ABSTRACT
This chapter explores the legal frameworks and regulatory structures for the governance of biomedical research involving human subjects in Nigeria. It describes the history of biomedical research in Nigeria from the colonial era to the year 2000. The chapter examines the sources of Nigerian law relevant to the oversight of biomedical research involving human subjects in Nigeria. It explains the provisions of the National Code for Health Research Ethics (the Code) promulgated by the National Health Research Ethics Committee (NHREC), as well as the National Health Act, 2011 which gave the Code a statutory underpinning. Nigeria has made substantial progress in the regulation of research involving human subjects in its territory; but the challenge is to ensure that it does not lose the regulatory momentum which it currently enjoys. More specifically, National Agency for Food and Drug Administration and Control Act (NAFDAC) plays an important role in the regulation of research involving human subjects in Nigeria.
