Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2014 Jan;11(1):e1001584.
doi: 10.1371/journal.pmed.1001584. Epub 2014 Jan 14.

Managing incidental genomic findings in clinical trials: fulfillment of the principle of justice

Rafael Dal-Ré  1 , Nicholas Katsanis  2 , Sara Katsanis  3 , Lisa S Parker  4 , Carmen Ayuso  5
Affiliations

Managing incidental genomic findings in clinical trials: fulfillment of the principle of justice

Rafael Dal-Ré et al. PLoS Med. 2014 Jan.

Abstract

Rafael Dal-Ré and colleagues discuss how incidental findings are likely to be viewed as potential benefits of research participation in genomics trials, and investigators should implement mechanisms to ensure provision of timely and appropriate care. Ensuring provision of such interventions in countries lacking a universal public health care system may prove challenging.

Please see later in the article for the Editors' Summary

PubMed Disclaimer

Conflict of interest statement

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.

References

    1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) Belmont report: ethical principles and guidelines for the protection of human subjects of research. Fed Regist 44: 23192–23197.
    1. Dresser R (2011) The role of patient advocates and public representatives in research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, et al. The Oxford textbook of clinical research ethics. Oxford: Oxford University Press pp. 231–241.
    1. Mestan KK, Ilkhanoff L, Mouli S, Lin S (2011) Genomic sequencing in clinical trials. J Trans Med 9: 222. - PMC - PubMed
    1. Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, et al. (2008) Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 36: 219–248. - PMC - PubMed
    1. Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, et al. (2013) ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 15: 565–574. - PMC - PubMed