title: Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice.
abstract: The federal Certificate of Confidentiality plays an important role in research on sensitive topics by authorizing researchers to refuse to disclose identifiable research data in response to subpoenas in any legal setting. However, there is little known about how effective Certificates are in practice. This article draws on our legal and empirical research on this topic to fill this information gap. It includes a description of the purpose of Certificates, their legislative and regulatory history, and a summary of the few reported and unreported cases that have dealt with Certificates. In addition, we outline other statutory confidentiality protections, compare them to the Certificate's protections, and analyze some of the vulnerabilities of a Certificate's protections. This analysis allows us to make specific recommendations for strengthening the protections afforded to research data.
authors.affiliation: Professor of Law at Georgia State University College of Law in Atlanta, Georgia, and Director of the GSU Center for Law, Health & Society. She received her J.D. in 1991 from Harvard Law School in Cambridge, Massachusetts and her M.P.H. in 1997 from Johns Hopkins School of Public Health in Baltimore, Maryland.
authors.forename: Leslie E
authors.initials: LE
authors.lastname: Wolf
authors.affiliation: Attorney with Jones Day in Atlanta, Georgia. He received his J.D. in 2012 from Georgia State University College of Law in Atlanta, Georgia and his M.P.H. in 2009 from the George Washington University in Washington, D.C. He was a research assistant with Professor Wolf from 2010-2012.
authors.forename: Mayank J
authors.initials: MJ
authors.lastname: Patel
authors.affiliation: Attorney with Insley & Race in Atlanta, Georgia. She received her J.D. in 2012 from Georgia State University College of Law in Atlanta, Georgia. She was a research assistant with Professor Wolf from 2010-2012.
authors.forename: Brett A
authors.initials: BA
authors.lastname: Williams Tarver
authors.affiliation: Research associate with the University of North Carolina School of Government in Chapel Hill, North Carolina. He received his J.D. in 2012 from Georgia State University College of Law in Atlanta, Georgia. He was a research assistant with Professor Wolf from 2010-2012.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Austin
authors.affiliation: Associate Director of Graduate Studies, MA in Bioethics and Science Policy at Duke University and a Senior Lecturing Fellow at Duke University School of Law in Durham, North Carolina. She received her J.D. in 1983 from Harvard Law School in Cambridge, Massachusetts and her M.P.H. in 1992 from the Harvard School of Public Health in Boston, Massachusetts.
authors.forename: Lauren A
authors.initials: LA
authors.lastname: Dame
authors.affiliation: Associate Professor with the Duke Clinical Research Institute and the Duke University School of Medicine, Department of General Internal Medicine. She received her M.P.H. in 1995 from Boston University and her Ph.D. in Health Policy and Administration with a minor in Epidemiology in 2005 from the University of North Carolina in Chapel Hill, North Carolina.
authors.forename: Laura M
authors.initials: LM
authors.lastname: Beskow
mesh_terms: D003219:Confidentiality / Q000331:legislation & jurisprudence*; D006801:Humans; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D012926:Social Control, Formal