Department of Bioethics, National Institutes of Health, Bethesda, Maryland.
Child Health Innovation Leadership Department, Johnson & Johnson, Raritan, New Jersey; and.
Pediatrics. 2019 Mar;143(3). doi: 10.1542/peds.2018-1703. Epub 2019 Feb 20.
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.
美国法规仅允许机构审查委员会在风险最小化或（在某些情况下）仅略高于最小化时批准儿科临床试验，或者当风险因参与者潜在直接获益而合理时。但是，机构审查委员会应如何确定儿科临床试验的风险是否因参与者潜在获益而合理？在本期伦理圆桌会议中，我们考虑了哪些潜在获益可以证明哪些研究风险是合理的，重点是随机临床试验。
