The Law and Ethics of Medical Research

International Bioethics and Human Rights

Aurora Plomer

• Publisher: Routledge-Cavendish
• Year: 2013
• eBook ISBN: 9781135338329
• Topic: Law
• Subtopic: Ethics & Professional Responsibility in Law
• Index: Law

The growing globalization of medical research and the application of new biotechnologies in morally contested areas has forced a revision of international ethical guidelines.

This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and changes in form and content of international instruments regulating the conduct of biomedical research.

The approach adopted is comparative and includes an evaluation of human rights and UK and US law on embryonic stem cell research, the HIV/AIDS trials in the developing world, the Alder Hey Inquiry and the human radiation and nerve gas experiments on human subjects in the US and the UK. This is the first book to analyze some of the major issues in biomedical research today from an international, comparative human rights perspective.

CHAPTER 1

FROM BIOETHICS TO HUMAN RIGHTS
IN BIOMEDICINE

Landmark international codes on medical research, such as the Declaration of Helsinki (1964) and the growth of the modern bioethics movement, were prompted by the appalling abuse of human lives during the Holocaust.¹ In the last decade, however, it is the pace of scientific advances in the application of biotechnologies which has forced a global and international revision of ethical and legal controls in biomedicine, particularly in the field of research involving human subjects.² This chapter provides an overview and analysis of the evolution and changes in form and content of international instruments regulating the conduct of biomedical research from the Declaration of Helsinki to the Council of Europe’s Convention on Human Rights & Biomedicine (CHRB) (Oviedo, 1997). The chapter begins with an analysis of the Declaration of Helsinki, its history, changes and controversy over its substantive norms and its limitations as regards legal enforcement. The evolution of the Declaration of Helsinki is set against the global growth of the bioethics movement, its impact on public policy and the emergence of national and international bioethics committees. A central claim of this chapter is that the increasing globalisation of medical research is highlighting the tension between the aspiration to universality of ethics driven regulation and the emerging reality of the diversity of moral cultures and the need to respect plurality and ethical diversity in democratic societies. I suggest that ethics driven regulation is limited both by its weak legal effect and by the underdeterminacy of general ethical principles and their potential compatibility with a diversity of moral values and theories. The chapter concludes with an overview of the CHRB and argues that the shift to human rights driven regulation represents a fundamental change in the form of regulation of biomedicine which has the potential to offer greater protection to human subjects.

1.1 THE ORIGINS OF INTERNATIONAL BIOETHICS

The origin of modern international bioethics has been traced to the brutal abuse of human lives in the Holocaust.³ At the Nuremberg ‘Doctors Trial’ (1946–47) medical researchers were convicted of ‘crimes against humanity’ on the basis of 10 ethical principles which were said to be fundamental and universally applicable to all eras and cultures.⁴ In the decade that followed, increasing efforts were made to formalise and codify a set of principles which would command international approval.

The World Medical Association (WMA) was founded in 1947 to represent physicians and to promote medical ethics and professional freedom worldwide. In 1948, the WMA issued the Declaration of Geneva,⁵ the first international document stating the ethical duties of physicians to their patients. The Declaration consists of a Physician’s Oath ‘not to use my medical knowledge contrary to the laws of humanity’ and an undertaking to ‘practise my profession with conscience and dignity; the health of my patient will be my first consideration’. The Declaration of Geneva was followed in 1949 by the adoption of the first International Code of Medical Ethics.⁶ The 1949 Code contains a brief statement of a doctor’s duties, which include an obligation to ensure that ‘any act or advice which could weaken physical or mental resistance of a human being may be used only in his interest’, ‘complete loyalty to the patient’, ‘absolute secrecy on all he knows about his patient’ and a list of practices relating to conflicts of interest and monetary benefits which are deemed unethical. The International Code was amended twice in 1968 and last in 1983.⁷ The most notable amendments are to the language, where categorical prescription ‘a physician shall’ replaces the original normative language of ‘should’ and ‘ethical duties’. The 1983 revision of the Code also introduces a requirement that the rights of patients and colleagues shall be respected.⁸ However, in terms of practical impact, it is the Declaration of Helsinki adopted by the WMA in 1964 which has had and continues to have the greatest influence on the international regulation of biomedical research.

1.1.1 The Declaration of Helsinki: content and evolution of norms

The Declaration of Helsinki was originally adopted in 1964. Like the earlier codes, it is intended ‘as a statement of ethical principles to provide guidance’ to physicians and others conducting medical research on human subjects. In terms of its content, the values evinced in the original Declaration look somewhat outdated today. For instance, an assumption of paternalistic benevolence is evident in the relaxed approached to informed consent adopted in the context of therapeutic research. Paragraph II.I states that: ‘If at all possible, consistent with patient psychology, the doctor should obtain the patient’s freely given consent after the patient has been given a full explanation.’⁹

The Declaration has undergone five revisions since it was originally adopted in 1964.¹⁰ The last two revisions (1996 and 2000) in particular have been the subject of fierce international disagreement from within and without the medical profession.¹¹

The distinction between therapeutic and non-therapeutic research in the original 1964 version was declared to be ‘fundamental’.¹² Section II(2) of the 1964 Declaration further added that: ‘The doctor can combine clinical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that clinical research is justified by its therapeutic value for the patient’ (emphasis added). However, the distinction between therapeutic and nontherapeutic research was removed in the 2000 version after a protracted debate and amidst concerns from critics that the removal of the distinction would lower the protection of research participants.¹³ The terms ‘therapeutic’ and ‘non-therapeutic’ have been avoided in new human rights instruments such as the CHRB but, as will be seen, not the related conceptual and normative issues (see Chapter 2).

