Abstract

http://ssrn.com/abstract=2217833
 
 

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


Leslie E. Wolf


Georgia State University College of Law

Mayank J. Patel


Jones Day

Brett A. Williams


Centers for Disease Control

Jeffrey L. Austin


Georgia State University

Lauren Dame


Duke University

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

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.

Number of Pages in PDF File: 78

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

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Date posted: February 15, 2013 ; Last revised: February 6, 2014

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: http://ssrn.com/abstract=2217833

Contact Information

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
Georgia State University ( email )
35 Broad Street
Atlanta, GA 30303-3083
United States
Lauren Dame
Duke University ( email )
100 Fuqua Drive
Durham, NC 27708-0204
United States
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