Certificates of Confidentiality: Legal Counsels’ Experiences with and Perspectives on Legal Demands for Research Data

J Empir Res Hum Res Ethics, October 2012

13 Pages Posted: 26 Apr 2015

See all articles by Leslie E. Wolf

Leslie E. Wolf

Georgia State University College of Law

Lauren Dame

Duke University

Mayank Patel

Jones Day

Brett Williams

Centers for Disease Control

Jeffrey Austin

Law Office of Jeffrey L. Austin

Laura M. Beskow

Vanderbilt University Medical Center

Date Written: 2012

Abstract

The Certificate of Confidentiality (Certificate) is an important tool for protecting identifiable, sensitive human subjects research data in the United States. However, little is known about the Certificate’s effectiveness in protecting identifiable data. We interviewed 24 legal counsel representing U.S. research institutions about their experiences with legal demands for research data. Our respondents reported few, if any, legal demands over the course of their tenure, but two- thirds had experience with legal demands for data protected by a Certificate. They reported such demands often were resolved without disclosure of identifiable research data, typically without court intervention. While our respondents reported similar success protecting identifiable data in court, they often did not rely on the Certificate to do so.

Suggested Citation

Wolf, Leslie E. and Dame, Lauren and Patel, Mayank and Williams, Brett and Austin, Jeffrey and Beskow, Laura M., Certificates of Confidentiality: Legal Counsels’ Experiences with and Perspectives on Legal Demands for Research Data (2012). J Empir Res Hum Res Ethics, October 2012, Available at SSRN: https://ssrn.com/abstract=2597825

Leslie E. Wolf (Contact Author)

Georgia State University College of Law ( email )

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

Lauren Dame

Duke University ( email )

100 Fuqua Drive
Durham, NC 27708-0204
United States

Mayank Patel

Jones Day ( email )

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

Brett Williams

Centers for Disease Control ( email )

Atlanta, GA
United States

Jeffrey Austin

Law Office of Jeffrey L. Austin ( email )

Durham, NC 27704
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

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