Ethical Review of Research Involving Human Subjects in Nigeria: Legal and Policy Issues

Abstract

IND. INT'L & COMP. L. REV. recommendations by the NBAC 5 and the Nuffield Council on Bioethics. 6 The conduct of biomedical research and clinical trials in developing countries 7 could be motivated by altruistic concerns to help developing countries confront particular health care problems, thereby reducing the inequality in global health research expenditures. 8 However, this conduct (i.e. biomedical research) could also exploit and take advantage of the abundant research subjects, poverty and disease, low level of regulation, and comparatively cheaper cost of clinical trials in developing countries. 9 For instance, a developed country's pharmaceutical corporation may undertake clinical trials in a developing country simply out of convenience and to quickly generate clinical data that would support drug registration application in the developed country.' 0 A myriad of factors contribute to recent public sensitivity to trials in developing countries. This includes the placebo-controlled trials that took 5. NBAC, supra note 3. 6. See NUFFIELD COUNCIL ON BIOETHICS, THE ETHICS OF RESEARCH RELATED TO HEALTHCARE IN DEVELOPING COUNTRIES (2002). 7. The expressions "developing" and "developed" countries have contested meanings and are not used here in any technical sense. The term "developing" is used to describe nonindustrialized countries in South Africa that are still caught in the throes of poverty and economic underdevelopment. Similarly, "developed" is used to describe industrialized and wealthy countries in North Africa.

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

“…In addition, a few highly-publicized controversies have led to greater attention to the potential for exploitation in the context of international collaborative research. For example, a lawsuit currently pending against the foreign sponsors of a Nigerian study of an anti-meningitis drug alleges that children in the control group were not given adequate medications, that parents were not told that effective treatment for meningitis was readily available outside of the study, and that documents claiming that the study had been approved by a Nigerian ethics review process were forged [ 19 ]. Publicity about cases like this has given sponsors a greater incentive to support the development of local RECs.…”

Tracing the Weaknesses of the Regulatory Framework for Clinical Trial in Nigeria

“…There has been the existence of Rockefeller Foundation which initiated the Rockefeller Foundation Yellow Fever Commission for West Africa, called the Yellow Fever Commission in 1925. It built a research unit in Yaba, Lagos (Nwabueze, 2004). Although it was only the issue of consent that was considered, there was a question of ethics as one of the corner stone in every clinical trial around the world.…”

“…The law that established it made no specific provision regarding the kind of research and no mention was made of ethical aspect of it. Thereafter, the University College Hospital was established in Ibadan 1953, twenty years after the Nigeria military government established Medical Research Council of Nigeria (MRC) which was established to conduct medical research in Nigeria (Nwabueze, 2004).…”