastating. The emotional effect may be deeply traumatic and long-lasting for an individual. In such a case the Witness community would be quick to provide emotional and spiritual support to the child and family.

Summary

Many individuals who refuse blood products appreciate high-quality surgical and medical care and effective alternative modalities are available. As one example, Jehovah’s Witnesses’ refusal of blood stems from a deeply held core belief. As clinicians, we need to balance these beliefs with current guidelines and UK law – as well as our own values and thoughts on the subject. It is obvious through these conflicting principles that ethical dilemmas can arise. These can appear in sharp focus when caring for children. A multi-disciplinary, collaborative approach that respects and seeks to accommodate the patient’s beliefs where possible is preferable.

Recommended Reading

Althoff C et al. (2019). Multimodal patient blood management program based on a three-pillar strategy: A systematic review and meta-analysis. Annals of Surgery, 269(5): 794–804.

Blood Bank Guy Essentials Podcast. Available at: https://www.bbguy.org/podcast/ (accessed 30 June 2023).

Jehovah’s Witnesses (2021b). Medical Information for Clinicians. Available at: https://www.jw.org/en/medical-library/ (accessed 30 June 2023).

References

Bolcato M et al. (2021). Physician autonomy and patient rights: lessons from an enforced blood transfusion and the role of patient blood management. Vox Sanguinis, 116(10): 1023–1030.

Crombie N et al., RePHILL collaborative group (2022). Resuscitation with blood products in patients with trauma-related haemorrhagic shock receiving prehospital care (RePHILL): A multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Haematology, 9(4): e250–261.

Graw JA et al. (2018). Risk perception of blood transfusions – A comparison of patients and allied healthcare professionals. BMC Health Services Research, 18(1): 122.

Health and Care Professions Council (2016). Standards of conduct, performance and ethics. Available at: https://www.hcpc-uk.org/standards/standards-of-conduct-performance-and-ethics (accessed 30 June 2023).

Johnson-Arbor K and Verstraete R (2022). Bloodless management of the anemic patient in the emergency department. Annals of Emergency Medicine, 79(1): 48–57.

Jehovah’s Witnesses (2022). How Many Jehovah’s Witnesses Are There Worldwide? Available at: https://www.jw.org/en/jehovahs-witnesses/worldwide (accessed 30 June 2023).

Klein A et al. (2018). Association of Anaesthetists of Great Britain and Ireland. Anaesthesia and peri-operative care for Jehovah’s Witnesses and patients who refuse blood. Anaesthesia, 74(1): 74–82.

The Penrose Inquiry (2015). Final Report: Scottish Public Inquiry into contaminated blood and blood products. Available at: https://www.penroseinquiry.org.uk/ (accessed 30 June 2023).

Royal College of Surgeons of England (2018). Caring for Patients Who Refuse Blood — Royal College of Surgeons. Available at: https://www.rcseng.ac.uk/standards-and-research/standards-and-guidance/good-practice-guides/patients-who-refuse-blood (accessed 30 June 2023).

Shander A et al. (2022). A global definition of patient blood management. Anesthesia & Analgesia, 135(3): 476–488.

Triggle N (2019). Lives have been ruined – contaminated blood victims. BBC News, 30 April 2019. Available at: https://www.bbc.com/news/health-48104413 (accessed 30 June 2023).

World Health Organization (2021). The Urgent Need to Implement Patient Blood Management: Policy Brief. Available at: https://apps.who.int/iris/handle/10665/346655 (accessed 30 June 2023).

Ziebart D (2007). Jehovah’s Witnesses – medical care, minors, and the religious rite/right. Denning Law Journal, 19: 219–247.

Chapter 10

The Role of Organ and Tissue Donation and the Paramedic Profession

Edd Bartlett and Antonia Cook

Indeed it seems clear that the benefits from cadaver transplants are so great, and the reasons for objecting so transparently selfish or superstitious, that we should remove altogether the habit of seeking the consent of either the deceased or relatives. This we already do when post-mortem examinations are ordered without any consents being required and despite the fact that these too involve interference with the dignity of a dead body and the removal (albeit temporarily) of organs. It has always seemed to me curious that the state can order a post-mortem examination to satisfy its curiosity about the cause of death, but not order cadaver transplants in order to save the lives of living citizens.

(Harris, 1992, pp. 102–3)

Introduction

This chapter introduces some of the ethical and legal principles surrounding organ and tissue donation. This subject is perhaps not widely associated with paramedics, even though the profession is synonymous with the provision of out-of-hospital advanced life support. It is surprising that since there are over 30,000 out-of-hospital cardiac arrests a year in the UK, where only 30% of patients who have an out-of-hospital cardiac arrest are likely to achieve return of spontaneous circulation, and only 9% of patients survive to hospital discharge (Perkins et al., 2021), that more emphasis is not placed on considering the importance of organ and tissue donation and the conversations around this. This chapter serves as an introduction to these topics and asks the reader to consider their viewpoint on the role of organ and tissue donation, and whether the paramedic profession may have more involvement in such decisions and discussions as the law and medical practice surrounding this subject continues to evolve.

Posthumous Ethics

The concept that actions by the living can affect the dead goes back to ancient times. In the Old Testament, Amos specifically condemns the desecration of a King’s body by burning his bones to ash, considered to be a serious transgression against the deceased at the time (Amos 6:10). The bodies of the deceased are almost universally considered to be of some ethical significance. Some believe the bodies of the deceased are ends in themselves, that they hold intrinsic value and dignity by the nature that they are an extension of our consciousness and require the respect of identity (Jones and Whitaker, 2009).

On this basis, some believe that utilising body parts is a violation of the body’s intrinsic dignity (Kass, 2004). Others believe that the deceased’s body has instrumental value and can therefore be used as a means to an end (Harris, 1992). It also has instrumental value as a source of memories and can be an integral part of the grieving process (Jones and Whitaker, 2009). It is now accepted by most major world religions that while the body has intrinsic value, it also has instrumental value, and that procurement of organs is a morally acceptable practice (Veatch and Ross, 2015).

There are two common intuitive reactions to the question of whether the dead can be harmed: either yes, they can, or no, they cannot. The intuition that they can is supported by the Aristotelian view that both evil and good are thought to exist for a dead man (Brown, 2009). The most influential contributors to this view are Pitcher (1984) and Feinberg (1984).

The view that they cannot is supported by the Epicurean view that death does not harm the person who has died. The Epicurean stance is built on by Taylor, who supports ‘full-blooded Epicureanism’, the view that ‘death is not a harm to the person who dies (either intrinsically, or extrinsically), … that posthumous harm is impossible, and that persons cannot be wronged after their deaths’ (Taylor, 2012).

Feinburg’s case for posthumous harm relies on four key points (Feinburg, 1984, p. 90):

1.The dead cannot be hurt but they can be harmed.

2.Death can be a harm to the person who dies in virtue of the interests [they] had antemortem (before death) that are totally and irrevocably defeated by [their] death.

3.Only the person who no longer has an interest in any goal that can be set back by [their] death is unharmed by [their] death.

4.Posthumous harm occurs when one of the deceased’s surviving interests is thwarted after [their] death.

Feinberg’s Thought Experiment for Point 1

Case A: A woman works hard over thirty years of her life on furthering key critical interests, which culminate in the development of an institution dedicated to these interests. A month before she dies this institution collapses and her reputation is destroyed. However, this is concealed from her, and she dies content that her critical interests have been accomplished.

Case B: The facts are the same as in Case A, except the institution dedicated to the woman’s critical interests continues to thrive. Then, after the woman dies, the institution collapses and the woman’s reputation is destroyed.

Case C: The facts are the same as in Case B, except the collapse of the woman’s institution is caused by a group of malevolent employees, who break promises they had made to the woman before she died and spread lies about her and her institution, with the aim of causing her critical interests to fail.

In Case A the woman suffered harm, despite dying unaware of what had happened, and in Case B the woman suffered the same harm, but after death (posthumously), then in Case C, Feinberg argues, the harm is caused by the malevolent employees; they have posthumously harmed her (Feinberg, 1984).

Feinberg concludes that events causing posthumous harm do not cause harm to the person at an earlier time, instead they allow people to re-evaluate the person’s wellbeing when they were alive. The implication of this is that persons are living in a perpetual state of harm, caused by future events that they are not aware of and have not yet occurred.

Taylor argues that the dead can both not be harmed, nor wronged, after their deaths, arguing that once dead both they and their critical interests cease to exist (Dworkin, 1993; Taylor, 2012). Rebutting Feinberg, Taylor states that unlike the woman in Case A, the woman in Cases B and C cannot suffer this harm as they can no longer be deceived, or their autonomy restricted, their lives are not affected by their critical interests being thwarted (Taylor, 2012).

The is a very brief introduction to the ethics of posthumous harm. Reading the rest of this chapter will help you to consider to what extent a person’s antemortem critical interests in donating, or not donating, organs or tissue post-mortem should be respected. If they are not (for example, because of an objection by their family), is the person harmed or wronged, or does it no longer matter?

Uncontrolled Donation After Circulatory Death

In the UK around 600,000 people die each year and of these around 40% die in a community setting (National Records of Scotland, 2022; Office for National Statistics, 2022; Northern Ireland Statistics and Research Agency, 2022). Only those who die in very specific circumstances in hospital are eligible for donation, yet approximately 6,000 people are waiting for organ or tissue donations (British Transplant Society, 2015), and in 2021/22, 429 people on the transplant list died waiting for transplants; for comparison in 2020/21, 525 people died (NHS Blood and Transplant, 2022a).

In 2006, an organ donation taskforce was set up to identify barriers to donation. One barrier they explored was the UK’s position on non-heartbeating donors. Non-heartbeating donors are those who have died following a cardiac arrest and are known as donation after circulatory death (DCD) donors. The taskforce noted a perceived lack of legal clarity among clinicians on when they could continue treatment to preserve organs if that treatment was not in their patient’s best interests medically and would normally be withdrawn (Organ Donation Taskforce (ODT), 2008a).

The legal position has since been clarified for in-hospital resuscitations, there has been an expansion of DCD programmes, and the number of donors has increased from 42 donors in 2001/02 to 612 in 2021/22, representing 44% of all organ donors in the 2021/22 period (NHS Blood and Transplant (NHSBT), 2022a).

In 2013, the UK completed an organ donation programme reform, learning from similar reforms undertaken in leading international programmes, this resulted in the publication of the strategy document ‘Taking Organ Donation to 2020’ (NHSBT, 2013). This document underpins the current state of knowledge and the donation programme within the UK today. In 2020 and 2021 respectively, the organ donation laws in England and Scotland (Organ Donation (Deemed Consent) Act 2019; Human Tissue (Authorisation) (Scotland) Act 2019) were brought in line with those already in place in Wales (Human Transplantation (Wales) Act 2013), with an opt-out system of consent replacing the opt-in system. Adults are now considered to have given consent for their organs to be donated on their death, unless they have recorded a decision not to. Nine years after implementation of the national strategy and two years after the legal changes, donor numbers are steadily going up. The strategy highlighted three main challenges that needed to be addressed: improving family consent rates, the identification of potential donors and improving healthcare professionals’ attitudes and options around donation (NHSBT, 2019).

Categorisation for Organ Donors

Following the success of the increase in DCD programmes, NHS Blood and Transplant’s strategy for 2020 looks at the potential for Maastricht Category I/II DCD being introduced across the UK following a pilot programme in Scotland (NHSBT, 2013). The different Maastricht categories are outlined in Table 10.1.

Table 10.1 Maastricht categories.

Maastricht Category

Definition

Maastricht I

Organs are retrieved following an unexpected cardiac arrest outside of hospital.

Maastricht II

Organs are retrieved following an unexpected cardiac arrest in hospital.

Maastricht III

Organs are retrieved following an expected cardiac arrest following withdrawal of treatment.

Maastricht IV

Organs are retrieved following an expected cardiac arrest in a brainstem dead patient.

Pilot Models in the UK

Historically in the UK, organs have only been procured from Maastricht Category III and IV donors. The first hospital in the UK to introduce uncontrolled donation after circulatory death (uDCD) procedure was the Royal Infirmary of Edinburgh (Reed and Lua, 2013), which ran a pilot in the Lothian region to explore the efficacy of introducing a uDCD procedure for patients who had an out-of-hospital cardiac arrest, or who had an untreatable cardiac arrest in the emergency department. When treatment was considered futile chest compressions and ventilations continued to allow for organ donation to take place, subject to inclusion and exclusion criteria (Reed and Lua, 2013).

In the Lothian procedure, once futility has been decided by the emergency department consultant and a second senior doctor, confirmation of registration in the Organ Donor Register, or another indication of wishes to donate, is established by a Specialist Nurse-Organ Donation (SNOD). The patient’s next of kin must also be available for consultation (Reed and Lua, 2015). If it is established that the patient is a potential donor, resuscitation continues while the family is consulted. This does not differ from the common practice of informing the family of futility in a normal emergency department resuscitation (Reed and Lua, 2015). Following consultation with the family and with their authorisation, mechanical resuscitation continues to be used to preserve the organs until the transplant team is ready; only then is death formally pronounced (Reed and Lua, 2015).

The Lothian procedure warrants praise for its thoroughness and transparency; its operation is underpinned by fundamental principles which emphasise a ‘complete separation of resuscitation and consideration of organ donation’ (Currie et al., 2014). This is strongly emphasised throughout the procedure document (Reed and Lua, 2015). The only component of the procedure that could be considered to be at odds with Department of Health guidance and that could cause problems if it were to be applied in England and Wales (as the guidance only applies in England and Wales) is ‘continued resuscitation’ (Department of Health, 2009).

However, the guidance from the Department of Health appears not to take into consideration that the resuscitation, which is being taken to predominantly refer to external cardiac massage, is not being instigated, but continued, with continuing mechanical ventilation being considered acceptable (Department of Health, 2009). As mentioned previously, it is commonplace for external cardiac massage to be continued while the family is informed that the resuscitation has been deemed futile in both in-hospital and out-of-hospital cardiac arrest. Sometimes resuscitation is also provided where doctors believe there to be no clinical benefit because the family continue to want it (Troug, 2010).

There is no indication that continued external cardiac massage causes the patient any harm, provided that the family is consulted and, in the event of distress or objection, external cardiac massage is not continued. In these circumstances extending the duration of external cardiac massage using a mechanical chest compression device to fulfil a person’s desire to be an organ donor has the potential to be deemed unacceptable (Ave et al., 2016).

However, it must be considered that extended periods with no cardiac massage and poor tissue perfusion will result in ischaemic injury to solid organs and may result in the patient becoming an unviable donor (Hawkes et al., 2017; NHSBT, 2022a). To be eligible to donate organs in the UK, a patient must meet strict medical criteria, their blood and tissue samples must be compatible with those on the waiting list, the death must be controlled and in the correct setting to facilitate the donation journey, and finally, arguably most importantly, the family must have consented to the donation (Human Tissue Authority, 2017). All of this must have been established in enough time to for the National Organ Retrieval Service (NORS) to have been mobilised and logistics arranged. Donation is not a quick process, and from family approach to retrieval it commonly takes over 15 hours (McGowen, 2017).

In other countries, such as France and Spain, and in New York (USA), organs are also procured from patients who suffer an out-of-hospital cardiac arrest (Jox, Assadi and Marckmann, 2016). While some of these countries, like France and Spain, have seen an increase in organ procurement following the introduction of uDCD, there are significant ethical concerns about the blurring of boundaries between active resuscitation and organ retrieval, as well as the potential for deceitful practices (Farrell, Price and Quigley, 2011; Jox, Assadi and Marckmann, 2016).

The French-Spanish Model

In France and Spain, organs are procured from patients who have suffered an out-of-hospital cardiac arrest. The method of retrieving organs requires the use of a mechanical chest compression device to facilitate perfusion en route to the hospital after resuscitation has been deemed futile by the attending emergency medical services (Fondevila et al., 2012; Punch and Anderson, 2012). In the French-Spanish model, it is only upon arrival at the hospital that the mechanical chest compression device is paused for at least five minutes so that death can be declared, despite a physician who could declare death being available on the response vehicle (Fondevila et al., 2012).

This delay in declaration of death has been criticised as a strategic decision to circumvent informing the next of kin that the person is being taken to hospital purely as a potential organ donor (Jox, Assadi and Marckmann, 2016). There are also concerns about resource allocation, with an emergency response vehicle being ‘tied up’ with a person who does not require further medical assistance and might not even be accepted by the receiving organ retrieval team (Jox, Assadi and Marckmann, 2016).

There have been a number of cases in France and Spain where patients destined for organ donation have developed restoration of spontaneous circulation. In some rare cases, neurological function has also been restored, with one person being discharged from hospital neurologically intact (Rodriguez-Arias et al., 2013; Jox, Assadi and Marckmann, 2016). Mateos-Rodriguez et al. responded to this by simply stating that: ‘if these individuals had not been included in the protocol, resuscitation would have stopped after 30 min and the patients would not have survived’ (2010, p. 906). This suggests that being a potential organ donor in France and Spain may be in a patient’s best interests as it could slightly increase their chance of survival, although it also raises concerns about their resuscitation protocols and that they may be prematurely deeming resuscitation attempts futile. As death is declared at hospital, the patient does not ‘come back’ from a legally declared death, and Mateos-Rodriguez et al. make assurances that ‘guidance for diagnosing death is strictly followed on arrival at the transplant centres’ (2010, p. 906).

A significant criticism of the French-Spanish uDCD model is the absence of transparency. In Spain, uDCD was practised for four years before it was explicitly authorised by the law (Jox, Assadi and Marckmann, 2016). Both the French and Spanish laws were passed (in 2006 and 2000, respectively) without any stakeholder or public involvement. In contrast, the New York model actively involved key stakeholders in the development of its protocol (Jox, Assadi and Marckmann, 2016).

Have you had a conversation with your family about your wishes for your organs and tissues after death?

Gardener raises concerns that in the French-Spanish models, there is ‘Third World’ resuscitation and ‘First World’ organ donation (Jox, Assadi and Marckmann, 2016). If the introduction of uDCD was interpreted in this way in England and Wales, it could have catastrophic implications for public trust in organ donation. The gateway to consent for donation is through the family of the deceased, how these conversations are had and framed are vital to success. It must be made clear to the family that all that can be done has been and that the patient will not survive, but that the patient’s body may have onward value in line with their and their family’s wishes. It is recommended by Reed and Lua (2013) that uDCD in the emergency department is carefully reviewed, as unconventional resuscitation interventions such as extracorporeal membrane oxygenation (ECMO) and coronary angiography become common practice. Should these interventions be considered potentially beneficial, it is recommended that it is ensured that patients are given the opportunity to benefit from these interventions, where appropriate, before donation is considered.

Consent Models

In 2015, Wales introduced the UK’s first ‘opt-out’ model, coined as a ‘deemed consent’ model as opposed to the term ‘presumed consent’ used in other European jurisdictions. Wales made the decision to introduce deemed consent following a public consultation, which concluded that there was a public preference for a soft opt-out system (Human Transplantation (Wales) Act 2013). In 2020 and 2021 respectively, England and Scotland also introduced opt-out consent models. Such a system had been advocated by the British Medical Association (BMA) for some time, despite the ODT concluding in 2008 that an opt-out system would not deliver a significant increase in organs (BMA, 2017; ODT, 2008b; Organ Donation (Deemed Consent) Act 2019; Human Tissues [Scotland] Act 2019). The opt-in model only survives in Northern Ireland (this is due to be reviewed in 2022), and is widely recognised as an individual placing their name on the Organ Donor Register, although relatives can also give consent on the deceased’s behalf if they are not on the Register.

A common misconception is that the success of the Spanish system, with the highest rate of organ donation from deceased donors in the world (34.4 donors per million of the population in 2009), is due to presumed consent legislation. In fact, presumed consent was introduced in 1979, but donation rates only began to rise in 1989 following the introduction of the Organización Nacional de Transplantes (National Transplant Organization), which put a national network of dedicated clinicians in charge of the donation process (Farrell, Price and Quigley, 2011).

The law change in England and Scotland has seen them join Wales in being deemed a ‘soft’ opt-out consent model, meaning that family and friends can prevent organs from being procured if they believe the deceased did not wish to donate their organs (Organ Donation (Deemed Consent) Act 2019; Human Tissues [Scotland] Act 2019; Human Transplantation (Wales) Act 2013). In the UK, which had one of the highest family refusal rates in the Western world, this law change has tackled one of the foremost barriers to non-consent, it has created an open platform for organ donation conversations and is lessening the taboo around the subject of death (Department of Health and Social Care, 2019).

Ethical Considerations within Uncontrolled Donation after Circulatory Death

Opt-out models have been criticised as a breach of autonomy. With the rest of medicine moving away from paternalism and promoting patient autonomy, introducing an opt-out policy for donation is considered by some to be wrong. Veatch and Ross (2015) argue that under such as system, people’s wishes will not be respected 25% of the time, and in some cultures this rate would be higher. On the other hand, the ODT described presumed consent as ‘consent for the disorganised’ (2008b, p. 8), perceiving its purpose as being to provide consent for those who had not found the time to register their consent. One of the key questions in the debate about these models is do opt-out models promote or violate autonomy?

Some writers go a step further, suggesting that a system of organ conscription should be introduced, often comparing it to the compulsory coronial autopsy (Jox, Assadi and Marckmann, 2016). Harris (1992), a utilitarian philosopher, believes that informed consent and personal autonomy cannot be absolute rights; the reduction of suffering and saving the most lives possible must be the highest priorities. In such a system, there would be no option to opt out or for the wishes of relatives stating that their loved one did not want to be a donor to be respected.

Since many people can benefit greatly from organ and tissue transplants, the demand usually exceeds the supply. In addition, the costs related to organ and tissue transplants are very high as well. Therefore, many questions are raised today regarding how best to procure more organs, how to fairly distribute limited resources, and whether all transplants should be covered by public funds.

The procurement of organs from people who have suffered an out-of-hospital cardiac arrest is presumed to only be practical in an opt-out system. However, with advancements in information sharing, more ambulance trusts moving towards electronic patient records, and GPs being able to add donation wishes to patient Summary Care Records, pre-hospital clinicians are now more able to access these records and facilitate discussions with the family, or act in the recorded interests of the patient.

Should Uncontrolled Donation After Circulatory Death Be Introduced Across the UK?

Roberts (2011) noted that before uDCD could become even a theoretical option in the UK it would require a cultural opinion change and acceptance from the general public. He identified that the ambulance workforce would have a significant part to play if this came to be reality. Batt et al. (2016) generally concurred with Robert’s opinions, but recognised that paramedics in the community may be well positioned to identify and begin the discussion around donation. They also noted that paramedics should be involved in the discussion around organ donation if it were to arise in conversation.

Since Roberts’ paper, the Royal Infirmary of Edinburgh uDCD pilot has resulted in one uDCD donation, and Wu and Oniscu (2022) have identified what they consider to be lessons learned for the development of future programmes and the future steps required to establish a sustainable uDCD programme. In particular they note that the potential for a more aggressive approach to resuscitation efforts, including increased use of ECMO, will mean novel perfusion and preservation technology such as normothermic regional perfusion (NRP) can be used to mitigate warm ischaemic insult to organs procured via future uDCD programmes (Wu and Oniscu, 2022).

As referred to previously, the availability of the NORS is one of the key logistical considerations that would be required for successful implementation of a sustainable uDCD programme. Wu and Oniscu (2022) consider the next iteration of the development of this would be considering the co-location of large emergency departments (where patients who would be eligible for uDCD are most likely to be conveyed to) with the NORS teams who can then rapidly respond and have access to the NRP infrastructure required to mitigate warm ischaemic insult.

However, Wu and Oniscu also note that the most important factors to successful implementation is the legal and strategic framework, and public support. Clinicians having access to a patient’s donation wishes have seen concerns raised that this might compromise their duty of care, causing patients to be disadvantaged by premature cessation of resuscitation and the implementation of organ-preserving measures. However, the UK Donation Ethics Committee (2011) has considered these concerns to be misplaced.

Before uDCD can be introduced across the whole of the UK, the relevant Departments of Health would have to produce a new position statement on continuing resuscitation to facilitate uDCD. Following this, uDCD could initially be introduced in appropriate emergency departments; once successfully established, a pilot uDCD protocol could be introduced in an urban environment where there are good ambulance response times and paramedics are available to provide clinical leadership at cardiac arrests where the decision to convey a potential donor is made.

Explicit opt-in consent is preferable for uDCD due to the invasive interventions required to preserve the organs. Also, due to the already traumatic nature of an out-of-hospital cardiac arrest, if the next of kin object to organ-preserving measures, clinicians should not proceed and recognition of life extinct should be confirmed on scene. If the patient is to be conveyed as a potential donor, it would be considered good practice for the pre-hospital clinician to speak to a SNOD prior to conveyance to ensure that the patient is suitable to be a donor. If this is not the case, conveyance would not be in the patient’s best interests.

Ultimately, the efficacy of such a protocol is likely to influence its future, although the conveyance of a patient to the emergency department will mean that an ambulance is not available to respond to 999 calls for that period. If the project yielded more organs for transplant, the cost savings (for dialysis and other treatments given to those with organ failure) and lives saved may mitigate resourcing concerns.

Tissue Donation

Most people are aware that they can donate organs on their death; however, the awareness of tissue donation is significantly less, despite the national organ donor register asking registrants to identify which organs and/or tissues they consent to donate (NHSBT, 2022b). The yearly activity reports also omit mention of tissue specific figures, successes and strategies, with the exception of corneal transplants (NHSBT, 2022a). Despite this, the NHSBT Strategic Plan 2022 (2022d) does show a conjoined front, discussing its three operational areas in turn. A key strategic goal of the Tissue and Eye Services is to provide high quality care for donor families, based on compassion and consistency in approach (NHSBT, 2022d). In addition to SNODs, there are also specially trained Specialist Nurses in Tissue Donation (SNTD). SNODs have a base knowledge in tissue donation, but it is not their primary focus. It would appear from the commentary, that few patients who translate into organ donors also have tissues retrieved for donation (NHSBT, 2022c).

The aspiration to honour donation wishes in death should better cover all aspects of the registered consent. Furthermore, the inclusion criteria for tissue donation are far broader, and as such more people die in circumstances in which tissue donation is an option (Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC), 2013); Maastricht I criteria patients can donate tissues. Both in hospital and in the community, tissue donation should be considered as an option by HCPs and the conversation advocated for families. To facilitate this the National Tissue Referral Centre is available 24 hours a day to both HCPs and family. After initial referral, SNTD contact the family to discuss the referral, the process in depth and to gain consent (South Central NHSBT, 2011). The timeframes for tissue referral and retrievals are much less demanding. The potential donor must be in a mortuary within six hours of death and blood sample obtained within 24-hours by the retrieval team. Eye tissue collection has a 24-hour time window post-death and all other tissues within 48 hours.

Ethical Considerations

Feinburg’s case can be well applied to potential posthumous tissue donors (Feinburg, 1984). There is time to establish if the patient recorded their wishes on the national donor register and to explore the understanding of the patient’s wishes with family. Therefore, this gives the opportunity to ensure there is no harm caused by failing to follow decisions made with understanding and thought during life.

