Ross Lainie Friedman
Department of Pediatrics, MacLean Center for Clinical Medical Ethics, University of Chicago, IL, USA.
Kennedy Inst Ethics J. 2004 Jun;14(2):165-86. doi: 10.1353/ken.2004.0023.
Subpart D of 45 CFR 46 focuses on research involving children. Section 46.407 addresses research that is not otherwise approvable. The research is not otherwise approvable because either (1) it seeks to enroll healthy children, but offers no prospect of direct benefit and entails more than minimal risk; or (2) it seeks to enroll children with a disorder or condition, but offers no prospect of direct benefit and entails more than a minor increase over minimal risk. According to 46.407, such research can be permissible if it is approved by a panel of experts. Prior to 2000, only two 407 panels had been convened, but in 2001, the Office for Human Research Protections received more than 20 protocols for 407 review. The first, entitled "Precursors to Diabetes in Japanese American Youth," serves here as a case study in human subject protections.
《联邦法规法典》第45编第46条D分部着重关注涉及儿童的研究。第46.407节涉及其他情况下不可批准的研究。该研究在其他情况下不可批准，原因如下：（1）它试图招募健康儿童，但没有直接受益的前景，且风险超过最低限度；或者（2）它试图招募患有某种疾病或病症的儿童，但没有直接受益的前景，且风险比最低限度略有增加。根据第46.407节，如果此类研究得到专家小组的批准，则可能是允许的。2000年之前，仅召集了两个407专家小组，但在2001年，人类研究保护办公室收到了20多个需要进行407审查的方案。第一个方案题为“日裔美国青少年糖尿病的先兆”，在此作为人类受试者保护的一个案例研究。
