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?

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