Regulation of biomedical research in Africa

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Abstract
The case for local statutory regulation The current debate on research ethics in Africa and other developing countries has focused on informed consent,1–4 7 12 15 standards of care,8–10 17 18 ethical review, and distributive justice.4–12 15 To promote ethical research in Africa, appropriate legislative controls, increases in research capacity, new career structures, and appropriate allocation of resources may be needed. Although most developing countries adhere to international ethical codes, some research sponsors and regulatory agencies may ignore these codes to pursue national interests.5 19 Some foreign researchers have taken advantage of the lack of local legislation and have ignored rudimentary local statutes.20 This tendency by some researchers and sponsors to circumvent international guidelines suggests paternalism and double standards. When accused of unethical behaviour during trials of the drug trovafloxacin mesylate (Trovan) in Nigeria, Pfizer claimed that the trial did not aim to gather clinical data but to help sick children in a poor region of Nigeria.12 Claimants in the ensuing case against Pfizer alleged that several children were denied effective alternative treatment so that clinical data could be obtained to support approval by the regulatory agency.4 Act-Up Paris (an AIDS lobby group) accused researchers carrying out trials of tenofovir in Africa of unethical conduct, because treatment was not supplied after the study.6 In a study by Merck in Guatemala on indinavir sulphate (Crixivan), arrangements were not in place for treatment to continue after the study, even though neither the participants nor the government could afford the drugs on the open market.11 The right to informed consent and US exceptionalism “The right to informed consent is a fundamental human and legal right, which the judiciary takes very seriously. It would appear, however, that federal oversight agencies—Office of Human Research Protections and Food and Drug Administration—fail to enforce informed consent requirements by major American institutions—even when they have been caught in gross violation.”12 Alliance for Human Research Protections, 2003 The need for research oversight and regulation “When research involves human participants, the uncertainties inherent in any research study raise the prospect of unanticipated harm… Thus there can be a conflict between the need to test hypotheses and the requirement to respect and protect individuals who participate in research. This conflict and the resulting tension that can arise within the research enterprise suggest a need for guidance and oversight.”3 US National Bioethics Advisory Commission, 2001 What is an ethics committee? “An independent body in a member state, consisting of healthcare professionals and non-medical members, whose responsibilities it is to protect the rights, safety, and wellbeing of human subjects involved in a trial and provide public assurance of that protection by, among other things, expressing an opinion on the trial protocol, the suitability of the investigator and the adequacy of the facilities, and on methods and documents to be used to inform trial subjects and obtain their informed consent.”16 Current EU definition of an ethics committee, 2001 Disclosure of information to research participants is a legal requirement under United States federal regulations, but the National Bioethics Advisory Committee found that disclosures relating to diagnosis, risk, research design, and benefits after the trial were not always clearly presented in developing countries.3 Thus countries in Africa need to introduce a framework for research governance, based on international guidelines and local cultural, medical, and legal realities. These regulations could provide guidance on forming local research ethics committees, informed consent procedures, standards of care in biomedical research, and aspects of distributive justice, such as post-trial benefits or compensation for injuries arising from research. Most problems in sponsored research among vulnerable populations occur in these areas, as illustrated by recent cases.3–12 15 21 Regulations to govern these aspects of research have been introduced in Western countries—for example, a recent EU directive and US federal regulations.3 16 19 21 Also, although many ethical dilemmas and issues on patients' rights may arise in research, certain rights may have only a prima facie standing and can be over-ridden by equally compelling moral considerations.