Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the Principle of Justice

Rafael Dal-Ré mail,
Nicholas Katsanis,
Sara Katsanis,
Lisa S. Parker,
Carmen Ayuso

Citation: Dal-Ré R, Katsanis N, Katsanis S, Parker LS, Ayuso C (2014) Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the Principle of Justice. PLoS Med 11(1): e1001584. doi:10.1371/journal.pmed.1001584

Published: January 14, 2014

Copyright: © 2014 Dal-Ré et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: This work required no funding.

Competing interests: The authors have declared that no competing interests exist. The opinions expressed in this article are those of the authors and may not reflect the opinions of the organizations that they work for.

Abbreviations: ACMG, American College of Medical Genetics and Genomics; IRB/REC, Institutional Review Board/Research Ethics Committee; WGS/WES, whole genome or exome sequencing

Summary Points

Genome/exome data are likely to play an increasing role in clinical trials, and incidental findings are likely to be viewed as potential benefits for individuals of research participation.
Participants in clinical trials across differing trial sites utilizing genome/exome sequencing information should be afforded the same standard of care, including return of incidental genomic findings.
Participants may opt in to receiving incidental genomic findings, and clinical trial investigators should implement mechanisms to ensure provision of timely and appropriate care to prevent or ameliorate conditions associated with incidental findings.
Ensuring the provision of such interventions in countries lacking a universal public health-care system may prove more challenging than in countries with public health-care support.