Chapman Carolyn Riley, Quinn Gwendolyn P, Natri Heini M, Berrios Courtney, Dwyer Patrick, Owens Kellie, Heraty Síofra, Caplan Arthur L
NYU Grossman School of Medicine.
The Translational Genomics Research Institute.
Am J Bioeth. 2025 Feb;25(2):47-60. doi: 10.1080/15265161.2023.2276161. Epub 2023 Nov 27.
Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward.
在研究背景下，对群体和第三方的危害及风险可能很大，尤其是在涉及基因组学、人工智能和/或机器学习技术的以数据为中心的研究中。本文探讨美国联邦法规是否以及应如何调整，以更好地与当前的伦理思维保持一致并保护群体利益。关于群体利益，《通用规则》的三个方面值得关注和重新审视：机构审查委员会（IRB）对研究风险/益处的评估；知情同意过程中的披露要求；以及知情同意豁免标准。根据对个人和社区的尊重，研究人员和IRB在设计和审查方案时应分别系统地考虑潜在的群体危害。研究参与者应在同意过程中被告知任何潜在的群体危害。我们呼吁就这些问题进行更多的公开讨论、实证研究和规范分析，以确定正确的监管和政策前进方向。
