Is it Clinical Care? Is it Research? Navigating the Difference in Genomic Medicine

Red glass double helixes
Thursday, August 31, 2017

A working group of the Clinical Sequencing Exploratory Research (CSER) Consortium has published the first-ever study describing new approaches to a crucial question: how should genomics investigators handle the increasingly blurry boundary between research and clinical practice? The article, "Navigating the Research-Clinical Interface in Genomic Medicine" appeared in Genetics in Medicine, which is published by ACMG. A new blog post by Consortium Chair Susan M. Wolf, JD and Wylie Burke, MD, PhD (Department of Bioethics and Humanities at the University of Washington) describes the results of CSER's empirical research. A 22-item survey was administered to investigate how investigators were conceptualizing and navigating the research-clinical interface. The results were striking: most of the studies describe a merger of research and clinical care. According to Wolf and Burke, "This challenges the conventional wisdom that while clinical care benefits patients, research seeks only generalizable knowledge." CSER encompasses nine National Institutes of Health (NIH)-funded projects driving the translation of genomic sequencing into clinical care; among these are grants for which Consortium Chair Susan M. Wolf serves as a co-Principal Investigator: Disclosing Genomic Incidental Findings in a Cancer Biobank (with Gloria Petersen of Mayo Clinic and Barbara Koenig of UCSF) and LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (with Ellen Wright Clayton of Vanderbilt and Frances Lawrenz of the University of Minnesota). Prof. Wolf was the lead author on the Genetics in Medicine article.