Approving High Risk, Rejecting Low Risk

In private conversation, business meetings of IRBs, and workshops on human subject research, concern is often expressed over the apparent lack of consistency in the way in which IRBs evaluate protocols. Conclusions are sometimes perceived as arbitrary and capricious. We have observed that protocols with high-risk elements are often quickly approved, while other protocols that present apparently lower risks run into great difficulty during the evaluation process. We will use two recent cases, not to provide solutions to the problems, but rather to indicate the dynamics that led to different outcomes

Complex Systems and Decision Making · Evaluation and Performance Assessment · Medicine · Software Engineering Techniques and Practices