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

Abstract

In 1999, the United States National Bioethics Advisory Commission (NBAC) commissioned an empirical study to analyze the impact of U.S. regulations on the conduct of United States biomedical research sponsored in Nigeria. ' The study, conducted by Patricia Marshall, was part of the NBAC's larger project on the ethical and policy issues involved in clinical trials in developing countries. On April 30, 2001,2 NBAC produced its recommendations in two volumes; volume one contained analyses and recommendations,3 and volume two contained the reports on commissioned studies. Marshall's case study of genetic epidemiology research in Nigeria highlighted the various problems confronting researchers and ethics review committees in Nigeria. Specifically, the study focused on the implications of cultural relativism on the implementation of United States rules of informed consent in Nigeria.4 Though Marshall was not concerned with broader issues, such as the general regulation of research involving human participants in Nigeria, the analysis provides a useful forum for beginning such an important discussion. Some problematic ethical issues in the conduct of biomedical research have gained notoriety in the wake of globalization of biomedical research. These issues have attracted much attention in recent years, warranting copious