The Potential Benefits of Research May Justify Certain Research Risks.
Document Type
Article
Publication Date
3-2019
Identifier
DOI: 10.1542/peds.2018-1703
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.
Journal Title
Pediatrics
Volume
143
Issue
3
MeSH Keywords
Administration, Intravenous; Biliary Atresia; Biomedical Research; Child; Ethics Committees, Research; Glucocorticoids; Humans; Methylprednisolone; Prospective Studies; Randomized Controlled Trials as Topic; Risk Assessment
Keywords
Administration, Intravenous; Biliary Atresia; Biomedical Research; Child; Ethics Committees, Research; Glucocorticoids; Humans; Methylprednisolone; Prospective Studies; Randomized Controlled Trials as Topic; Risk Assessment
Recommended Citation
Wendler D, Nelson RM, Lantos JD. The Potential Benefits of Research May Justify Certain Research Risks. Pediatrics. 2019;143(3):e20181703. doi:10.1542/peds.2018-1703
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