Ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from a National Heart, Lung, and Blood Institute working group
National Heart, Lung, and Blood Institute working group, Richard R Fabsitz, Amy McGuire, Richard R Sharp, Mona Puggal, Laura M Beskow, Leslie G Biesecker, Ebony Bookman, Wylie Burke, Esteban Gonzalez Burchard, George Church, Ellen Wright Clayton, John H Eckfeldt, Conrad V Fernandez, Rebecca Fisher, Stephanie M Fullerton, Stacey Gabriel, Francine Gachupin, Cynthia James, Gail P Jarvik, Rick Kittles, Jennifer R Leib, Christopher O'Donnell, P Pearl O'Rourke, Laura Lyman Rodriguez, Sheri D Schully, Alan R Shuldiner, Rebecca K F Sze, Joseph V Thakuria, Susan M Wolf, Gregory L Burke, National Heart, Lung, and Blood Institute working group, Richard R Fabsitz, Amy McGuire, Richard R Sharp, Mona Puggal, Laura M Beskow, Leslie G Biesecker, Ebony Bookman, Wylie Burke, Esteban Gonzalez Burchard, George Church, Ellen Wright Clayton, John H Eckfeldt, Conrad V Fernandez, Rebecca Fisher, Stephanie M Fullerton, Stacey Gabriel, Francine Gachupin, Cynthia James, Gail P Jarvik, Rick Kittles, Jennifer R Leib, Christopher O'Donnell, P Pearl O'Rourke, Laura Lyman Rodriguez, Sheri D Schully, Alan R Shuldiner, Rebecca K F Sze, Joseph V Thakuria, Susan M Wolf, Gregory L Burke
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.
Conflict of interest statement
Conflict of Interest Disclosures:
Leslie G. Biesecker, MD: Serve as an uncompensated advisor to the Illumina Corporation, which is part of my official duties as an NIH employee and this activity is in compliance with NIH conflict of interest rules.
George Church, PhD: http://arep.med.harvard.edu/gmc/tech.html, in particular Knome Inc. which develops and sells software and service for "Reporting Genetic Research Results To Study Participants"
Jennifer R. Leib, ScM, CGC: Vice-President HealthFutures, LLC specializing in personalized and preventive medicine
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Source: PubMed