TY - JOUR
T1 - Ethical and practical guidelines for reporting genetic research results to study participants
T2 - Updated guidelines from a national heart, lung, and blood institute working group
AU - Fabsitz, Richard R.
AU - McGuire, Amy
AU - Sharp, Richard R.
AU - Puggal, Mona
AU - Beskow, Laura M.
AU - Biesecker, Leslie G.
AU - Bookman, Ebony
AU - Burke, Wylie
AU - Burchard, Esteban Gonzalez
AU - Church, George
AU - Clayton, Ellen Wright
AU - Eckfeldt, John H.
AU - Fernandez, Conrad V.
AU - Fisher, Rebecca
AU - Fullerton, Stephanie M.
AU - Gabriel, Stacey
AU - Gachupin, Francine
AU - James, Cynthia
AU - Jarvik, Gail P.
AU - Kittles, Rick A
AU - Leib, Jennifer R.
AU - O'Donnell, Christopher
AU - O'Rourke, P. Pearl
AU - Rodriguez, Laura Lyman
AU - Schully, Sheri D.
AU - Shuldiner, Alan R.
AU - Sze, Rebecca K.F.
AU - Thakuria, Joseph V.
AU - Wolf, Susan M.
AU - Burke, Gregory L.
PY - 2010/12
Y1 - 2010/12
N2 - 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.
AB - 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.
KW - Consent
KW - Ethics
KW - Genetics
KW - Research genetics
KW - Risk prediction
KW - Single-nucleotide polymorphism genetics
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U2 - 10.1161/CIRCGENETICS.110.958827
DO - 10.1161/CIRCGENETICS.110.958827
M3 - Article
C2 - 21156933
AN - SCOPUS:79951863517
SN - 1942-325X
VL - 3
SP - 574
EP - 580
JO - Circulation: Cardiovascular Genetics
JF - Circulation: Cardiovascular Genetics
IS - 6
ER -