A Role for Pre-Hospital Clinicians

Considering the privileged and humbling position ambulance staff are placed in following a patient’s death, there is a gap to be filled that coincides with the national strategy for organ and tissue donation. It could be possible to identify potential donors, fulfil a patient’s final wishes and to bring comfort to the family, by raising the conversation. This will only be possible by developing staff knowledge, understanding and attitudes around the topic and by understanding the importance of how to approach the conversation in a manner that is both sensitive and has the best chance of gaining family consent. Competence in practice is not simply the ability to replicate a skill over and over; it is the ability to combine knowledge, skill and attitude in a multitude of environments, to achieve the best results possible (Cate et al., 2010). This is the attitude to which paramedics should look at any newly applied concept, policy or skill.

Ambulance staff, by the nature of their work, have regular interaction with families of recently deceased patients, whether this is a patient who has been found already deceased or an unsuccessful resuscitation. There is currently no guidance provided by the NHSBT, the National Institute for Health and Care Excellence (NICE), the Joint Royal Colleges Ambulance Liaison Committee (JRCALC) or the Association of Ambulance Chief Executives (AACE) regarding organ or tissue donation conversations with families. The ODT (NHSBT, 2013) identified one of its greatest challenges to be improving healthcare professionals’ attitudes and opinions to donation. Several instances of effective training and education for healthcare professionals and medical staff in hospitals have been observed, especially in departments with a higher likelihood of encountering potential donors, like the emergency department and intensive care unit (NHSBT, 2022c).

There has been no strategy or education aimed specifically at paramedics (or pre-hospital clinicians) other than campaigns developed for the general population– both in the UK and across the world (James, Lanos and Batt, 2018). As identified, pre-hospital clinicians are often with the families at the point they are coming to terms with the death of a loved one. Families are looking to what is next, which may be contacting the patient’s GP to inform them of their death, contacting family or an undertaker. Paramedics should feel empowered to continue to advocate for the patient, specifically considering what the patient’s wishes after their death may have been. A common professional barrier to raising the donation conversation, is that these discussions may upset families too much. Some studies disprove this (Brown et al., 2010; NHSBT, 2015; Opdam, 2015;), and in fact that it often provides the family with a sense of comfort to have the opportunity to take an active part in such a decision (ODT, 2008b).

It is therefore clear that there are three barriers faced by the question of prehospital organ donation at this time. First, the cultural acceptance of imminent death and the necessity of specialist-led conversations around the topic (JPAC, 2013). Second, the moral and professional responsibility to preserve life; it could be suggested there is an ethical compromise if a patient is seen as a potential donor as opposed to a life to be saved. There is also an ethical question around continuing cardiac resuscitation efforts purely to transport a patient for donation (British Transplant Society, 2015). Third, the organ retrieval network’s infrastructure in the UK is not currently able to support a potential exponential increase in donor referrals (NHSBT, 2015).

However, there is the potential to advocate for posthumous value of the body of the deceased in discussing the option of tissue donation. Where a person has indicated that they want to be a donor, by instigating a conversation about donation paramedics would be advocating for their patient’s antemortem interests. As such it is recommended that every effort is made to find out if a patient is a registered organ donor before entering into a discussion about donation with the family. If this is not possible, it would be important to explore the family’s knowledge of their loved one’s wishes. Raising the conversation can aid in the grief of the family members, but this will depend on individual family members, and the interpersonal skills of the paramedic to judge the timing, tempo and contents. It would be important not to rush the decision; due to time frames available, the family have time to decide and change their minds. It would be equally acceptable to raise the confirmation, provide information and leave referral information with the family to make a later decision.

Summary

The concept of uDCD and tissue donation is likely to be a new one to the reader. While there are as yet no UK-wide models considering procedures associated with out-of-hospital cardiac arrest and uDCD, it is likely these will emerge now that the legislation for organ donation has changed in England, Northern Ireland and Wales. It is important to be mindful that uDCD protocols carry great legal and ethical obligations, and it is paramount that they are undertaken in a legally and ethically satisfactory way. Not only will this ensure that the paramedic acts within the legal boundaries of their profession, but it will ensure that the risk of public backlash is significantly decreased. Crucially, the successful introduction of uDCD and instigation of conversations about tissue donation would see an increase in the number of organs and tissue available for transplantation in the UK.

Recommended Reading

Jox R, Assadi G and Marckmann G (eds) (2016). Organ Transplantation in Times of Donor Shortage: Challenges and Solutions. London: Springer.

University of Oxford (2023). Blog: Practical Ethics: Organ Donation. Available at: https://blog.practicalethics.ox.ac.uk/tag/organ-donation/ (accessed 30 June 2023).

Wu D and Oniscu G (2022). Piloting Uncontrolled DCD Organ Donation in the UK; Overview, Lessons and Future Steps. Current Transplantation Reports. Available at: https://doi.org/10.1007/s40472-022-00374-1 (accessed 20 June 2023).

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British Medical Association (BMA) (2017). Organ Donation. Available at: https://www.bma.org.uk/collective-voice/policy-and-research/ethics/organ-donation (accessed 30 June 2023).

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Chapter 11

Legislation Relating to Mental Health

Carly Lynch and Samantha McCabe-Hogan

Introduction

A mental health need is as important as a physical health need and this concept, known as ‘parity of esteem’, was enshrined in law through the Health and Social Care Act 2012. Despite best efforts, as clinicians, we will know that true parity has not yet been realised, as there remain inequalities in health outcomes for people that live with a severe mental illness. Those living with conditions such as schizophrenia and bipolar affective disorder have, on average, a shorter life expectancy, by between 15 and 20 years, than the rest of the population who do not experience such illnesses (The King’s Fund, 2019). The ‘Five Year Forward View on Mental Health’ (NHS England, 2017) estimated that two in three deaths related to mental health were, in fact, from preventable physical health conditions, such as cardiovascular and respiratory diseases.

Mental health calls are a significant part of a paramedic’s workload, regardless of their clinical setting. In some areas of the United Kingdom (UK), it is estimated that mental health incidents account for around 10% of overall ambulance call volume (Duncan et al., 2019), with a comparative increase in attendances at emergency departments or in primary care for this patient group (Saini et al., 2020). Nearly half of people who have a mental health condition also have a long-term physical health condition, and it is now widely accepted in contemporary healthcare that the mind and body should not be separated in the treatment of health conditions.

The theory that the mind and body were two distinct parts was prevalent in the 17th century and credited to Rene Descartes. According to him, human beings consisted of two quite unlike substances, which could not exist in unity. Mind was unextended, an immaterial but thinking substance, and body was an extended, material, but unthinking substance. The body was subject to mechanical laws; however, the mind was not (Descartes, 1952). At a time when Christian views of the mind–body relationship had thwarted the development of medical science, Descartes, through mind–body dualism, demythologised the body and handed over its study to medicine. Thus, the way was paved for progress in medical science through the study of physiology and anatomy. However, at the same time, by isolating the mind, mind–body dualism denied the significance of the mind in an individual’s experience of health, and thus restricted interventions to deal with the same.

Paramedics working across all clinical settings hold the unique and privileged role of working with people at times of acute crisis. This opportunity should be utilised to ensure we engage our patients in an assessment of both their mental and physical health needs. For example, a paramedic may not only assess and treat the acute mental health problem at hand, but may also offer a health screening and onward management for conditions such as hypertension.

Mental health care is a unique area of healthcare in terms of the use of legislation that can be applied to treat people against their wishes. It is imperative that we act as advocates for our patients and ensure they are made aware of their rights under this legislation, rather than needlessly looking to apply it. Clinicians need to ensure that they always work in the least restrictive way and in the best interests of their patient. It is vital to ensure that patients are always kept informed about their care plan and if restraint is used in order to prevent harm it should be proportionate to the situation and the patient’s needs should be respected.

There remain significant inequalities in society, which will impact on people’s health. The impact of adverse childhood events, trauma, poverty, prejudice and discrimination due to ethnicity, gender and sexuality can all affect mental health. The Equality Act 2010 legislates the protected characteristics to prevent discrimination and harassment. Some mental health conditions may last for a year or more, and so can often be considered a disability. With this in mind, healthcare providers have an obligation to make reasonable adjustments to ensure accessibility for these patients, which may include providing patients with details of advocacy services or offering adjusted treatment options such as longer appointment times. Such adjustment is supported by The Care Act 2014, which outlines the right of individuals to access, and receive, health services that will prevent their care needs from increasing. It also champions advocacy and choice of care services for users.

This chapter will focus on the most pertinent pieces of legislation relating to mental health care in paramedic practice and their application to patients in a mental health crisis. However, providing care for those with mental ill health is not only dependent on legislation specific to mental health, but also in overlap with the Human Rights Act 1998, the Suicide Act 1961, Equality Act 2010 and the Care Act 2014. While this chapter considers the legislation relating to mental health across the UK, particular emphasis is given to legislation in England and Wales under the Mental Health Act 1983.

The Mental Health Act 1983 for England and Wales

The Mental Health Act 1983, updated in 2007, applies only to England and Wales. This legislation addresses the assessment, treatment and rights of people with a mental health disorder.

It is important to note that the vast majority of people receiving treatment under mental health services in the England and Wales have given informed consent, and so are sometimes referred to as voluntary or informal patients. Most people experiencing mental ill health are treated in the community by services such as community mental health teams, home treatment teams, or psychological services that focus on improving access to psychological therapies. Admission to hospital would be seen as a last resort to safely mitigate patients at risk to themselves or others. It is worth noting at this point the latter is rare, as people with a serious mental illness are more likely to be victims of violent crime as opposed to perpetrators (Khalifeh et al., 2015).

If a patient declines admission and/or treatment there are provisions in the Mental Health Act 1983 that allow someone to be admitted and detained in hospital against their will. This is sometimes colloquially known as ‘sectioning’ which relates to being detained under a particular section of the Mental Health Act 1983.

Principles

There are five overarching principles that clinicians working within the Mental Health Act 1983 should follow. These are laid out within the Mental Health Code of Practice as follows:

1.Working in the least restrictive way and ensuring we maximise independence

All efforts should be made to treat a patient without detaining them. The independence of the patient and their recovery should be promoted by all healthcare professionals.

2.Empower and involve the patient and others

Patients should always be involved in decisions regarding their care and treatment. Where possible, and if appropriate to do so, family and carer’s views should be obtained and considered. If a healthcare professional goes against the wishes of the patient, a clear explanation should be offered to the patient (and their family or carer) and the reason justified.

3.Treat the individual with respect and dignity

Patients, their family and their carers should be treated with respect and in a dignified manner. Their values, views and beliefs should be listened to and considered when decisions are made about the care or treatment of the patient.

4.Ensure treatment plans have purpose and are effective

Treatment and care plans should be appropriate to the individual patient and reflective of their current needs and risk. There should be clear therapeutic aims and timescales to the treatment, which should be developed in conjunction with contemporary and recommended guidelines.

5.Provide efficient and accessible services

There is a requirement for commissioners, providers and other organisations to ensure there is adequate provision of high-quality services that encompass access to physical health care and social care. Services should also work together to ensure that discharge from detention is timely, safe and supportive and continues to be in the best interests of the patient.

Between 2020 and 2021, the overall number of people being detained in England and Wales under the Mental Health Act 1983 rose by 4.5%. Out of these detentions, people of colour were four times more likely to be detained than Caucasians.

Is it likely that ethnicity is a causative factor for a mental health problem requiring detention? Or might it be the case that the system, and those that act within the system, is prejudiced (overtly or inadvertently) towards the behaviours, values or beliefs of people or colour, as these may be different from those of Caucasians?

As paramedics, we must ensure that we do all we can to advocate and challenge any practice that we think is not proportionate to the individual patient’s presentation and risk – respecting their values, rather than simply comparing them with our own.

Common Sections Encountered by Paramedics

The following sections are the most pertinent for paramedics working in an out of hospital setting.

The criteria of detention is set out in the Mental Health Act 1983 Part II as a person:

suffering from a mental disorder [or suspected mental disorder] of a nature or degree which warrants the detention of the patient in a hospital for assessment or assessment followed by medical treatment for at least a limited period and [they] ought to be so detained in the interests of [their] own health and safety or with a view to the protection of other persons.

Section 2

This section gives the authority for an application to be made for a person to be admitted to hospital for up to 28 days for assessment and, if needed, treatment. In order for a person to be detained under Section 2, the patient will need to be examined by two medical professionals, who make a written recommendation that the patient should be admitted to hospital and provide reasons for this. The patient is also assessed by an Approved Mental Health Professional (AMHP), who decides whether to make the application to the hospital.

This section does not have to run for the full 28 days and can be rescinded by the responsible clinician at any point. A Section 2 cannot be renewed.

Section 3

Section 3 is similar in process to a Section 2 in that the patient will be examined by two medical professionals and an AMHP. However, the detention can last for up to 6 months, but again can be rescinded at any point. A Section 3 can be renewed.

Section 4

This section provides provision for emergency detention for up to 72 hours. The patient is examined by one doctor only and an application made by an AMHP.

For this section, it is important to know that an application can only be made by an AMHP once a bed in the receiving unit has been identified. This can cause delay in the Mental Health Act assessment if there are no beds available. An AMHP may assess the patient to ascertain if they meet the criteria for detention in the absence of the bed and an interim care plan should be put in place to support the patient and their family/carers.

Section 6

This section of the Mental Health Act 1983 relates to the conveyance of the patient to hospital. Once an application for admission has been made, this section allows the applicant (usually the AMHP), or a person designated by the applicant, to take the patient and convey to hospital.

The ambulance service will often convey the patient as designated by the AMHP.

Section 12

This section outlines the approval process for doctors who may make medical recommendations for the compulsory admission of a mentally ill person to hospital, or for their reception into guardianship. Section 12 approved doctors are those approved by the Secretary of State ‘as having special experience in the diagnosis or treatment of mental disorder’. Whenever the Mental Health Act requires the recommendations of two doctors, one of them must be Section 12 approved. This includes instances of compulsory admission under Section 2 (for assessment) or Section 3 (for treatment) or for reception into guardianship under Section 7. Every doctor who is an Approved Clinician (a role created, along with that of Responsible Clinician, by the Mental Health Act 2007 amendments to the 1983 Act), is automatically Section 12 approved.

Section 13

Section 13 relates to the duty of local authorities and AMHPs to consider whether an application for detention may need to occur. The AMHP may conclude that an assessment under the Mental Health Act does not need to occur and so it is a useful section for prehospital clinicians to be aware of when they are liaising with local authorities.

Section 17

Section 17 gives provision to permit temporary leave from hospital for patients. This may include leave to attend health appointments or to return home for leave as part of discharge planning.

Section 18

Under Section 18 a patient becomes absent without leave (AWOL) if they are absent from the ward without Section 17 leave or if they fail to return after a period of Section 17 leave. Section 18 gives police, AMHPs, hospital staff and anyone authorised by a hospital manager in writing to re-detain and return the patient back to the hospital.

Absent Without Leave

Paramedics in the ambulance service may, on occasion find themselves dispatched to a patient who is on Section 17 leave from a mental health ward. If the patient does not return to the ward, they are known as AWOL and the ward may request emergency services to attend the patient’s home for a welfare check, and potentially to return the patient back to the ward.

If the patient is in a private residence and refuse entry of emergency services to their property, or decline to return, the ward will need to apply for a Section 135(2) warrant.

Sections 137 and 138(1)(b) give authority for a person who is AWOL to be returned, even if they refuse, if they are in a public place or once access has already been gained to a property.

If police are with the patient, they are permitted to take the patient back to the ward under Section 18 of the Mental Health Act 1983, and the ambulance should be considered as the vehicle of choice for conveyance.

Lessons from the inquest into the death of Sasha Forster noted that it should be the responsibility of the ward in the first instance to return an AWOL patient (if they know where they are) and that the police can decline to provide assistance (Reid, 2019).

Section 135(1)

Section 135(1) relates to a warrant issued by a magistrate that authorises the police, an AMHP and medical professional to gain entry into premises in order to undertake a mental health act assessment in the premises. This section would typically be utilised when a patient is refusing access to their property.

Section 135(1) also allows the patient to be conveyed to a health-based place of safety (HBPOS) if the assessment cannot take place on the premises.

An AMHP will make the application to the courts and provide evidence that a warrant is needed. Paramedics in the ambulance service will usually be involved in the conveyance of the patients subject to Section 135(1). Paramedics working in out-of-hospital settings, such as primary care, may also be involved in making recommendations that a patient may require assessment under the Mental Health Act 1983 to mental health providers and local authorities following an assessment.

Section 135(2)

Section 135(2) is a court-issued warrant that allows police and mental health staff to gain access to a premises and return a patient who is detained in hospital but AWOL in conjunction with Section 18.

Section 136

This is probably the most commonly used section of the Mental Health Act 1983 that paramedics may encounter. Section 136 is a police-only power that allows a police officer to detain someone whom they believe to be suffering from a suspected mental disorder where the person is in need of immediate care and/or control and is not in a private dwelling.

The definition of a private dwelling in the Act is ‘any house, flat or room where that person, or any other person, is living and any yard, garden, garage or outhouse that is used in connection with the house, flat or room, other than one that is also used in connection with one or more other houses, flats or rooms’. Section 136 cannot be applied inside a private dwelling or associated non-shared spaces. Paramedics in the ambulance service in particular may find themselves called to hotel rooms and custody suites to a person in mental health crisis. In such a situation, it is important to defer to policing colleagues and their expertise as to the application of Section 136. Generally, if the stay is temporary then Section 136 may be applied. An update in Section 136 legislation in 2017 under the Police and Criminal Evidence Act 1984 advised that, where practicable, police officers should consult a registered healthcare professional, which would include a paramedic, prior to instigating Section 136. However, this does not include ambulance technicians or assistants. The purpose of this consultation is to explore least restrictive options for the patient.

Once a patient has been detained under Section 136, the police officer will inform them and make arrangements for them to be conveyed to a HBPOS, occasionally also colloquially called a place of safety or 136 suite. Once here, the patient can be assessed by relevant mental health professionals, who will include mental health nurses, psychiatrists and an AMHP.

A person can be detained under Section 136 for up to 24 hours. Although a HBPOS is the preferred destination for a patient detained under section, there may be a medical need which requires them to attend an emergency department for ongoing clinical monitoring. Police custody can never be used as a place of safety for patients under the age of 18 detained under Section 136. For adults it should also not be used unless there are extreme circumstances with no clinical monitoring needs.

For patients being admitted to a mental health ward under section, it is recommended that the transporting clinician has sight of the section papers to ensure they are correctly filled in. It is vital they are signed and have the correct details of the patient and receiving hospital, as they may be invalid if not correctly filled in. Section papers can be electronic and sent to the receiving ward digitally, so it is important to familiarise yourself with the local protocols.

Transport

The Code of Practice states that patients should be transported in a manner that is most likely to preserve dignity and privacy while managing the risk to the patient, and others, safely. An ambulance should always be used as first choice of transport for patients detained under section. The role of the ambulance paramedic is to medically screen the patient to ensure they are fit to attend the mental health hospital ward or HBPOS and, if not, convey them to the most appropriate destination, such as an emergency department if there is a physical health need that needs to be attended to.

It is important that a patient travels in an ambulance where possible. A mental health crisis is a health need and travelling in a police car can be stigmatising. There may be exceptions to this and each case will need to be considered on an individual basis. The police will always need to travel with the patient as until a handover of clinical responsibility has been accepted by the receiving hospital the patient remains in the custody of the police.

What is our ethical duty to ensure we do not stigmatise patients with acute mental health needs further?

Learning Disabilities

The mental health Code of Practice (Section 2) states that the Mental Health Act 1983 should not be applied to someone with a learning disability (and no other form of mental disorder) unless their learning disability is accompanied by high levels of aggression or irresponsible conduct. As part of a mental health assessment, the assessing paramedic must document reasons as to why such behaviour relates to their learning disability and not an unmet need, such as physical health issues (for example, pain), social needs (for example, inadequate placement) or emotional needs (for example, emotional neglect).

Drug and Alcohol Dependence

Section 1(3) of the Mental Health Act 1983 does not consider drug and/or alcohol dependence in isolation as a condition that requires detention under the Act. Some patients may have co-morbid mental disorders which do fall into the detention criteria. The Act also does not exclude mental health conditions related to substance misuse, such as psychosis, which can be treated under the Act.

While the Mental Health Act 1983 does not offer provision for the sole treatment of drug and alcohol misuse, paramedics may need to rely on the relevant mental capacity act within their nation depending on the clinical presentation, risk and outcome of a Mental Capacity Assessment.

Upcoming Changes in Practice

An independent review of the Mental Health Act 1983 was conducted in 2018. The review was led by Professor Sir Simon Wessely to address issues relating to increasing levels of detention and the disproportionate number of people from Black and minority ethnic groups being detained under the Act. Following on from this, a white paper, released by the Department for Health and Social Care, set out the proposed changes in law and practice. If the Bill is passed, the main changes will include a higher threshold for compulsory detention, statutory advance choice documents, stronger patient rights, culturally appropriate advocacy, strengthening the right of the patient as well as strengthening the interface between the Mental Health Act 1983 and the Mental Capacity Act 2005 in order to modernise treatment of people experiencing mental ill health. The Bill is due to be passed in the later part of 2023, so it is important that paramedics across all clinical settings familiarise themselves with the changes that are relevant to their clinical practice.

The Mental Capacity Act (Northern Ireland) 2016

Previous legislation relating to mental health in Northern Ireland (the Mental Health (Northern Ireland) Order 1986) has been replaced by the Mental Capacity Act (Northern Ireland) 2016, in which impairment of decision-making capacity and best interests are the only criteria to be used when making decisions across health and social care. This ‘fusion’ legislation provides equally for all circumstances in which a person’s autonomy might be compromised on health grounds, placing treatment of mental illness within the same legislative framework as physical illness. By treating mental and physical illnesses equally under the law, it reduces the stigma associated with separate mental health legislation, and is respectful of a person’s autonomy and decision-making capacity regardless of their health problem (Guidelines and Audit Implementation Network, 2011). This has huge potential to improve mental health care. This is discussed in more detail in Chapter 7: Legislation Relating to Mental Capacity.

The Mental Health (Scotland) Act 2015

The Mental Health (Scotland) Act 2015 looks to improve mental health services across Scotland and ultimately ensure that people affected by mental health are able to access effective treatments in a timely manner. The Act has three main parts:

Part 1 outlines the key provisions in the Act, which include: emergency and short-term detention in hospital, the appointment of a named person, outlining of independent advocacy services, safeguarding the patient’s interests, and the cross-border transfer of patients outside of Scotland and the EU.

Part 2 deals explicitly with mental health in criminal cases and how offenders with mental health issues are represented under the Criminal Procedure (Scotland) Act 1995. This includes amended assessment and treatment timescales and the right to information sharing and provides variation on certain orders relating to criminal cases.

Part 3 focuses on the rights of the victim, including their right to information and the interaction with the Criminal Justice (Scotland) Act 2003. This also allowed the creation of a Victim Notification Scheme for victims of mentally disordered offenders.

Sections 301–303 cover the powers to re-detain Scottish mental health patients who have absconded from these provisions and are still in Scotland.

The Mental Health (Wales) Measure 2010

The introduction of the first Wales-specific mental health legislation – the Mental Health (Wales) Measure 2010 – is not concerned with compulsion, but to improve access to and the delivery of mental health care in primary and secondary care. It has the overriding aim of helping those with mental health issues by increasing independent mental health advocacy and ensuring care across Wales for all mental health needs.

The Measure has four main parts:

Part 1 aims to ensure that more mental health services are available within primary care. It aims to provide a service delivered within and alongside primary care settings, focusing on:

Assessment

Short-term interventions

Information, advice and onward referral to other services (where appropriate).

Part 2 makes sure that all patients in secondary services have a care and treatment (CAT) plan. Care co-ordinators are appointed to guarantee that CAT plans are informed by the service user and their carers/families. This ensures that plans are individually tailored and helps mental health services to focus on the recovery model of care and treatment.

Part 3 enables eligible adults discharged from secondary services to refer themselves back to those services if they feel their mental health is becoming worse. This means that service users known to the services can bypass primary care.

Part 4 supports every in-patient to have help from an independent mental health advocate, as required and if wanted. This extends the independent mental health advocacy scheme. It covers patients subject to compulsion under the Mental Health Act 1983 and those in hospital voluntarily.

Mental Capacity and Mental Health

England and Wales

As capacity to consent relates to all healthcare treatment decisions it is important there is discussion on the application of the Mental Capacity Act 2005 to a person experiencing a mental health crisis. The application of the Mental Capacity Act 2005 in a mental health crisis can be a grey area for paramedics given that cases may often be of an emergency nature and it is not always appropriate, or safe, for paramedics to wait with the patient for capacity to return.

Capacity to consent is time and decision specific and we must work with the five guiding principles of the Mental Capacity Act 2005 as follows:

1.A presumption of capacity

2.Individuals should be supported to make their own decisions

3.A person with capacity can make an unwise decision

4.You must act in patient’s best interests

5.Apply the least restrictive option.

We must ensure that any decision taken on behalf of the patient is in their best interests and the paramedic should look to ensure the risks and benefits of each potential option are considered.

While the Mental Capacity Act 2005 should not be used where there is provision given in the Mental Health Act 1983, there are times when the Mental Capacity Act 2005 needs to be applied in order to provide life-sustaining treatment or to prevent an immediate risk of harm, and this is considered in Section 4B. When considering how this relates to risk in mental health, this may include overdoses, serious self-harm, psychotic risk or suicide risk.

Section 4B of the Mental Capacity Act (2005) and Mental Health Risk

Section 4B of the Mental Capacity Act 2005 is clear that a person may be deprived of their liberty while a decision concerning any relevant issue is sought from the court. Considered in the context of paramedics, the first condition considers whether a paramedic is authorised to deprive the person of their liberty under Section 4a. The second condition is that the deprivation of liberty is wholly or partly for the purpose of giving life-sustaining treatment or doing any vital act. The third condition is that the deprivation of liberty is necessary in order to give the life-sustaining treatment or do the vital act. A vital act is any act that is reasonably believed to be necessary by the paramedic to prevent a serious deterioration in the patient’s condition.

This ruling is a reminder to clinicians that any act undertaken must be proportionate to the risk – and we should not rely on the Mental Capacity Act 2005 where there is provision in the Mental Health Act 1983. This does not mean that the Mental Capacity Act 2005 can never be applied to a patient in a mental health crisis, but Section 4B of the Mental Capacity Act 2005 is clear around when a person is deprived of their liberty.

Northern Ireland

The Mental Capacity Act (Northern Ireland) 2016 provides a statutory framework for people who lack capacity to make a decision for themselves and for those who now have capacity but wish to make preparations for a time in the future when they lack capacity. This is discussed further in Chapter 7: Legislation Relating to Mental Capacity.

Scotland

The Adults with Incapacity (Scotland) Act 2000 creates provisions for protecting the welfare of adults who are unable to make decisions for themselves because of a mental disorder or an inability to communicate.

Part 5 of the Act allows treatment to be given to safeguard or promote the physical or mental health of an adult who is unable to consent. The principles apply as much to medical treatment decisions as to any other areas of decision making. Where a welfare attorney or guardian has been appointed with healthcare decision-making powers, a treating clinician must seek their consent where is it practicable and reasonable to do so. Where the adult has no proxy, a clinician is authorised to provide medical treatment, subject to certain safeguards and exceptions. This is discussed further in Chapter 7: Legislation Relating to Mental Capacity.

