Healthcare Research Ethics and Law

Regulation, Review and Responsibility

Hazel Biggs

• Publisher: Routledge-Cavendish
• Year: 2009
• ISBN:
  9781135309275
• Edition: 1
• Topic: Law
• Subtopic: Law Theory & Practice
• Index: Law

The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject.

Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.

Chapter 1
Research ethics and law in context

Introduction

When new healthcare interventions, including pharmaceutical products, are being investigated for their potential use in human applications it is inevitable that they will need to be tested on human beings. This book concerns the regulation of research involving human participants, human tissues and data pertaining to the health, welfare and social care of individuals. It will assess the ethics and law that govern the conduct of healthcare research, taking account of biomedical and pharmaceutical research, as well as studies that are more concerned with social and practical issues associated with the provision of care. The central focus of the work will be the role and responsibilities of research ethics committees (RECs) in relation to the process of the ethical review of research involving human participants. It will therefore be relevant to RECs operating in the NHS, social care organisations and universities, as well as some private sector organisations. A close examination of the operation of RECs will be conducted to assess the legal and regulatory mechanisms that confront them in the practical conduct of their work. Through this, the extent of the potential legal liability of RECs and their members will be investigated and placed in context. In so doing the book aims to join up the dots and make connections between the theoretical philosophical and ethical principles that underpin the review process and the relevant law, regulation and guidance that pertain in practice.

The relationship between research, ethics and law has a rather fraught history. Researchers have often complained that they are prevented from the exploits of what they regard as beneficial research by restrictive and overly bureaucratic laws (Brazier, 2005). More recently, controversy has been sparked by suggestions that RECs do and should bear greater responsibility than has hitherto been acknowledged (Roy-Toole, 2008). This book aims to explain how law and ethics operate in the context of the review of healthcare research. To do this it will explore the background, form and operation of the law and regulation that applies to medical research in the United Kingdom and locate it within the context of the philosophies and ethical guidelines that underpin the process of ethical review.

This introductory chapter will briefly outline the background against which RECs operate. It will do so by first defining what is meant by research and how it differs from experimentation and innovative treatment, before giving an overview of the process of drug development. Pharmaceutical research takes place within a highly formalised regulatory environment which places constraints on researchers and RECs. This, in turn, has been influential in shaping the organisational approach to the ethical review of healthcare research in the United Kingdom, and also has implications for the regulation and ethical review of social care and university-based research.

Since the early 1960s, a number of prominent professional bodies in the United Kingdom have developed guidance on the ethical conduct of research involving human participants. Notable amongst these was a document formulated by the Medical Research Council (MRC) in 1963 which located the necessity to obtain informed consent from the participant at the centre of any research proposal (MRC, 1967). In 1967 this was followed by a call from the Royal College of Physicians for the establishment of formal RECs to oversee the conduct of medical research (Rosenheim, 1967). After that a system for the ethical review of healthcare research developed in an ad hoc way until the Department of Health (DoH) eventually recommended the formation of properly constituted local RECs in 1991 (DoH, 1991). The fact that these RECs were locally based and locally administered was at once their strength and their weakness, however. Their local knowledge made them ideally placed to assess locally based applications from local researchers, but where investigators sought to conduct studies in a number of centres across many geographical boundaries, the level of bureaucracy involved in the process and inconsistency of outcomes between committees often resulted in delays and discontent (Lewis et al, 2001).

These problems were partially resolved in 1997 by the establishment of multi-centre NHS RECs, which were authorised to conduct a single ethical review of research to be conducted in more than four NHS sites (DoH, 1997). Shortly after this, in 2000, the Central Office for Research Ethics Committees (COREC), which subsequently became the National Research Ethics Service (NRES), was established, and quickly took over responsibility for the governance of all NHS RECs. It published Governance Arrangements for Research Ethics Committees (DoH, 2001) (GAfREC), and embarked on an extensive programme of training and education for REC members, as well as introducing formal processes for member recruitment and standardised researcher applications.

