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As the tissue samples and DNA of more and more people are shared with researchers, the question of what information buried in those samples to give back is more pressing than ever. Now, a 335-page report from the National Academies of Sciences, Engineering, and Medicine (NASEM) released this morning urges researchers and regulators to return more biological data to the people whose samples yielded it in the first place. Giving back data to individuals is part of a broader push to offer participants a voice in research, especially research on their own tissues—but how best to do it in a way that is helpful to recipients and their physicians remains murky.
The issue has been charged for years, since expanded DNA sequencing started turning up unexpected findings in research participants’ samples that weren’t always connected to the original study—such as a gene predisposing a person to breast cancer in a project studying heart disease. In addition, scientists often uncover mutations or other findings that have questionable medical significance to an individual. A DNA quirk that might raise the risk of disease only marginally, for example, or carry uncertain medical meaning may still merit publication and help advance a field of research. For participants, this distinction can be frustrating. If their DNA is worth publishing and helps boost a scientist’s career, why can’t it also be shared with them?
Questions - Regulations - US - Agencies - Food
Given these questions, along with inconsistent regulations, three major U.S. agencies--the Food and Drug Administration, the Centers for Medicaid and Medicare Services (CMS), and the National Institutes of Health (NIH)—turned to NASEM for help. And about a year after its work began, the NASEM authors concluded that “the expanded return of results on a cautious basis is the way to go,” says Jeffrey Botkin, a pediatrician and bioethicist at the University of Utah School...
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