Circulation: Cardiovascular Genetics: Journal of the Heart Associations, Vol. 3, No. 6, pp. 574-580, 2010
8 Pages Posted: 15 Jan 2011 Last revised: 29 Jul 2015
Date Written: December 1, 2010
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.
Keywords: Genetics, Genomics, Research Genetics, Human Subjects Research, Research Ethics, Bioethics, Return of Results, Incidental Findings, Risk Prediction, NIH, NHLBI
Suggested Citation: Suggested Citation
Fabsitz, Richard R. and McGuire, Amy L. and Sharp, Richard R. and Puggal, Mona and Beskow, Laura M. and Biesecker, Leslie G. and Bookman, Ebony and Burke, Wylie and Burchard, Esteban Gonzalez and Church, George and Wright Clayton, Ellen and Eckfeldt, John H. and Fernandez, Conrad V. and Fisher, Rebecca and Fullerton, Stephanie M. and Gabriel, Stacey and Gachupin, Francine and James, Cynthia and Jarvik, Gail P. and Kittles, Rick and Leib, Jennifer R. and O'Donnell, Christopher and O'Rourke, P. Pearl and Rodriguez, Laura Lyman and Schully, Sheri D. and Shuldiner, Alan R. and Sze, Rebecca K.F. and Thakuria, Joseph V. and Wolf, Susan M. and Burke, Gregory L., Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from a National Heart, Lung, and Blood Institute Working Group (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. Available at SSRN: https://ssrn.com/abstract=1737891