Peer-reviewed article
The Potential Benefits of Research May Justify Certain Research Risks.
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…
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.
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About the author
John D. Lantos is a pediatrician and bioethicist writing on AI in medicine, neonatal intensive care, and end-of-life decisions. His essays appear in JAMA, JAMA Pediatrics, the Hastings Center Report, the New England Journal of Medicine, and Aeon. Read more about John.