Suicide and Use of the Mental Health Act 1983

The Suicide Act 1961 decriminalised the act of suicide in England and Wales. The text of Sections 1 and 2 of this Act was enacted verbatim for Northern Ireland by Sections 12 and 13 of the Criminal Justice Act (Northern Ireland) 1966. The Act did not apply to Scotland, as suicide was never an offence under Scots Law. It is vitally important that we move away from the language of ‘committing suicide’, which harks back to a time when attempting to or completing suicide was illegal. Although suicide is no longer a crime, it remains a criminal offence in the UK for a third party to assist or encourage someone to attempt suicide. There is a maximum sentence of up to 14 years imprisonment if someone is found guilty of this.

While suicidality is not a mental illness in itself, people experiencing mental illness can experience suicidal thoughts and intent, and we must be alert to the fact that suicidality with intent and imminent risk should be viewed as a potentially life-threatening situation. It is important that paramedics ask ‘What is the risk of suicide?’ and whether the person meets the threshold for detention under the Mental Health Act 1983.

While there is a presumption of capacity enshrined in Section 1(2) of the Mental Capacity Act 2005, this presumption is not a substitute for an assessment of capacity. Where there is proper reason to think that a person may lack capacity to take their own life, it is necessary to carry out a proper assessment of their capacity (Royal Bank of Scotland PLC v. AB [2020]).

In the inquest touching upon the death of Cynthia Finlay, coroner Caroline Topping encouraged caution in the discharge of patients who are awaiting Mental Health Act assessment who may be alone and at risk while waiting for the assessment to be completed (Topping, 2022).

Article 2 of the Human Rights Act 1998 protects the right to life. In times of acute suicidality, as clinicians we may need to act in the patient’s best interests to preserve the right to life. However, English courts accept that a person can have the capacity to take their own life (R (Maughan) v. Senior Coroner for Oxfordshire [2019]). This could include both refusing either the starting or the continuing of life-saving treatment (Kings College Hospital NHS Foundation Trust v. C & Anor [2015]), or the taking of active steps to bring about their own death regarding the capacity to take the decision to go to Dignitas (A Local Authority v. Z [2004]).

This issue is complex and it is strongly recommended that paramedics seek advice from appropriate specialists if they find themselves in situations where a patient with mental capacity is attempting to end their own life. This may take the form of internal escalation, such as clinical support desks in the ambulance service, clinical supervisors in other settings, discussion with mental health provider trusts and even local authorities.

Summary

Throughout the UK, separate pieces of legislation (The Mental Health Act 1983, Mental Capacity Act (Northern Ireland) 2016, The Mental Health (Scotland) Act 2015 and the Mental Health (Wales) Measure 2010) provide the legal framework for the assessment and treatment of mental ill health.

Clinicians must always ensure that they work in the least restrictive way that is proportionate to the risk. In our role as paramedics, we have a duty of care to individuals to advocate for them and be mindful of the inequalities that exist both in society and in the mental health system.

Regardless of the legal framework we are working within we must always ensure our practice is underpinned by guiding ethical principles and the relevant codes of practice. We must always ensure that we hold the patient’s wishes at the centre of our practice and advocate for patients and their carers. If we are making a best interests decision, in accordance with the legislation in the country in which we work, we should also inform the patient of the decision we have made and the reasons why. If a person lacks capacity to consent to a particular treatment or care plan, any decision and action we take must be proportionate to the risk and must be taken in the least restrictive way.

Patients experiencing acute episodes of mental ill health, or ongoing chronic issues associated with mental ill health, are often in a state of heightened distress. Paramedics may view their involvement with these patients as a position of advocacy, to reduce the experience being any more traumatising. While legislation gives a clear legal framework for paramedics to work within, the nature of clinical work for paramedics can often be unpredictable, with those working in emergency departments or ambulance services having no prior knowledge of a patient. It is important to seek support where needed, both in terms of clinical advice to support patient care and also any individual welfare needs for our own well-being.

Recommended Reading

Rolfe U and Partlow D (2022). Mental Health Care in Paramedic Practice. Bridgwater: Class Professional Publishing.

References

Descartes R (1952). Meditations on the first philosophy. In Great Books of the Western World, Hitchins RM (ed.). New York: Britannica.

Duncan S et al. (2019). Epidemiology of emergency ambulance service calls related to mental health problems and self harm: A national record linkage study. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, 27(1): 34.

Guidelines and Audit Implementation Network (2011). Guidelines on the Use of the Mental Health (Northern Ireland) Order 1986. Available at: https://www.rqia.org.uk/RQIA/files/4e/4ee9f634-be47-4398-afc9-906a20ff3198.pdf (accessed 30 June 2023).

Khalifeh H et al. (2015). Violent and non-violent crime against adults with severe mental illness. British Journal of Psychiatry, 206(4): 275–282.

The King’s Fund (2019). Mental Health: Our position. Available at: https://www.kingsfund.org.uk/projects/positions/mental-health (accessed 30 June 2023).

NHS England (2017). The Five Year Forward View for Mental Health. Available at: https://www.england.nhs.uk/publication/the-five-year-forward-view-for-mental-health/ (accessed 30 June 2023).

Reid D (2019). Regulation 28: Report to Prevent Future Deaths (1). Available at: https://www.judiciary.uk/wp-content/uploads/2019/08/Sasha-Forster-2019-0169_Redacted.pdf (accessed 30 June 2023).

Saini P et al. (2020). Predictors of emergency department and GP use among patients with mental health conditions: A public health survey. British Journal of General Practice, 70(690): e1–e8.

Topping C (2022). Regulation 28: Report to Prevent Future Deaths. Available at: https://www.judiciary.uk/wp-content/uploads/2022/05/Cynthia-FINLAY-Prevention-of-future-deaths-report-2022-0138_Published.pdf (accessed 30 June 2023).

Wessely S (2018). Modernising the Mental Health Act: Increasing choice, reducing compulsion. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/778897/Modernising_the_Mental_Health_Act_-_increasing_choice__reducing_compulsion.pdf (accessed 30 June 2023).

Chapter 12

Overview of Ethics and Legislation Surrounding Medicines

Andy Collen

Introduction

Medicines safety and governance is a key aspects of paramedic practice. Paramedics are trusted, in law and in practice, to possess and administer a range of medicines for use in diverse and complex clinical presentations. The provision of medicines to patients in urgent, emergency and critical care settings can be challenging – both legally and ethically. Patients may have very clear expectations about receiving certain types of medicines or they may have no knowledge or expectations, relying instead on the paramedic to guide their care entirely. The fact that paramedics, as a profession, are legally authorised to practise with the responsibility of using almost all legal mechanisms relating to medicines (depending on level and scope of practice, and employer authority) means that practice for paramedics involves the consideration of a myriad of factors associated with these different legislative and, of course, ethical drivers.

While it seems fundamental, paramedics do sometimes get it wrong legally when it comes to medicines, and therefore the starting point must be to understand the mechanisms available to paramedics. By understanding the principles and limitations of each legal mechanism, paramedics can promote safe and effective care for patients, and approach their practice with confidence. Necessarily, the law that informs the use of medicines is specific and may appear restrictive, but the requirement to work within the law – despite the temptation to deviate based on patient need – is paramount.

This link between the legal, ethical and practical aspects of healthcare is particularly important when considering medicines. Broadly speaking, a medicine cannot be ‘ungiven’ and therefore the approach taken must be considered and judicious – there is little room for the action-biased interventionist in a modern healthcare profession, and the desire to do things to patients must be challenged where the motivations are not solely focused on the patient. There are some medicines that, in the context of paramedic practice, need to be given quickly, but for the most part there is always time to think and consider the medicines that are available.

In medicines-related practice, perhaps the most pertinent ethical consideration (beyond preventing harm) is the Kantian deontological principle which states that the subject (the patient) must never be the means to an end and must only ever be the end in their own right (Kant, 1948). Each clinical encounter and any subsequent planned therapies must be based on the patient’s needs alone. When this is considered holistically, along with legislation and competence, the patient’s safety will be promoted, optimised and maintained as far as is practicable.

Paramedic Practice Guidance Relating to Medicines

The College of Paramedics, as the professional body for the paramedic profession, is required to publish practice guidance along with the other documents it publishes, such as curriculum and scope of practice guidance. Practice guidance is produced by all allied health professions’ professional bodies and these documents form an important aspect of the role of these organisations (Allied Health Professions Federation, 2018).

These documents are vital to ensure that paramedics have the information they need in practice which is specific to the profession. Legal mechanisms pertaining to medicines relating to all healthcare professionals are the same as described in law. However, specific professions may have some, or none, of the stated legal mechanisms contained in the legislation. For example, orthoptists are able to use exemptions to supply and administer listed medicines. Paramedics, on the other hand, can sell or supply General Sales List (GSL) medicines from premises that can be closed to exclude the public (Human Medicines Regulations 2012 (Section 221 and Schedule 15)).

Practice guidance outlines the essential standards that need to be adhered to in practice in order to ensure that the legislation is upheld, patients are kept safe and paramedics can practice confidently and competently. The practice guidance supports and clarifies legislation and works to remove ambiguity for clinicians in order to promote safe and confident practice (Royal Pharmaceutical Society, 2016).

There are three main legal mechanisms available to paramedics:

Exemptions

Practice Guidance for Paramedics for the Administration of Medicines under Exemptions within the Human Medicines Regulations 2012 (College of Paramedics, 2018)

Patient group directions (PGDs)

Patient Group Directions (National Institute for Health and Clinical Excellence, 2017)

Supplementary and independent prescribing

Practice Guidance for Paramedic Independent and Supplementary Prescribers (College of Paramedics, 2021).

There are other mechanisms which do not necessarily have specific legislation assigned to them but are also important to understand:

Administration of prescribed medicines. Anyone can administer a prescribed medication to the person it is prescribed for, with the exception of parenteral medicines. The Human Medicines Regulations 2012 (Section 214) outline that parental medicines can only be administered by an appropriate practitioner or a person acting under the directions of an appropriate practitioner, such as a parent administering insulin to their child under directions of their GP.

Patient specific directions.

Administration of non-prescription only medicine, using a protocol.

These additional methods of administering medicines are not covered in this book in detail, and any clinician (or associated professional) who is unsure should seek support from their employer’s medicines governance team to ensure legal practice with authorisation to use these methods in practice. Many of the oral medicines cited in ambulance service practice guidance are General Sales List (GSL) or Pharmacy items (P), which can be administered under an organisational protocol. Practice guidance is not a legal mechanism, and paramedics should seek to ensure that where practice guidance serves as a protocol, the organisational policies clearly state this.

Exemptions

Legal exemptions are stated in the Human Medicines Regulations 2012 and allow stated groups to operate otherwise than in accordance with the Medicines Act 1968. The use of exemptions varies between the different groups in terms of what is exempt. For example, podiatrists can sell and/or supply courses of medicines under an exemption, but paramedics may only administer. Importantly, in the paramedic-specific exemption in Schedule 17 to the Human Medicines Regulations 2012, there are the two following important statements:

The following prescription only medicines for parenteral administration [Box 12.1].

The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.

(Human Medicines Regulations 2012)

These limitations in the legislation cannot be overlooked. Paramedics cannot use alternative routes for administration of the medicines listed in Box 12.1 as these are all for parenteral use – for example, paracetamol cannot be given orally under this exemption, and neither can it be supplied under this exemption. Other legislation exists to support this; however, in the context of a paramedic being employed by an organisation, the authority and governance within that organisation may limit practice to specific areas of legislation or approved activity.

Box 12.1 Schedule 17 Medicines – the Human Medicines Regulations 2012

Diazepam 5 mg per mL emulsion for injection

Succinylated Modified Fluid Gelatin 4% intravenous infusion

Medicines containing the substance Ergometrine Maleate 500 mcg per mL with Oxytocin 5 iu per mL, but no other active ingredient

Prescription-only medicines (POMs) containing one or more of the following substances, but no other active ingredient:

Adrenaline acid tartrate

Adrenaline hydrochloride

Amiodarone

Anhydrous glucose

Benzylpenicillin

Compound sodium lactate intravenous infusion (Hartmann’s solution)

Ergometrine maleate

Furosemide

Glucose

Heparin sodium

Lidocaine hydrochloride

Metoclopramide

Morphine sulphate

Nalbuphine hydrochloride

Naloxone hydrochloride

Ondansetron

Paracetamol

Reteplase

Sodium chloride

Streptokinase

Tenecteplase.

Importantly, most of the medicines included in the list of exemptions are POMs, and of these some are Controlled Drugs (CDs).

The Misuse of Drugs Regulation 2001, the wider legislation that prevents medicines from being accessed illegally and/or abused, provides additional statuses for CDs, organising them into classes and schedules. While it is broadly legal to possess any POM (or P/GSL), it is illegal to possess certain schedules of CDs and the exemptions that facilitate paramedic practice include a group authority to possess the CDs listed (there is also specific allowance for certain CDs to be possessed using PGDs (see the section on PGDs later in this chapter). The CD classes (A, B and C) relate only to their legal use (and risk of misuse) and have no relation to their therapeutic use. The schedule of CDs relates to the access and safe custody requirements for CDs in healthcare practice. For example, Schedule 1 CDs cannot be used in practice except where there is a special licence issued to use the medicine for clinical trials or other similar application. Schedules 2 and 3 are where strong opioids and benzodiazepines are scheduled (among other medicines). Weaker, oral opioids (such as codeine) appear in Schedules 4 and 5 (depending on whether it is mixed with another medicine, such as co-codamol). Safe custody of all medicines, but particularly CDs, is vital in promoting ethical, legal and safe practice. CDs should be viewed with significant rigour, and the application of organisational policy and procedure must be observed in order to prevent loss and/or illicit use, noting that the employers’ authority may limit practice more than the full allowance in law (for example, the administering of Schedule 5 CDs (The Misuse of Drugs Regs 2001, Section 7 (1)).

Legal exemptions list only the medicines which are exempt, and do not include any information on dosing or other considerations. It is, however, worth noting that there is a significant difference between Schedule 17 and Schedule 19 with regards to the clinical indications for certain listed medicines, such as adrenaline for the treatment of anaphylaxis (this stipulation for adrenaline does not appear in Schedule 17). Therefore, any medicines used under an exemption must have an accompanying protocol, and clinicians using the medicines must be competent to use the medicines. There should be no presumption that because the medicine is listed as an exemption, this can or should be included in practice. Therefore, it should only be used where the clinician has been specifically trained to do so, or the employer has authorised administration, and an approved protocol can be followed.

There are two further schedules in the Human Medicines Regulations 2012 which provide exemptions that are relevant to paramedics: Part 3(9) of Schedule 17 (although this duplicates the medicines listed in Part 3(8) – the paramedic section) and Schedule 19. Schedule 19 lists a range of medicines that anyone can use in an emergency in order to save a life. This list duplicates many of the Schedule 17 medicines, but also includes anti-venoms and antidotes. The medicines in Schedule 19 can be administered by anyone. This is commonly utilised in ambulance trusts to allow these life-saving drugs to be given by patient-facing staff who are not paramedics (Box 12.2).

Exemptions are a useful method for ensuring that paramedics (and other authorised clinicians) can access medicines for immediate use in an emergency. Paramedics must ensure that they work within the confines of the law when using exemptions and must not deviate from the legislation. Practice guidance should always be followed to ensure that practice is safe and appropriate and pitfalls are avoided, such as supplying medicines in error.

Box 12.2 Schedule 19 Medicines – the Human Medicines Regulations 2012

Adrenaline 1:1000 up to 1 mg for intramuscular use in anaphylaxis

Atropine sulphate and obidoxime chloride injection

Atropine sulphate and pralidoxime chloride injection

Atropine sulphate injection

Atropine sulphate, pralidoxime mesilate and avizafone injection

Chlorphenamine injection

Dicobalt edetate injection

Glucagon injection

Glucose injection

Hydrocortisone injection

Naloxone hydrochloride

Pralidoxime chloride injection

Pralidoxime mesilate injection

Promethazine hydrochloride injection

Snake venom antiserum

Sodium nitrite injection

Sodium thiosulphate injection

Sterile pralidoxime

Requisition of Controlled Drugs

Paramedics are entitled to privately requisition for use in private practice all medicines in Schedule 17 of the Human Medicines Regulations 2012. This list includes morphine and diazepam, which are Schedule 2 and Schedule 4 CDs. In order for paramedics to requisition CDs they must (Rovardi, 2022):

Register with their local controlled drugs accountable officer (CDOA); this will typically be through the medicines management team at their local clinical commission group/health board/integrated care system.

Obtain a private CDs requisition/prescribing code.

The CDAO may request standard operating procedures for the purchase, recording, safe storage and disposal of the CDs. The College of Paramedics recommends this good practice should be followed by all paramedics even if not required.

Requisitions must be written on approved stationery only.

Paramedics must adhere to law regarding safe storage, recording and disposal of CDs.

Patient Group Directions

PGDs became a legal entity in 2000, following recommendations made by Dr June Crown in her report from 1989. The Crown Report (Department of Health, 1989) highlights gaps in care provision associated with access to medicines where prescribers are not available. PGDs are not in themselves a prescribing mechanism and are instead intended to treat patients who are not yet known to the clinician. Importantly, the word ‘group’ refers to a collection of patients who have a common disease process and can therefore be treated under a broad protocol – for example, patients over the age of 55 with a chest infection. Indication, dosage and routes of administration and/or method of supply are fixed in the protocol and allow only limited latitude to apply clinical judgement as to the suitability of patients to be treated using inclusion, exclusion and caution criteria.

PGDs are by their very nature prescriptive and cannot be deviated from. Clinicians who use PGDs must accept that their practice is confined by the limitations of the detail in the PGD, remembering also that PGDs (and exemptions) do not allow delegation of any related task, such as preparation and administration. Again, the clue is in the name – patient group direction. The group of patients at a population level who can be treated with antibiotics for a chest infection may not consider highly complex or unusual individual patient histories, underlying disease status, allergies or preferences. The temptation to deviate from the given conditions of a PGD in the interests of the patient must be avoided; if the patient does not belong to the group stated, they cannot be treated using the PGD and should be referred to a prescriber.

PGD are legally defined in Schedule 16 of the Human Medicines Regulations 2012. This section of the legislation details the purpose and scope of the use of PGDs, and which types of organisations may legally utilise PGDs. Only specified healthcare professionals can use PGDs, including paramedics, and these clinicians can use the PGD to possess, administer and/or supply certain medicines.

You should always ensure that you are legally permitted to use PGDs in relation to the type of organisation you are working for.

The Misuse of Drugs Regulations 2001 (Section 7) outlines that any drug specified in Schedule 2, 3 or 4 may be administered to a patient in accordance with the directions of a doctor (or dentist). It is through this mechanism that parenteral and non-parenteral CDs can be administered and/or supplied under PGD. While the legislation is broad, paramedics should keep in mind the difference between the breadth of what the law technically permits and what employers may authorise. It is also important to consider what actions they indemnify against and what they provide for their staff in terms of medicines. Employers who are legally allowed to use PGDs will by association be carrying out legally regulated activity – in this case healthcare – meaning that organisations such as the Care Quality Commission (CQC) will scrutinise adherence to regulatory standards as well as legal requirements. Medicines governance systems within healthcare providers need to consider devolved activity across the workforce and this means that, similar to the patient groups described in PGDs, staff are also grouped, and their authority limited accordingly. Indemnity may not cover clinicians who act outside of the limits of organisational authority hence the importance of understanding what the law may permit at its fullest extent versus the reality of practice as an employee within a governed system.

Unlike exemptions, which are universal, PGDs are organisationally specific and therefore care should be taken when working in different settings. The legal authority to use each PGD is derived from the signatories, and this cannot be done on behalf of another organisation (except where a specific contract or memorandum of understanding exists). This must be considered by paramedics who work across multiple organisations.

Another common error made with PGDs relates to the medicines provided as stock to supply to patients as a course of treatment. Medicines provided to be supplied as a course relate only to the PGD they are provided for. There is no mechanism for facilitating supply of medicines carried outside of a PGD, as even with a prescription from a doctor, the act of providing medicines in this way may be considered dispensing (particularly where the supply is repackaged), which can only be done by a pharmacist.

PGDs are extremely useful in paramedic practice settings and facilitate care for patients needing medicines to be supplied or administered. They are by their very nature restricted in their use, as suggested by the name of the mechanism, but this should not detract from their utility. There is considerable guidance on PGDs available in legislation, and from the Medicines and Healthcare products Regulatory Agency (MHRA, 2018) and the National Institute for Health and Clinical Excellence (NICE, 2017), and developing an understanding of this mechanism provides an excellent opportunity to enhance practice and to start developing practice towards prescribing.

Independent and Supplementary Prescribing

Non-medical prescribing began in the early 1990s, following recommendations made in the Cumberledge Report (Department of Health and Social Security, 1986), which suggested that limited formulary prescribing by district nurses would improve access to medicines for patients in the community. Prescribing was extended iteratively over the subsequent years, following the Crown Report written by Dr June Crown in 1989 (Department of Health, 1989), and this paved the way for non-medical prescribing being extended beyond nursing and pharmacists. In 2013, physiotherapy and podiatry achieved independent prescribing responsibilities, and radiographers achieved supplementary prescribing. In 2017, dietetics achieved supplementary prescribing and paramedics achieved independent prescribing in 2018.

Definitions of Independent and Supplementary Prescribing

Supplementary Prescribing

While its utility may be less relevant to paramedic practice, supplementary prescribing is not a ‘lesser’ mechanism compared to independent prescribing, and there are applications for its use. The basis of supplementary prescribing is that the patient has a clinical management plan prepared by a medical independent prescriber in which a list of medicines is provided and against which a supplementary prescriber can prescribe. Supplementary prescribers must therefore have an existing relationship with their patients, and these patients must have a diagnosis and treatment plan in place.

Independent Prescribing

Independent prescribing is prescribing by a practitioner who is responsible and accountable for the assessment of patients, and the planning of any treatments requiring the consideration of medicines. Prescribing practice may be seen in isolation as always inferring the addition of medicines to a patient’s treatment plan, but in reality, includes the decision to not prescribe and/or to de-prescribe, as well to prescribe.

Prescribing rarely involves the supply of medicines and introduces the process of dispensing medicines in the presence of a prescription by a pharmacist, which has significant safety benefits. The College of Paramedics, along with all other profession-specific professional bodies, provide practice guidance relating to prescribing. This document provides guidance on topics such as simultaneous prescribing and administration and simultaneous prescribing and supply, and serves to assist with balancing best practice with ensuring patients receive timely care (College of Paramedics, 2021). It is extremely important that paramedic prescribers understand the legal aspects of prescribing in their practice and how authority is derived, as well as the standards of practice that are required.

The law that informs the prescribing of medicines is the Medicines Act 1968. This piece of legislation is very well established and still provides the core tenets of medicines law in the UK. Subsequently, a range of regulations have been developed to help modernise care for patients, and the Human Medicines Regulations 2012 were developed to support the changes needed to facilitate non-medical medicines mechanisms. Specific to paramedics independent prescribing, the Human Medicines Regulations 2012 were subject to an amendment in 2018, which authorised the changes made to the overarching regulations using the ‘statutory instrument’ (meaning that the change in the law did not require debate in the Houses of Parliament).

The responsibility for authorising prescribing for individuals falls to the professional regulator, which for paramedics is the Health and Care Professions Council (HCPC). The HCPC validates education programmes for prescribers and ‘annotates’ the registration of those individuals who fulfil the criteria as a prescriber. Annotation is in effect the legal authority for practical prescribing in practice and is subject to the usual HCPC scrutiny. Annotation, like core registration, may be subject to conditions in the event of a fitness to practise concern. Also, individuals with prescribing annotations must continue to fulfil the requirements of annotation for their prescribing practice and must voluntarily remove their annotation should their role change and cease to include prescribing (HCPC, 2013).

Prescribing must be done in line with education, training, competency, supervision, audit and oversight. It requires a significant professional insight from the individual practitioner in order to ensure patient safety. Paramedic prescribing allows prescribing within the paramedic’s scope of practice from the whole of the British National Formulary (BNF, 2018) (with the exception of some CDs, cytotoxic drugs and specialist drugs).

The prescribing of CDs is subject to additional safeguards, requiring additional changes to the Misuse of Drugs Regulations 2001, which follow after the changes to the Human Medicines Regulations 2012 are made. The Advisory Council on the Misuse of Drugs was formed to oversee the main piece of CD legislation – the Misuse of Drugs Act 1971 – and is responsible for considering changes to arrangements for CDs in clinical care and other applications. Paramedics, common to all other allied health professional non-medical prescribers, have developed a short list of essential CDs that may be prescribed, and this is reflected within the Misuse of Drugs (Amendment) Regulations.

Independent and supplementary prescribing are the most significant medicines mechanisms that any healthcare professional can practise using, and responsibility associated with prescribing requires well-developed professional insight. One of the most challenging situations for prescribers, which differs from other mechanisms, is the autonomy to decide what and when to prescribe rather than following a protocol. The constant tension between legal, ethical and practical considerations in practice applies to all medicines mechanisms open to paramedics and highlights the trust in the profession by the establishment and patients.

Professional and Ethical Issues in Paramedics’ Medicines Practice

As with many aspects of practice, professional fluency and a clear understanding of what is being asked of the clinician are of vital importance. For paramedics, the range of medicines, legal mechanisms, practice settings, and of course patient variety and demand, mean that navigating the legal and professional issues is extremely complex. When an ethical perspective is added – particularly where complex judgement is required by prescribers – the challenge becomes even more extreme.

There are additional factors that should also be considered with all of the mechanisms within which paramedics practise using medicines, but particularly as our practice develops from exemptions, through PGDs and on to prescribing. These may be interpreted differently depending on the mechanism being used and are, to some degree, reliant upon the model of care and system which is being worked within, as well as the types of patients seen. While there are many more concepts, the three brief definitions given here demonstrate how medicines management is applicable across a range of ethical principles.

Rule-based (Evidence-based) Deontology

In its simplest form, deontology is the requirement to do the right thing (but does not assume doing things right). The duty-based effect of deontology may resonate closely with paramedics, particularly in the ambulance setting and when using medicines exemptions. Where protocols and clinical guidelines exist, this may infer a requirement towards action rather than a measured consideration to treat, and this may be justified by the linking of the duty aspects of rule-based care with the doing-to aspects.

Reductionism

Reductionism is the simplification of concepts; encompassing the most fundamental principles, it collectively accepts all of the detailed contributing aspects. For example, homeostasis could be considered a reductionist term as it just happens, and you could (if you so desired) ignore all of the anatomical and physiological processes which exist to maintain it. As reductionism seeks to simplify concepts and actions, this may infer a blanket approach to tasks and dilemmas, leaving little room for further judgement. Again, this works well with protocol-based models of care and target-led cultures, but may grate with those practising at higher levels, including prescribers.

Positivism

Positivism is a principle which places that which is proven (or provable), or is established in law, over metaphysical concepts (such as belief systems), essentially placing the rules over morality. Giving every patient with chest pain aspirin, regardless of the lack of cardiac-sounding history or signs, is an example of this. It may be wrong from a rule-based perspective but correct from a positivist standpoint – irrespective of the risks of giving aspirin without a true clinical indication. PGDs and exemptions-derived protocols are by their very nature positivist and leave no room for complex moral judgements in the presence of the patient being indicated for treatment.

