Rationalizing Risk Assessment in Human Subject Research

Professor Coleman takes a critical look at the process institutional review boards (IRBs) use to review research protocols, focusing specifically on risk assessment, one of the most important, and least understood, elements of protocol review. He argues that IRBs’ current approach to risk assessment closely mirrors the deliberative process used by common-law juries, and that in both juries and IRBs this process suffers from considerable flaws.