Health Research Governance in Africa

Law, Ethics, and Regulation

Cheluchi Onyemelukwe-Onuobia

• Publisher: Routledge
• Year: 2018
• ISBN:
  9781351713054
• Edition: 1
• Topic: Negocios y empresa
• Subtopic: Gobierno empresarial

The globalisation of research has resulted in the increased location of research involving humans in developing countries. Countries in Africa, along with China and India, have seen research grow significantly. With emerging infectious diseases, such as Ebola and Zika, emphasising the risk of public health crises throughout the world, a further increase in health research, including clinical research in developing countries, which are often the sites of these diseases, becomes inevitable. This growth raises questions about domestic regulation and thegovernance of health research.

This book presents a comprehensive and systemic view of the regulation of research involving humans in African countries. It employs case studies from four countries in which research activities continue to rise, and which have taken steps to regulate health research activity: South Africa, Nigeria, Kenya, and Egypt. The book examines the historical and political contexts of these governance efforts. It describes the research context, some of the research taking place, and the current challenges. It also looks at the governance mechanisms, ranging fromdomestic ethical guidelines tolegal frameworks, the strengthening of existing regulatory agencies to the role of professional regulatory bodies. The book analyses the adequacy of current governance arrangements within African countries, and puts forward recommendations to improve the emerging governance systems for health research in African and other developing countries.It book will be a valuable resource for academics, researchers, practitioners and policy-makers working in the areas of health research, biomedical ethics, health law and regulation in developing countries.

1 Introduction

The globalisation of research has resulted in increased location of research in developing countries. Countries in Africa, and developing countries like China and India, have seen research grow significantly. With emerging infectious diseases such as Ebola and Zika raising the spectre of public health crises throughout the world, an increase in clinical and other kinds of research in developing countries, often the sites of these diseases, becomes inevitable.¹ But how is this research regulated? How are the regulatory, safety, and public health concerns of research addressed within domestic contexts?

From the late nineties to now, the questions concerning health research involving human participants have expanded to encompass the matter of ethics and whether or not the ethics practised by health researchers in resource-constrained settings should differ from the ethics of research in richer countries. Health research in developing countries, including countries in Africa, has also raised questions of health and economic justice: the effects of economic inequality on what diseases receive attention. The results of the soul-searching of experts have spilled over from the pages of academic journals into amendments of international ethics guidelines, such as the World Medical Association’s Helsinki Declaration,² and into efforts by organisations such as the United States National Institutes of Health to train bioethicists in African countries.³

The increase in externally sponsored research in developing countries, including African countries, has only intensified the need for a proper scrutiny of the regulation and governance of such research. Important questions of global justice and equity, and the arguably greater vulnerability of research participants in poor countries continue to be raised. What naturally follows, then, is concern about how adequately research participants in such countries are protected and the existence and sufficiency of any governance mechanisms for that purpose.

Historical events in several countries, including developed countries, have underscored the need for regulation and oversight of health research involving humans. These include the oft-cited examples of human experimentation atrocities during the Second World War in Germany, the United States Tuskegee Syphilis Study,⁴ the Willowbrook studies,⁵ the Jewish Chronic Hospital Disease Study in Brooklyn,⁶ and the Cameron experiments in Canada.⁷ The controversies surrounding the Zidovudine trials in several developing countries in the late 1990s⁸ brought to the fore that poorer countries could not be excluded from discussions of how best to protect human participants within research. Further, some evidence of such research has only recently been uncovered, such as the Guatemalan syphilis studies.⁹

The local examples within African countries further underscore the need to ensure appropriate research governance. From the Pfizer incident in Nigeria in the mid-nineties, where it was alleged that Pfizer acted unethically in its testing of a drug during a meningitis epidemic,¹⁰ (including failure to obtain informed consent and lack of ethics review approval) to the conviction of a doctor in Zimbabwe for failure to seek relevant approvals and for failure to obtain informed consent for human experimentation in the 1990s,¹¹ the need to protect participants in health research is a widespread concern. The recent movement towards genomic research, such as was captured in the H3Africa project, further highlights the potential benefits of research and emphasises the need for understanding and enforcing ethics in health research.

Several factors, both global and local, have had a significant impact on the adoption of domestic governance research governance frameworks. The combination of the increase in externally funded research, greater cognizance of research scandals, increased awareness of the need to protect research participants, more bioethics expertise and capacity, and the drive towards the use of clinical trials registries has resulted in more formalised governance frameworks within some African countries, including through legislation, strengthening of drug regulatory authorities, and ethics review mechanisms. In this regard, a number of African countries have developed instruments for guiding and regulating health research involving humans. These instruments form the basis of governance of research in these countries, and this seems to be an appropriate time, therefore, to consider the governance of health research in Africa.¹²

What are the governance mechanisms currently employed in African countries? While some aspects of research governance have received attention, others have only begun to receive attention, such as the legal frameworks. What is the contribution of law to health research governance in Africa? Professional regulatory bodies, often functioning under the shadow of law, could also play an important role in health research governance. What is their place in the current health research governance matrix? Other institutions potentially involved in research governance such as non-governmental organisations and civil society bodies have not received much attention in current literature. Evidence from other areas of health indicates that these organisations are a powerful force in the health space in many African countries. What is their place, if any, in current health research governance structure? What role could they or ought they to play? Can research participants find a voice through civil society organisations as has happened in some developed countries? What challenges do African countries face in regulating research?

