Incidental genetic findings in randomized clinical trials: recommendations from the Genomics and Randomized Trials Network (GARNET).
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.
National Human Genome Research Institute, 5635 Fishers Lane, Bethesda, MD 20892, USA.
Ebony B
EB
Bookman
Touro College of Osteopathic Medicine, 2090 Adam Clayton Powell Jr Blvd, New York, NY 10027, USA.
Corina
C
Din-Lovinescu
Department of Neurology, Box 800394, University of Virginia School of Medicine, Charlottesville, VA 22908, USA.
Bradford B
BB
Worrall
National Human Genome Research Institute, 5635 Fishers Lane, Bethesda, MD 20892, USA.
Teri A
TA
Manolio
University of Washington, 46200 NE 74th Street, Bldg 29, Suite 310, Seattle, WA 98195, USA.
Siiri N
SN
Bennett
University of Washington, 46200 NE 74th Street, Bldg 29, Suite 310, Seattle, WA 98195, USA.
Cathy
C
Laurie
The Broad Institute, 7 Cambridge Center, Cambridge, MA 02142, USA.
Daniel B
DB
Mirel
The Center for Inherited Disease Research, Johns Hopkins University, 333 Cassell Drive, Suite 2000, Baltimore, MD 21224, USA.
Kimberly F
KF
Doheny
Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-A410, Seattle, WA 98109, USA.
Garnet L
GL
Anderson
University of Washington, Box 359461, UW Tower 15th Floor, 4333 Brooklyn Ave NE, Seattle, WA 98195, USA.
Kate
K
Wehr
Mayo Medical School, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.
Richard
R
Weinshilboum
Center for Biomedical Ethics and Humanities, Box 800758, University of Virginia School of Medicine, 101 Hospital Drive, Barringer 5380, Charlottesville, VA 22908, USA.
Donna T
DT
Chen