In 2002, following a series of scandals involving poor research practices (the details of which will be discussed in Chapter 2), the DoH published the Research Governance Framework for Health and Social Care (DoH, 2002) (‘Research Governance Framework’), which was revised and updated in 2005. Research ethics is just one aspect of this framework, which also lays down detailed arrangements for maintaining and monitoring standards in health and social care research. Its central aim is to protect the interests of research participants by imposing a chain of responsibility and accountability between researcher and the NHS so that any risks can be identified and managed. Since the introduction of this strict regulatory approach to human research in the health service, there has been a gradual proliferation of formal processes to scrutinise the ethical aspects of all forms of research involving human participants. It is now the case, for example, that universities’ research-funding bodies, like the Economic and Social Research Council (ESRC) (ESRC, 2007), and many private research organisations, compel researchers to submit their research proposals to an ethical review procedure before they can begin their research. Whilst ethical review and research governance may be regarded as providing greater protection for human research participants, its ability to safeguard those participants and the bureaucratic processes that accompany it are not without controversy (Hammersley, 2009).

Some of the reasons behind the increasing formalisation of research ethics will be investigated in Chapter 2, which briefly traces the history of research ethics, including examples of research misconduct in recent history that have resulted in the ethical guidance and regulatory frameworks that now govern healthcare research. Through an exposition of some of the high-profile scandals that have characterised healthcare research in the past, this chapter will demonstrate how we got to where we are today, and try to explain and contextualise the current emphasis on precautionary regulation as a mechanism to safeguard the interests of future research participants.

From there the discussion will continue in Chapter 3 with an overview of the ethical and philosophical frameworks within which research ethics operate in practice. It will consider the philosophical theories that underpin the process of ethical review, such as the interaction between consequentialism and deontology, and the relationship with applied biomedical ethics in this context. Chapter 3 will also investigate the legal status of numerous guidelines relating to the conduct of research involving humans, setting the scene for a more detailed discussion in Chapter 4 of the legal responsibilities of those who undertake the ethical review of research. The aspects of this discussion that relate to the EU Clinical Trials Directive (2001/20/EC), and the Regulations that transpose it into domestic law (the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031 (‘Clinical Trials Regulations’)), will relate specifically to the legal status of both NHS RECs themselves and their individual members. However, the common law implications of conducting ethical review and the application of guidance issued by non-statutory bodies will also be of relevance to ethics committees outside the NHS.

Some features of the ethics and law of research involving human participants, such as the need to protect their dignity and well-being, ensuring that they have given consent and that their confidentiality and privacy are assured, are common to all types of research involving human participants. These aspects, amongst others, are central to the work of NHS RECs and will therefore be discussed at length in Chapters 5 and 6 respectively. From there, Chapter 7 will conduct an in-depth analysis of issues relating to the recruitment of members of particularly vulnerable groups as research participants. Particular emphasis will be placed on research involving children, and adults who lack mental capacity. The impact of the Mental Capacity Act 2005 and its interaction with the Clinical Trials Regulations will be assessed at length, to explain the responsibilities of RECs and researchers in this regard. Chapter 8 will consider the significance of the Human Tissue Act 2004 in relation to research involving human tissue and organs, as well as biobanks and tissue databases. Finally, once the reader is familiar with the central features of the law attached to these areas of healthcare research, Chapter 9 will conclude by drawing together some of the threads and themes apparent throughout the book and introducing some concerns around the issue of research fraud and misconduct.

Research involving the participation of human beings may range from simple surveys or questionnaires, through laboratory research on human tissues and cells, to the study of the effects of new surgical procedures or novel pharmaceutical compounds on healthy volunteers. It is also important to recognise that the researchers themselves are also participants in the research process, and that sometimes their own involvement, for example in some kinds of participatory research methods, or where they are conducting their research in remote locations, may in itself raise ethical concerns. In addition, different regulatory mechanisms exist for different types of research; hence it is sometimes necessary to review these separately in order to generate an understanding of the differences and similarities between them. Pharmaceutical research, for example, is today governed by rigid definitions, regulations and guidelines that pertain only in that context and relate particularly to product licensing. By contrast, much social care research is conducted against a backdrop of ethical guidelines developed by professional bodies and local institutions such as universities. However, international instruments like the World Health Organisation’s Declaration of Helsinki 2008, and the Council for International Organisations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002), apply generally to research involving human beings, though their legal status may be ambiguous.

Much of the legislation recently introduced in the United Kingdom and Europe applies specifically to the regulation of research involving clinical trials of investigational medicinal products (CTIMPs) and medical devices. Therefore, after outlining some of the methodological techniques associated with healthcare research more generally, this introductory chapter will briefly describe the various stages of drug development in order to outline the broad scientific and regulatory context within which RECs charged with reviewing clinical research involving drugs operate. This will provide some insight into the background against which law and ethics interact in the context of research. The impact of other recent legal changes will be assessed in dedicated chapters on vulnerable groups and the Human Tissue Act 2004. However, before embarking on this process it is important to first introduce and define the concept of research so that the associated ethics and regulatory processes are clearly located within their practical context.