The issues

There continues to be considerable interest in health research involving humans in developing countries, including African countries. The increasing awareness of the difference in the circumstances of developing countries and developed countries; the higher burden of disease; and the higher level of vulnerability of persons in developing countries, including African countries, to exploitation have, at the same time, prompted concerns about the ethical conduct of research involving humans in these countries. The conduct of external researchers in developing countries has been criticised by several commentators for failing in some cases to meet the ethical standards which such researchers would have been compelled to adopt in developed countries. There have also been a number of claims that multinational pharmaceutical companies have conducted trials in developing countries not using the same ethical standards that they would adopt abroad and possibly endangering the lives of the research participants involved in such trials.¹³

Previous research has focussed in part on examining the ways in which the economic inequalities and disparity in access to healthcare between developing countries and developed countries have affected the types of research conducted in developing countries by external sponsors and who dictates the research agenda, including the types of research to be conducted.¹⁴ Earlier research also focussed on how these inequalities, and the difficulties in applying the international ethical guidelines, give rise to ethical concerns and controversies.¹⁵ The literature has therefore focussed on several ethical concerns in research in developing countries, including the adequacy of informed consent procedures in developing countries, the standard of care to be offered to persons involved in randomised clinical trials, access to the benefits of the research, and the inadequacy of ethics review in developing countries.¹⁶

Although these challenges have become well recognised, and the need to balance ethical requirements and sociocultural differences is understood, there is little consensus on precisely how they are to be addressed by researchers in practical situations. For instance, when, if ever, is it appropriate to deviate from international ethical guidelines? Does cultural relativity justify ethical relativism? Is ethical relativism permissible in particular instances? Does it constitute “ethical imperialism” to impose the requirements of the international ethical guidelines, regardless of differing circumstances, or is a universal standard the only justifiable standard? These questions also have great relevance for concerns surrounding the standard of care¹⁷ issue, an ethical concern that has received much attention in the literature.

The standard of careissue can rightly be said to be the issue that thrust ethical issues in research involving humans in developing countries into the limelight in recent years. It is perhaps the most hotly debated issue in internationally sponsored research in developing countries. This concern revolves mostly around the nature of the care and treatment provided during research, including all the preventive or therapeutic treatment that ought to be provided to participants in the course of the research.¹⁸ The debate originates from the basic ethical requirement that participants in research should not be exploited. But how this basic ethical requirement is to be translated into actual practice, especially in developing countries, which have more limited healthcare options, has created heated debate in the literature. Several broad issues arise with regard to standard of care in research. In view of the limited healthcare options available in many developing countries, what standard of care should be offered to participants in the control arm of clinical research? Should this differ in any respect from the standard of care offered within similar research elsewhere in the world, particularly in developed countries? Should the same ethical standards apply across borders, irrespective of the different contexts, including poverty and poor healthcare systems? Is a different standard justifiable on the grounds that the results of the research will ultimately benefit wider populations in developing countries?¹⁹

The debates surrounding the issue of standard of care were ignited by the 1997 article of Lurie and Wolfe in the New England Journal of Medicine.²⁰ In this, they objected to the apparently unethical nature of clinical trials conducted by the United States National Institutes of Health (NIH) and the Center for Disease Control (CDC) for the prevention of perinatal transmission of HIV involving HIV-positive women in South Africa, Uganda, Thailand, and other developing countries. The women were not provided with antiretroviral treatment, thereby arguably allowing many infants to contract HIV unnecessarily. The trials were argued to be against international ethical guidelines, notably the Helsinki Declaration, which at that time required that “every patient, including those of a control group, if any … should be given the best proven diagnostic and therapeutic method.”²¹ Commentators insisted that since the use of a placebo would have been unethical in the United States, the use of placebos in zidovudine trials in these developing countries was also unethical.²² Critics countered that placebo-controlled trials were necessary to produce faster, clearer, and more reliable results than would otherwise be obtained through the use of active controls, which would be more expensive and less efficient. There have been other cases, for instance, the Surfaxin trials in several Latin American countries, in which a placebo was to be used, although effective treatment was available in the United States²³ and other allegations of improper placebo use in South Africa.²⁴ This issue remains problematic. For example, a rotavirus vaccine study with infants in India in which placebos were used, reported in The Lancet in 2014, has raised concern.²⁵

Ethical issues arise also with respect to issues such as informed consent in situations where people are vulnerable because of their economic circumstances, their levels of education, or the lack of health infrastructure. Other ethical concerns include privacy and confidentiality in different cultural contexts and access to the benefits of the research when it is over. Thus, despite the provisions of the international ethical guidelines on these issues, there continues to be controversy in this area and a diversity of thinking on the issues,²⁶ and new revisions of international guidelines do not appear to have solved all the controversial issues.²⁷

More recently, newer ethical issues are also emerging, for example, around access to experimental medicines, especially in the wake of the Ebola epidemic;²⁸ privacy and confidentiality; and informed consent in relation to genomic research and biobanking.²⁹ Aspects of the governance mechanisms and instruments have also become more prominent.³⁰

In this book, I focus on what the current and emerging governance frameworks say about these issues. What effect have these debates had on the domestic governance frameworks of African countries? Do the ethical guidelines differ from international ethical guidelines, such as the Helsinki Declaration and the Council for International Organizations of Medical Sciences International Ethical Guidelines for Human Research involving Humans, 2016 (CIOMS Guidelines)³¹ on these issues? What ethical frameworks govern externally sponsored researchers in African countries at this time? What is the role of the international ethical guidelines? Are they a descriptive standard of what is to be done or an aspirational ideal? Is the world evolving to a unified standard? Do domestic policies reflect such a unified stand...