Title |
Incidental genetic findings in randomized clinical trials: recommendations from the Genomics and Randomized Trials Network (GARNET)
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Published in |
Genome Medicine, January 2013
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DOI | 10.1186/gm411 |
Pubmed ID | |
Authors |
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 |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United Kingdom | 5 | 42% |
United States | 2 | 17% |
Austria | 1 | 8% |
Montenegro | 1 | 8% |
Saudi Arabia | 1 | 8% |
Unknown | 2 | 17% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Scientists | 5 | 42% |
Members of the public | 4 | 33% |
Science communicators (journalists, bloggers, editors) | 2 | 17% |
Practitioners (doctors, other healthcare professionals) | 1 | 8% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Iran, Islamic Republic of | 1 | 2% |
United Kingdom | 1 | 2% |
United States | 1 | 2% |
Netherlands | 1 | 2% |
Unknown | 41 | 91% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 10 | 22% |
Other | 7 | 16% |
Student > Ph. D. Student | 4 | 9% |
Professor | 4 | 9% |
Student > Postgraduate | 4 | 9% |
Other | 12 | 27% |
Unknown | 4 | 9% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 16 | 36% |
Agricultural and Biological Sciences | 11 | 24% |
Biochemistry, Genetics and Molecular Biology | 6 | 13% |
Philosophy | 2 | 4% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 4% |
Other | 3 | 7% |
Unknown | 5 | 11% |