The Potential Benefits of Research May Justify Certain Research Risks.
Level V
Where this comes from
- Record sourced from PubMed, PMID 30787097.
- Also identified by DOI 10.1542/peds.2018-1703 and PMC identifier 10081016.
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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.
Medical subject headings
- Biomedical Research
- Ethics Committees, Research
- Randomized Controlled Trials as Topic