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Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from a National Heart, Lung, and Blood Institute Working GroupRichard R. FabsitzNational Institutes of Health (NIH) - National Heart, Lung, and Blood Institute Amy L. McGuireBaylor College of Medicine Richard R. SharpCleveland Clinic - Department of Bioethics Mona PuggalNational Institutes of Health (NIH) - National Heart, Lung, and Blood Institute Laura M. BeskowDuke University - Institute for Genome Sciences & Policy Leslie G. BieseckerNational Institutes of Health (NIH) - National Human Genome Research Institute Ebony BookmanNational Institutes of Health (NIH) - National Human Genome Research Institute Wylie BurkeUniversity of Washington - Department of Bioethics & Humanities Esteban Gonzalez BurchardUniversity of California, San Francisco (UCSF) - Pulmonary and Critical Care Division George ChurchHarvard Medical School Ellen Wright ClaytonVanderbilt University - Law School John H. EckfeldtUniversity of Minnesota - Twin Cities - Laboratory Medicine and Pathology Conrad V. FernandezDalhousie University - Department of Pediatrics Rebecca FisherPatient Advocate Stephanie M. FullertonUniversity of Washington - Department of Bioethics & Humanities Stacey GabrielBroad Institute of MIT and Harvard University Francine GachupinSouthwest Tribal Epidemiology Center Cynthia JamesJohns Hopkins University - Department of Medicine/Cardiology Gail P. JarvikUniversity of Washington - Division of Medical Genetics Rick KittlesUniversity of Illinois Chicago - College of Medicine Jennifer R. LeibHealthFutures, LLC Christopher O'DonnellFramingham Heart Study - National Heart, Lung, and Blood Institute P. Pearl O'RourkePartners HealthCare Laura Lyman RodriguezNational Institutes of Health (NIH) - National Human Genome Research Institute Sheri D. SchullyNational Institutes of Health (NIH) - National Cancer Institute Alan R. ShuldinerUniversity of Maryland - School of Medicine Rebecca K.F. SzeCharles B. Wang Community Health Center Joseph V. ThakuriaMassachusetts General Hospital - Genetics Unit; Harvard Medical School - Department of Genetics Susan M. WolfUniversity of Minnesota Law School Gregory L. BurkeWake Forest University - School of Medicine December 1, 2010 Circulation: Cardiovascular Genetics: Journal of the Heart Associations, Vol. 3, No. 6, pp. 574-580, 2010 Minnesota Legal Studies Research Paper No. 11-08 Vanderbilt Law and Economics Research Paper No. 11-10 Vanderbilt Public Law Research Paper No. 11-6 Abstract: Tremendous controversy surrounds return of individual research results and incidental findings in genetic and genomic research on human participants. Researchers traditionally have not offered individual research results back to human participants. However, with increasing recognition of the potential health importance of those results (which may indeed be life-saving), scholars, researchers, and policy makers have begun considering under what circumstances results should be offered back to participants, what results would warrant this effort, and how it should be done. This article is a significant new consensus statement growing out of a workshop convened by the National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH). Thirty top researchers, scholars, and participants in the policy debate worked for over a year to reach agreement on 5 core recommendations. The group offers two 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 investigators' obligation 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 working with identifiable research participant communities to engage those communities on the return of aggregate and individual research results.
Number of Pages in PDF File: 8 Keywords: Genetics, Genomics, Research Genetics, Human Subjects Research, Research Ethics, Bioethics, Return of Results, Incidental Findings, Risk Prediction, NIH, NHLBI Accepted Paper SeriesDate posted: January 15, 2011 ; Last revised: February 4, 2011Suggested CitationContact Information
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