Incidental genetic findings in randomized clinical trials: recommendations from the Genomics and Randomized Trials Network GARNETReport as inadecuate




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Genome Medicine

, 5:7

2. Pharmacogenomics and personalized medicine

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 aims 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.

AbbreviationsCLIAClinical Laboratory Improvement Amendments

GARNETGenomics and Randomized Trials Network

GINAGenetic Information Nondiscrimination Act

GWASgenome-wide association studies

IRBInstitutional Review Board

VISPVitamin Intervention for Stroke Prevention

WHIWomen-s Health Initiative.

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Author: Ebony B Bookman - Corina Din-Lovinescu - Bradford B Worrall - Teri A Manolio - Siiri N Bennett - Cathy Laurie - Daniel 

Source: https://link.springer.com/







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