Controversy also continues to rage over the standards set by Helsinki in relation to the ‘export’ of clinical trials to underdeveloped countries by large pharmaceutical corporations in the fast increasing globalisation of medical research. An audit of external sponsoring of research in developing countries carried out by the US Food and Drug Administration (FDA) in 2001 showed a steep increase in the number of foreign researchers carrying out research in the decade 1990–2000. Numbers grew from 271 in 1990 to 4,458 in 1999. The FDA survey also reveals that the number of countries conducting research increased threefold from 28 to 79 in the same period, with the largest growth occurring in Latin America and Eastern European countries.¹⁴ The controversy over Helsinki standards was prompted by the trials of the drug zidovudine (AZT) to prevent mother to child transmission of HIV. The trials were conducted in Africa under the aegis of the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization (WHO). Previous trials had already established that long courses of the drug reduced transmission of the virus, but the cost of the drug was outside the reach of local populations. The new trials were designed to test the efficacy of shorter and more affordable courses. The shorter courses of zidovudine were tested against a placebo instead of the ‘best proven treatment’ which could not be afforded locally. A furious exchange took place through the pages of the New England Journal of Medicine, following allegations in an editorial that the trials were unethical and exploited populations who were already vulnerable.¹⁵ The dispute centred on the question of whether the standards set in the Declaration are universal or whether they should be adjusted to reflect local circumstances, particularly socio-economic constraints affecting developing countries lacking the health resources available to the industrialised world.¹⁶

The strength of the language used on both sides and accusations by developing countries that it is ‘ethical imperialism’ for outsiders to dictate what sort of research is ethical or unethical¹⁷ have raised questions not only about the universality of Helsinki principles but about the ability of the WMA genuinely to represent an international spectrum of opinion and to achieve the broad consensus required to legitimate its authority.

In addition to the controversies surrounding the relative or universal status of Helsinki norms, increasing concerns have been voiced about the process through which revisions of the Declaration are adopted by the WMA. Both the content of the 1996 revision and the process by which the revisions were made were challenged by the American Medical Association (AMA) which produced its own alternative draft within a year. The WMA rejected the AMA’s draft and produced a new draft which was issued for worldwide public consultation for the first time ever in response to criticisms about the WMA’s lack of accountability.¹⁸ In an international climate where globalisation has prompted concerns about democratic accountability, the authority of the WMA will inevitably become increasingly dependent on its ability to satisfy concerns about public scrutiny and accountability.

1.1.2 Helsinki’s legal status

From a purely legal perspective, the authority of the Declaration is weak and limited. As the language of the Declaration itself makes clear, it is a statement of professional ethical principles or ideals issued by members of the medical profession to other members of the medical profession. The preamble to the original Declaration (1964) stressed that: ‘… the standards as drafted are only a guide to physicians all over the world. Doctors are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries’ (emphasis added).

The practical contribution of the Declaration of Helsinki lies primarily in the influence that it can carry in the area of professional self-regulation in the elaboration of professional codes of practice or alternatively in the drafting of legal instruments which endorse its principles.¹⁹ The Declaration of Helsinki has often been traced as a core influence on the development of many international and national codes governing research on human subjects,²⁰ but where the Declaration has been invoked in legal proceedings, a close analysis of the court rulings reveals that the legal force of the Helsinki Declaration is severely limited by local procedural and substantive rules of law.

The Declaration has been invoked in a series of cases heard by US courts, where it has been cited along with the International Covenant on Civil and Political Rights (ICCPR) as a guide to international legal principles on the conduct of medical experiments.²¹

For instance, in the Pfizer case,²² a claim relying on international law in the US courts had to be founded on an alleged breach of a domestic statute – ‘The Aliens Tort Claims Act’ – in addition to other general rules contained in s 404 of the US Restatement (Third) prescribing the conditions under which claims for breach of international law can be brought by an individual against another private party or the State.²³ The pharmaceutical company Pfizer was alleged by the claimants to have embarked on a medical experiment involving the new and untested antibiotic Trovan which resulted in the deaths of 11 children and caused serious injury to other children including paralysis, deafness and blindness. The children selec...

Table of contents

• COVER PAGE
• TITLE PAGE
• COPYRIGHT PAGE
• ACKNOWLEDGMENTS
• TABLE OF CASES
• INTRODUCTION
• CHAPTER 1: FROM BIOETHICS TO HUMAN RIGHTS IN BIOMEDICINE
• CHAPTER 2: HUMAN RIGHTS AND UNIVERSAL PRINCIPLES
• CHAPTER 3: NON-THERAPEUTIC RESEARCH: DOMESTIC REMEDIES AND CONVENTION RIGHTS
• CHAPTER 4: EMBRYONIC STEM CELL RESEARCH: HUMAN DIGNITY AND THE RIGHT TO LIFE
• CHAPTER 5: THE RIGHTS OF THE DEAD: RESEARCH ON HUMAN TISSUE AND BODY PARTS AFTER BRISTOL AND ALDER HEY
• CHAPTER 6: RESEARCH IN DEVELOPING COUNTRIES: NEW ETHICS AND NEW THREATS TO HUMAN RIGHTS
• BIBLIOGRAPHY