Smilan Lisa E
Visiting scholar at the Institute of Law, Psychiatry, and Public Policy at the University of Virginia and a member of the National Institutes of Health Intramural Institutional Review Board.
Ethics Hum Res. 2022 Sep;44(5):22-31. doi: 10.1002/eahr.500140.
Biobanks and health data repositories provide rich reservoirs of information for use in biomedical research. These repositories depend on participants donating identifiable health data and biospecimens that may be used in perpetuity by unlimited numbers of researchers for unnamed research topics. Since 1991, U.S. federal regulatory provisions, collectively known as the Common Rule, have required informed consent of participants in federally funded human subjects research, but recent changes to the Common Rule now sanction "broad consent" in the repository research context. Broad consent is not defined in the revised Common Rule; thus, researchers and their institutions are left to determine ad hoc what broad consent means and requires. Without leadership and guidance from the U.S. Department of Health and Human Services, stakeholders with potential conflicts of interest will reach their own conclusions and craft new and varied standards for consent. The result will be uneven protections for participants.
生物样本库和健康数据储存库为生物医学研究提供了丰富的信息资源。这些储存库依赖于参与者捐赠可识别的健康数据和生物样本，这些数据和样本可能会被无数研究人员永久用于未指明的研究课题。自1991年以来，美国联邦监管规定，统称为《通用规则》，要求联邦资助的人体受试者研究的参与者给予知情同意，但最近对《通用规则》的修改现在在储存库研究背景下批准了“广泛同意”。修订后的《通用规则》中没有对广泛同意进行定义；因此，研究人员及其机构只能自行临时确定广泛同意的含义和要求。由于缺乏美国卫生与公众服务部的领导和指导，存在潜在利益冲突的利益相关者将自行得出结论，并制定新的、各不相同的同意标准。结果将是对参与者的保护参差不齐。
