Determining risk in pediatric research with no prospect of direct benefit: Time for a national consensus on the interpretation of federal regulations
Determining risk in pediatric research with no prospect of direct benefit: Time for a national consensus on the interpretation of federal regulations
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DOI：
10.1080/15265160601171572
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发表时间：
2007-03-01
影响因子：
13.4
通讯作者：
Prentice, Ernest D.
中科院分区：
文献类型：
--
作者：
Fisher, Celia B.;Kornetsky, Susan Z.;Prentice, Ernest D.
美国联邦关于无直接获益前景的儿科研究的法规限制机构审查委员会（IRB）批准的程序：1）不超过"最小风险"（45CFR46.404）;或2）不超过"最小风险的轻微增加"如果研究与受试者以前或预期的经历相称，并且旨在获得有关儿童健康的至关重要的信息，疾病或病症（45CFR 46.406）（卫生和公众服务部，2001年）。自通过以来的25年里，这些法规帮助委员会平衡了受试者保护与追求科学知识以促进儿童福利的关系。与此同时，IRB将这些法规应用于儿科方案的不一致性很普遍，部分原因是法规语言的模糊性。在过去的十年中，三个联邦委员会已经解决了这些含糊之处：1）国家人类研究保护咨询委员会（NHRPAC）（华盛顿，DC），2）医学研究所（IOM）儿童临床研究伦理行为委员会（华盛顿）;以及3）美国卫生与公众服务部人类研究保护部长咨询委员会（SACHRP）（华盛顿，DC）。各委员会就条例45 CFR 46.404和406中的语言解释得出了类似的结论;这些结论与最近的国际建议以及现行条例所依据的国家生物医学和行为研究人类受试者保护委员会（1977年）原始报告的建议非常一致。根据委员会的公开报告，本文确定了监管语言的模糊性所带来的伦理问题，总结了委员会的审议，并呼吁就建议的标准达成全国共识。
United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" ( 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition ( 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria.