The Potential Benefits of Research May Justify Certain Research Risks.

Wendler, David; Nelson, Robert M; Lantos, John D · Pediatrics · 2019

Level V

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Abstract

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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