Return of incidental genetic findings: guidelines for clinical trials

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The decrease in cost and increase in efficiency of genome-scale studies means we can enjoy fast-paced generation of genomic data. In the clinic, this growth has attracted a lot of attention and many randomized clinical trials are using genomic data. During the course of a particular trial, clinicians may stumble upon genetic findings that could have health implications, but which are of no interest to the investigation in progress – so called incidental findings. The return of these incidental findings to patients has important ethical and practical considerations, but the fast pace in the genomics field has not been matched by the publication of recommendations on how best to handle them.

The Genomics and Randomized Trials Network (GARNET) analyzes genomic data, collected in the context of clinical trials, with the aim of identifying genetic variants that influence the response to therapy in conditions of clinical and public health relevance. Based on the experiences of this authoritative group, Ebony Bookman and colleagues are publishing in Genome Medicine much needed guidelines on how to handle the return of incidental findings in the context of clinical trials.

According to GARNET, plans related to sharing incidental findings should be discussed explicitly in the consent form, and the return of actionable results should be discussed with internal review boards. All incidental findings, discussions with institutional review boards, and actions should be catalogued and researchers should follow national and international efforts to determine the established clinical relevance of a specific genetic result. If the returning of results has been approved, this should be done with the assistance of a genetic medicine clinic.

Since clinical trials might be considered somewhere in between clinical care and research, it is important, when adding genomics data, to consider the clinicians’ responsibility to communicate incidental genetic findings with medical relevance. The GARNET experience and recommendations inform better decision-making in this respect.