While the subject of biomedical ethics extends significantly beyond the scope of this chapter, these examples may form an ethical baseline for clinicians to consider their ethical standpoint on medicines. The world of ethics in healthcare is rich in literature and evidence and is an area of expertise beyond the reach of most clinicians. Suffice to say that law and ethics exist closely, and in medicines-related practice they co-exist in a complex relationship.

You are an advanced paramedic working in a rural primary care setting. You have completed your independent prescribing course.

You see a 24-year-old patient who is home from university but has forgotten their medication for insomnia associated with anxiety. The patient is normally prescribed Lorazepam daily. They are really struggling without their medication, and during your consultation, they are jittery, paranoid and increasingly anxious. The patient has been trying to cope over the weekend, but has another two weeks at home before returning to university and their medication.

What ethical principles are at play here?

Can you prescribe the lorazepam as a repeat prescription?

Would any legislation be breached by your actions?

What risks might your actions create for the patient?

What are the potential consequences for you as a clinician?

Summary

Medicines legislation exists to ensure that the public can be treated safely and effectively with pharmaceutical therapeutic products, while controlling access to those medicines at a population level to guard against the risk of illicit use and criminality. Medicines legislation exists in two main groups: laws that control medicines for use on humans, and laws that control the possession of drugs and prevent misuse.

Paramedics may view legislation as restrictive and, in an age in which clinicians are ever more aware of the evidence base, may be tempted to practise outside legislative boundaries on the basis of promoting the best care for patients. Thinking back to the ethical principles discussed in Chapter 2: An Introduction to Ethics, doing the right thing for patients (beneficence) and preventing harmful things from happening (non-maleficence) is crucial in promoting safe care. The notion of justice is important too; practising to, but not beyond, the limit of legal authority means that patients can be treated appropriately and without paramedics putting themselves in professional and/or legal jeopardy.

A clear understanding of the legislation is essential in roles that include the autonomous use of medicines. This is particularly so for the paramedic profession, which has the privilege of being able to practise using all of the main mechanisms (depending on their seniority and training) – exemptions, PGDs, prescribing. The application of these mechanisms in practice requires consideration of the most appropriate mechanism to use, and avoidance of confusing or interchanging the approaches of each one. Primary education and ongoing professional development for paramedics should include a focus on medicines legislation and should also include other published guidance, such as practice guidance documents from professional bodies and other agencies (College of Paramedics, 2018, 2021; HCPC, 2016; Royal Pharmaceutical Society, 2016).

Recommended Reading

Blaber A, Morris H, Collen A (2018). Independent Prescribing for Paramedics. Bridgwater: Class Professional Publishing.

References

Allied Health Professions Federation (2018). Outline Curriculum Framework for Education Programmes. Available at: http://www.ahpf.org.uk/files/Joint%20OCF%202018%20update%20College%20of%20Paramedics%20March18%20minor%20error%20corrected.pdf (accessed 30 June 2023).

British National Formulary (BNF) (2018). British National Formulary. Available at: https://bnf.nice.org.uk (accessed 30 June 2023).

College of Paramedics (2018). Practice Guidance for Paramedics for the Administration of Medicines under Exemptions within the Human Medicines Regulations 2012. Available at: https://collegeofparamedics.co.uk/COP/News/practice_guidance_for_paramedic_supplementary_and_independent_prescribers.aspx (accessed 30 June 2023).

College of Paramedics (2021). Practice Guidance for Paramedic Independent and Supplementary Prescribers. Available at: https://collegeofparamedics.co.uk/COP/News/practice_guidance_for_paramedic_supplementary_and_independent_prescribers.aspx (accessed 30 June 2023).

Department of Health and Social Security (1986). Neighbourhood Nursing: A Focus for Care (Cumberledge Report). London: HMSO.

Department of Health (1989). Report of the Advisory Group on Nurse Prescribing (Crown Report). London: Department of Health.

Health and Care Professions Council (HCPC) (2013). Standards for Prescribing. Available at: https://www.hcpc-uk.org/resources/standards/standards-for-prescribing/ (accessed 30 June 2023).

Health and Care Professions Council (HCPC) (2016). Standards of Conduct, Performance and Ethics. Available at: https://www.hcpc-uk.org/standards/standards-of-conduct-performance-and-ethics/ (accessed 30 June 2023).

Kant (1948) [1785]. Grounding for the Metaphysics of Morals. Cambridge: Hackett.

Medicines and Healthcare products Regulatory Agency (MHRA) (2018). MHRA Available at: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (accessed 30 June 2023).

National Institute for Health and Clinical Excellence (NICE) (2017). Patient Group Directions. Available at: https://www.nice.org.uk/guidance/mpg2/resources (accessed 30 June 2023).

Royal Pharmaceutical Society (2016). A Competency Framework for All Prescribers. Available at: https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Professional%20standards/Prescribing%20competency%20framework/prescribing-competency- framework.pdf (accessed 30 June 2023).

Rovardi D (2022). Medicines and Medicine Management. Available at: https://collegeofparamedics.co.uk/COP/Professional_development/Medicines_and_Independent_Prescribing/COP/ProfessionalDevelopment/Medicines_and_Independent_Prescribing.aspx?hkey=04486919-f7b8-47bd-8d84-47bfc11d821a (accessed 30 June 2023).

Chapter 13

Law and Ethics of Palliative Medicine and End-of-Life Care

Tom Mallinson

You matter because you are you and you matter to the end of your life. We will do all we can not only to help you die peacefully, but also to live until you die

Dame Cicely Saunders – Founder of The Hospice Movement (2003)

Introduction

The specialty of palliative medicine concerns itself with the management of patients for whom the focus of care is the control and management of symptoms, rather than aiming for curative treatment. Such care is multi-dimensional, taking into account social, psychological and spiritual factors as well as physiological and medical issues. Palliative medicine is also a truly multi-professional field of medicine, which relies on the expertise not only of physicians, but also of nurses, physiotherapists, occupational therapists, social workers and psychologists (Saunders, 2003). Paramedics are increasingly becoming involved in end-of-life care decision making, whether working in hospital or in the community (Long, 2019; Lord et al., 2019; Anderson et al., 2021; Eaton-Williams et al., 2020).

Increasingly, the terms ‘palliative’ and ‘end-of-life care’ are being used to encompass not only patients in the last hours or days of life, but more widely to include patients with any advanced and progressive disease, where there is an acknowledgement that medical management will not lead to a curative outcome nor be able to reverse progressive frailty. This includes conditions such as heart failure, chronic obstructive pulmonary disease and dementia. It has been said that any health service can be judged by the quality of the end-of-life care it provides. A similar assertion could be made about paramedic practice, for although palliative care is only a small element of a paramedic’s traditional scope of practice, it is an important one and is an area in which there is little room for substandard care.

There is a wide range of documentation which may be used in the management of palliative patients. Much of this documentation will discuss the patient’s wishes in relation to their treatment and is about decision making in the event that they are unable to make further decisions themselves. While they retain capacity, patients are free to make decisions about their own care, including going against a clinician’s recommendation, making unwise decisions or the refusal of life-saving interventions (Moore, 2020). Some of the documentation relating to planning for the future is legally binding in nature; while some will contain advice, guidance and further information relating to the patient, their wishes and their medical conditions. Paramedics must be able to incorporate both sources of information into any management plan they formulate for (and with) a patient who is approaching the end of their life. Such plans allow us to continue to enact and respect patient wishes towards the end of their life, continuing Dame Cicely Saunders’ views on ensuring palliative patients are viewed as individuals who are valued until the very end of their lives.

Lasting Power of Attorney

England and Wales

A Lasting Power of Attorney (LPA) decision can be made by anyone over the age of 18. It involves nominating one or more individuals who will be enabled to make decisions on the patient’s behalf if or when they lack capacity at a future point in time (they are donating this ability). There are two different types of LPA: LPA for health and welfare and LPA for property and financial affairs. This chapter will only cover LPA for health and welfare, also known as personal welfare (LPA-PW). These attorneys can make decisions when a person lacks capacity to make a specific welfare decision, although the person may put restrictions on the decisions that the LPA-PW can make (Office of the Public Guardian, 2018).

In cases where the patient lacks capacity, if they have an LPA-PW, this attorney should be contacted, where practicable, to advise on any healthcare decision made for that patient. The decisions made by the attorney must still be guided by the principles of the Mental Capacity Act 2005, the 2019 amendment and the best interests test (Section 4(a)). If there is more than one person appointed as LPA-PW, then the document may state whether they are to come to a decision together, whether they may make a decision independently or whether they must make some decisions together and may make others independently (Section 10(4)). This means that they must work together on all matters either jointly and severally where they can act together, or separately as they subsequently choose. It could also be specified that the attorneys must act jointly for certain decisions; these may be specifically important or difficult decisions. Replacement attorneys can also be nominated in cases where an attorney dies or becomes incapacitated themselves. If it is not stated on the document, the default presumption is that they must make decisions jointly (Section 10(5)).

While an LPA gives the attorney the power to make decisions on behalf of the patient in relation to certain matters, the attorney must still make such decisions in the patient’s best interests. This includes giving due consideration to the patient’s beliefs and decisions as expressed prior to losing their capacity. The attorney must also register the LPA with the Public Guardian in order for it to be valid.

Northern Ireland

The Mental Capacity Act (Northern Ireland) 2016 sets out a statutory provision for decision making on behalf of people who do not have capacity. Furthermore, the Enduring Power of Attorney (NI) Order 1987 makes provision for individuals with capacity to allow a second individual to have an Enduring Power of Attorney in relation to decisions made about their care, if or when they lose capacity in the future. An Enduring Power of Attorney can give two forms of authority: a general authority and a specific authority. A general authority allows for any decisions to be made on behalf of the incapacitated individual, while a specific authority has restrictions or conditions applied to the scope of such decision making.

Scotland

In Scotland, the Adults with Incapacity (Scotland) Act 2000 applies to those over the age of 16 who have capacity to appoint a welfare attorney to make decisions on their behalf once they lose the capacity to make these decisions for themselves. There is also provision in Scottish law for a Sheriff to appoint a welfare guardian for individuals who do not have capacity to choose their own welfare attorney (Scottish Government, 2011).

Advance Directives

Advance Decisions to Refuse Treatment

Advance Decisions to Refuse Treatment (ADRTs) enable adults with capacity to refuse specific medical interventions for a time in the future when they lack capacity. In England and Wales, this is covered by the Mental Capacity Act 2005. In Northern Ireland, an ADRT is recognised under common law, and while there is currently no statutory provision for ADRTs, there is statutory recognition of them. More specifically, the Mental Capacity Act (Northern Ireland) 2016 requires that an advance decision should be complied with, if it is valid and applicable under common law. There is a similar situation in Scotland, where the Adults with Incapacity (Scotland) Act 2000 instructs that account must be taken of the past wishes of an adult patient, but does not provide further statutory enforcement of such documents.

An ADRT comes into effect only when the person lacks capacity and the decision that is being made is one to which the ADRT pertains. They are normally very precise in nature, for example, refusing artificial ventilation or another specific type of life-sustaining treatment. Sometimes an ADRT may be particularly complex or there may be concerns about its contents or validity (Amblum-Almer, 2016). If there is dispute or doubt about the validity of an ADRT in an emergency setting, then the paramedic should document why they are in doubt about the validity of the document and should continue to follow their normal best interests decision-making processes, and the receiving hospital should be alerted to the validity concerns as soon as is practicable to do so.

Such a case may need to be referred to the Court of Protection. While the Court makes its determination, life-sustaining treatment, or treatment to prevent a serious deterioration in the patient’s condition, may continue (Mental Capacity Act 2005).

Where a patient suffering a mental disorder has a valid ADRT, it may be appropriate to detain (‘section’) the patient in order to provide treatment under the powers of the Mental Health Act 1983. Further information about this is available in Chapter 11: Legislation relating to Mental Health.

It is important to note that even if an ADRT is in place, this may be invalidated if the patient has elected another individual to hold an LPA (for personal welfare) and has given this individual the power to make the same decision as that documented in the ADRT. In this case, the decision-making ability relating to this issue has passed to the attorney and has therefore invalidated the ADRT, although the attorney would still be expected to advocate for the patient’s prior expressed wishes. An ADRT is also invalid if it has been withdrawn and may be invalid if the patient has acted in a way that is clearly inconsistent with the ADRT (Mental Capacity Act 2005), thus demonstrating that their beliefs or feelings may have altered since the ADRT was written.

An ADRT can be both verbal and written; however, for life-sustaining treatment, it must meet the criteria set out by the Mental Capacity Act 2005 and must be made by a capacitous person over the age of 18, in writing, be signed by the person making the decision (or by another person on that person’s behalf) and also be signed by a witness. ADRTs for life-sustaining treatment can be recorded as a specific document or within healthcare notes. The statement must also be clear that the decision made is still valid even when or if their life is at risk. ADRTs do not need to be written with the input of a solicitor and they do not need to be documented in any formal way above what is set out in the Mental Capacity Act 2005. They may also be written in layman’s terms. Once signed, they form a legally binding document and any person who knowingly treats a patient against the ADRT could be found guilty of the tort of battery.

There are a number of reasons why a healthcare professional may have reason to doubt whether an ADRT is valid (Amblum-Almer, 2016). Core issues that may lead to questioning the validity of an ADRT may include if the patient has acted in a manner which clearly contradicts the ADRT, if the patient has directly withdrawn their decision or if the patient has subsequently conferred the power of attorney to another individual.

If a healthcare professional concludes that the ADRT is not valid for a specific reason, it may still be taken into consideration as a prior expression of the patient’s wishes at a point in the past, even if it does not have current legal authority.

ReSPECT Forms

ReSPECT stands for Recommended Summary Plan for Emergency Care and Treatment, and it is both a process (of gaining and clarifying information) and a form for documenting such material (Resuscitation Council UK, 2020). The ReSPECT initiative was developed by a multi-disciplinary team, including representatives of various royal colleges, associations and patient groups, and is now being widely adopted across the United Kingdom (UK) (Perkins and Fritz, 2019). The ReSPECT forms are designed to be an easy-to-access reference form providing a summary of recommendations in the event of an emergency situation. These recommendations will either be based upon the patient’s stated wishes or, for patients who lack capacity, the views of either their legal proxy or close family members in relation to what they feel the patient would have wanted.

ReSPECT forms are designed to be kept with the patient at all times for easy access and reference. ReSPECT forms will contain valuable information to inform the clinical decision-making process of paramedics, including a recommendation relating to resuscitation attempts. The same form can be used for both adult and paediatric patients. It is important to remember that the ReSPECT process is not only used at the end of life, and the presence of such a form does not imply a patient is in a palliative stage of their journey. In this regard, a ReSPECT form is far more nuanced, and provides guidance in relation to the patient’s transition from wanting treatments aimed at curing or treating disease and interventions aimed at symptom control and those prioritising comfort. A ReSPECT form is not legally binding and does not necessarily replace or supersede other related documentation, such as a DNACPR or Treatment Escalation Plan. An example of a ReSPECT form is in Appendix A.

DNACPR

The terminology used in relation to advance decisions relating to resuscitation is important and continues to evolve. Historically, the term ‘Do Not Resuscitate’ (DNR) was superseded by ‘Do Not Attempt Resuscitation’ (DNAR). However, the term ‘resuscitation’ is recognised as a broad one, encompassing a wide array of treatments (such as intravenous fluid therapy); therefore, such terms have now largely been replaced by ‘Do Not Attempt Cardiopulmonary Resuscitation’ (DNACPR) or ‘Allow Natural Death’ decision documents, which relate specifically to chest compressions, positive pressure ventilation and defibrillation (British Medical Association, Resuscitation Council UK and the Royal College of Nursing (BMA, RCUK and RCN), 2016). There has also been a move away from referring to such documents as ‘orders’, as they are intended to guide treatment decisions in a crisis situation, much like the ReSPECT forms, with neither form being legally binding in the UK, unlike an ADRT (Pitcher et al., 2017). It is vital to acknowledge that a patient with a DNACPR in place may still benefit from a degree of active treatment if not full resuscitation efforts, and that a DNACPR does not mean do not treat. To this end, it may be better practice to refer to such documents as CPR decision documents. Paramedics are increasingly becoming involved in the care of patients with DNACPR forms in place, and it is vital that they are confident incorporating these forms into their clinical practice (Armitage and Jones, 2017; Moffat et al., 2019), and in many situations paramedics are the ones completing such forms for patients. While a DNACPR form may initially be completed by any competent healthcare professional, it is good practice to have it counter-signed by the senior clinician responsible for a patient’s care, this usually being a consultant grade doctor or general practitioner.

DNACPR forms may be completed for a number of reasons with some presented in Box 13.1, and such a decision is usually supported by a medical history of a progressive incurable illness or current and worsening frailty. Advanced age alone is usually insufficient to justify a DNACPR decision, apart from in the very extremes of old age. A DNACPR form may be completed as a result of a patient’s request even without such medical history, but this would be unusual. Such a request would likely prompt further investigation into the patient’s motivations behind such a request.

In some cases, a DNACPR form may be completed for a patient without their knowledge, for example, if they are acutely unwell or lack capacity. In such cases, the decision to withhold resuscitation should be discussed with the patient at the earliest opportunity, so long as doing so does not lead to the patient experiencing physical or emotional harm (BMA, RCUK and RCN, 2016; General Medical Council (GMC), 2020). If such discussions are avoided or delayed for this reason, this must be clearly documented. Capacitous patients may grant permission for such conversations to occur with their family or friends, even if they do not want to be involved themselves. For patients lacking capacity, you should inform their legal proxy or those close to them about the decision as soon as practicable (BMA, RCUK and RCN, 2016; GMC, 2020). In some cases, other barriers to effective communication may be present, whether these are language barriers or more nuanced cultural or religious differences. Such cases will call upon the clinician to develop and demonstrate a high level of cultural intelligence, which is often developed after practising for some time in a certain region or with specific social groups. A direct approach of asking the patient or their family to help you understand their beliefs and decisions can be extremely helpful, as can seeking assistance from other sources of support, such as chaplaincy services and cultural support workers (Islam, Taylor and Faull, 2021).

An example DNACPR form is included for reference at the end of the chapter (Appendix B). Such forms should be clear, concise and easily recognisable (and ideally printed in colour).

The decision of whether or not to offer or initiate a specific clinical intervention (in this case cardiopulmonary resuscitation) rests with the clinician responsible for the patient’s care. Therefore, there may be rare occasions where the attending clinician makes the decision to initiate CPR when a DNACPR decision form is in place. In such a situation, the clinician would be expected to adequately justify this decision, in the same way as any other clinical decision. The two most common reasons for undertaking CPR in such situations would be if the cardiac arrest was due to an unforeseen event, leading to circumstances not envisaged when the DNACPR form was completed, or in cases where a DNACPR decision was temporarily suspended. An example of such a situation would be a patient with a progressive neurological disease and a tracheostomy. Such a patient may have a DNACPR in place to ensure that CPR was not undertaken in the anticipated case of future disease progression leading to cardiac arrest. However, CPR may still be appropriate to resuscitate the individual from a blocked or dislodged tracheal tube. A DNACPR decision may also be suspended temporarily, such as for a patient undergoing a planned procedure, such as cardioversion, which carries the risk of inducing cardiac arrest, and where resuscitation would be immediately available. DNACPR decisions are also often suspended for patients undergoing general anaesthesia for surgery. Some DNACPR forms may also have specific instructions or a specific duration, and the presence of such a form should not preclude all aspects of resuscitation without reading its contents in detail.

Box 13.1 Reasons for a DNACPR form to be completed.

The patient does not wish to be resuscitated.

CPR will not be successful and is not a treatment option for this patient.

CPR may be successful but has been judged to not be of overall benefit to the patient.

You are working in a semi-rural area on a single-crew response car for the ambulance service. You are called to the home of a 28-year-old patient; you have attended this address on previous occasions when the patient’s carers have phoned 999 due to various concerns. You recall that the patient suffered a motorcycle accident around four years ago which has left them quadriplegic and reliant on a ventilator. You are aware that the patient has a DNACPR form in place and that a copy is kept in a folder by their bed. The form is filled out appropriately and has not expired.

This form was completed after the patient experienced a respiratory arrest secondary to pneumonia and was admitted to hospital for a prolonged period of time, requiring Level 3 (intensive care) support. After this episode, the patient requested that a DNACPR form was put in place in case they experienced another respiratory arrest. They do not have any other advance decision documentation and have not appointed a power of attorney.

Today the carers have phoned 999 because the patient has suffered a respiratory arrest due to mechanical failure of their ventilator. On your arrival, one carer is ventilating the patient with a self-inflating ambu-bag, using room air via the patient’s tracheostomy tube. Good air entry is being achieved and the patient’s chest is clear on auscultation with equal air entry and no added sounds. The patient has a weak irregular radial pulse. Their vital signs are: SpO2: 93%; HR: 40–50 irregular with multiple ventricular ectopics; BP: 81/33 mmHg. Capillary refill is 3 seconds centrally, but 6 seconds peripherally. The patient is unresponsive to painful stimuli.

You suspect the patient is peri-arrest due to a period of apnoea and subsequent cerebral hypoxia. You review the DNACPR and note that it is still valid and in date. The form indicates that ‘CPR could be successful but the likely outcome would not be of overall benefit to the patient. The patient does not want CPR to be attempted’. The form is signed by a specialist paramedic in primary care and counter-signed by the patient’s mother and their GP. The form indicates that all three have witnessed the patient express this opinion.

As you finish reviewing the DNACPR form, your monitor alerts you to the fact that the patient’s heart rate is dropping significantly and is now between 30 and 40 beats per minute with a blood pressure of 75/30. The patient is still unresponsive.

What Is the Best Course of Action Here?

At this stage, the patient is not in cardiac arrest and therefore the DNACPR is not directly applicable; consequently, the patient could have their lower airways suctioned via the tracheostomy and be ventilated with 100% oxygen. Furthermore, you could gain intravascular access and administer atropine to correct their heart rate and inotropes or vasopressors to improve their blood pressure if this is within your skill set.

If the patient went into cardiac arrest now, two options are open to you: accept the patient’s wishes expressed on the DNACPR form and withhold resuscitation; or while acknowledging that a DNACPR form is in place, you could consider that the cause of this arrest was unforeseen at the time of completing the DNACPR form and therefore it is not applicable in this situation, and thus undertake resuscitation. As discussed previously, a DNACPR form is not legally binding, but does provide information about the patient’s prior wishes. In this case, you must be able to defend your decision, whether you choose to withhold or commence CPR. The defence for undertaking CPR in this case would be that the mechanical fault with the ventilator was an unanticipated occurrence that was not envisaged when the DNACPR form was completed.

What would you do in this situation?

Ethical Considerations

Clinicians delivering palliative care encounter a wide range of ethical dilemmas. While many of these involve clinical issues (the core principles of which are discussed here), such predicaments may include broader ethical challenges, such as navigating organisational policies, tackling resource allocation or navigating inter-professional conflicts (Schofield et al., 2021). The core principles underpinning healthcare ethics are usually stated as non-maleficence (causing no harm), beneficence (causing benefit), respect for the patient’s autonomy (to think and act independently, without external hinderance) and justice (utility or fairness in a broader sense) (Parkinson, 2015). An outline of the different ethical positions is given in Chapter 2: An Introduction to Ethics. While these are theoretical ethical building blocks, they can be directly applied to clinical dilemmas and may be a helpful aid to decision making.

An example could be as follows: an elderly patient reaching the end of their life due to severe emphysema is in the last days of life and is semi-conscious. The family have called 999 and have requested that the attending paramedic provide intravenous fluid therapy to the patient. In deciding whether this is an ethical intervention, the paramedic could first consider if the parenteral fluids could cause harm to the patient (maleficence), if they would benefit the patient (beneficence) and whether providing this intervention respects the patient’s autonomy, before, finally, considering if providing this intervention to this patient is fair and just.

In terms of non-maleficence, there is harm involved here. Actual and possible harm is associated with this intervention: there is the direct harm associated with a needle piercing skin and a blood vessel, the risk of unintended injury from this needle or associated healthcare associated infection, or iatrogenic fluid overload. There may also be other harms that are less clearly foreseeable, both physical and psychological. In terms of beneficence, it is unclear if intravenous fluids would benefit this patient either by improving symptoms or extending life; however, it may be that this patient is semi-conscious due to an easily reversible cause such as hypovolaemia, which could be addressed with intravenous fluids. When considering this intervention in relation to respect for the patient’s autonomy, the paramedic would need to know what the patient’s stated wishes had been before they lost the capacity for decision making, and advance directives and documents such as the ReSPECT form could be helpful in this regard (RC UK, 2020). Information from those who knew the patient before they lost capacity can also provide an insight into the patient’s wishes here.

While these four principles are the basis for all healthcare ethics, there are a number of other core concepts that are central to healthcare ethics in relation to end-of-life and palliative medicine. These concepts can directly or indirectly influence the decision-making process of a paramedic attending a patient with palliative care needs. Furthermore, palliative care is acknowledged as an ethically complex area of medical practice, and many issues faced by clinicians will be unique challenges requiring a thoughtful approach and joint decision making with the patient, those close to them, and other professionals (Schofield et al., 2021).

You are working on a single-crewed ambulance response car in a rural area. You are called in the early hours of the morning to a patient you know well, a 66-year-old who has end-stage chronic obstructive pulmonary disease (COPD). The patient phoned 999, but was unable to speak due to breathlessness. On your arrival, the patient is breathless, tachypnoeic and distressed; they have a DNACPR document and an advance care plan, which details their refusal to be conveyed to hospital under any circumstances. The patient has prescribed palliative medications in a ‘just in case’ box in their home. After you administer two doses of subcutaneous morphine, the patient’s respiratory embarrassment improves, but they are still upset and do not want to be left alone. You have arranged the out-of-hours palliative care specialist nurse to attend, but they will take around 40 minutes to arrive. You feel the patient is likely to die within hours. You are also aware that multiple high-priority 999 calls are being held in your area and the next nearest resource is at least an hour away.

What Would You Do in This Situation?

The patient is requesting that you stay and provide reassurance, although no further medical input is currently required. The patient does not want to be conveyed to hospital and a specialist has been arranged. In terms of providing patient-centred care, you should not leave this patient until they are either less distressed or someone else arrives to comfort them. Many clinicians would also argue strongly that this patient should not die alone and would feel uneasy about leaving them alone at home. However, taking a wider utilitarian stance, it could be argued that in terms of upholding beneficence and justice at a societal level, your time and skills would be best used by attending to another emergency call and leaving this patient alone at home. This is a difficult situation and one where a clinician’s duty of care to their patient is to some extent in conflict with their wider duty of care to society, and certainly their employer’s duty of care to a larger population. There is no easy answer here.

The Principle of Double Effect

A core ethical consideration for paramedics providing treatments to patients nearing the end of their life is the principle of double effect (Billings, 2011; Shaw, 2002). This is where it is accepted that a specific treatment given for one desired effect may also cause a second, less desirable effect. The most common example of this is giving a strong analgesic in the knowledge that it will depress cardiorespiratory function and shorten someone’s life. Such an action is deemed to be morally, and likely legally, acceptable when such an action adheres to three rules: first, this is only acceptable for a patient who is already dying; second, the intervention must be right and proper professional practice; and third, the motive for such an intervention must be to improve symptoms and not to shorten life.

