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)

The Journal of Law, Medicine &Ethics, Volume 43, Issue 4, Page 673-674, Winter 2015.

Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common Rule and dramatically tightening the criteria for waiving consent to biospecimen research. After considerable pushback from both researchers and patients and amid rumors of intractable disagreement among Common Rule agencies, the Final Rule published on the last day of President Obama's administration left out these troubling changes, and there was a collective sigh of relief. (...) Relief is appropriate, but celebration premature: researchers have little reason to avail themselves of the new broad consent option offered in the Final Rule, and the question of whether biospecimens ought to be treated as inherently identifiable has merely been postponed. (shrink)

In addressing the creation and regulation of biobanks in different countries, a short descriptive introduction to the social and cultural backgrounds of each country is mandatory. The State of Israel is relatively young, and can be characterized as a multi-religious, multi-ethnic, multi-cultural society, somewhat similar to the American melting pot. The current population is 8.3 million, a sharp rise resulting from a 1.2 million influx of immigrants from the former Soviet Union in the 1990s. Seventyfive percent are Jewish, 20% Arabs, (...) and several other minorities. The birth rate is 3.8 per family, the highest in the Organization for Economic Cooperation and Development. (shrink)