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

Author:

Wolf Leslie E.,Patel Mayank J.,Tarver Brett A. Williams,Austin Jeffrey L.,Dame Lauren A.,Beskow Laura M.

Abstract

Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to publish identifying data.The interests of others, however, can threaten researchers' promises of confidentiality when legal demands are made to access research data (e.g., through subpoena). In some cases, the subject of the litigation is tightly connected to the research questions, and litigants' interest in the data is not surprising. Researchers conducting studies on tobacco or occupational or other chemical exposures, for example, are relatively frequent targets of subpoenas.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference149 articles.

1. 124. See Wolf, , supra note 95 for a fuller discussion of our legal analyses regarding Certificates.

2. 83. People v. Still, 369 N.Y.S.2d at 761 (App. Div. 1975).

3. 65. PremPro Order, supra note note 61, at 1; Transcript of Hearing on Motion to Quash/Motion for Protective Order at 3, Dummit v. CSX Transportation, Inc., 01-C-145 (Cir. Ct. W. Va. Dec. 7, 2006) (on file with author).

4. 132. United States v. Mead Corp., 533 U.S. 218, 241 (2001). The Court has ruled that “interpretive rules…enjoy no Chevron status as a class.” Id., at 232. However, guidance documents are entitled to Skidmore deference. Christensen v. Harris County, 529 U.S. 576, 585–87 (2000) (relying on cases in which Skidmore deference was used for guidance documents).

5. 33. People v. Newman, 298 N.E.2d 651 (N.Y. 1973).

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