Ethical review of biobank research: Should RECs review each release of material from biobanks operating under an already-approved broad consent and data protection model?

BACKGROUND: The use of broad consent in biobank research has implications for the procedures of ethics review. This paper describes these implications and makes a recommendation for how to deal with them. ANALYSIS: Two steps in the ethics review of biobank research can be distinguished. In a first step, a research ethics committee (REC) reviews a biobank's framework regarding oversight procedures (e.g. broad consent form and data protection model). A second step then reviews specific projects that require the release of particular biomaterial and/or data. This paper argues that only a few research-related risks remain for the second step of ethical review and that a self-regulated body such as a biobank internal access committee would suffice (in principle) to address these risks.
CONCLUSION: The reduction of REC involvement in biobank research proposed here has three aims: (i) to conserve time and money, (ii) to allow RECs to focus on higher-risk areas, and (iii) to promote professional self-regulation. Assuming that the public understands that neither REC involvement nor competent access committees can guarantee 100% protection against misuse of data, the proposed reduction of REC involvement could also enhance the public perception of biobank research as an ethically-sensitive enterprise that can be sufficiently controlled through competent self-regulation. In order to compensate for reduced REC involvement and to maintain public trust, biobanks should implement safeguards such as public information on approved projects.