TY - JOUR
T1 - Incidental genetic findings in randomized clinical trials
T2 - Recommendations from the Genomics and Randomized Trials Network (GARNET)
AU - Bookman, Ebony B.
AU - Din-Lovinescu, Corina
AU - Worrall, Bradford B.
AU - Manolio, Teri A.
AU - Bennett, Siiri N.
AU - Laurie, Cathy
AU - Mirel, Daniel B.
AU - Doheny, Kimberly F.
AU - Anderson, Garnet L.
AU - Wehr, Kate
AU - Weinshilboum, Richard
AU - Chen, Donna T.
N1 - Funding Information:
The authors would like to thank the investigators within GARNET for their contribution to the GARNET Incidental Findings Subcommittee Recommendations as well as to this manuscript. We would also like to thank the NHGRI Return of Results consortium for their thoughtful comments and input. This work was supported in part by National Institutes of Health grants HG005137 (parent study SUCCESS A), HG005152 (parent study WHI),
PY - 2013/1/30
Y1 - 2013/1/30
N2 - 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.
AB - 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.
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U2 - 10.1186/gm411
DO - 10.1186/gm411
M3 - Letter
AN - SCOPUS:84873042619
SN - 1756-994X
VL - 5
JO - Genome medicine
JF - Genome medicine
IS - 1
M1 - 7
ER -