The Sulmasy Test

Dr Sulmasy (1996) has posited a test to allow clinicians to assess what their intention really is. The clinician should ask themselves:

‘If the patient were not to die after my actions, would I feel that I had failed to accomplish what I had set out to do?’

One could of course argue against any of these three rules. For example, a consequentialist ethicist may argue that the morality of any act is dependent on the outcome caused, and therefore even if your motive was to improve symptom burden (as in rule three), if your action also caused a patient’s life to end prematurely, this could be judged to be an immoral act, as it resulted in an early death. It could also be argued that someone’s motive for an action does not change whether such an action is intrinsically right or wrong, making rule three unhelpful.

The theory of Divergence of Care (Figure 13.1) is one way to discuss this difficult concept in relation to discussing management decisions near the end of life with both patients and their families. In clinical medicine we often walk the line between focussing on the curative treatment of disease, often entailing invasive or uncomfortable treatments or investigations and a palliative approach, where the focus is on the relief of symptoms and distress, often at the expense of fully investigating a pathology or attempting to cure a disease or disorder.

Figure 13.1 Divergence of care.

Euthanasia

Euthanasia and physician-assisted suicide are not legal in the UK (NHS Choices, 2020; RCN, 2016), although support for euthanasia may be growing (Danyliv and O’Neill, 2015; Davis, 2018). An argument to legalise euthanasia could be based on the ethical principle of autonomy, arguing that an individual should have the autonomy to choose the time and manner of their death. This is commonly referred to as the ‘right to die’ principle (Young, 2017). This perspective becomes further complicated when we utilise any specific ethical model; Kantian ethics, for example, traditionally conclude that murder and suicide are moral wrongs, and it is therefore often extrapolated that euthanasia is also wrong (Brassington, 2006). However, Kantian ethics are also strongly supportive of an individual’s autonomy, which would support the option of euthanasia with some ethicists going so far as stating that Kantian ethics would create a duty to die, for those with impending debilitating diseases (Cooley, 2007; Cholbi, 2014).

The counter-arguments to euthanasia are also many and complex. One of the core opposing positions being the principle of the sanctity of life (Singer, 2018), which states that all human life is sacred and intrinsically special. This argument is closely aligned with some religious philosophies and is also often used to argue against contraception and abortion. Another argument is that euthanasia seeks to place value on people’s lives and furthermore assigns a lesser value to some lives (the sick, frail or disabled) than others (the young and healthy). It has also been argued that once legalised, euthanasia would create a slippery slope, leading to involuntary or coercive euthanasia (Lewis, 2007). A more practical argument is that with advances in modern palliative care, euthanasia should not be needed, as symptoms can be controlled fully, allowing people to be comfortable in the time leading up to their death.

There is, unfortunately, also often confusion about what is and is not euthanasia. It is important as a clinician to be clear as to what acts or omissions are not euthanasia. The act of sedation at the end of life to control distressing symptoms is not euthanasia, nor is the discontinuation of life-prolonging interventions (for example parenteral nutrition, hydration or ventilation), where such interventions are futile. Issuing a DNACPR, terminating resuscitation or not starting resuscitation where it would be futile are also not forms of euthanasia.

The Acts/Omissions Doctrine

This doctrine determines the ethical difference of whether a person actively intervenes to bring about a result, or omits to act in circumstances in which it can be foreseen that as an outcome of the omission, the same result occurs (Huxtable, 2020). This doctrine is most often applied to discussions around euthanasia. Suppose someone wishes another person dead. If they bring about this person’s death, they are a murderer. But if they discover this person is in danger of death and fail to act to save them, they are not acting and therefore, according to the doctrine, are not a murderer. ‘Doing nothing’ can be a way of ‘doing something’. The absence of bodily movement can also constitute acting deliberately, and depending on the context may be an act of negligence through deceiving, betraying or killing. Nevertheless, criminal law often finds it useful to distinguish discontinuing an intervention, which is permissible, from acting to bring about a result, which may not be if, for instance, the result is the death of a patient. The question is whether the difference (if there is one) between acting and omission, can be described or defined in a way that bears any clear moral weight.

The trolley problem was highlighted in Chapter 2: An Introduction to Ethics and is an example of the acts/omissions doctrine. The situation is structurally similar to others in which utilitarian reasoning seems to lead to one course of action, but a person’s values or principles may oppose it. Some hold that there is no morally significant difference between the two; therefore, occasions may arise when killing a person may be no less bad or wrong than letting the person die.

You are undertaking a lunchtime home visit to a 65-year-old patient with dyspnoea. On your arrival, the patient is in severe respiratory distress and has central cyanosis. They are sarcopenic and appear exhausted; they gesture to a letter by the bed, which is from their consultant detailing a diagnosis of metastatic carcinomatosis made a year ago. Between laboured breaths the patient manages to tell you that they do not want to go to hospital and just want to die at home. They ask you to stop their suffering and end their life.

Euthanasia and assisted suicide are illegal in the UK, so you cannot actively end the patient’s life. It is, of course, still legal to treat them by providing symptomatic relief. However, taking them to hospital would be against their wishes and therefore inappropriate, likely illegal and in breach of the ethical concept of autonomy. If treatment were to be provided to ease the patient’s breathlessness, for example, through the use of opioids, such treatment would likely dramatically shorten their life. This may be acceptable when giving consideration to the principle of double effect – if the three rules of this principle are met, as discussed previously.

This patient does not appear to have made an advance directive and there is no DNACPR form that you can find.

How would you treat the patient’s breathlessness?

How would you feel if the patient stopped breathing soon after you had administered treatment for breathlessness?

What would you do if this patient went into respiratory or cardiac arrest?

From this case study, it appears that this patient would benefit from treatment aimed at improving their symptoms. Currently, morphine is the most widely available appropriate drug that can be carried by paramedics for this indication (fentanyl or diamorphine could also be appropriate). Oxygen therapy may also be considered and may improve symptoms in patients where hypoxaemia is a problem – most commonly, a target oxygen saturation of 88–90% is utilised. In a case such as this, although opiate doses will usually be started low and subsequently increased, it may be the case that any initial dose could lead to significant respiratory depression, hypercapnia and possibly apnoea. If so, this would be a clear example of the principle of double effect, where the intention was to improve symptoms and an unwanted effect was to hasten death. It is important to fully understand this concept to ensure you are practicing safely and legally, but also for your own peace of mind in such situations. If this patient were to suffer a cardiac arrest, it would most likely be inappropriate to commence resuscitation. This patient has a clear history of a progressive, terminal illness, appears to be in their last days (or hours) of life and it is unlikely that any resuscitation attempt would be successful or appropriate.

Recognition of Death

It is worth noting that in English law, any competent adult can recognise death, and delaying such recognition may be an understandable source of distress for bystanders, rescuers and any friends or family in attendance. There has also been specific provision for ambulance personnel undertaking formal recognition of death for a number of years (Baskett, Fisher and Marsden, 1996). More recently, the RCN (2020) has clarified that competent nurses are able to verify both expected and unexpected deaths in adults. With paramedics increasingly working in areas of practice away from their traditional ambulance service roles, it may be helpful to align paramedic practice in verifying death to that recommended to our medical colleagues, and fortunately the Academy of Medical Royal Colleges (2008) has provided a clear guide concerning what is expected when death is verified. Certification of death (completing a medical certificate of cause of death), on the other hand, is a procedure which can currently only be undertaken by registered medical practitioners.

Summary

The current law surrounding death and dying in the UK is complex and ever-changing. It is important for paramedics to have a good grounding in the concepts involved and also to know how to stay up to date with new developments. The same can be said for the ethical concepts involved in end-of-life decision making. Although some ethical principles have stood the test of time, there are constantly discussions and developments in the field of medical ethics.

When discussing the multifaceted nature of pain in palliative care Dame Cicely Saunders coined the term ‘staff pain’ to explain the effects of prolonged or repeated exposure to the suffering of dying patients and their families on clinical staff. In today’s parlance we might discuss the same issue using the terms burnout or complex post-traumatic stress disorder. No matter what terminology is used, it is imperative to remember that providing care to dying or distressed patients can be emotionally draining, and it is vital to recognise the potential impact of this on your mental health and well-being, as well as that of your colleagues.

Recommended Reading

Ashcroft RE et al. (eds) (2007). Principles of Health Care Ethics. 2nd edn. Chichester: Wiley-Blackwell.

Bauby J (1997). The Diving-bell and the Butterfly. London: Harper-Perennial.

Brazier M and Cave E (2016). Medicine, Patients and the Law. 6th edn. Oxford: Oxford University Press.

Randall F and Downie RS (2002). Palliative Care Ethics: A Companion for all Specialities. 2nd edn. Oxford: Oxford University Press.

Watson M et al. (2005). Oxford Handbook of Palliative Care. 2nd edn. Oxford: Oxford Medical Publications.

References

Academy of Medical Royal Colleges (2008). A Code of Practice for the Diagnosis and Confirmation of Death. Available at: https://aomrc.org.uk/wp-content/uploads/2016/04/Code_Practice_Confirmation_Diagnosis_Death_1008-4.pdf (accessed 30 June 2023).

Amblum-Almer J (2016). Critical evaluation of advance statements from patients lacking mental capacity. Journal of Paramedic Practice, 8(9): 463–469.

Anderson NE et al. (2021). Paramedic care of the dying, deceased and bereaved in Aotearoa, New Zealand. Progress in Palliative Care, 29(2): 84–90.

Armitage E and Jones C (2017). Paramedic attitudes towards DNACPR orders. Journal of Paramedic Practice, 9(10): 445–452.

Baskett P, Fisher J and Marsden A (1996). Recognition of death by ambulance personnel. Joint Royal Colleges Ambulance Liaison Committee Newsletter. 1.

Billings JA (2011). Double effect: A useful rule that alone cannot justify hastening death. Journal of Medical Ethics, 37(7): 437–440.

Brassington I (2006). Killing people: What Kant could have said about suicide and euthanasia but did not. Journal of Medical Ethics, 32(10): 571–574.

British Medical Association, Resuscitation Council UK and the Royal College of Nursing (BMA, RCUK and RCN) (2016). Decisions Relating to Cardiopulmonary Resuscitation: Guidance from the British Medical Association, the Resuscitation Council (UK) and the Royal College of Nursing. 3rd edn, 1st rev. Available at: https://www.resus.org.uk/library/publications/publication-decisions-relating-cardiopulmonary (accessed 30 June 2023).

Cholbi M (2014). Kant on euthanasia and the duty to die: Clearing the air. Journal of Medical Ethics, 41(8): 1–4.

Cooley D (2007). A Kantian moral duty for the soon-to-be demented to commit suicide. American Journal of Bioethics, 7(6): 37–44.

Danyliv A and O’Neill C (2015). Attitudes towards legalising physician provided euthanasia in Britain: the role of religion over time. Social Science & Medicine, 128: 52–56.

Davis J (2018). Most UK doctors support assisted dying, a new poll shows: The BMA’s opposition does not represent members. British Medical Journal, 360: k301–302.

Eaton-Williams P et al. (2020). A national survey of ambulance paramedics on the identification of patients with end of life care needs. British Paramedic Journal, 5(3), 8–14.

General Medical Council (GMC) (2020). Treatment and Care Towards the End of Life: Good Practice in Decision Making. Manchester: GMC.

Huxtable R (2020). On killing and letting die, acts and omissions: For and against the distinctions. In Contemporary European Perspectives on the Ethics of End of Life Care, Emmerich N et al. (eds), Cham: Springer, pp. 229–241.

Islam Z, Taylor L and Faull C (2021). Thinking ahead in advanced illness: Exploring clinicians’ perspectives on discussing resuscitation with patients and families from ethnic minority communities. Future Healthcare Journal, 8(3): 1–6.

Lewis P (2007). The empirical slippery slope from voluntary to non-voluntary euthanasia. Journal of Law, Medicine & Ethics, 35(1): 197–210.

Long D (2019). Paramedic delivery of community-based palliative care: An overlooked resource? Progress in Palliative Care, 27(6): 289–290.

Lord B et al. (2019). Palliative care in paramedic practice: A retrospective cohort study. Palliative Medicine, 33(4): 445–451.

Moffat S et al. (2019). ‘Do not attempt CPR’ in the community: The experience of ambulance clinicians. Journal of Paramedic Practice, 11(5): 198–204.

Moore E (2020). Respecting an autonomous decision to refuse life-saving treatment: A case study. Journal of Paramedic Practice, 12(8): 304–309.

NHS Choices (2020). Euthanasia and assisted suicide. Available at: https://www.nhs.uk/conditions/euthanasia-and-assisted-suicide/ (accessed 30 June 2023).

Office of the Public Guardian (2018). LPA for financial decisions: Make and register (complete pack). Available at: https://www.gov.uk/government/publications/make-a-lasting-power-of-attorney (accessed 30 June 2023).

Parkinson M (2015). Pain: Highlighting the law and ethics of pain relief in end-of-life patients. Journal of Paramedic Practice, 7(7): 344–349.

Perkins GD, Fritz Z (2019). Time to change from do-not-resuscitate orders to emergency care treatment plans. JAMA Network Open, 2(6): e195170.

Pitcher D et al. (2017). Emergency care and resuscitation plans. British Medical Journal, 356: j876.

Resuscitation Council UK (RCUK) (2020). ReSPECT. Available at: https://www.resus.org.uk/respect (accessed 30 June 2023).

Royal College of Nursing (RCN) (2016). When Someone Asks for Your Assistance to Die, 2nd ed. London: Royal College of Nurses.

Royal College of Nursing (RCN) (2020). Special Edition of Care After Death: Registered Nurse Verification of Expected Adult Death (RNVoEAD) Guidance. London: Hospice UK.

Saunders C (2003). Watch with me: Inspiration for a life in hospice care. Lancaster: Observatory Publications.

Schofield G et al. (2021). Real-world ethics in palliative care: A systematic review of the ethical challenges reported by specialist palliative care practitioners in their clinical practice. Palliative Medicine, 35(2): 315–334.

Scottish Government (2011). Code of practice for anyone authorised under an intervention or guardianship order. Available at: https://www.gov.scot/publications/adults-incapacity-scotland-act-2000-code-practice-persons-authorised-under-intervention-orders-guardians/ (accessed 13 August 2023).

Shaw A (2002). Two challenges to the double effect doctrine: Euthanasia and abortion. Journal of Medical Ethics, 28(2): 102–104.

Singer P (2018). The challenge of brain death for the sanctity of life ethic. Ethics & Bioethics, 8(3–4): 153–165.

Sulmasy D (1996). The use and abuse of the principle of double effect. Clinical Pulmonary Medicine, 3(2): 86–90.

Young S (2017). A right to die? Examining the centrality of human rights discourses to end of life policy and debate in the UK. (PhD thesis). London: Kingston University. Available at: https://eprints.kingston.ac.uk/id/eprint/39248/1/Young-S.pdf (accessed 30 June 2023).

Appendix A: Example ReSPECT Form

Source: Reproduced with the kind permission of RCUK.

Appendix B: Example DNACPR Plan

Chapter 14

A Note on the Legal and Ethical Issues in the Use of Social Media

Aidan Baron

Introduction

Since the publication of the first edition of this book, I have been contacted by a range of individuals across the United Kingdom (UK), whose care, or the rescue or incident in which they were involved was shared on social media by emergency services. Many of these individuals have suffered psychological distress as a result, and have required counselling, which has in some cases been extensive. Their feelings of violation and abuse of trust occurred because emergency services had posted one of the most traumatic events of their life in a public forum without their consent. In some cases, family and friends of the patient or victim were able to identify their involvement in the incident before having formal notification. I wish to extend my sincere thanks to these strong individuals for sharing their stories with me, and to convey to them our apology as a profession. We are sorry and will do better. I share this with you, the reader, so that you may understand that, while the discussion throughout this chapter is based on theory and principles, the impact of our actions is real. When we as individuals, and as a profession, put social media followers over the interests of our patients, the resulting harm can be severe and long-lasting.

Social Media and Privacy

The use of social media by paramedics is governed by multiple complementary layers of legislation, professional codes, policies and organisational guidelines. Personal information is protected under the UK General Data Protection Regulation (GDPR), which explicitly specifies the rights of individual people, and the responsibilities of organisations to protect this data. This superseded the Data Protection Act 1998, partly due to the complexity of the internet era. A large focus of the GDPR is the role of technology and how data (which includes patient information in this context) is processed.

Additionally, the UK is a human rights jurisdiction which recognises privacy as a human right (Human Rights Act 1998) and a basic need ‘essential to the development and maintenance both of a free society and of a mature and stable individual personality’. These legal frameworks act in concert with professional codes and standards, such as the Health and Care Professions Council (HCPC) Standards of conduct, performance and ethics (HCPC, 2016) and Guidance on the use of social media (HCPC, 2020) and the Standards of proficiency – Paramedics (HCPC, 2023a). With regard to the use of social media, paramedic practice should be informed by not only these laws, codes and guidelines, but also by professional bodies (such as the College of Paramedics) and employer policies – provided they are consistent with the law and regulatory body requirements (Baron and Townsend, 2017).

Social media is a series of platforms that has significantly changed the way our society interacts. It has become a part of our daily lives and created a more aware and conscious global community through the sharing of vast amounts of information. However, there exists a tension between social media and the professional responsibilities of paramedics as healthcare professionals. A benefit of social media is that it can promote the sharing of knowledge and experiences, most often in real time. This feature is particularly useful, for example, in major disasters where social media has proven to be a vital tool for public health information dissemination (Simon et al., 2014). Social media has also contributed to an educational revolution in that it has allowed the sharing of knowledge among health practitioners from multiple disciplines around the world, and Free Open Access Medical education (FOAMed) has been identified as a unique online community of practice (Roland, Spurr and Cabrera, 2017).

Social media can be a great way to share information. However, you should make reasonable checks to ensure that information you share is true and accurate. You should ensure that any views you express are evidenced-based, responsible, and professional.

Social media use can also pose risks to both users and those to whom the content of social media posts might refer. There is an unquestionable tension that rightfully exists between healthcare, where confidentiality and privacy are core tenets of practice, and social media, the underpinning principle of which is to share.

The Importance of Confidentiality on Social Media

Before the ancient Greek physician and philosopher Hippocrates, disease was believed by most people to be a form of punishment from divine beings. Hippocrates was one of the first recorded individuals to dispel this theory and suggest that disease was a result of natural causes. Still, there remained an element of shame and social stigma surrounding most disease, which persists to this day. In his now famous oath, Hippocrates pledges ‘… And whatsoever I shall see or hear in the course of my profession, as well as outside my profession in my [interactions with others], if it be what should not be published abroad, I will never divulge, holding such things to be holy secrets …’ (Conrad, 1995).

Although many facets of the original Hippocratic Oath are now outdated, the responsibility of the healthcare professional to be entrusted with highly personal, intimate and important information by their patient, and to preserve the confidentiality (privacy and secrecy) of this information, remains a universal duty. As a result of the development of our society and its needs, there are now multiple mechanisms that govern what healthcare professionals, including paramedics, can do and must not do – especially when it to comes to the sharing of information and the privacy of patients. The invention of the internet and its rapid growth has meant that at times these principles may appear not to apply; however, they continue to exist, and the onus is on the healthcare professional to ensure that they are aware of the way in which these principles can be applied and upheld when new technologies emerge.

Preserving a patient’s privacy is important for several reasons. The obvious reason is that patients can suffer significant psychosocial, financial and sometimes even physical harms when their private information is made public or falls into the wrong hands. This is recognised in many pieces of privacy law both in the UK and elsewhere that place a special privilege on personal health information. This is because health information is usually the most intimate type of information that an individual holds which may not even be shared with those closest to the individual. Paramedics are one of the few likely to be privy to these most intimate secrets of an individual’s life, and as such, must take that privilege and the responsibility that accompanies it extremely seriously. As paramedics, we are given a great deal of trust by the patients whose crises we enter into, often in their homes, or private places, and of whom we ask invasive questions about their lives, medical history, social history and personal relationships. It is a legitimate fear for an individual that their privacy could be breached, and information they do not wish to share with others could be made public. Therefore, it is vital to preserve the public’s trust in the entire profession’s ability to maintain patient confidentiality and protect their privacy. If the public begins to distrust the ability of paramedics (either individually or as a whole profession) to maintain confidentiality and preserve the privacy of their information, then it is very possible that members of the public will be less likely to call paramedics for help in a health emergency. For this reason, behaviours which violate or breach the confidential nature of the relationship between the patient and a paramedic can not only harm that patient, but can also harm the professional reputation of all paramedics and the patients whom they might care for.

Even a social media post that is lawful, but appears, or can be perceived to be a breach of privacy, can still cause real harm in this way. The rules about the use of social media therefore do not just simply refer to the paramedics’ duty to act lawfully; there is also a duty to act ethically to preserve not only the confidentiality of the patient, but that patient’s (and all people’s) confidence in the profession, and indeed all health professionals. This principle underpins the foundation of the healthcare practitioner regulatory scheme (Health and Social Work Professions Order 2001), which recognises that trust and confidence by a patient in a practitioner is essential to the effective and efficient functioning of the healthcare system.

As registered healthcare professionals, paramedics also have a duty to consider whether the information they share on social media is accurate. Consideration should be given to the original sources of the information that is reposted/shared by paramedics on their social media accounts (even if these accounts are personal).

Social Media Posts for Public Education

On the 1st October 2018, the HCPC issued a letter that expanded on their 2017 updated Guidance on the use of social media (HCPC, 2020). The then HCPC Head of Policy and Standards, Ms Katherine Timms, said that:

… HCPC registrants’ primary consideration should be their service user; raising the profile of their profession should only ever be a secondary consideration, and should not impact the service user’s privacy or dignity. When live tweeting in order to raise the profile of the profession, registrants should take care to only share information required to achieve that objective. They should post in a modest manner; only providing the information the public needs to understand the role, and they should ensure any additional information, in particular service user identifiable information, is not included.

(HCPC, 2018)

This is an important explanation of the rules that have always existed but which, at times, have appeared to be unclear to some paramedics and ambulance services. In most cases where paramedics have abused their privileged position and breached their duty of confidentiality towards patients by posting on social media, they have mistakenly relied on the excuse that publication of patient information is in the ‘public interest’ because it is posted by publicly funded organisations for the benefit of ‘public education’, ‘improving understanding of the role of paramedics’, ‘decreasing inappropriate use of ambulances’ or ‘service promotion’.

Public campaigns that use stories of patients to either promote a service or to discourage the ‘inappropriate’ use of healthcare services have never been demonstrated to be effective. Further, the tone of many of these posts often has the unintended consequence of maligning patients (commonly referred to as ‘patient blaming’). The promotion of work undertaken by an emergency service is a positive aspiration; however, the means by which this is accomplished should be healthily scrutinised. One must remember that the entire purpose of a healthcare service is to care for those in crisis and vulnerable situations, not to (ab)use the tragedy of others for the promotion of an organisation, whether that be a public institution or charitable service. There is a common misconception amongst paramedics and service managers that information and advice can be shared to improve public education as this is in ‘the public interest’. However, the use of any confidential information for the public interest actually refers to a very specific legislative exemption from confidentiality provisions, where the risk of breach of privacy of an individual is deemed to be less than the risk posed by not disclosing particular public health information to either select government agencies or the wider community. This is a tightly controlled area of law with a very high threshold required to be met before disclosure can occur. Examples of this include mandated reporting of sexual misconduct or assault of vulnerable persons, or the mandated public health reporting of infectious diseases (notifiable diseases) so that public health agencies can act for the greater public good by limiting spread and contagion – as demonstrated during the COVID-19 pandemic.

Can I Post This?

In 2017, Dr Ruth Townsend and I first discussed the issue of live posting/sharing by ambulance services and created the ‘Intention to Tweet Decision Matrix’ as a decision tool to aid practitioners (Table 14.1) (Baron and Townsend, 2017). While the matrix and article refer specifically to Twitter (now formally known as X), the principles apply equally for any other social media platform.

Table 14.1 Intention to Tweet Decision Matrix.

Matrix

Stage 1

Why am I tweeting this?

Does this tweet:

Promote my own account or the service I work for?

Tell people what specific types of incidents I have been involved with?

Aim to inform or educate the public about what I do using specific examples?

Aim to raise the profile of my charitable organisation?

This is exploitative: Do not Tweet.

Am I tweeting about my work to:

Benefit public safety (generic hazard warning)

OR

Educate peers (generic disease education)

Proceed to criteria below

Stage 2

Red Criteria

Photo/(s) from the scene

3 points

Do Not Tweet

Photo of patients medical records, care reports or dispatch screens

Patient ECG that has not been anonymised

Exact time and date the incident occurred

Exact age

Orange Criteria

Approximate age

(either in the tweet or in your bio)

2 points

Consider Carefully and have someone else proof-read before tweeting

Location or region

Tweeting on the same day/date the incident occurred

Referring to the time/date when the incident occurred long afterwards

Green Criteria

The mechanism of injury or illness

1 points

Re-Read and Re-Check

Gender

The care the patient received

De-identified ECG for educational use with a specific learning outcome

3 or more points = Do not tweet

This article was in response to a significant issue at the time, which had evolved from a misuse of social media by ambulance trusts and paramedics, where posting of incidents attended was common. Subsequent to this, the HCPC have published a blog outlining how social media can be used wisely by registrants (HCPC, 2023b). This likely pre-empts their review of their Standards of Conduct Performance and Ethics and Social Media Guidance, though an updated publication date has not yet been clarified.

When sharing content on social media about clinical cases, one must understand that if a person can identify the patient from that information, it is clearly unlawful. And, if the patient themselves can reasonably identify themselves from a post, then that is clearly unethical and may also be unlawful. Even if a patient mistakenly believes a case to be about themselves, this still risks decreasing the public’s trust in the profession and is therefore potentially unethical. Consideration must also be given to content that is reposted, even if you are not the original author.

If in doubt, get advice. But if you think something could be inappropriate, or offensive, do not post it.

Posting and Filming with Consent

Often a false equivalence is made between social media activity by ambulance services and paramedics, and some television shows which feature real footage of ambulance calls and care of patients by paramedics (though not all of these shows adhere to correct standards). There is a crucial distinction that must be made between these two formats, and that is the distinction of voluntary informed consent. When major broadcasting agencies produce television programs that feature real-life footage of emergencies, they should (and in most cases do) go through a rigorous process of obtaining voluntary informed consent from the patients and or family members being filmed, as well as the paramedics. This process involves not only seeking permission to film while an incident is occurring, but also going back to the patient and/or family afterwards (often months later) to seek actual written consent when that person is not under the duress of an emergency situation. Approaching patients and/or the family sometime after the incident ensures they do not feel compelled by the nature of the emergency to agree to the filming and publication (broadcasting). They must also show the patient the exact footage that will be published. It is also important that the patient is asked by the film crew and not the paramedic during an episode of care so that a conflict of interest does not exist in the provision of care by paramedics.

Jax, a newly qualified paramedic on their first solo shift, and Jill, an experienced technician, are on an evening shift on a dual crewed ambulance (DCA) when they get called to a 28-year-old in labour.

On arrival the crew find the patient in active labour on the living room floor with the baby’s head visible and the patient’s mother and sister supporting her. Jax assists the mother to deliver her baby and the birth occurs smoothly without any adverse events or complications. The crew receive clinical support over the phone from the Trust’s consultant midwife, who advises them to transport the mother and baby to hospital for neonatal checks after the third stage of labour is complete.

