ABSTRACT
Suppose that you are a Dutch academic working on a collaborative project with colleagues in Nigeria. Together with your Nigerian collaborators, you are assessing a program for delivering dental care to those with limited or no access to oral health services. While the subjects in this study will not be exposed to more than a minimal risk of harm, this is a research project, and as such it requires ethical oversight to ensure adequate protection for participants. So far, so good. But the question arises: whose ethical standards should be applied to this research in Nigeria? In the Netherlands, there are regulations governing the conduct of research with human subjects. The Central Committee on Research Involving Human Subjects oversees research involving humans, supervising the work of the local medical research ethics committees that review and approve research protocols. Nigeria does have a system for the protection of human subjects of research; it is a system that uses Institutional Review Boards (IRBs), a model of research review developed in the United States in the late 1970s. While Nigerian IRBs are certified by the U.S. Office for Human Research Protections (OHRP, 2009), you know that in Nigeria it is not unusual for research to go ahead without IRB approval, and even when a research project is approved, the protocol submitted to the ethics board might not be followed in the field. You are also aware of the mixed motivation that lies behind the creation and use of IRBs in Nigeria (and elsewhere in Africa). It is true that the IRB mechanism-like your medical research ethics committee review-is intended to protect vulnerable research subjects. But the rush to win U.S. certification for IRBs in Africa is also linked to the need of North American and European researchers to obtain the imprimatur of an IRB in order to publish their findings or gain certification from the U.S. Food and Drug Administration for a new drug or medical device. The bottom line is that, when (and if ) an IRB approves a research protocol in Nigeria, it is often the result of applying a set of standards based on an ethical tradition developed in a different culture, which is suited to the hypothesisdriven nature of most modern health science, but not to the values and urgent needs of the local population (Simon, Mosavel, & van Stade, 2007).
