US regulations allow institutional review boards to approve pediatric clinical trials only when the risks are minimal or (in some cases) a minor increase over minimal, or when the risks are justified by a potential for direct benefit to the participants. But how should an institutional review board determine if the risks of pediatric clinical trials are justified by a potential for participant benefit? In this Ethics Rounds article, we consider which potential benefits can justify which research risks with a focus on randomized clinical trials.
Copyright © 2019 by the American Academy of Pediatrics.