The patient is recovering well and is overjoyed, as are her mother and sister. Jill is smiling and steps away from the family to speak with Jax who is packing away their equipment to get ready for transport. ‘Well done!’ Jill says. ‘You’ve done your first delivery! Come get a photo with the baby.’ Jax is uncomfortable but follow’s Jill’s lead. Jill asks the mother if it is ok to take a photo of Jax holding her newborn and the mother, incredibly grateful to the crew for their help, agrees to this and hands Jill the baby. Jill wraps the newborn up and passes them over to Jax, then takes a photo of Jax and the baby on her phone. Jax then hands the baby back to the mother and continues with the rest of the call: transporting the mother, baby and new grandmother to hospital and eventually clearing for a new call. Jill texts Jax the photo and Jax, proud of their first delivery, posts it on Facebook and Instagram at the end of the shift.

Two days later, the photo is shared on the official ambulance trust Facebook page with a caption: ‘Newly qualified paramedic Jax with a healthy baby after their first delivery with Fakeshire Ambulance Trust’.

The mother of the newborn baby and her family see the post within a few hours and are quite upset. The newborn ended up being diagnosed with a congenital condition and, although not acutely unwell, had to spend a few days in hospital while further tests were conducted. The mother feels upset and uncomfortable. She did not give permission for the photo to be posted on social media, and is upset by the post as it serves as a painful reminder of her child’s condition. She also reflects that when she was asked by Jill if Jax could have a photo taken with her baby, she was reluctant to agree but did not feel she could say ‘no’ given the overwhelming experience she had just been through and because she was still relying on the crew to care for her and transport her and her newborn to hospital.

What We Can Learn from This Case Study

By now, one is able to fully appreciate the complex ethical dilemmas present in the case described. It is important to underatand that there is no way for us to know which patients will have negative health experiences following our handover of their care. This case also highlights that simply because something is commonplace or an established tradition within the culture of an organisation, does not mean this behaviour is lawful or ethical. As the registered practitioner in this case study, Jax is ultimately responsible for what has occurred in this instance. They have been the individual who first posted the image on social media causing it to be in the public domain. The ambulance trust’s social media manager is also responsible for not ensuring that appropriate policies were in place and being implemented to protect patient privacy and comply with regularity requirements. Lastly, we must be attuned to the very unequal power dynamic that exists between patients and paramedics; especially when they are reliant on our care.

The reason a paramedic should not, for example, ask a patient if they may take a photo of their injury and post it to social media, is that if a paramedic were to make this request of a patient during care, or immediately after, patients may feel obliged or pressured into granting consent for images or information to be shared. This not only represents a potential conflict to the paramedic, it may also pose a legal and ethical dilemma by invalidating the consent. This action is likely unethical on two fronts; first, it can place the patient in an uncomfortable position, and second, it calls into question whether the consent given is truly voluntary and informed. The paramedic has a professional duty to advocate for their patient and place their patient’s interests above all else as part of their therapeutic relationship.

As is covered in more depth in Chapter 6: Consent, consent that is valid is the difference between a paramedic performing an intramuscular injection to deliver medication and a person who is charged with assault and/or battery for stabbing someone with a needle. Valid consent is also therefore the key decider between whether the sharing or disclosure (publication) of someone’s information is legal and ethical, or not. For consent to be considered valid, it must satisfy four criteria: it must be informed, it must be given voluntarily, it must be given by a person with the competency and capacity to have made the decision for themselves, and it must be consent that is requested for something which is lawful (and in the context of paramedic practice, something which is in a patient’s interest).

In the context of sharing a patient’s information, whether that be online or on TV, we can understand that gaining a patient’s consent to share their story involves a complex and well-prescribed process.

This begins with the patient being informed. Being informed means that a patient understands the benefits, risks and alternatives to a choice or intervention. Regarding risk, patients must be informed to the level of material risk. This means not only the risks that are likely, but also those that are very unlikely but would have a major impact on their well-being. For sharing a patient’s information this includes the details of exactly what information will be shared, the reason it will be shared, whom it will be shared with, how it will be presented, who will have access to this, the potential that this could negatively affect them, and how that might occur. All of these factors must be explicitly communicated. Not only must this occur, but this must be done in an environment where the patient can freely object or agree to this without feeling pressured to do so. During an episode of care, even if it is not an emergency call, there is simply no way to avoid the asymmetrical power dynamic that exists between a paramedic and a patient.

At 21:30 on the 6th of April 2023, a 19-year-old driver and their 16-year-old sibing are involved in a major road traffic collision (RTC) when their car hits black ice on the road and crashes into a tree beside the carriageway. Local emergency services crews respond to the incident. An investigative journalist wants to find out what happened and so pieces together the following publicly available information shared on social media posts:

06/04/2023, 2150: The local news broadcast posts on X and Facebook:

Two female passengers are being treated by Fakeshire ambulance and rescue crews after a major crash on the M70, closing down traffic in all lanes. Please drive safely.

06/04/2023, 2200: Fakeshire Ambulance Trust posts the following:

Multiple crews have been dispatched to treat two young females involved in a major collision on the M70. Both have been transported to Fakeshire hospital in a critical condition. Remember to call 999 in an emergency.

06/04/2023, 0830: Sam Sun, a paramedic and official Fakeshire ambulance trust X user posts:

On the truck today with Stephanie Sticks, ready for a great week ahead.

06/04/2023, 2025: Fakeshire Air Ambulance Charity shares:

Our advanced medical team attended a major RTC tonight. Two patients, one with major head and chest injuries. Thanks to our sponsors, we are able to deliver prehospital anaesthesia and blood products to those who need it most, saving lives in critical moments.

06/04/2023, 2230: Melanie Smith, a trainee critical care paramedic and official X user for Fakeshire ambulance service posts:

Tough job tonight. First time doing a needle chest decompression this year. Big hugs to my emergency services family.

06/04/2023, 2330: Tim Chu, not an official X user for Fakeshire ambulance service, but tagged in a photo from the previous day with Melanie Smith, where they are clearly seen as crew mates.

#MyEMSday

78F asthma salbutamol neb -> A&E

65M fall at home, referred to GP and falls team

16M head injury, RSI and thoracostomies -> MTC

21yo, intoxicated and badly sprained ankle -> local MIU

06/04/2023, 2240: Stephanie Sticks, not an official Fakeshire ambulance trust X user:

Thanks Fakeshire Air Ambulance and Fakeshire Fire and rescue for all your help. Great teamwork as always tonight.

07/04/2023, 0900: Sam Sun, official Fakeshire ambulance trust X user:

Remember that sometimes emotional shock can present in unusual ways. Catatonia, incontinence and paralysis can be psychologically induced from seeing a loved one being injured. Be alert!

What We Can Learn from This Case Study

The investigative journalist is able to piece together that the younger sister who is 16 years old has suffered a head injury and chest injuries causing a tension pneumothorax requiring needle decompression, rapid sequence intubation, and blood product transfusion, and was then transported to Fakeshire major trauma centre, while the older sister who is 19 likely suffered an acute stress reaction, which resulted in catatonia and urinary incontinence. This information, when pieced together contains the age, injury pattern, treatments and clinical decisions made by paramedics for the patients while under their care. Such a level of detail should never be publicly available and is the private information belonging to the patient. Unfortunately, in this case, this highly sensitive and private information has now been made public.

This is an example of how seemingly non-identifying or non-compromising pieces of information can, in combination, reveal a large amount.

Summary

Ethical, lawful and beneficent social media use by paramedics can be summarised as online behaviour that avoids referring to specific patients in any way, but instead focuses on education and public health promotion regarding diseases and advice, warning, or communication relating to generic public circumstances. Social media should be used to advance the health of the public in a way which reflects positively on the profession and does not cause harm to minority groups of patients, or cause people to experience feelings of shame or regret.

Remember that the professional standards expected of you do not change just because you are communicating on social media.

Recommended Reading

The College of Paramedics (2019). Social Media Guidance. Available at: https://collegeofparamedics.co.uk/COP/Professional_development/Social_Media_Guidance/COP/ProfessionalDevelopment/social_media_guidance.aspx?hkey=9424140f-ca5e-444d-bb9a-2b7126bd876f (accessed 30 June 2023).

References

Baron A and Townsend R (2017). Live tweeting by ambulance services: A growing concern. Journal of Paramedic Practice, 9(7).

Conrad LI (1995). The Western Medical Tradition: 800 BC to AD 1800. Cambridge: Cambridge University Press.

Health and Care Professions Council (HCPC) (2016). Standards of conduct, performance and ethics. Available at: http://www.hcpc-uk.org/publications/standards/index.asp?id=38 (accessed 30 June 2023).

Health and Care Professions Council (HCPC) (2020). Guidance on the use of social media. Available at: https://www.hcpc-uk.org/standards/meeting-our-standards/communication-and-using-social-media/guidance-on-use-of-social-media/ (accessed 30 June 2023).

Health and Care Professions Council (HCPC) (2018). Social media in professional practice. Available at: http://hcpc-uk.blogspot.com/2018/10/social-media-in-professional-practice.html (accessed 30 June 2023).

Health and Care Professions Council (HCPC) (2023a). Standards of proficiency – Paramedics. Available at: https://www.hcpc-uk.org/resources/standards/standards-of-proficiency-paramedics/ (accessed 30 June 2023).

Health and Care Professions Council (HCPC) (2023b). Using Social Media Wisely. Available at: https://www.hcpc-uk.org/news-and-events/blog/2022/using-social-media-wisely/ (accessed 11 October 2023).

Roland D, Spurr J and Cabrera D (2017). Preliminary evidence for the emergence of a health care online community of practice: Using a netnographic framework for Twitter hashtag analytics. Journal of Medical Internet Research, 19(7): e252.

Simon T et al. (2014). Twitter in the cross fire? The use of social media in the Westgate Mall terror attack in Kenya. PLoS ONE (Edited by V. Gupta), 9(8): e104136.

Chapter 15

Legal and Ethical Considerations in Paramedic Research

John Renshaw

Introduction

In recent years, there has been a noticeable growth in the number of paramedics who are embarking on a career in research and are working within ambulance services research departments, clinical trials units and multi-disciplinary research collaborations (College of Paramedics, 2017; Paramedic PhD, 2023). Previously, research concerning the paramedic profession has focussed on the ambulance service, and has predominantly been carried out by medical, nursing or non-clinical colleagues with a particular interest in prehospital care. However, more recently, paramedics have started to develop the knowledge, skills and experience to carry out original research in the prehospital setting. The welcomed growth of research skills among the paramedic profession appears to have been facilitated by the introduction of research skills within pre-registration paramedic programmes and the integration of the research and development pathway within the College of Paramedics (College of Paramedics, 2017). Now that paramedics are able to pursue a career in research and make a more substantial contribution to multi-disciplinary research, the paramedic profession also ought to be familiar with the main legal, ethical and moral principles that support research that is ethically and scientifically sound (Paramedic PhD, 2023; Health Research Authority (HRA), 2017a).

The purpose of this chapter is to review the main legal and ethical considerations associated with undertaking research in the emergency and prehospital setting. It will focus upon the ethical standards, guidelines and applications that paramedic students, paramedics and early career researchers are most likely to encounter during the course of their studies and will outline the process of submitting an ethics application to the Integrated Research Application System (IRAS). This edition will also provide an overview of information relating to the United Kingdom’s (UK’s) departure from the European Union, changes to UK legislation for clinical trials, and the General Data Protection Regulation (GDPR) and Data Protection Act 2018. Noticeably, detailed explanations of the ethical principles and moral values are beyond the remit of this chapter and are covered elsewhere within this book (Chapter 3: Applied Ethics in Paramedicine considers a case of applied ethics in research).

What Is Health Research?

The term ‘health research’ describes the process of systematically generating new, generalisable or transferable knowledge that can be used to either improve patient care, reduce uncertainties about treatment effectiveness or change how health services operate (National Institute for Health Research (NIHR), 2018; HRA, 2017b). Research is fundamental to the development of health and social care as it helps to strengthen the evidence base to improve people’s experience of healthcare and provides unique access to some of the most cutting-edge treatments currently available (NHS England, 2021). As one of the key providers of emergency and urgent care, paramedics use research during their patient assessment, physical examination and clinical decision making. Lately, ambulance paramedics have been more involved in research and have played an integral role in the recruitment of participants into large multi-centre clinical trials involving regional ambulance services. As paramedics are gradually becoming more involved in research, they need to recognise their unconditional responsibility to carry out research to the highest ethical and professional standards mentioned within this chapter.

Research Ethics

The term ‘research ethics’ is commonly used to describe a set of moral principles that guide research from its initial planning stage through to its completion (British Psychological Society (BPS), 2021). While the main ethical principles of autonomy, beneficence, justice and non-maleficence are known to encompass most of the different moral issues that arise within healthcare (Gillon, 1994), there are some additional ethical principles that are relevant to health research that require consideration. Within the UK, the UK policy framework for health and social care Research describes 15 key principles that act as a benchmark for good clinical practice in research, with a further 4 principles for interventional research design (HRA, 2017b). Therefore, these ethical principles also set the standard expected for research in the emergency and prehospital setting.

Ethical Principles

The first ethical principle listed within the UK policy framework for health and social care research is safety and the need to put the well-being of participants and researchers who are involved in the planning, collection or interpretation of the research before the interests of science (HRA, 2017a). Subsequently, each member of the research team is required to possess the relevant education, training and skills to be able to conduct research that is scientifically and ethically sound (HRA, 2017a; BPS, 2021). Individuals who are less experienced can be deemed to be competent to perform tasks if they receive adequate supervision from a suitably qualified person (HRA, 2017a; BPS, 2021).

Research in health and social care should be designed to respect the rights, privacy, confidentiality, choice and well-being of everyone involved in research (Medical Research Council (MRC), 2014). The information and data collected from participants needs to be handled correctly and stored safely to protect their confidentiality and right to privacy (HRA, 2017a). Meanwhile, it is considered good practice for researchers to organise research projects within a documented protocol, so that both researchers and participants can be clear about the design, objectives, methods of study and the relevant legalities and ethical considerations associated with taking part in the study. The protocol should evidence the favourable ethical approval when it is expected or required; it should include information about research such as its registration on the appropriate international research registries that help to prevent unnecessary duplication or waste (HRA, 2017c; National Library of Medicine, 2018). After all, research is thought to be a social process and researchers should appreciate their responsibility to discover new knowledge and information in the most effective and efficient way (BPS, 2021).

Research participants must be afforded the respect and autonomy to decide whether they wish to take part in research, or not. Therefore, participants should be provided with sufficient information in an understandable form to inform their choice to take part in the research, unless a university ethics committee agrees otherwise (BPS, 2021; HRA, 2017c). Participants must be able to easily differentiate between the proposed research and the standard care to be able to provide their informed and voluntary consent to take part (HRA, 2017c). In addition, they should feel able to refuse or withdraw from the study without any reprisal, and should be made fully aware of the benefits, potential risk of harm and inconvenience associated with the research. Accordingly, researchers also need to make adequate provision for indemnity and insurance to cover any potential liabilities that arise from being involved in the project (HRA, 2017c). As registered healthcare professionals, paramedics who undertake research and do not comply with these fundamental ethical principles are likely to face legal challenge or the appropriate sanction from sponsors, employers and professional regulators (HRA, 2017c).

Although the majority of these ethical principles are well-established, one of the more recent principles to be factored into planning and design stages is the need to build patient representation and public involvement throughout the research project (HRA, 2017a). Patient representation is known to enhance the integrity, quality and improve the overall transparency of the research, and provides valuable experience of health and social care to promote the culture of openness, honesty and transparency between the researchers, participants and members of the public.

Finally, after the research has been gathered and interpreted, researchers have an obligation to accurately report and communicate their findings in a timely manner, regardless of whether their findings were positive or negative. The findings should also be made available to those who took part in the research unless otherwise justified (HRA, 2017a).

Important Regulations, Frameworks and Guidelines

The development of international standards for ethics in research is undoubtedly one of the most significant moments in the history of clinical research. These documents have subsequently enabled researchers from around the world to be able to collaborate on international projects with a shared understanding of the ethical principles, responsibilities and expectations associated with carrying out research involving human participants. Previously, researchers would have undertaken large international studies across many different countries, continents, and cultures, and they would be challenged by the variation in the legal, ethical guidelines and local arrangements from each different country (World Medical Association (WMA), 2013). However, since the development of these overarching recommendations, researchers have a more streamlined understanding of ethical considerations in research, regardless of where the research is being undertaken (WMA, 2013). Large international research collaborations are now relatively common in health and social care and there appears to be a growing number of projects being carried out in the prehospital setting (Roberts et al., 2013). These examples demonstrate the possibility to undertake international collaboration in the emergency and prehospital setting to the highest ethical and professional standard. In order to gain an overview of the relevant regulations, frameworks and guidelines for conducting research in the prehospital arena, paramedics need to have a basic understanding of the Nuremberg Code, the Declaration of Helsinki, the European Clinical Trials Directive, Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, and the UK Policy framework for health and social care research (WMA, 2013; HRA, 2017a).

Paramedics can find out more about international research within the International Ethical Guidelines for Health-related Research Involving Humans publication (Council for International Organizations of Medical Sciences (CIOMS, 2016).

The Declaration of Helsinki (1964)

In 1964, the WMA announced the Declaration of Helsinki at the WMA General Assembly in Helsinki, Finland, to provide ethical principles for medical research involving human subjects, or any of their material or data (WMA, 2013). The original declaration was widely adopted by the international medical and scientific community. However, since then there have been multiple amendments to the original version (WMA, 2013). The Declaration of Helsinki has become the benchmark for ethical consideration for researchers who are conducting research involving human subjects, which new proposals are compared to. In 2005, the Good Clinical Practice Directive included the recommendation for clinical trials to be conducted in accordance with the principles of the Declaration of Helsinki, and this underpins current UK law. Although it is not possible to discuss the Declaration of Helsinki in detail within this chapter, paramedics must review this important document, which makes the specific recommendation in the following areas:

General principles

Risks, burdens and benefits

Vulnerable groups and individuals

Scientific requirements and research protocols

Research ethics committees

Privacy and confidentiality

Informed consent

Use of placebo

Post-trial provisions

Research registration and publication and dissemination of results

Unproven interventions in clinical trials.

The Nuremberg Code (1947)

The Nuremberg Code (1947) is one of the most influential documents in the history of medical research ethics (Annas and Grodin, 1992). This pivotal work stems from the Nuremberg trial in 1947, where Nazi doctors stood trial for conducting barbaric experiments on innocent victims and attempting to disguise their actions in the name of scientific research (Shuster, 1997). The court’s judgement in this trial contained 10 principles to protect everyone from harm during experimental and non-experimental research, which remain a powerful symbol to medical, nursing and allied health professionals involved in research. While the Nuremberg Code has never been fully adopted into law within the UK, it is has undoubtedly become one of the most instrumental documents in the history of clinical research, and many of its principles that serve to protect the rights of participants have subsequently been incorporated into international human rights agreements. As a starting point, it would be helpful for paramedics and student paramedics to have an awareness of the Nuremberg Code, each of the Code’s 10 principles, and the history that led to its development. A summary of the 10 principles of the Nuremberg Code is shown within Box 15.1.

Box 15.1 The Nuremberg Code as described within Shuster, 1997.

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable [them] to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to [them] the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon [their] health or person which may possibly come from [their] participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7. Proper preparations should be made, and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if [they have] reached the physical or mental state where continuation of the experiment seems to [them] to be impossible.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if [they have] probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of [them], that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Clinical Trials Regulation

In January 2022, the European Commission replaced the existing European Clinical Trials Directive (EC2001/20) with the Clinical Trials Regulation (EC536/2014) (CTR). The new regulation streamlines the rules for conducting clinical trials and the application procedure, and improves the procedures in place for more thorough assessment and to strengthen the transparency of clinical trials data (European Commission, 2018). The regulations include improved assessment and supervision processes for clinical trials undertaken throughout the EU using a clinical trials information system (CTIS). The CTIS includes a single-entry point for submitting clinical trials information to the EU, and applicants will submit a detailed application form and supporting documentation considering the relevant ethical and regulatory assessments from each member state (European Medicines Agency, 2021).

As the CTR is a legislative act, it subsequently requires each individual European country to transfer the requirements and standards for clinical trials within Europe into law in each country.

Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

In 2019, the UK government published three separate pieces of legislation to allow the Medicines and Healthcare products Regulatory Agency (MHRA) to carry out regulatory roles previously undertaken by the European Medicines Agency, and continued access and sale of medicines, medical devices and clinical trials following the UK’s departure from the European Union. The new Medicines for Human Use (Clinical trials) (Amendment) (EU Exit) Regulations 2019 (SU 2019/744) include changes to the aforementioned legislation since ‘exit day’ in England, Scotland and Wales. Northern Ireland continues to be aligned to EU legislation and regulations regarding clinical trials. The Ireland/Northern Ireland Protocol came into effect on 1 January 2021 and results in changes to regulations on importation requirements for medicines.

Although many of the original principles within the legislation are unchanged, there are some key amendments:

Registration of clinical trials: all new trials must be registered on an established international register, such as ISRCTN (International Standard Randomised Controlled Trial Number) or clinicaltrials.gov.

Sponsor legal representative: the sponsor or sponsor legal representative of a UK clinical trial must be in the UK or in a country on an approved country list. A sponsor established in the UK and conducting a clinical trial in the EU/EEA must ensure that a sponsor or a legal representative is established in the EU/EEA.

Publication of trial results: trial results should be published on the public database where the trial has been registered.

Medical devices: the UK law for medical devices will remain as Medical Devices Regulations 2002 (SI 2002 No. 618 as amended), and the route to going to market for Britain and United Kingdom Conformity Assessment (UKCA) marking requirements will continue to be based on the requirements derived from current EU legislation. The UK government is also currently reviewing the Medicines and Medical Devices Act 2021 to supplement the law relating to human medicines, veterinary medicines and devices, and the enforcements of regulations for protecting health and safety in relation to medical devices (Quigley et al., 2020).

GDPR: UK GDPR is based on the EU GDPR (General Data Protection Regulation (EU) 2016/679), which applied in the UK before that date, with some changes to make it work more effectively in a UK context post Brexit, and the UK is a third country for data protection purposes. Data flows between the UK and the EU/EEA and data sent to the EU/EEA and stored by EU/EEA processors will need to be compliant with UK GDPR and EU GDPR.

Considerations Regarding Changing Legislation

There have been several different amendments over the past 10 years to this legislation, with the most recent affecting England, Scotland and Wales following exit from the EU. Consequently, paramedics should refer to the regulations as amended so they include these compulsory changes and can understand the advancement of this legislation over time. Moreover, students, paramedics and early researchers should pay close attention to the statutory requirements for informed consent of participants in clinical trials of investigational medicinal products, which also consider the challenge of collecting informed consent in an emergency situation (HRA, 2020).

Data Protection Act 2018 and UK General Data Protection Regulation

Paramedics, researchers, universities and organisations who undertake research that involves the processing, handling and management of data must ensure they meet the legal requirements relating to their research activity (UK Research and Innovation, 2021a). In the UK, researchers must adhere to standards within two key documents that set out the legal requirements when managing and sharing personal data: the Data Protection Act 2018 and the GDPR (EU/2016/679). For health and social care research, the REC approval and legal gateway for processing confidential information is considered on the advice of the Confidentiality Advisory Group (HRA, 2021).

Personal Data

The UK Data Service (2021) defines personal data as ‘any information relating to an identified or identifiable natural person, whereby the person can be identified, directly or indirectly’. Hence, if data has been anonymised and a person can no longer be identified, then the Data Protection Act 2018 and UK GDPR no longer apply, as this is not considered personal data. However, anonymisation must be complete and not pseudonymised, which may still allow for identification of an individual (Data Protection Commission, 2021).

The Data Protection Act 2018 controls how personal information is used by organisations, businesses and government agencies. The Data Protection Act 2018 is the UK’s implementation of GDPR into UK Law. It aims to increase exceptions of how organisations process personal data, so it is lawful, fair and transparent (BPS, 2018). The data protection requirements set out within the Data Protection Act 2018 and GDPR apply to all living people irrespective of where they live, and they safeguard good research practices involving personal data (BPS, 2018). Although the majority of the data protection legislation does apply to health and social care research, there are some noticeable exceptions. As an example, data can be stored for much longer periods of time for the purposes of research. Therefore, paramedics and researchers are advised to seek guidance from their research development teams and data protection officers before deciding upon the legal compliance of the research and research applications. Importantly, researchers must be aware of serious financial penalties for any organisation failing to abide by UK GDPR and data protection legalisation. Fines can be high as 17 million pounds or more, depending on the size and annual turnover of the organisation (Information Commissions Office, 2021).

GDPR General Principles

In total, the GDPR sets out seven key principles for processing personal data:

1.Lawfulness, fairness and transparency

2.Purpose limitation

3.Data minimisation

4.Accuracy

5.Storage limitation

6.Integrity and confidentiality (security)

7.Accountability.

(Information Commissioner’s Office (ICO), 2021)

Legal Basis

Under the UK GDPR, organisations must have a legal basis to process personal data (ICO, 2021a). They should only process personal data when it is necessary, meaning the same outcome cannot be achieved without processing personal data. In total there are six lawful bases, and at least one of the following must apply (ICO, 2021):

1.Consent: consent must be informed, unambiguous and given for a specific purpose.

2.Contract: the processing of personal data is necessary for a contract that exists, or is soon to exist, between an organisation and an individual.

3.Legal obligation: the processing of personal data is necessary to comply with the law.

4.Vital interests: the processing of personal data is necessary to protect someone’s life.

5.Public task/interest: the processing of personal data is necessary to perform a task in the public interest and the function has a clear basis in law.

6.Legitimate interests: the processing of personal data is necessary for a legitimate interest, or those of a third party, unless there is a good reason to protect the individual’s personal data which overrides those interests.

Although paramedics should have an awareness of the key legislation, definitions and principles regarding data protection, it is unlikely they will need detailed knowledge of each article. Instead, paramedics undertaking research should work collaboratively with their research supervisors, data protection officers, sponsors, university research support team and ethics committee, to build research protocols and applications that are scientifically and ethically sound, and that comply with data protection legislation and UK GDPR. More detailed information relating to the Data Protection Act (2018) and GDPR in health and social care research can be found using the UK Research and Innovation (UKRI) guidance for researchers (UKRI, 2021a) and best practice guidelines (UKRI, 2021b).

Good Clinical Practice

In research, good clinical practice is a set of internationally recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.

Organisations that may have to comply with good clinical practice include:

Charities

Contract research organisations

GP practices

Laboratories analysing samples originating from a clinical trial (including NHS, academic and commercial laboratories)

NHS hospitals

Pharmaceutical companies

Universities.

Guidance on good clinical practice has been produced by the International Conference on Harmonisation (ICH) on technical requirements for registration of pharmaceuticals for human use. It is important to highlight that there is no legal obligation for research, other than clinical trials of investigational medicinal products, to adhere to the conditions and principles of good clinical practice. Nevertheless, it remains crucial that such research is always carried out in a manner that assures the public that the rights, safety and well-being of research participants are safeguarded and that the research data is trustworthy. While it is essential for paramedics to have a good knowledge of good clinical practice involving the investigation of medicinal products, paramedics should be aware that these recommendations only apply to the clinical trials, and currently there is no legal requirement to conduct other types of research under these conditions.

