Publication Title

Journal of Law, Medicine & Ethics

Document Type

Article

Publication Date

Fall 2015

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.

Comments

External Links
SSRN

Recommended Citation

Leslie E. Wolf, Mayank J. Patel, Brett A. Williams Tarver, Jeffrey L. Austin, Lauren A. Dame, & Laura M. Beskow, Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice, 43 J.L. Med. & Ethics 594 (2015).

DOI

10.1111/jlme.12302

Volume

43

Issue

3

First Page

594

Last Page

609

Download

Share

COinS