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This commentary is a critical response to the article written by David Resnik regarding the use of a standard of evidence for Institutional Review Board (IRB) decision making. Resnik suggests that IRBs should not only base decisions on evidence, but that this evidence should be sufficient to ensure a “clear and convincing” standard similar to that used by juries for legal proceedings. We agree that the increased use of evidence to meet this standard would be ideal since this provides clear guidance and could allow for a more transparent IRB review. However, to effectively meet this standard, significant modification would be required for researchers as well as for IRBs’ processes. First, researchers would be required to identify, understand and include appropriate scientific and ethics evidence in support of their protocol. IRB members and IRB professionals would need to discuss the importance, value, and significance of evidence in order to come to a collective decision regarding each protocol. Such responsibilities are justifiable and could bring much needed rigor and transparency to the system but they would require time, training, research, and education. While Resnik’s suggestion seems to incorporate a small change with respect to a standard, in application it would actually require a novel system.

Reimagining IRB review to incorporate a clear and convincing standard of evidence