What is research?

Research can be difficult to define, particularly in the healthcare setting where there are a number of practices allied to research, such as audit, service development and project evaluation, which are peripheral to research and can generate confusion (Smith, 1992; Wade, 2005). Ordinarily, this can be overcome by referring to the stated aims of audit and service evaluation, which involve measuring an existing form of care or an established service against predetermined standards. Such techniques never assign patients to specific groups to generate new data or study outcomes, and they rarely involve anything more than the administration of a brief questionnaire. As a result there is generally no need for systematic ethical review of audit or service evaluation. By contrast, research involving human subjects, which has the potential to expose the participant to some risks, however minimal, ought properly to be subjected to a thorough ethical review prior to commencement. So great has been the uncertainty about the distinctions between research, audit and service evaluation amongst RECs, however, that they have become the subject of specific guidance from the NRES (NRES, 2007(a)).

The controversy over the potential overlap between these procedures is hardly surprising since there are some clear examples of projects that would not ordinarily be categorised as research that have led to valuable and generalisable results. The long-term institutional confidential inquiries into maternal or peri-operative deaths are described by the Royal College of Physicians as a clear example of this kind of phenomenon (Royal College of Physicians, 2007:17). It is also not unknown for audit, or service evaluation, to raise ethical issues, although this is rare. As a result, whilst it is broadly accepted that their primary aims take them out of the realms of formal research, some grey areas remain. It is therefore important that researchers are prepared to consider whether projects described as audit pose ethical risks, and, if so, whether those risks are proportional to the prospective benefits of the project concerned. In general, concerns about the overlap between service evaluation, audit, and research in the NHS and social care can be resolved by recourse to appropriate guidance and experienced managers under the Research Governance Framework. Similarly, in the university sector, research managers and RECs will usually be able to assess whether a research proposal requires full ethical scrutiny.

Many authors have attempted to produce a precise form of words to describe research, and as part of this endeavour the British Medical Association provides a helpful working definition:

‘Research’ can be defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions using systematic and rigorous methods. All research must meet certain minimum standards. It must, for example, have a well designed protocol, constitute a well conducted project, involve statistically appropriate participant numbers, not necessarily duplicate previous research, and be subject to external review and continuing surveillance. In addition, research involving people who are somehow dependent or vulnerable must also take special account of their interests and priorities.

(BMA, 2004:490)

From this it is apparent that where the aim of research is to generate new knowledge and understanding, it will not usually be expected to benefit the individual participants. Occasionally there will be an incidental benefit to the individual, but in general the beneficiaries of healthcare research will be future patients. Any definition of healthcare research should also recognise that an assortment of practices, ranging from simple observation to more intrusive pharmaceutical or physical interventions, may be included under its auspices. In practice, deciding what counts as simple observation and what amounts to a minimal intervention is often problematic. Merely observing patients, for example, can sometimes require taking measurements and recording changes using intrusive methods such as electrocardiograms or blood tests, for which ethical approval would be required.

Research should also be distinguished from experimentation (Dickens, 1975), which implies a more ‘speculative, ad hoc, approach to an individual subject’ or patient (Mason and Laurie, 2006:651), and from innovative therapy, which aims to treat a specific patient, often where there is no alternative treatment available. In practice it is clear that there may be some overlap between experimentation and innovative treatment since an experiment is quite likely to involve the application of a novel therapeutic approach. However, whilst research involving medicinal products, drugs and the testing of medical devices is highly regulated and requires ethical scrutiny, the regulation of new surgical or physical diagnostic procedures have not traditionally been monitored to the same degree. The controversy surrounding the somewhat unorthodox approaches to children’s heart surgery adopted at the Royal Bristol Infirmary is illustrative of some of the problems inherent in using untested techniques without formal scientific o...

Table of contents

• Biomedical Law and Ethics Library
• Contents
• Acknowledgements
• Preface
• Case list
• Statute list
• List of abbreviations
• Chapter 1 Research ethics and law in context
• Part I Universal themes
• Part II Specialist concerns
• Bibliography
• Index