With the Supreme Court's decision in Dobbs, 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.
Keywords: confidentiality; ethics; law; protection of research subjects.
© The Author(s) 2024. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School.