title: Ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from a National Heart, Lung, and Blood Institute working group.
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.
authors.affiliation: Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Epidemiology Branch, 6701 Rockledge Drive/ MSC 7935, Bethesda, MD20892, USA. fabsitzr@nhlbi.nih.gov
authors.forename: Richard R
authors.initials: RR
authors.lastname: Fabsitz
authors.forename: Amy
authors.initials: A
authors.lastname: McGuire
authors.forename: Richard R
authors.initials: RR
authors.lastname: Sharp
authors.forename: Mona
authors.initials: M
authors.lastname: Puggal
authors.forename: Laura M
authors.initials: LM
authors.lastname: Beskow
authors.forename: Leslie G
authors.initials: LG
authors.lastname: Biesecker
authors.forename: Ebony
authors.initials: E
authors.lastname: Bookman
authors.forename: Wylie
authors.initials: W
authors.lastname: Burke
authors.forename: Esteban Gonzalez
authors.initials: EG
authors.lastname: Burchard
authors.forename: George
authors.initials: G
authors.lastname: Church
authors.forename: Ellen Wright
authors.initials: EW
authors.lastname: Clayton
authors.forename: John H
authors.initials: JH
authors.lastname: Eckfeldt
authors.forename: Conrad V
authors.initials: CV
authors.lastname: Fernandez
authors.forename: Rebecca
authors.initials: R
authors.lastname: Fisher
authors.forename: Stephanie M
authors.initials: SM
authors.lastname: Fullerton
authors.forename: Stacey
authors.initials: S
authors.lastname: Gabriel
authors.forename: Francine
authors.initials: F
authors.lastname: Gachupin
authors.forename: Cynthia
authors.initials: C
authors.lastname: James
authors.forename: Gail P
authors.initials: GP
authors.lastname: Jarvik
authors.forename: Rick
authors.initials: R
authors.lastname: Kittles
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Leib
authors.forename: Christopher
authors.initials: C
authors.lastname: O'Donnell
authors.forename: P Pearl
authors.initials: PP
authors.lastname: O'Rourke
authors.forename: Laura Lyman
authors.initials: LL
authors.lastname: Rodriguez
authors.forename: Sheri D
authors.initials: SD
authors.lastname: Schully
authors.forename: Alan R
authors.initials: AR
authors.lastname: Shuldiner
authors.forename: Rebecca K F
authors.initials: RK
authors.lastname: Sze
authors.forename: Joseph V
authors.initials: JV
authors.lastname: Thakuria
authors.forename: Susan M
authors.initials: SM
authors.lastname: Wolf
authors.forename: Gregory L
authors.initials: GL
authors.lastname: Burke
mesh_terms: D000047:Academies and Institutes; D028744:Ethics Committees, Research; D036281:Genetic Research / Q000941:ethics*; D006801:Humans; D054555:National Heart, Lung, and Blood Institute (U.S.); D057766:Policy; D014481:United States