Study participants share their blood and spit in the name of biomedical research. Now, a national group of experts says these volunteers should be told what scientists learn about their health from those samples.

In a report published Tuesday, an expert committee convened by the National Academies of Sciences, Engineering, and Medicine concluded that scientists and their institutions should routinely — and carefully — consider whether to return study results to participants. The report, which was sponsored by three of the leading federal health agencies, also recommends revising a federal regulation that’s caused confusion about when it’s permissible to share research findings with a participant.

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  • This is a good summary of the recent report from The National Academies. The new report adds important additional weight to recommendations that have been made by the Multi-Regional Clinical Trials Center at Harvard, and the Secretary’s Advisory Committee on Human Research Protections (SACHRP) sub-committee. The points made in this report about the need for genetic counseling to understand the clinical implications of genetic testing – whether intentional testing or incidental findings – also connect back to recent stories in STAT and other publications about the challenges that patients have in interpreting complicated genetic data.
    When we give patients’ results back to them, we also have to provide the support to help them know what to do with those results, particularly when the interpretation of the results requires genetic understanding and expertise.
    To this end, as an organization focused on clinical trial ethics and on improving the quality of clinical research, we very much support the services of our partner, InformedDNA, which provides experienced genetic counselors to work with clinical research teams. Having the consultation of a genetic counselor available when needed to discuss genetic testing results, their implications, and possible next steps with patients and their families is critical in the conduct of ethical research.
    Lindsay McNair, MD, MPH, MSB, Chief Medical Officer, WIRB-Copernicus Group

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