Proper procedures for informed consent are widely recognized as an ethical requirement for biomedical research involving human beings, in particular as a means to respect the autonomy and personal integrity of potential and actual research participants.

Biobanks are repositories of human biological materials collected for biomedical research. There are over 300 million stored specimens in the United States, and the number grows by 20 million per year. In the post-genome world of high throughput gene sequencing and computational biology, biobanks hold the promise of facilitating large-scale research studies. New organizational and operational models of research repositories also raise complex issues of big science, big business, and big ethical concerns.

Objective: To examine how research ethics boards review research projects in emerging disciplines such as functional neuroimaging.Design: To compare the criteria applied and the decisions reached by REBs that reviewed the same mock research protocol in functional neuroimaging.Participants: 44 Canadian biomedical REBs, mostly working in public university or hospital settings.Main measurements: The mock research protocol “The Neurobiology of Social Behavior” included several ethical issues operating at all three levels: personal, institutional and social. Data consisting of responses to closed questions were (...) analysed quantitatively. Qualitative analysis of open-question responses used mixed classification.Results: Similar criteria were used by most participating REBs. Yet the project was unconditionally approved by 3 REBs, approved conditionally by 10 and rejected by 30.Conclusions: The results point to the difficulty for REBs of reviewing all kinds of research projects, regardless of field, by relying on international and national norms framed in general terms and a possible variation between REBs in the interpretation of their mandate for the protection of research subjects. (shrink)