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Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice

78 Pages Posted: 15 Feb 2013 Last revised: 6 Feb 2014

Leslie E. Wolf

Georgia State University College of Law

Mayank J. Patel

Jones Day

Brett A. Williams

Centers for Disease Control

Jeffrey L. Austin

Law Office of Jeffrey L. Austin; University of North Carolina (UNC) at Chapel Hill - School of Government

Lauren Dame

Duke University

Date Written: 2013

Abstract

Researchers often require and collect sensitive information about individuals to answer important scientific questions that impact individual health and well-being and the public health. Researchers recognize they have a duty to maintain the confidentiality of the data they collect and typically make promises, which are documented in the consent form. The legal interests of others, however, can threaten researchers’ promises of confidentiality, if they seek access to the data through subpoena. Certificates of Confidentiality (Certificates), authorized by federal statute, are an important tool for protecting individually identifiable sensitive research data from compelled disclosure. However, questions persist in the research community about the strength of Certificate protections, and the evidence on which to judge the strength is scant. In this article, we address those questions through a careful examination of the legislation and regulations concerning Certificates and the reported and unreported cases we have identified through our legal research and interviews with legal counsel about their experiences with Certificates. We also analyze other statutes that protect research data to compare them to the Certificate’s protections, and we review other legal strategies available for protecting research data. Based on our analysis, we conclude with recommendations for how to strengthen protection of sensitive research data.

Keywords: certificates of confidentiality, research data, human subjects research, confidentiality, disclosure, sensitive, law, subpoena

JEL Classification: I18, I19, K00, K20, K23, K32, K39, K40, K41, K49, Z00

Suggested Citation

Wolf, Leslie E. and Patel, Mayank J. and Williams, Brett A. and Austin, Jeffrey L. and Dame, Lauren, Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice (2013). Minnesota Journal of Law, Science & Technology, Vol. 14, No. 1, 2013; Georgia State University College of Law, Legal Studies Research Paper No. 2013-07. Available at SSRN: https://ssrn.com/abstract=2217833

Leslie E. Wolf (Contact Author)

Georgia State University College of Law ( email )

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

Mayank J. Patel

Jones Day ( email )

3500 SunTrust Plaza
303 Peachtree Street, N.E.
Atlanta, GA 30308-3242
United States

Brett A. Williams

Centers for Disease Control ( email )

Atlanta, GA
United States

Jeffrey L. Austin

Law Office of Jeffrey L. Austin ( email )

P.O. Box 15905
Durham, NC 27704
United States

University of North Carolina (UNC) at Chapel Hill - School of Government ( email )

CB 3330 Knapp Sanders Building
Chapel Hill, NC 27599
United States

Lauren Dame

Duke University ( email )

100 Fuqua Drive
Durham, NC 27708-0204
United States

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