Ethical and Practical Guidelines for Reporting Gen... [Circ Cardiovasc Genet. 2010] - PubMed result

Circ Cardiovasc Genet. 2010 Dec 1;3(6):574-580.
Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines From a National Heart, Lung, and Blood Institute Working Group.

Fabsitz RR, McGuire A, Sharp RR, Puggal M, Beskow LM, Biesecker LG, Bookman E, Burke W, Burchard EG, Church G, Clayton EW, Eckfeldt JH, Fernandez CV, Fisher R, Fullerton SM, Gabriel S, Gachupin F, James C, Jarvik GP, Kittles R, Leib JR, O'Donnell C, O'Rourke PP, Rodriguez LL, Schully SD, Shuldiner AR, Sze RK, Thakuria JV, Wolf SM, Burke GL.

Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Md; the Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Tex; the Department of Bioethics, Cleveland Clinic, Cleveland, Ohio; Duke Institute for Genome Sciences and Policy, Duke University, Durham, NC; the Genetic Diseases Research Branch, National Human Genome Research Institute, Bethesda, Md; Office of Population Genomics, National Human Genome Research Institute, Bethesda, Md; the Department of Bioethics and Humanities, University of Washington, Seattle, Wash; the Pulmonary and Critical Care Division, University of California San Francisco, San Francisco, Calif; the Department of Genetics, Harvard Medical School, Boston, Mass; the Center for Biomedical Ethics and Society, Vanderbilt University School of Law, Nashville, Tenn; the Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minn; IWK Health Center, Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada; Patient Advocate, Oakton, Va; Genetic Analysis Platform, Broad Institute, Boston, Mass; Southwest Tribal Epidemiology Center, Albuquerque, NM; the Division of Medicine/Cardiology, Johns Hopkins University, Baltimore, Md; the Division of Medical Genetics, University of Washington School of Medicine, Seattle, Wash; the College of Medicine, University of Illinois Chicago, Chicago, Ill; Health Futures, LLC, Washington, DC; the Framingham Heart Study, National Heart, Lung, and Blood Institute, Framingham, Mass; Health Research Affairs, Partners Health Care System, Inc, Boston, Mass; Office of Policy, Communications, and Education, National Human Genome Research Institute, Bethesda, Md; Epidemiology and Genetic Research Program, National Cancer Institute, Bethesda, Md; the Division of Endocrinology, Diabetes, and Nutrition, University of Maryland School of Medicine, Baltimore, Md; Charles B. Wang Community Health Center, New York, NY; Harvard Catalyst, Boston, Mass; School of Law; School of Medicine, Center for Bioethics, Consortium on Law and Value in Health, Environment, and the Life Sciences, University of Minnesota, Minneapolis, Minn; and the Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC.

Abstract

In January 2009, the National Heart, Lung, and Blood Institute convened a 28-member multidisciplinary Working Group to update the recommendations of a 2004 National Heart, Lung, and Blood Institute Working Group focused on Guidelines to the Return of Genetic Research Results. Changes in the genetic and societal landscape over the intervening 5 years raise multiple questions and challenges. The group noted the complex issues arising from the fact that technological and bioinformatic progress has made it possible to obtain considerable information on individuals that would not have been possible a decade ago. Although unable to reach consensus on a number of issues, the working group produced 5 recommendations. The working group offers 2 recommendations addressing the criteria necessary to determine when genetic results should and may be returned to study participants, respectively. In addition, it suggests that a time limit be established to limit the duration of obligation of investigators to return genetic research results. The group recommends the creation of a central body, or bodies, to provide guidance on when genetic research results are associated with sufficient risk and have established clinical utility to justify their return to study participants. The final recommendation urges investigators to engage the broader community when dealing with identifiable communities to advise them on the return of aggregate and individual research results. Creation of an entity charged to provide guidance to institutional review boards, investigators, research institutions, and research sponsors would provide rigorous review of available data, promote standardization of study policies regarding return of genetic research results, and enable investigators and study participants to clarify and share expectations for the handling of this increasingly valuable information with appropriate respect for the rights and needs of participants.

PMID: 21156933 [PubMed - as supplied by publisher]
Ethical and Practical Guidelines for Reporting Gen... [Circ Cardiovasc Genet. 2010] - PubMed result