Safe from Subpoena - The Importance of Certificates of Confidentiality to the Viability and Ethics of Research

35 Pages Posted: 4 Jun 2020

See all articles by Emily Haney-Caron

Emily Haney-Caron

Independent

Naomi Goldstein

Drexel University

David DeMatteo

Drexel University Thomas R. Kline School of Law

Date Written: 2015

Abstract

One thousand individuals participate in a drug trial for an ulcerative colitis medication to see if it is effective for treatment-resistant colitis. Substantial debilitating side effects are discovered that were unknown before the drug was FDA-approved. Many people who were prescribed the drug and experienced these side effects-none of whom participated in the study-initiate a class-action lawsuit against the drug's manufacturer and cite the published results of the research study as evidence. The drug's manufacturer seeks to subpoena all of the research records and data, including the participants' identities and complete medical histories, to defend itself against the suit.

Keywords: Confidentiality, Ethics, Research

Suggested Citation

Haney-Caron, Emily and Goldstein, Naomi and DeMatteo, David, Safe from Subpoena - The Importance of Certificates of Confidentiality to the Viability and Ethics of Research (2015). Akron Law Review, Vol. 48, No. 2, 2015, Available at SSRN: https://ssrn.com/abstract=3595289

Emily Haney-Caron

Independent ( email )

Naomi Goldstein

Drexel University ( email )

3141 Chestnut St
Philadelphia, PA 19104
United States

David DeMatteo (Contact Author)

Drexel University Thomas R. Kline School of Law ( email )

3320 Market Street
Philadelphia, PA 19104
United States

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