Constitutional Confidentiality

Posted: 19 Sep 2022 Last revised: 11 Mar 2023

See all articles by Natalie Ram

Natalie Ram

University of Maryland Carey School of Law

Jorge L. Contreras

University of Utah - S.J. Quinney College of Law

Laura M. Beskow

Vanderbilt University Medical Center

Leslie E. Wolf

Georgia State University College of Law

Date Written: September 1, 2022


Federal Certificates of Confidentiality protect sensitive information about human research subjects from disclosure and use in judicial, administrative, and legislative proceedings at both the state and federal levels. While Certificates originally covered sensitive information collected in research about drug addiction use when they were authorized by Congress in the 1970s, today they extend to virtually all personal information gathered by biomedical research studies. The broad reach of Certificates, coupled with their power to override state subpoenas and warrants issued in the context of law enforcement, abortion regulation, and other police powers reserved to the states under the Tenth Amendment, beg the question whether Certificates are constitutional.

This Article, for the first time, examines the fundamental constitutional underpinnings of Certificates and situates them within the context of federal statutory privilege law. In so doing, it makes four contributions to the existing literature. First, after a brief background about Certificates and other congressional action relating to biomedical research, this Article locates the primary constitutional authority undergirding the Certificate statute in the Commerce Clause, with a particular focus on the law of federal statutory privileges and other federal regulation of access to sensitive data. Second, the Article argues that Congress’s power to tax and spend provides further constitutional grounding for Certificates, at least with respect to federally funded researchers and institutions. For both bases of constitutional authority, this Article maps new territory, yielding clarity where there has previously been uncertainty. Third, this Article brings together constitutional doctrines limiting both congressional power and evidentiary privileges to illuminate how these doctrines may require Certificate protections to give way in exceptional cases. In so doing, it bridges traditional constitutional law and evidence law, reaping insights from their intersection from which scholars in both fields may benefit. Finally, this Article considers the implications of this constitutional analysis not only on Certificates, but also on congressional action to regulate human subjects research more generally and for the law surrounding federal statutory privileges.

Keywords: Certificates of Confidentiality; privilege; statutory privilege; Commerce Clause; Spending Clause

JEL Classification: K32, K39

Suggested Citation

Ram, Natalie and Contreras, Jorge L. and Beskow, Laura M. and Wolf, Leslie E., Constitutional Confidentiality (September 1, 2022). University of Utah College of Law Research Paper No. 521, Available at SSRN:

Natalie Ram (Contact Author)

University of Maryland Carey School of Law ( email )

500 West Baltimore Street
Baltimore, MD 21201-1786
United States

Jorge L. Contreras

University of Utah - S.J. Quinney College of Law ( email )

383 S. University Street
Salt Lake City, UT 84112-0730
United States

Laura M. Beskow

Vanderbilt University Medical Center ( email )

Center for Biomedical Ethics and Society
2525 West End Ave., Suite 400
Nashville, TN 37203
United States

Leslie E. Wolf

Georgia State University College of Law ( email )

P.O. Box 4037
Atlanta, GA 30302-4037
United States

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