Health research raises profound concerns of an ethical and legal nature — concerns primarily centered on how to balance researchers’ quest for scientific discovery against societal interest in protecting individuals whose participation makes the discovery possible. Particularly in a country such as Nigeria, which, not too long ago, suffered major abuse of research subjects, deploying a robust ethicolegal regime capable of curbing excesses and protecting research participants whilst contemporaneously not frustrating scientific progress is not an easy task. This is even (...) more critical in the context of novel scientific endeavors, such as biobanking and genomic research, particularly when a significant pool of potential donors are inadequately informed about the processes involved in their participation or the result. (shrink)

In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect (...) it will have on research and whether it adequately protects the interests of research participants.There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data. This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation. (shrink)

Not many African countries have been able to develop a robust system for regulating health research within their respective jurisdictions, particularly in the realm of biobanking and genomics. This is not without reason. Aside from underdevelopment and all that it entails or perhaps in consequence thereof, countries in the region have been unable to make significant strides in medical research. But there are exceptions. Amongst the few seeming success stories is Uganda. Nonetheless, although the country has developed what appears to (...) be a functional framework to govern genomic research and biobanking, the consistency of key provisions with international standards, especially those pertaining to privacy of research participants and confidentiality of their health information, is not at all clear. Yet, making this determination – the main objective of this article – is critical in determining the adequacy of protection available to human research subjects in the country. (shrink)

The Human Heredity and Health in Africa Consortium is a conglomeration of research and infrastructure projects spread throughout Africa whose aim is to apply genomic methodology to diseases affecting the people in the region. Its operation is innovative in the sense that it is doing something new; that is, filling a hitherto existing void in genomic research capability of African scientists and infusing resources and manpower to institutions and investigators across Africa. But aside from developing and sustaining capacity in genomic (...) research and biorepositories, H3Africa is also invested in developing appropriate ethical regulatory regime to govern research in these areas. This latter concern –research ethics governance – is the major subject of this paper. Specifically, the paper discusses protection of research participants as envisaged by H3Africa in the area of consent, safeguarding privacy, maintaining confidentiality of health information and sharing of data/biospecimens. The ultimate goal is to determine whether H3Africa initiatives and processes are consistent or at odds with international guidelines and best practices. (shrink)