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.
Highlights
During clinical research, investigators may discover information with important health implications for a Genomics and Randomized Trials Network (GARNET) GARNET comprises a series of genomewide association studies (GWAS) of treatment responses in randomized clinical trials that aim to identify the genetic variants associated with response to treatments for conditions of clinical or public health significance [1]
The clinical trials that make up GARNET are the Women’s Health Initiative (WHI) Hormone Therapy Trial, designed to identify genetic variations that alter the risk of coronary heart disease, stroke, venous thromboembolism and incident diabetes after exposure to hormone therapy; the SUCCESS A breast cancer trial, which aims to identify genetic variations that influence the efficacy or toxicity of chemotherapy for breast cancer; and the Vitamin Inter vention for Stroke Prevention (VISP) trial, designed to identify genetic variants that influence the risk of recur rent stroke, myocardial infarction or death in response to vitamin therapy
State in consent forms and associated educational materials that study participants may not be informed of important genetic results if investigators and their Institutional Review Board (IRB) decide that no individual genetic results will be returned to participants
Summary
Investigators may discover information with important health implications for a. It was thought important to determine the kinds of incidental findings found when performing genome-wide genotyping, in order to provide information about this for researchers working on studies in which genomic analyses are prospectively or retrospectively incorporated into clinical trials. The precedent for this was set by the GENEVA con sortium [3], which encourages research groups perform ing genome-wide association studies, such as GARNET, to think prospectively about how clinically relevant inci dental findings will be addressed within their studies [4]. The sex chromosome anomaly find ings have possible treatment implications but were not raised to an actionable level as the anomalies may be acquired and, all participants with these anomalies were over reproductive age
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