{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:15:06Z","timestamp":1787022906689,"version":"build-2736575974"},"reference-count":15,"publisher":"American Academy of Pediatrics (AAP)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,3,1]]},"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.1542\/peds.2018-1703","type":"journal-article","created":{"date-parts":[[2019,2,20]],"date-time":"2019-02-20T08:31:23Z","timestamp":1550651483000},"source":"Crossref","is-referenced-by-count":4,"title":["The Potential Benefits of Research May Justify Certain Research Risks"],"prefix":"10.1542","volume":"143","author":[{"given":"David","family":"Wendler","sequence":"first","affiliation":[{"name":"Department of Bioethics, National Institutes of Health, Bethesda, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert M.","family":"Nelson","sequence":"additional","affiliation":[{"name":"Child Health Innovation Leadership Department, Johnson & Johnson, Raritan, New Jersey; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John D.","family":"Lantos","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Children\u2019s Mercy Hospital, Kansas City, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2019,3,1]]},"reference":[{"key":"2021121013192516500_B1","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1186\/s13052-015-0118-6","article-title":"Placebo-controlled trials in pediatrics and the child\u2019s best interest.","volume":"41","author":"Di Pietro","year":"2015","journal-title":"Ital J Pediatr"},{"key":"2021121013192516500_B2","first-page":"138","volume-title":"Ethical Conduct of Clinical Research Involving Children","author":"Field","year":"2004"},{"key":"2021121013192516500_B3","volume-title":"Code of Federal Regulations 45CFR46 Subpart D\u2014Additional DHHS Protections for Children Involved in as Participants in Research","author":"Department of Health and Human Services","year":"1991"},{"key":"2021121013192516500_B4"},{"key":"2021121013192516500_B5","unstructured":"Secretary\u2019s Advisory Committee on Human Research Protections. 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