The Web of Legal Protections for Participants in Genomic Research

95 Pages Posted: 8 Feb 2019

See all articles by Leslie E. Wolf

Leslie E. Wolf

Georgia State University College of Law

Erin C. Fuse Brown

Georgia State University College of Law

Ryan Kerr

Arnall Golden & Gregory, LLP

Genevieve Razick

Arnall Golden & Gregory, LLP

Gregory Tanner

Chilivis, Cochran, Larkins & Bever, LLP

Brett Duvall

Independent

Sakinah Jones

Bryan Cave LLP

Jack Brackney

Martin Clearwater & Bell LLP

Tatiana Posada

Georgia State University, School of Law, Students

Date Written: February 4, 2019

Abstract

The identification and arrest of the Golden State Killer using DNA uploaded to an ancestry database occurred shortly before recruitment for the National Institutes of Health's (NIH) All of Us Study commenced, with its goal of enrolling and collecting DNA, health, and lifestyle information from one million Americans. It also highlighted the need to ensure prospective research participants that their confidentiality will be protected and their materials used appropriately. But there are questions about how well current law protects against these privacy risks. This article is the first to consider comprehensively and simultaneously all the federal and state laws offering protections to participants in genomic research. The literature typically focuses on the federal laws in isolation, questioning the strengths of federal legal protections for genomic research participants provided in the Common Rule, the HIPAA Privacy Rule, or the Genetic Information Nondiscrimination Act (GINA). Nevertheless, we found significant numbers and surprising variety of state laws that provide greater protections than federal laws, often filling in federal gaps by broadening the applicability of privacy or nondiscrimination standards or by providing important remedies for individuals harmed by breaches. Identifying and explaining the protections these laws provide is significant both to allow prospective participants to accurately weigh the risks of enrolling in these studies and as models for how federal legal protections could be expanded to fill known gaps.

Keywords: human subjects research, DNA, genomic data, genetic privacy, health law, privacy law, state laws, clinical research, clinical trials

JEL Classification: I18, K32, K39

Suggested Citation

Wolf, Leslie E. and Fuse Brown, Erin C. and Kerr, Ryan and Razick, Genevieve and Tanner, Gregory and Duvall, Brett and Jones, Sakinah and Brackney, Jack and Posada, Tatiana, The Web of Legal Protections for Participants in Genomic Research (February 4, 2019). Health Matrix: Journal of Law-Medicine, vol. 29, 2019; Georgia State University College of Law, Legal Studies Research Paper . Available at SSRN: https://ssrn.com/abstract=3328892

Leslie E. Wolf (Contact Author)

Georgia State University College of Law ( email )

P.O. Box 4037
Atlanta, GA 30302-4037
United States

Erin C. Fuse Brown

Georgia State University College of Law ( email )

P.O. Box 4037
Atlanta, GA 30302-4037
United States

Ryan Kerr

Arnall Golden & Gregory, LLP ( email )

2800 One Atlantic Center
1201 West Peachtree Street
Atlanta, GA 30309-3450
United States

Genevieve Razick

Arnall Golden & Gregory, LLP ( email )

2800 One Atlantic Center
1201 West Peachtree Street
Atlanta, GA 30309-3450
United States

Gregory Tanner

Chilivis, Cochran, Larkins & Bever, LLP ( email )

3127 Maple Dr NE
Atlanta, GA 30305
United States

Brett Duvall

Independent ( email )

No Address Available

Sakinah Jones

Bryan Cave LLP ( email )

United States

Jack Brackney

Martin Clearwater & Bell LLP ( email )

220 East 42nd Street
New York, NY 10017
United States

Tatiana Posada

Georgia State University, School of Law, Students ( email )

Atlanta, GA
United States

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