Incidental genetic findings in randomized clinical trials: Recommendations from the Genomics and Randomized Trials Network (GARNET)

Ebony B. Bookman, Corina Din-Lovinescu, Bradford B. Worrall, Teri A. Manolio, Siiri N. Bennett, Cathy Laurie, Daniel B. Mirel, Kimberly F. Doheny, Garnet L. Anderson, Kate Wehr, Richard Weinshilboum, Donna T. Chen

Research output: Contribution to journalLetter

Abstract

Recommendations and guidance on how to handle the return of genetic results to patients have offered limited insight into how to approach incidental genetic findings in the context of clinical trials. This paper provides the Genomics and Randomized Trials Network (GARNET) recommendations on incidental genetic findings in the context of clinical trials, and discusses the ethical and practical issues considered in formulating our recommendations. There are arguments in support of as well as against returning incidental genetic findings in clinical trials. For instance, reporting incidental findings in clinical trials may improve the investigator-participant relationship and the satisfaction of participation, but it may also blur the line between clinical care and research. The issues of whether and how to return incidental genetic findings, including the costs of doing so, should be considered when developing clinical trial protocols. Once decided, plans related to sharing individual results from the aim(s) of the trial, as well as incidental findings, should be discussed explicitly in the consent form. Institutional Review Boards (IRBs) and other study-specific governing bodies should be part of the decision as to if, when, and how to return incidental findings, including when plans in this regard are being reconsidered.

Original languageEnglish (US)
Article number7
JournalGenome Medicine
Volume5
Issue number1
DOIs
StatePublished - Jan 30 2013

ASJC Scopus subject areas

  • Molecular Medicine
  • Molecular Biology
  • Genetics
  • Genetics(clinical)

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    Bookman, E. B., Din-Lovinescu, C., Worrall, B. B., Manolio, T. A., Bennett, S. N., Laurie, C., Mirel, D. B., Doheny, K. F., Anderson, G. L., Wehr, K., Weinshilboum, R., & Chen, D. T. (2013). Incidental genetic findings in randomized clinical trials: Recommendations from the Genomics and Randomized Trials Network (GARNET). Genome Medicine, 5(1), [7]. https://doi.org/10.1186/gm411