Can I be sued for that? Liability risk and the disclosure of clinically significant genetic research findings

Ethics, Policy & Law

Can I be sued for that? Liability risk and the disclosure of clinically significant genetic research findings.

Amy L McGuire et al. Genome Research, March 27, 2014

Can I be sued for that? Liability risk and the disclosure of clinically significant genetic research findings

1. Amy L McGuire1,4, 
2. Bartha Maria Knoppers2, 
3. Ma'n H Zawati2 and
4. Ellen Wright Clayton3

+Author Affiliations

1. ¹ Baylor College of Medicine;
2. ² McGill University;
3. ³ Vanderbilt University

1. ↵* Corresponding author; email: amcguire@bcm.tmc.edu

Abstract

Genomic researchers are increasingly faced with difficult decisions about whether, under what circumstances, and how to return research results and significant incidental findings to study participants. Many have argued that there is an ethical, maybe even a legal obligation to disclose significant findings under some circumstances. At the international level, over the last decade there has begun to emerge a clear legal obligation to return significant findings discovered during the course of research. However, there is no explicit legal duty to disclose in the United States. This creates legal uncertainty that may lead to unmanaged variation in practice and poor quality care. This paper discusses liability risks associated with the disclosure of significant research findings for investigators in the United States.

• Received December 4, 2013.
• Accepted March 14, 2014.

• Published by Cold Spring Harbor Laboratory Press

This article is distributed exclusively by Cold Spring Harbor Laboratory Press for the first six months after the full-issue publication date (seehttp://genome.cshlp.org/site/misc/terms.xhtml). After six months, it is available under a Creative Commons License (Attribution-NonCommercial 3.0 Unported), as described at http://creativecommons.org/licenses/by-nc/3.0/.