Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants
Author
Fabsitz, Richard R.
McGuire, Amy
Sharp, Richard R.
Puggal, Mona
Beskow, Laura M.
Biesecker, Leslie G.
Bookman, Ebony
Burke, Wylie
Clayton, Ellen Wright
Eckfeldt, John H.
Fernandez, Conrad V.
Fisher, Rebecca
Fullerton, Stephanie M.
Gachupin, Francine
James, Cynthia
Jarvik, Gail P.
Kittles, Rick
Leib, Jennifer R.
O'Donnell, Christopher
O'Rourke, P. Pearl
Rodriguez, Laura Lyman
Schully, Sheri D.
Shuldiner, Alan R.
Sze, Rebecca K.F.
Thakuria, Joseph V.
Wolf, Susan M.
Burke, Gregory L.
Burchard, Esteban Gonzalez
Gabriel, Stacey
Published Version
https://doi.org/10.1161/circgenetics.110.958827Metadata
Show full item recordCitation
Fabsitz, R., Richard, Mcguire, R., Amy, Sharp, M., Richard, Puggal, G., Mona, Beskow, Gonzalez, Laura, Biesecker, Wright, Leslie, Bookman, H., Ebony, Burke, V., Wylie, Burchard, M., Esteban, Church, P., George, Clayton, R., Ellen, Eckfeldt, Pearl, John, Fernandez, Lyman, Conrad, Fisher, D., Rebecca, Fullerton, R., Stephanie, Gabriel, K.F., Stacey, Gachupin, V., Francine, James, M., Cynthia, Jarvik, L., Gail, Kittles, L., Rick, Leib, L., Jennifer, Oʼdonnell, L., Christopher, Oʼrourke, L., P., Rodriguez, L., Laura, Schully, L., Sheri, Shuldiner, L., Alan, Sze, L., Rebecca, Thakuria, L., Joseph, Wolf, L., Susan, and Burke, L., Gregory. 2010. Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines From a National Heart, Lung, and Blood Institute Working Group." Circulation: Cardiovascular Genetics 3, no. 6: 574-80.Abstract
In January 2009 the National Heart, Lung, and Blood Institute (NHLBI) convened a 28-member multidisciplinary Working Group to update the recommendations of a 2004 NHLBI Working Group focused on Guidelines to the Return of Genetic Research Results. Changes in the genetic and societal landscape over the intervening five years raise multiple questions and challenges. The group noted the complex issues arising from the fact that the technologic and bioinformatic progress has made it possible to obtain considerable information on individuals which would not have been possible a decade ago. While unable to reach consensus on a number of issues, the Working Group produced five recommendations. The Working 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 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 IRBs, 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.Terms of Use
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http://nrs.harvard.edu/urn-3:HUL.InstRepos:42667837
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