Wolf Leslie E, Ram Natalie, Contreras Jorge, Beskow Laura M
Georgia State University College of Law, 85 Park Place, Atlanta, GA, 30303, United States.
University of Maryland Francis King Carey School of Law, 500 W. Baltimore Street, Baltimore, MD 21201, United States.
J Law Biosci. 2024 Feb 22;11(1):lsae003. doi: 10.1093/jlb/lsae003. eCollection 2024 Jan-Jun.
With the Supreme Court's decision in , reproductive research now joins other sensitive research topics that present legal risks to research participants, underscoring the role of Certificates in protecting them. Yet, stakeholders question whether Certificates will hold up in court. In this article, we describe the essential arguments supporting Congress's regulation of biomedical research and, thus, Certificates, under its authority to regulate interstate commerce. Our analysis should reassure researchers and Institutional review boards who rely on Certificates to protect the confidentiality of research participants' data. We conclude with recommendations for stakeholders based on our analysis.
随着最高法院在[具体案件]中的裁决,生殖研究如今已加入其他对研究参与者存在法律风险的敏感研究主题行列,这凸显了证书在保护他们方面的作用。然而,利益相关者质疑证书在法庭上是否能站得住脚。在本文中,我们阐述了支持国会依据其监管州际商业的权力对生物医学研究进行监管,进而对证书进行监管的关键论点。我们的分析应能让依赖证书来保护研究参与者数据保密性的研究人员和机构审查委员会安心。我们根据分析结果为利益相关者提出了建议。