That being said, now that the paramedic profession is becoming increasingly involved in the recruitment of participants into clinical trials within ambulance services, it seems sensible to review the main principles of good clinical practice. The main principles listed within Articles 2, 3 and 5 of the current Good Clinical Practice Directive (EC 2005/28) and the Medicines for Human Use (Clinical Trials) Amended Regulations 2006 are listed within Box 15.2.

Box 15.2 Main principles of good clinical practice

1. The rights, safety and well-being of the trial subjects shall prevail over the interest of science and society.

2. Each individual involved in conducting a clinical trial should be qualified by education, training and experience to perform [their] task.

3. Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects.

4. The necessary procedures to secure the quality of every aspect of the trial shall be complied with.

5. The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.

6. Clinical trials should be conducted in accordance with the principles of the Declaration of Helsinki.

7. The protocol shall provide for the definition of inclusion and exclusion of subjects participating in a clinical trial, monitoring and publication policy.

8. The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting a clinical trial.

9. All clinical information shall be recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected.

10. Before the trial is initiated, foreseeable risks and inconveniences have been weighted against the anticipated benefit for the individual subject and other presented and future patients. A trial should be initiated and continued only if anticipated benefits justify the risks.

11. The medical care given to, and medical decision made on behalf of, the subject shall always be the responsibility of an appropriately qualified doctor or, when appropriate, a qualified dentist.

12. A trial should be initiated only if an ethics committee and the licensing authority comes to the conclusion that the anticipated therapeutic benefits justify the risks, and may be continued only if compliance with this requirement is permanently monitored.

13. The rights of each subject to physical and mental integrity, to privacy and to the protection of data concerning [them] in accordance with Data Protection Act 1998 are safeguarded.

14. Provision has been made for insurance or indemnity to cover liability of the investigator and sponsor which may arise in relation to the clinical trial.

(The Good Clinical Practice Directive (EC 2005/28): The Medicines for Human Use (Clinical Trials) Amended Regulations 2006; HRA, 2017).

UK Policy Framework for Health and Social Care Research

The UK policy framework for Health and Social Care Research provides a comprehensible summary of the principles of good clinical practice in the management of health and social care research (HRA, 2017a). The policy framework sets out to reduce the amount of bureaucracy within research and try to encourage researchers to utilise the resources that have been created to support the implementation of its key principles within health and social care research. Subsequently, this document provides a clear and relatively concise overview of the relevant legislation, ethical standards and international guidelines for ethical research, which may be particularly useful for student paramedics. It outlines various ethical principles, roles and responsibilities for researchers and healthcare professionals who are involved in research that includes patients, services users, or their relatives or carers. Some of the main responsibilities that are discussed within the policy framework include (HRA, 2017a):

Responsibility of individuals and organisations

Chief investigators

Research teams

Funders

Sponsors

Contract research organisations

Research sites

Regulators of professions

Other regulators

Employers

Health and social care providers.

Professional Guidelines

Within the UK, there are multiple different research councils, professional societies and regulators that also publish their own guidance for researchers within a specific subject area, or as part of a professional group. While most of the legislation, ethical principles and international guidlines mentioned within this chapter have focused upon clinical trials and research within the NHS, it is recognised that a large proportion of student paramedics and postgraduate students will not be undertaking clinical trials or research within health and social care. Therefore, it is important for prospective researchers to explore the various professional organisations, regulators and research associations within their area of research, as they may provide more relevant and specific guidance to their project. Some examples of different professional guidelines for ethics in research are listed below:

General Medical Council (GMC) (2013). Good Practice in Research and Consent to Research.

Medical Research Council (MRC) (2004). MRC Ethics Guide: Medical research involving children.

Royal College of Nursing (RCN) (2009). Research ethics: RCN guidance for nurses.¹

The British Educational Research Association (BERA) (2018). Ethical guidelines for education research.

The British Psychological Society (BPS) (2021). Code of Human Research Ethics.

Applying for Ethical Approval

As soon as paramedics, and student paramedics, have become familiar with the legislation, guidelines and frameworks that support ethical research in emergency and pre-hospital care, they then need to develop their initial research proposal, identify which of the different approvals they require, and subsequently submit their ethics application. Generally, paramedics will be able to determine what type of approval they will require based upon what type of research is being undertaken, what method is being used, who is involved, where it takes place, and whether the study involves the use of medicinal products or access to participants’ personal information. Henceforth, the remainder of this chapter will outline some of the most common approvals associated with undertaking research in the pre-hospital setting, namely, the NHS Health Research Authority (HRA) and the NHS Research Ethics Committee (REC). It will also summarise the legal requirements for data protection outlined within the Data Protection Act 2018 and the UK General Data Regulations (GDPR). Noticeably, this section will describe the process for undertaking research involving adult patients within NHS organisations within England, as there appears to be some variation between the application process between England, Wales, Northern Ireland and Scotland (HRA, 2017a).

Research Proposals

A research proposal is one of the first documents that researchers are likely to work on during the initial planning and design stage of their research project. Proposals are thought to be particularly useful in their ability to formalise an original research idea and expand it into a more coherent breakdown of the proposed study. As the proposal is developed, each member of the research team should be involved in the development, enhancement and subsequent review of the document over time, which will help researchers to refine their research questions and method of study. While there are no firm templates for a research proposal like there are for more comprehensive research protocols, a research proposal will typically outline the background, aims, objectives, research questions, context and method of study. For some time now, postgraduate university admissions teams have also used research proposals to help to assess an applicant’s suitability for postgraduate study and try to match them to an appropriate supervisor within the same field of work (University of Birmingham, 2018).

Is My Project Classed as Research?

The HRA have consistently highlighted the need for researchers and managing organisations to be able to accurately determine whether their project is considered to be research and whether it needs to be managed as such (HRA, 2018a). The HRA have clarified that it is the managing organisation’s responsibility to assess whether a project is classed as research, as they would then ultimately have to take on the role of research sponsor (HRA, 2018a). However, paramedic researchers should appreciate the importance of this initial step as it can change how research projects are managed and will dictate what additional approvals and permissions are needed before the research can take place. Helpfully, the HRA have created an online decision tool entitled ‘Is my study research?’ to help prospective researchers decide whether or not their study meets the definition of research as described by the UK Policy Framework for Health and Social Care Research (HRA, 2018a; HRA, 2017b). Therefore, it is advisable for paramedics to visit the online decision tool to determine whether their project is considered to be research, which is based upon the Research Ethics Service’s more comprehensive table of research and non-research (HRA, 2017b). The online decision tool considers at least three questions to determine whether a project is research, and if researchers answer ‘yes’ to any of the questions, the project is deemed to be research. These include:

1.Are participants in your study randomised into different groups?

2.Are treatments, care or services allocated by randomisation?*

3.Is your study designed to produce generalisable or transferable findings?

*Clinical Audit and Service Evaluation do not allocate treatments, care or services by randomisation according to protocol.

(HRA, 2018a)

University Ethics Committees

University ethics committees are structured to regulate the vast amount of research undertaken within higher education and to safeguard against research being undertaken that is undesirable, unethical or not well thought out. Ethics committees work to preserve the integrity of research by ensuring that research applications comply with the aforementioned legal, ethical and professional requirements. Meanwhile individual reviewers will assess each research application to determine whether researchers have accurately described the main ethical considerations within their area of study, and have set out how they plan to overcome these issues within their application and research protocol. Reviewers are also required to ensure that each application complies with their university’s policies, procedures and guidance for undertaking health research at university. Afterwards, and depending on the strength of the application, the ethics committee will either reject the application and explain their decision, or they will grant permission for the research to proceed within the specified timeframe based upon information provided. When ethical approval is awarded to a research project, the work will receive an individual reference number, which should be added to the research protocol to demonstrate ethical clearance, and should be published at a later date. However, it is important to recognise that university ethics committee approval may be insufficient for more research involving patients, service users or their relatives within the NHS, which will require external ethics approval from the NHS HRA approval service and/or the NHS REC. Lastly, paramedics should recognise that ethical approval is granted based upon the reviewer’s assessment of the information provided; therefore, if there are any subsequent changes to this research project, the researcher would need to submit an amended application for additional review.

The Integrated Research Application System

The IRAS is a single-system online platform used to streamline the application process for research approvals within health and social care research (IRAS, 2018). Previously, paramedic researchers were asked to submit their application across several different application platforms, which was time-consuming and generated a lot of unnecessary duplication.

However, the IRAS has subsequently enabled researchers to be able to create multiple different application forms simultaneously based upon the information inputted by the researcher (IRAS, 2018). As soon as paramedics have created an IRAS account and have started to input their details, the IRAS system will ask for a more detailed step-by-step breakdown of the proposed study and its core activities. Therefore, to increase the chance of being successful in their applications, paramedics are advised to seek the necessary guidance and preparation from their research supervisors beforehand. Completing an IRAS application form is one of the first initial steps in applying for either HRA and NHS REC approval (HRA, 2018c). The various review bodies that are integrated within IRAS are shown in Figure 15.1.

Research Protocols

The second step in applying for approval from either the HRA or NHS REC involves preparing the necessary study documents and developing research protocol (HRA, 2018b). Once paramedics have completed a research application on IRAS, they should then work to assemble their participant information sheet, statement of activities, funding support and honorary contract information to support their application (HRA, 2018b). As this chapter has already discussed, the Good Clinical Practice directive makes it a requirement for researchers to describe their research design and justify the inclusion and exclusion criteria of their clinical trial within a research protocol (EC 2005/28). Research protocols are often compared to a project manual, as they are known to organise research projects and provide a more comprehensive breakdown of each element for participants, researchers and the relevant review bodies (HRA, 2017a). Consequently, they allow researchers to monitor the study’s adherence to its approved study design and methodology. In recent years, it has become good practice to share and publish their completed research protocol, which can help to create an early scientific record of the proposed work and limit the wasteful duplication of research effort (HRA, 2018a). Finally, paramedics are advised to utilise the HRA’s templates for clinical trials or qualitative research that have been deigned to help researchers build their own research protocol with all the relevant elements included (HRA, 2018c).

Figure 15.1 A diagram summarising the approval bodies accessible through the IRAS.

Source: IRAS(2018).

Health Research Authority

The HRA aims to protect the interests of patients and members of the public by making sure that the research taking place within the health service is safe, legal and ethical (HRA, 2018a). The HRA approval service currently provides an expert assessment of research governance and legal compliance for all project-based research applications within the NHS in England and Wales, alongside independent ethical opinion from the NHS REC (HRA, 2018d). Before paramedics submit their HRA application, they should build their IRAS application, prepare the relevant research documents, and use the HRA decision tool to confirm that their project is considered to be research. Afterwards, paramedics should then compare their project against the eligibility criteria for whether their project requires HRA approval as illustrated within Figure 15.2. If their project does match the criteria for HRA approval, paramedics will need to contact the Central Booking Service to arrange an appointment with their nearest REC and submit their IRAS application on the same day (HRA, 2018e). Whereas research that does not meet the criteria for HRA approval, but does involve either a research tissue bank, a research database or is taking place in a non-NHS setting may require approval from NHS REC and/or the Confidentiality Advisory Group (HRA, 2018f). Most often, projects that are not classed as research do not require HRA or NHS REC approval.

Figure 15.2 is a diagram of the various types of research that require HRA approval as listed on the HRA website (HRA, 2018c).

Figure 15.2 Research that requires HRA approval.

NHS Research Ethics Committee

The NHS Research Ethics Committee (REC) is one of the core functions of the HRA, which is set up to safeguard the rights, safety and well-being of participants taking part in research (HRA, 2018e). Within the UK there are over 80 local research ethics committees, who examine individual research applications in order to determine whether research is considered to be ethical, based upon all of the information provided (HRA, 2018g). Thankfully, paramedics can now accurately determine whether their research project requires REC approval by using the HRA online decision tool entitled ‘Do I need NHS REC approval?’ and answering the questions as accurately as possible (HRA, 2018a). It is likely that this online decision tool may be particularly helpful for paramedics who are undertaking research involving tissue banks, research databases or research taking place in a non-NHS setting, where REC approval may still be required. Meanwhile, paramedics who have identified that they require REC opinion as part of their HRA approval may find this tool a little less significant.

Once paramedics have created their electronic application via IRAS and have contacted the Central Booking Service, they will be given an appointment at the nearest and most convenient REC meeting, depending on their type of study (HRA, 2018g). Researchers are then required to submit their electronic IRAS application on the same day and await email confirmation of their appointment and confirmation that the submission is valid. In some cases, where their research is deemed to be particularly low risk on first assessment, paramedics may be entered into the proportionate review service (HRA, 2018e). This service provides an accelerated review of research that has no significant issues and can elevate some of the pressure placed upon the larger RECs. Unlike a normal ethics committee meeting, a proportionate review may be reviewed via email, via online conference calls or face-to-face meetings with smaller sub-committees (HRA, 2018e). Research ethics committees aim to arrive at their decision within 10 working days of the committee meeting. The four possible outcomes include (HRA, 2018e):

1.A favourable opinion to proceed

2.A favourable opinion to proceed but with conditions

3.A provisional opinion

4.An unfavourable opinion, which does not give permission to proceed.

Paramedics who receive a favourable opinion to commence with their research should note the HRA and REC approval number and share it with participants, sponsors, colleagues and members of the research team. They can then commence with their research project in the prehospital setting.

Summary

Over the past decade there has been an exponential growth in the number of paramedics who are working in research or who are studying for postgraduate and doctorate programmes. Paramedics are now more likely to be involved in the recruitment of participants into studies within ambulance services, designing research proposals as part of an undergraduate programme, or undertaking original research as part of a multidisciplinary research team. Therefore, paramedics need to be familiar with the ethical considerations and challenges of conducting research in the prehospital setting. On a more practical level, they should know how to build an ethics application on the main digital platforms to be able to submit their application for review. Finally, while this chapter has provided a short overview of the ethical considerations in research, it cannot provide a comprehensive overview of such a broad topic, and so paramedics are encouraged to explore the attached recommended reading in more detail. Paramedic research remains one of the most exciting and fast-moving areas of both paramedic practice and health research. By contributing to the evidence base of our profession, we have the power to transform not only our practice, but also our profession. Using research as this mechanism, change is in our hands.

Recommended Reading

Davies H et al. (2014). Guide to the design and review of emergency research when it is proposed that consent and consultation can be waived. Emergency Medicine Journal, 31: 794–795.

Siriwardena A and Whitley G (2022). Prehospital Research Methods and Practice. Bridgwater: Class Professional Publishing.

References

Annas GJ and Grodin MA (eds) (1992). The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press.

British Educational Research Association (BERA) (2018). Ethical Guidelines for Educational Research. 4th edn. Available at: https://www.bera.ac.uk/researchers-resources/publications/ethical-guidelines-for-educational-research-2018 (accessed 30 June 2023).

British Psychological Society (BPS) (2018). Data Protection Regulation: Guidance for Researchers. Available at: https://www.bps.org.uk/guideline/data-protection-regulation-guidance-researchers (accessed 30 June 2023).

British Psychological Society (BPS) (2021). Code of Human Research Ethics. Available at: https://explore.bps.org.uk/binary/bpsworks/06096a55b82ca73a/9787a5959b2bfdff7ed2a43ad5b3f333a5278925cfd667b1b2e64b5387c91b92/inf180_2021.pdf (accessed 30 June 2023).

College of Paramedics (2017). Post Graduate Curriculum Guidance. Available at: https://collegeofparamedics.co.uk/COP/ProfessionalDevelopment/Post_Graduate_Curriculum_Guidance.aspx (accessed 30 June 2023).

Council for International Organizations of Medical Sciences (CIOMS) (2016). International Ethical Guidelines for Health-related Research Involving Humans. Available at: https://cioms.ch/shop/product/international-ethical-guidelines-for-health-related-research-involving-humans/ (accessed 30 June 2023).

Data Protection Commission (2021). Guidance: Anonymisation and Pseudonymisation. Available at: https://www.dataprotection.ie/en/dpc-guidance/anonymisation-pseudonymisation (accessed 30 June 2023).

European Commission (2018). Medicinal Products: Clinical Trials. Available at: https://ec.europa.eu/health/human-use/clinical-trials_en (accessed 30 June 2023).

European Medicines Agency (2021). Clinical Trial Regulation. Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation (accessed 30 June 2023).

Gelling L et al. (2021). Ethical conduct of nursing research. Journal of Clinical Nursing, 30: e69–e71.

General Medical Council (GMC) (2013). Good Practice in Research and Consent to Research. Available at: https://www.gmc-uk.org/-/media/documents/good-practice-in-research-and-consent-to-research_pdf-58834843.pdf (accessed 30 June 2023).

Gillon R (1994). Medical Ethics: Four Principles Plus Attention to Scope. British Medical Journal, 308: 184.

Health Research Authority (HRA) (2017a). UK Policy Framework for Health and Social Care Research. Available at: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/ (accessed 30 June 2023).

Health Research Authority (HRA) (2017b). Defining Research Table. Available at: http://www.hra-decisiontools.org.uk/research/docs/DefiningResearchTable_Oct2017-1.pdf (accessed 30 June 2023).

Health Research Authority (HRA) (2017c). Research: Before You Apply for Approval. Available at: http://www.hra.nhs.uk/research-community/before-you-apply/protocol/ (accessed 30 June 2023).

Health Research Authority (HRA) (2018a). Is My Study Research? Available at: http://www.hra-decisiontools.org.uk/research/ (accessed 30 June 2023).

Health Research Authority (HRA) (2018b). Protocol. Available at: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/protocol/ (accessed 30 June 2023).

Health Research Authority (HRA) (2018c). What Approvals and Decisions Do I Need? Available at: https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/ (accessed 30 June 2023).

Health Research Authority (HRA) (2018d). Do I Need NHS REC Approval? Available at: http://www.hra-decisiontools.org.uk/ethics/ (accessed 30 June 2023).

Health Research Authority (HRA) (2018e). Research Ethics Committee Review. Available at: https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/research-ethics-committee-review/applying-research-ethics-committee/ (accessed 30 June 2023).

Health Research Authority (HRA) (2018f). Confidentiality Advisory Group. Available at: https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/confidentiality-advisory-group/ (accessed 30 June 2023).

Health Research Authority (HRA) (2018g). Central Booking Service. Available at: https://www.hra.nhs.uk/about-us/committees-and-services/central-booking-service/ (accessed 30 June 2023).

Health Research Authority (HRA) (2020). Medicines for Human Use (Clinical Trials Regulations): Informed Consent in Clinical Trials. Available at: https://www.hra.nhs.uk/documents/294/informed-consent-in-ctimps.pdf (accessed 30 June 2023).

Health Research Authority (HRA) (2021). Data Protection and Information Governance. Available at: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/ (accessed 30 June 2023).

Information Commissioner’s Office (ICO) (2021). The Principles. Available at: https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/principles/ (accessed 30 June 2023).

Integrated Research Application System (IRAS) (2017). A Step by Step Guide to Using IRAS to Apply to Conduct Research in or through the NHS/HSC. Available at: https://www.myresearchproject.org.uk/help/hlpnhshscr.aspx (accessed 30 June 2023).

Integrated Research Application System (IRAS) (2018). Homepage. Available at: https://www.myresearchproject.org.uk/SignIn.aspx (accessed 30 June 2023).

Medical Research Council (MRC) (2004). MRC Ethics Guide: Medical Research Involving Children. Available at: https://www.ukri.org/wp-content/uploads/2022/03/MRC-010322-MRCESRCJointGuidanceInvolvingChildrenResearch.pdf (accessed 24 July 2023).

Medical Research Council (MRC) (2014). Good Research Practice: Principles and Guidelines. Available at: https://www.ukri.org/publications/principles-and-guidelines-for-good-research-practice/ (accessed 24 July 2023).

National Institute for Health Research (NIHR) (2018). Why Research Matters: What Is Research. London: NIHR.

National Library of Medicine (2018). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/home (accessed 30 June 2023).

NHS England (2021). Making Research Matter: Chief Nursing Officer for England’s Strategic Plan for Research. Available at: https://www.england.nhs.uk/wp-content/uploads/2021/11/B0880-cno-for-englands-strategic-plan-fo-research.pdf (accessed 24 July 2023).

Paramedic PhD (2023). Registers: Paramedic Register. Available at: https://www.paramedicphd.com (accessed 30 June 2023).

Quigley M et al. (2020). Medicines and Medical Devices Bill 2019–2020: This note deals mainly with Parts 1 and 3 of the Bill. Available at: https://www.birmingham.ac.uk/Documents/research/Public-Affairs/2019-20/UoB-Briefing-MMDB-July-2020.pdf (accessed 30 June 2023).

Roberts I et al. (2013). The Crash-2 trial: A randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion require in bleeding trauma patients. Health Technology Assessment, 17(10): 1–79.

Royal College of Nursing (RCN) (2009). Research Ethics: RCN Guidance for Nurses. Available at: https://www.qub.ac.uk/elearning/EBN/EBNFilestore/Filetoupload,595987,en.pdf (accessed 24 July 2023).

Shuster E (1997). Fifty Years Later: The Significance of the Nuremberg Code. New England Journal of Medicine, 332(20): 1436–1440.

UK Data Service (2021). Data Protection Act and GDPR. Available at: https://ukdataservice.ac.uk/learning-hub/research-data-management/data-protection/data-protection-legislation/data-protection-act-and-gdpr/ (accessed 30 June 2023).

UK Research and Innovation (2021a). GDPR and Research – An Overview for Researchers. Available at: https://www.ukri.org/wp-content/uploads/2020/10/UKRI-020920-GDPR-FAQs.pdf (accessed 30 June 2023).

UK Research and Innovation (2021b). Data Protection and GDPR Best Practice Guidelines. Available at: https://www.ukri.org/wp-content/uploads/2021/08/MRC-0208212-GDPR-Public-interest-approvals-and-techorg-measures_v180719_updated-2021-01-15.pdf (accessed 30 June 2023).

University of Birmingham (2018). How to Write a Research Proposal. Available at: https://www.birmingham.ac.uk/schools/law/courses/research/research-proposal.aspx (accessed 30 June 2023).

World Medical Association (WMA) (2013). WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants. Available at: https://www.wma.net/policiespost/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-humansubjects/ (accessed 30 June 2023).

¹ However, appreciating the year of publication, arguments have been put forward that this guidance is out of date, and does not reflect current legislative developments or ethical review practices (see Gelling et al., 2021).

Table of Cases and Legislation

Page numbers are given in italics after each case or piece of legislation.

Cases

A County Council v. SB [2010] EWHC 2528 (Fam), 173

A Local Authority v. E & Others [2012] EWHC 1639, 117

A Local Authority v. JB [2021] UKSC 35, 114

A Local Authority v. Z [2004] EWHC 2817 (Fam), 221

A NHS Foundation Trust v. Ms X [2014] EWCOP 35, 122

Aintree University Hospitals NHS Foundation Trust v. James [2013] 1 AC 591, 127

AMDC v. AG [2020] EWCOP 58, 122

Antoniades v. East Sussex Hospitals NHS Trust [2007] EWHC 517 (QB), 55

Arksey v. Cambridge University Hospital NHS Foundation Trust [2019] EWHC 1276 (QB), 62

Attorney General’s Reference (No.6 of 1980) [1981] QB 715, 103

Attorney General’s Reference (No 3 of 1994) [1997] 3 WLR 421, 175

B v. Croydon Health Authority [1995] 1 All E.R. 683, 138

Bailey v. The Ministry of Defence & Anor [2008] EWCA Civ 883, 59

Barnett v. Chelsea and Kensington Hospital Management Committee [1969] 2 WLR 42, 59

Beatty v. Cullingworth [1896] Q.B Unreported 44 CENT L.J. 153 (s896) 121, 94

Black v. Forsey [1988] SLT 57, 112

Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582, 55

Bolitho v. Hackney Health Authority [1997] 1 All ER 771, 57

Border v. Lewisham and Greenwich NHS Trust [2015] EWCA Civ 8, 58

Burne v. A [2006] EWCA Civ 24, 58

C v. North Cumbria University Hospitals NHS Trust [2014] EWHC 61 (QB), 55

CC v. KK [2012] EWHC 2136 (COP), 115

Chatterton v. Gerson [1981] QB 432, 103

Chester v. Afshar [2004] UKHL 41 Pt 2., 104

Choudhury v. South Central Ambulance Service NHS Trust and Portsmouth Hospitals NHS Trust [2015] EWHC 1311 (QB)., 13

De Freitas v. O’Brien [1995] 6 Med LR 108, 54

Devi v. West Midlands RHS [1980] CLY 687, 103

Donoghue v. Stevenson [1932] UKHL 100, 53

E & F (Minors: Blood Transfusion) [2021] EWCA Civ 1888, 170

East of England Ambulance Service NHS Trust v. Mrs J Sanders [2016] UKEAT/0217/14/RN, 14

G v. West Lothian Council [2014] GWD 40–730 ((Sh Ct (Lothian) (Edinburgh)), 144

General Medical Council v. Bawa-Garba [2018] EWHC 76, 68

Gillick v. West Norfolk & Wisbech Area Health Authority [1985] UKHL 7, 165

Glass v. UK [2004] CFLQ 339, 172

Hanson v. Airedale Hospital NHS Trust [2003] CLY 2989 (QB), 58

Hart v. Brown [1972] 289 A 2D 386, 175

Hayes v. South East Coast Ambulance Service [2015] EWHC 18 (QB), 60

Heart of England NHS Trust v. JB [2014] EWHC 342 (COP), 115

Horton v. Evans [2006] EWHC 2808 (QB), 55

Hunter v. Hanley [1955] SLT 213, [1955] ScotCS CSIH_2, 1955 SC 200, [1955–95] PNLR 1, 94

James and Evans v. Alder Hey Children’s NHS Foundation Trust [2018] EWHC 308 (Fam)., 172

Johnson v. Williams [2022] EWHC 1585 (QB), 62

Jones v. Manchester Corporation [1952] 2 QB 852, 55

Judge v. Huntingdon Health Authority [1995] 6 Med LR 223, 54

Kent v. Griffiths [2000] 2 ER 474, 54

King v. Sussex Ambulance NHS Trust [2002] EWCA Civ 953, 14

Kings College Hospital NHS Foundation Trust v. C & Anor [2015] EWCOP 80, 221

LBL v. RYJ [2010] EWHC 266 (COP), 115

Leach v. North East Ambulance Service NHS Foundation Trust [2020] EWHC 2914 (QB), 60

Leigh v. London Ambulance NHS Trust [2014] EWHC 286 (QB), 59

Local Authority X v. MM & Anor (No. 1) [2007] EWHC 2003 (Fam), 109

London Ambulance Service NHS Trust v. S Small [2009] EWCA Civ 220, 13

Marriott v. West Midlands Health Authority [1999] LI Med Rep 23, 57

Maynard v. West Midlands Regional Health Authority [1985] 1 All ER 635, 56

Mental Health Trust v. DD (Therapeutic Sterilisation) [2015] EWCOP 4 (Fam), 116

Montgomery v. Lanarkshire Health Board [2015] SC 11 [2015] 1 AC 1430, 57, 95

Mulholland v. Medway NHS Foundation Trust [2015] EWHC 268 (QB), 58

Nottinghamshire Healthcare NHS Trust v. RC [2014] EWHC 1317 (COP), 138

P (by his litigation friend the Official Solicitor) (Appellant) v. Cheshire West and Chester Council and another (Respondents) P and Q (by their litigation friend, the Official Solicitor) (Appellants) v. Surrey County Council (Respondent) [2014] UKSC 19, 136

