From Genetics to Genomics: Facing the Liability Implications in Clinical Care

Gary Marchant1, Mark Barnes1, James P Evans1

  • 1Gary Marchant, B.SC., Ph.D., J.D., M.P.P., is Regents' Professor, Lincoln Professor of Emerging Technologies, Law & Ethics, and Faculty Director of the Center for Law, Science & Innovation at ASU. He researches, teaches and speaks about governance of a variety of emerging technologies including genomics, biotechnology, neuroscience, nanotechnology and artificial intelligence. Prior to starting at ASU in 1999, he was a partner in the Washington, DC office of Kirkland & Ellis. Mark Barnes, J.D., LL.M., is a partner in the life sciences practice at Ropes & Gray LLP; teaches health care law and the law of biomedical research at Yale Law School; and is founder and co-director of the Multi-Regional Clinical Trials Center (MRCT Center) of Harvard University and Brigham and Women's Hospital. James P. Evans, M.D., Ph.D., is a Medical Geneticist and Internist who is currently retired, but pursued a long-standing interest in genomics and its broad social implications. He is Professor Emeritus, University of North Carolina at Chapel Hill, Department of Genetics. Bonnie LeRoy, M.S., L.G.C., is a licensed genetic counselor with over 20 years of clinical experience. She developed and now directs the Graduate Program in Genetic Counseling at the University of Minnesota. She is a past president of the National Society of Genetic Counselors, the American Board of Genetic Counseling, and the Association of Genetic Counseling Program Directors. Susan M. Wolf, J.D., is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine; and Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota. She is a Principal Investigator on the LawSeq project funded by NIH. Institutions are listed for author identification only.

Summary

Healthcare is shifting from genetics to genomics, introducing new liability risks for providers and labs. This article outlines 11 key risk areas and offers management strategies for genomic medicine.

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