Protecting Participants in Genomic Research: Understanding the "Web of Protections" Afforded by Federal and State Law

Authors

• Leslie E. Wolf
• Catherine M. Hammack, Belmont University College of LawFollow
• Erin Fuse Brown
• Kathleen M. Brelsford
• Laura M. Beskow

Document Type

Article

Publication Date

2020

Abstract

Advances in genomic research increasingly rely on large-scale datasets combining biospecimens, electronic health records, and behavioral data. This article examines the complex legal framework governing privacy and confidentiality protections for participants in genomic research in the United States. Through a combination of qualitative interviews with national thought leaders and systematic legal analysis of federal and state statutes, the authors assess how existing legal protections operate in practice. The study evaluates several hypothetical research scenarios—including the return of individual results, data breaches, and legal demands for data access—to illustrate how laws such as the Common Rule, HIPAA, the Genetic Information Nondiscrimination Act (GINA), and state statutes collectively create a “web” of protections. The analysis highlights both the strengths and limitations of the current regulatory landscape and underscores persistent gaps that may expose participants to privacy risks.

Recommended Citation

Protecting Participants in Genomic Research: Understanding the “Web of Protections” Afforded by Federal and State Law, 48 J. L. Med. Ethics 1: 126-41 (2020) (with Leslie Wolf, Erin Fuse Brown, Kathleen Brelsford, & Laura Beskow).