Paton v. British Pregnancy Advisory Service [1978] 2 All ER 987,989, 175

Paton v. UK [1980] EHRR 408, 175

PC v. City of York Council [2013] EWCA Civ 478, 114

R (Axon) v. Secretary of State for Health [2006] EWCA 37, 166, 173

R (Maughan) v. Senior Coroner for Oxfordshire [2019] EWCA Civ 809., 221

R (Sessay) v. SLAM and Commissioner of the Police for the Metropolis [2011] EWHC 2617 (QB), 139–140

R v. Adomako [1995] AC 171, 61

R v. Birmingham and Solihull Coroner ex p Cotton [1996] 160 JP 123, 78

R v. Bournewood NHS Trust, Ex p. L [1998] 3 All E.R. 289, 112, 140

R v. Brown [1993] 97 Cr.App.R. 44, [1994] 1 A.C. 212, 103

R v. Pabon [2018] EWCA Crim 240, 82

R (on the application of Munjaz) v. Mersey Care NHS Trust [2003] EWCA Civ 1036, 112

RB Greenwich v. CDM [2019] EWCOP 32, 122

Re A (A Minor) (Wardship: Medical Treatment) [1993] 1 FLR 386, 169, 187

Re A (Children) (Conjoined Twins: Surgical Separation) [2001] Fam 147 (CA) 199 (Ward LJ), 172

Re AK (Medical Treatment: Consent) [2001] 1FLR 129, 101

Re B (A Minor) (Wardship: Medical Treatment) [1990] 1 WLR 1421, CA, 172

Re B (Adult: Refusal of Medical Treatment) [2002] 2 All ER 449, 111

Re C (Adult: Refusal of Treatment) [1994] 1 WLR 290, 110, 111

Re E (A Minor) (Wardship: Medical Treatment) [1993] 1 FLR 386, 187

Re F (Mental Patient: Sterilisation) [1990] 4 BMLR 1 (HL), 147

Re L (medical Treatment: Gillick Competency) [1998] 2 FLR 819, 169, 187, 188

Re LM (Reporting Restrictions: Coroner’s Inquest) [2007] EWHC 1902 (Fam), 83

Re MB (Caesarean Section) [1997] 38 BMLR 175, 111, 116

Re O (A Minor) (Medical Treatment) [1993] 4 Med LR 272, 188

Re PW (Jehovah’s Witness: Validity of Advance Decision) [2021] EWCOP 52, 186

Re R (A Minor) (Blood Transfusion) [1993] 2 FLR 757., 188

Re R (a minor) (wardship: Consent to Treatment) [1992] Fam 11 CA, 189

Re S (A Minor) (Consent to Medical Treatment) [1994] 2 F.L.R. 1065, 169, 187

Re T (A Minor) (Wardship: Medical Treatment) [1997] 1 WLR 242 CA, 172

Re T (Adult: Refusal of Medical Treatment) [1993] Fam. 95., 97, 117, 146

Re W (A Minor) (Medical Treatment: Court Justification) [1993] Fam 64, 169, 189

Re W (A Minor) (Medical Treatment) [1992] 4 All ER 627, 146

Re Wyatt (A child) (medical treatment: continuation of order) [2005] EWHC 693 (Fam), 172

Re X (A Child) (No 2): An NHS Trust v. X [2021] EWHC 65 (Fam), 169, 189

Richards v. Swansea NHS Trust [2007] EWHC 487 (QB), 56

Royal Bank of Scotland PLC v. AB: UKEAT [2020] UKEAT/0266/18/DA, 220

S (Child as Parent – Adoption – Consent) [2017] EWHC 2729 (Fam), 166

Smith v. Southampton University Hospital NHS Trust [2007] EXCA Civ 387, 58

Spencer v. Hillingdon Hospital NHS Trust [2015] EWHC 1058 (QB)., 95

St George’s Healthcare Trust v. S [1998] 3 All ER 673, 175

Stockdale v. Nicholls [1993] 4 Med LR 190, 54

Vo v. France [2004] 2 FCR 577 (ECtHR), 175

Wilsher v. Essex Area Health Authority [1986] AC 1074, 55

Wye Valley NHS Trust v. Mr B [2015] EWCOP 60, 125, 128

Yates and Gard v. Great Ormond Street Hospital for Children NHS Foundation Trust [2017] EWHC 1909 (Fam), 160, 172

ZH v. Commissioner of Police for the Metropolis [2012] EWHC 604 (Admin), 135

ZZZ v. Yeovil District Hospital NHS Foundation Trust [2019] EWHC 1642 (QB), 62

Cases Health and Care Professions Council

HCPC v. Edwards [2015], 12

HCPC v. Fisher [2017], 12

HCPC v. Garnham [2018], 13

Cases USA

Hunter v. Burroughs. June 13, 1918. [96 SE 360], 94

Salgo v. Leland Stanford Jr. University Board of Trustees 154 Cal. App.2d 560, 317 P.2d 170 (1957)., 94

Schloendorff v. Society of New York Hospital, 105 N.E. 92 (N.Y. 1914), 94

Table of Legislation

Table of Statutes

Adults with Incapacity (Scotland) Act 2000, 101, 144, 163, 168, 186, 188, 220, 239

Age of Legal Capacity (Scotland) Act 1991, 162, 165

Age of Majority Act (Northern Ireland) 1969, 162

Care Act 2014, 210

Children (Northern Ireland) Order 1995, 161, 174, 188

Children (Scotland) Act 1995, 162, 189

Children Act 1989, 160, 161, 167

Children Act 2004, 161

Children’s Services Co-operation Act (Northern Ireland) 2015, 162

Coroners and Justice Act 2009, 74, 79, 82

Coroners (Inquests) Rules 2013, 72, 74

Criminal Justice (Scotland) Act 2003, 218

Criminal Justice Act (Northern Ireland) 1966, 220

Criminal Procedure (Scotland) Act 1995, 217

Data Protection Act 1998, 257

Data Protection Act 2018, 105, 107, 281, 269, 276

Eighth Amendment of the Constitution Act 1983, 32

Enduring Power of Attorney (NI) Order 1987, 238

Equality Act 2010, 210

Family Law Reform Act 1969, 161, 169, 187, 189

Fire and Rescue Services Act 2004, 105

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, 67, 110

Health and Social Care Act 2012, 209

Health and Social Work Professions Order 2001, 11, 259

Human Fertilisation and Embryology Act 1990, 163

Human Rights Act 1998, 112, 127, 133, 147, 188, 210, 221, 257

Human Tissue (Authorisation) (Scotland) Act 2019, 196

Human Tissue Act 2004, 174

Human Transplantation (Wales) Act 2013, 196

Law Reform (Parent and Child) (Scotland) Act 1986, 162

Medicines Act 1968, 225, 231

Medicines and Medical Devices Act 2021, 275

Mental Capacity (2016 Act) (Commencement No.1) Order (NI) 2019, 140

Mental Capacity (Amendment) Act 2019, 133, 134, 136

Mental Capacity (NI) Act 2016, 174

Mental Capacity Act (Northern Ireland) 2016, 102, 140, 142–144, 163, 186, 217, 220, 238, 239

Mental Capacity Act 2005, 101, 109–110, 112–116, 118, 120, 122–124, 127–130, 132–140, 142, 143, 145, 146, 148, 152, 153, 163, 168, 186, 217–220, 238–240

Mental Health (Care and Treatment) (Scotland) Act 2003, 144, 151

Mental Health (Northern Ireland) Order 1986, 141, 174, 217

Mental Health (Scotland) Act 1984, 112

Mental Health (Scotland) Act 2015, 173, 217–218

Mental Health (Wales) Measure 2010, 218, 221

Mental Health Act 1983, 76, 82, 100, 123, 137–140, 152–153, 173, 210–221, 240

Mental Health Act 2007, 136, 213

Mental Health Units (Use of Force) Act 2018, 130

Misuse of Drugs Act 1971, 232

National Health Services Act 1946, 1

Organ Donation (Deemed Consent) Act 2019, 196, 199, 200

Police and Criminal Evidence Act 1984, 105, 215

Serious Crime Act 2015, 97

Suicide Act 1961, 210, 220

Table of Statutory Instruments

Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) regulations 2019 (SI 2019/744), 275–276

Medicines for Human Use (Clinical Trials) Amended Regulations 2006 (SI 2006/1928), 278

Misuse of Drugs Regulations 2001, 229, 232

Human Medicines Regulations 2012, 224, 225, 227–229, 231, 232

Table of European Legislation

Directives

Good Clinical Practice Directive (2005/28), 278

Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing directive 95/46/EC (General Data Protection Regulation)., 278

The European Clinical Trials Directive (EC2001/20), 272

Regulations

Clinical Trials Regulation (EC536/2014), 274

Index

ability to weigh information, 146

abortion, 32, 173

absolute right, 169, 184, 189

acid test, 134

actions-based practice, in healthcare, 6–9

acts/omissions doctrine, 248

ADRT. See Advance Decision to Refuse Specific Medical Treatment

Adults with Incapacity (Scotland) Act 2000, 101–102, 144, 147, 150

advance choices, provision for, 148

Advance Decision to Refuse Specific Medical Treatment, 184–186, 239–240

allied health professions, 224

altruism, 21

ambulance

driver, 3–4

NHS Trust, 80

service, professional regulation and accountability in, 13–14

AMHPs. See Approved Mental Health Professionals (AMHPs)

approved clinician, 213

Approved Mental Health Professionals (AMHPs), 212–215

Area Coroner, 75

Article 2 inquests, 80–81

asceticism, 21

Assistant Coroners, 75

assisted suicide, euthanasia and, 247

autonomy, 29–30, 31, 244–245, 247

right to, 33

mental capacity, 110

Bar Standards Board, 78

Baron, Aidan, 257

Bartlett, Edd, 193

beneficence, 28, 39, 244–245

best interests, 142, 143–144, 148, 172

approach, 148

assessments, 123–125, 127, 132

decisions, 109, 123–125

and life-limiting conditions, 127–128

in practice, 127

supporting information, 126

bioethics

autonomy, 29–30

beneficence, 28

justice, 30

non-maleficence, 28–29

blood products, refusal of, 181–191

advance decisions, 184–186

case study, 187–189

context, 182–184

emergency treatment, 186–187

ethical considerations, 191

rights and interests of children, 187–190

BMA. See British Medical Association (BMA)

BNF. See British National Formulary (BNF)

Bolam test, 55–57, 95

Bolitho test, 57–59

breach of duty, 54–55

breathlessness (case study), 248–249

Bristol Royal Infirmary Inquiry, 66

British Medical Association (BMA), 63, 160, 199

British National Formulary (BNF), 232

Broughton, Will, 159

burden of proof, 118

‘but for’ test, 59–60

CAMHS. See Child and Adolescent Mental Health Services

capacity, 96

care, ethics of, 24–25

Care Quality Commission (CQC), 9, 66, 110

causation, 59–61

CDs. See Controlled Drugs (CDs)

chaperones, use of, 175–176

Chief Coroner, 75, 78

Child and Adolescent Mental Health Services (CAMHS), 173

children and young people, 175

mental ill health in, 173–174

organ donation, 174–175

parental and medical disagreement, 172–173

parental responsibilities, 162–163

restraint, used to provide treatment, 177–178

rights and interests of, 160–162

Children’s Services Co-operation Act (Northern Ireland) 2015, 162

civil law, consent and, 103–104

Clarke, Vince, 93

clinical holding, 177–178

clinical negligence

breach of duty, 54–55

causation, 59–61

criminal negligence, 61

Dr Bawa-Garba case, 67–69

duty of care, 53–54

expert opinion, 61–63

learning from error, 66–67

problems with the current system, 63–66

recommendations for future, 69–70

Clinical Negligence Schemes for Trusts (CNST), 63

coercion, 97

College of Paramedics, 3, 224

Collen, Andy, 223

common law, 110–112

community treatment under Mental Health Act 1983

guardianship, 213

Section 17 leave, 213

conclusions, inquests, 83–86

confidentiality, 106, 270

children and, 173

social media and, 258–259

Consensus towards Understanding and Sustaining Professionalism in Paramedic Practice Project (CUSPPP), 6

consent

access to medical records, 105–107

appropriate, 102

brief history of, 94–96

and civil law, 103–104

and criminal law, 103

defined, 93–94

in emergency setting, 100–101, 170

forms of, 104

Fraser guidelines, 164–165

Gillick competence, 164–165

making valid, 96–98

to medical treatment of children, 163–171

and mental capacity, 101–102

models, in organ donation, 199–200

power of entry, 105

refusal to treatment, 104–105, 168–169

16- to 17-year-olds who lack mental capacity, 168

for treatment of non-Gillick competent children (under age of 16), 167–168

understanding proposed treatment, 98–100

consequentialism, 20–21

Controlled Drugs (CDs), 223, 226, 228

Convention for the Protection of Human Rights and Fundamental Freedoms. See European Convention of Human Rights (ECHR)

coroner’s court

history of Office of the Coroner, 73–74

key functions of, 75–76

people, 74–75

Prevention of Future Deaths, 77–78

steps after report, 77

Coroners (Inquests) Rules 2013, 74

Coroners (Investigations) Regulations 2013, 74

Court of Protection, 125

COVID-19 pandemic, 40–41, 43–44

CQC. See Care Quality Commission

criminal law, consent and, 103

criminal negligence, 61

Crown, June, 229, 230

Crown Office and Procurator Fiscal Service (COPFS), 90

Crown Report (1998), 229–230

data protection, 276–277

Declaration of Helsinki (1964), 272–273

deemed consent model, 199

deontology, 21–23

deprivation of liberty, 132–137

Deprivation of Liberty Safeguards, 136

descriptive ethics, 27

different decisions, 122

difficult conversations, 40

dignity, right to, 33–34

DNACPR (Do Not Attempt Cardiopulmonary Resuscitation) forms, 241–243

case study, 243–244

model, 255–256

doctors, in mental health, 213

documentary inquests, 79

documentation, use in management of palliative patients, 237–238

double effect, principle of, 246

Dr Bawa-Garba case, 67–69

Draft Mental Capacity Act 2005, 122

drug and alcohol dependence, 216

duty of care, 53–54

Eaton, Georgette, 159

ECHR. See European Convention on Human Rights (ECHR)

ECtHR. See European Court of Human Rights (ECtHR)

education, ethics in, 44–46

egoism, 21

Eighth Amendment of the Constitution Act 1983, 32

Emergency Medical Technician (EMT), 14

Employment Appeal Tribunal, 13

EMT. See Emergency Medical Technician

England and Wales, 112–113, 218–219

committees, 282–283

coroner’s court, 73–78

inquests, 78–89

Lasting Power of Attorney (LPA), 238–239

mental capacity, 112–140

mental health, 218–219

Mental Health Act 1983 for, 210–217

parental responsibilities, 162

rights and interests of children, 160–161

16- to 17-year-olds who lack capacity in, 168

Suicide Act 1961, 220–221

enhanced inquests. See Article 2 inquests

error, learning from, 66–67

ethical subjectivism, 27

ethics

of care, 24–25

descriptive, 27

in education, 44–46

feminist medical, 25

hermeneutics, 25–26

and law, 32–33

medical, 30–32

meta-ethics, 26–27

morals and, 19

normative, 19–20

research, 47–49

values and, 19

European Commission, Clinical Trials Directive (2001), 274

European Convention of Human Rights (ECHR), 29, 175

European Court of Human Rights (ECtHR), 172

European Union (EU), 275

euthanasia, 247

expert opinion, providing, 61–63

experts, inquests, 82–83

fact-finding inquiry, 77, 78

Family Law Reform Act 1969, 161, 169

feminist medical ethics, 25

fluctuating capacity, 122

foetal rights, 175

legal and ethical principles in treatment of, 159–178

formal equality theory, 30

Fraser guidelines, 164–165

free choice, making, 146

Free Open Access Medical Education (FOAMed) concept, 258

French-Spanish uDCD model, 198–199

fresh inquests, 79

functional test, 115

‘fusion’ approach, 153–154

GCP. See Good Clinical Practice Directive (2005)

GDPR. See General Data Protection Regulation (GDPR)

General Data Protection Regulation (GDPR), 257

General Medical Council (GMC), 95, 242

General Sales List (GSL), 224–225

Gillick competence, 164–165

GMC. See General Medical Council (GMC)

Good Clinical Practice (GCP) Directive (2005), 272, 278

guardianship, 213

HCPC. See Health and Care Professions Council (HCPC)

HCPTS. See Health and Care Professions Tribunal Service

Health and Care Professions Council (HCPC), 2–3, 159, 231–232

Guidance on Social Media 2017, 257, 259, 262

professional regulation and accountability, 9, 10–11

Standards of Conduct, Performance and Ethics, 181, 257

Standards of Proficiency for Paramedics, 257

Health and Care Professions Tribunal Service (HCPTS), 11–13

health research, 270

Health Research Authority, 269, 281, 284–285

hedonism, 21

hermeneutics, 25–26

Hippocrates, 258

Hippocratic Oath, 258

hospital managers, 213

IHCD. See Institute of Health and Care Development

IMPs. See investigational medicinal products (IMPs)

implied consent, 99, 102

inability to communicate decision, 147

independent prescribing, 230–232

informed consent, 94, 98–99, 102, 273, 276. See also consent

inquests, 78–79

Article 2, 80–81

attending, 87–89

conclusions, 83–86

documentary, 79

experts, 82–83

fresh, 79

handling, 79

inquisitorial nature of, 78

interested persons, 79–80

with jury, 81–82

longest-running, 79

record of, 83–86

types of, 79

Institute of Health and Care Development (IHCD), 2

Integrated Research Application System (IRAS), 269, 283, 285, 286

interested persons, 79–80

Internet, 257–258

Investigating Committee Panel (ICP), 11

investigational medicinal products (IMPs), 276, 278

IRAS. See Integrated Research Application System (IRAS)

Jehovah’s Witnesses, 182

Joint Royal Colleges Ambulance Liaison Committee (JRCALC), 3

jury, inquests with, 81–82

justice, 30

and ethics, 244

Kantian deontological principle, 223

Lasting Power of Attorney (LPA), 168

England and Wales, 238

Northern Ireland, 238–239

Scotland, 239

law, ethics and, 32–33

right to autonomy, 33

right to dignity, 33–34

right to life, 33

Law Reform (Parent and Child) (Scotland) Act 1986, 162

learning disabilities, 216

least restrictive option, 130, 145

legal exemptions, in Human Medicines Regulations, 225–227

Liberty Protection Safeguards (LPS), 136–137

life, right to, 33

longest-running inquests, 79

LPA. See Lasting Power of Attorney (LPA)

Maastricht categories, of organ donors, 196

Mallinson, Tom, 237

McCabe-Hogan, Samantha, 209

McFarlane, L.J., 172

medical ethics

history of, 30–31

at present, 31–32

medical records, access to, 105–107

medical research, 283

applying for ethical approval

ethical principles, 270–271

in health and social care, 270

health research, 270

regulations, frameworks and guidelines for, 271–281

research ethics, 270–271

Research Ethics Committee, NHS, 286

research projects, 282

research proposals, 281–282

research protocols, 283–284

university ethics committees, 282–283

medical treatment, mental capacity, 110–112

medicines

case study, 234

exemptions, 225–227

governance, 223

independent and supplementary prescribing, 230–232

paramedic practice guidance relating to, 224–232

patient group directions, 229–230

positivism, 233

professional and ethical issues in practice, 232–234

reductionism, 233

rule-based deontology, 233

in Schedule 17 and 19 to Human Medicines Regulations, 227, 228

memory of decision, 146

mental capacity, 109–110

alternative approach, 152–153

‘fusion’ approach, 153–154

autonomy, 110

common law, 110–112

England and Wales, 112–113

medical treatment, 110–112

Northern Ireland, 140–141

restraint, 112

Scotland

Advance Decisions to Refuse Treatment (ADRT) and, 239–240

best interests, 238

consent to medical treatment for children, 163–164

in England and Wales, 168, 238

mental capacity, consent and, 101–102

mental health

defined, 209

England and Wales, 218–219

Northern Island, 219

Scotland, 219

drug and alcohol dependence, 216

for England and Wales, 210–217

learning disabilities, 216

sections for persons with mental disorders, 212–215

transport, 216

treatment under, 210

mental health legislation

history of, 209–210

Human Rights Act 1998, 221

introduction, 209–210

mental ill health, in children, 173–174

meta-ethics

moral anti-realism, 27

moral realism, 26

Mid Staffordshire NHS Foundation Trust Public Inquiry, 9

Middleton inquests. See Article 2 inquests

Miller Report of 1964, 1

Misuse of Drugs Regulations 2001, 226–227, 229, 232

Montgomery ruling, 95

moral anti-realism, 27

moral nihilism, 27

moral philosophy. See applied ethics; ethics

moral realism, 26

morals, and ethics, 19

National Health Service (NHS), 1, 278, 280

National Health Service Training Authority (NHSTA), 2

National Institute for Health and Care Excellence (NICE), 56, 230

National Patient Safety Agency (NPSA), 66

NHSTA. See National Health Service Training Authority

NICE. See National Institute for Health and Clinical Excellence (NICE)

no-fault compensation system, 65

non-cognitivism, 27

non-maleficence, 28–29, 244

normative ethics, 19–20

consequentialism, 20–21

deontology, 21–23

virtue ethics, 23–24

normative mechanisms, 7

Northern Ireland, 140–141

Enduring Power of Attorney, 238–239

investigating deaths, 90

mental capacity, 141–142

mental health, 219

parental responsibilities, 163

rights and interests of children, 161–162

16- to 17-year-olds who lack capacity in, 168

NPSA. See National Patient Safety Agency

Nuremberg Code (1947), 273–274

ODT. See Organ Donation Taskforce (ODT)

Office of the Coroner, 73–74

one-off decisions, 122

‘opt-out’ model, 199–201

organ donation, 174–175

Organ Donation Taskforce (ODT), 195–196, 199–200, 203

palliative medicine and end-of-life care

Advance Decisions to Refuse Treatment (ADRT), 239–240

DNACPR forms, 241–243, 255–256

ethical considerations, 244–245

euthanasia, 247

Lasting Power of Attorney (LPA), 238–239

law and ethics in, 237–255

principle of double effect, 246

recognition of death, 249

ReSPECT forms, 240–241

paramedic practice guidance, relating to medicines, 224–232

paramedic profession

concise history of, 1–3

defined, 2

evolving practice, 3–4

parental and medical disagreement, 172–173

parental responsibilities, 162–163

patient blaming, 260

patient group directions (PGDs), 224, 229–230, 233–234

Patient Safety Incident Response Framework (PSIRF), 67

PGDs. See patient group directions (PGDs)

positivism, 233

power of entry, consent and, 105

practical ethics. See applied ethics

practice guidance, for paramedics, 224–232

pre-hospital clinicians, organ donation and, 203–204

preference utilitarianism, 21

prescription only medicines (POMs), 225

Prevention of Future Deaths (PFD), 75, 77–78, 109

principle of necessity, 147, 150

principlism, 28

prioritisation of resources, 40–44

profession. See also professionalism

defining, 2

HCPC professional regulation and accountability, 10–11

paramedic

concise history of, 1–3

defined, 2

evolving practice, 3–4

professionalism

actions-based practice, 6–9

allied health professions charter, 8–9

cognitive areas, 7

domains of, 6

normative mechanisms, 7

role of, 6

sociology underpinning identity, 4–5

symbolic mechanisms, 7

values-based practice, 9–10

professionals

guidelines, for ethics in research, 280–281

Mental Health Act 1983 deals with, 211–212, 214–215

proposals, research, 281–282

public campaigns, 260

public interest, 260

pulseless electrical activity (PEA), 38

recognition of death, 249

Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) forms, 240–241, 253–254

Record of Inquest (RoI), 83–86

reductionism, 223

refusal of consent, 104–105

refusal of treatment, 168–169

Renshaw, John, 269

repeated decisions, 122–123

research

ethics, 47–49, 270–271

health, 270

proposals, 281–282

protocols, 283–284

types of, 285

Research Ethics Committee, 286

Research Ethics Service, 282

resources, prioritisation of, 40–44

ReSPECT forms. See Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) forms

responsibilities, parental, 162–163

responsible clinicians, 212–213

restraint, used to providing treatment, 177–178

resuscitation, termination of, 38–40

right to autonomy, 33

right to dignity, 33–34

right to life, 33, 221

rights and interests of children

blood transfusion and, 187–190

England and Wales, 160–161

Northern Ireland, 161–162

Scotland, 162

rule-based (evidence based) deontology, 233

rule utilitarian, 20

same-sex partners, and parental responsibility, 163

Saunders, Dame Cicely, 237

Scotland

investigating deaths, 90

mental capacity, 144–152

mental health, 219

parental responsibilities, 163

rights and interests of children, 162

16- to 17-year-olds who lack capacity in, 168

welfare attorney, 239

Scottish Fatalities Investigation Unit (SFIU), 90

Scottish Independent Advocacy Alliance (SIAA), 149–150

Scottish Law Society, 148

sections of Mental Health Act 1983

for persons with mental disorders, 213, 215

Section 135, 214

Section 136, 215

Section 2, 212

Section 3, 212

Section 4, 212–213

self-harm, 76

self-neglect, 76

Senior Coroner, 75

Serious Crime Act 2015, 97

serious medical treatment (SMT), 128–129

short-term memory, 146

‘snail in the ale’ case, 53

social media

case study, 262–266

confidentiality and, 258–259

legal obligation for paramedics using, 257–258

television documentary and, 262

Specialist Nurse-Organ Donation, 197

statement writing, 86–87

Suicide Act 1961 (England and Wales), 220–221

supplementary prescribing, 230–232

teleological ethics. See consequentialism

television documentary, and social media, 262

tissue donation, 202–203

traffic light system for patient blood management, 183

transport, 216

treatment under Mental Health Act 1983, 210

trolley problem, 23

uDCD. See uncontrolled donation after circulatory death (uDCD)

UK General Data Protection Regulation (GDPR), 109, 276, 277, 281

general principles, 277

legal basis, 277–278

uncontrolled donation after circulatory death (uDCD)

background, 193

categorisation for organ donors, 196

consent models, 199–200

ethical consideration within, 200–201

French-Spanish model, 198–199

introduced in UK, 197–198

pilot models in UK, 197–198

pre-hospital clinicians and, 203–204

tissue donation, 202–203

United Kingdom and, 201–202

undue influence, 97–98

United Kingdom

Donation Ethics Committee, 201

pilot models in, 197–198

Policy Framework for Health and Social Care Research, 270, 280

uDCD introduced in, 197–198

university ethics committees, 282–283

utilitarianism theory, 20–21

values

-based practice, in healthcare, 9–10

and ethics, 19

verification of death, 249

virtue ethics, 23–24

voluntariness, 96–98

welfare attorneys, 149–150

welfare guardians, 149–150

WMA. See World Medical Association (WMA)

World Medical Association (WMA), 233, 272