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: 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

8 Pages Posted: 15 Jan 2011 Last revised: 29 Jul 2015

Richard R. Fabsitz

National Institutes of Health (NIH) - National Heart, Lung, and Blood Institute

Amy L. McGuire

Baylor College of Medicine

Richard R. Sharp

Cleveland Clinic - Department of Bioethics

Mona Puggal

National Institutes of Health (NIH) - National Heart, Lung, and Blood Institute

Laura M. Beskow

Duke University - Institute for Genome Sciences & Policy

Leslie G. Biesecker

National Institutes of Health (NIH) - National Human Genome Research Institute

Ebony Bookman

National Institutes of Health (NIH) - National Human Genome Research Institute

Wylie Burke

University of Washington - Department of Bioethics & Humanities

Esteban Gonzalez Burchard

University of California, San Francisco (UCSF) - Pulmonary and Critical Care Division

George Church

Harvard Medical School

Ellen Wright Clayton

Vanderbilt University - Law School

John H. Eckfeldt

University of Minnesota - Twin Cities - Laboratory Medicine and Pathology

Conrad V. Fernandez

Dalhousie University - Department of Pediatrics

Rebecca Fisher

Patient Advocate

Stephanie M. Fullerton

University of Washington - Department of Bioethics & Humanities

Stacey Gabriel

Broad Institute of MIT and Harvard University

Francine Gachupin

Southwest Tribal Epidemiology Center

Cynthia James

Johns Hopkins University - Department of Medicine/Cardiology

Gail P. Jarvik

University of Washington - Division of Medical Genetics

Rick Kittles

University of Illinois Chicago - College of Medicine

Jennifer R. Leib

HealthFutures, LLC

Christopher O'Donnell

Framingham Heart Study - National Heart, Lung, and Blood Institute

P. Pearl O'Rourke

Partners HealthCare

Laura Lyman Rodriguez

National Institutes of Health (NIH) - National Human Genome Research Institute

Sheri D. Schully

National Institutes of Health (NIH) - National Cancer Institute

Alan R. Shuldiner

University of Maryland - School of Medicine

Rebecca K.F. Sze

Charles B. Wang Community Health Center

Joseph V. Thakuria

Massachusetts General Hospital - Genetics Unit; Harvard Medical School - Department of Genetics

Susan M. Wolf

University of Minnesota Law School

Gregory L. Burke

Wake Forest University - School of Medicine

Date Written: December 1, 2010

Abstract

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

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

Richard R. Fabsitz (Contact Author)

National Institutes of Health (NIH) - National Heart, Lung, and Blood Institute ( email )

73 Mr. Wayte Avenue
Bethesda, MD 01702
United States

Amy L. McGuire

Baylor College of Medicine ( email )

One Baylor Plaza
Houston, TX 77030
United States

Richard R. Sharp

Cleveland Clinic - Department of Bioethics ( email )

9500 Euclid Ave.
Cleveland, OH 44195
United States

Mona Puggal

National Institutes of Health (NIH) - National Heart, Lung, and Blood Institute

73 Mr. Wayte Avenue
Bethesda, MD 01702
United States

Laura M. Beskow

Duke University - Institute for Genome Sciences & Policy ( email )

240 North Building
Box 90141
Durham, CA 27708
United States

Leslie G. Biesecker

National Institutes of Health (NIH) - National Human Genome Research Institute ( email )

Building 29, Room $a56
49 Convent Dr, MSC 4472
Bethesda, MD 20892
United States

Ebony Bookman

National Institutes of Health (NIH) - National Human Genome Research Institute ( email )

Building 29, Room $a56
49 Convent Dr, MSC 4472
Bethesda, MD 20892
United States

Wylie Burke

University of Washington - Department of Bioethics & Humanities ( email )

Box 356340
1925 N.E. Pacific Street
Seattle, WA 98195-6340
United States

Esteban Gonzalez Burchard

University of California, San Francisco (UCSF) - Pulmonary and Critical Care Division ( email )

San Francisco General Hospital
Box 2911
San Francisco, CA
United States

George Church

Harvard Medical School ( email )

250 Longwood Avenue
Boston, MA 02115
United States

Ellen Wright Clayton

Vanderbilt University - Law School ( email )

131 21st Avenue South
Nashville, TN 37203-1181
United States
615-322-1186 (Phone)
615-322-4548 (Fax)

John H. Eckfeldt

University of Minnesota - Twin Cities - Laboratory Medicine and Pathology ( email )

420 Delaware St. SE
Minneapolis, MN 55455
United States

Conrad V. Fernandez

Dalhousie University - Department of Pediatrics ( email )

6225 University Avenue
Halifax, Nova Scotia B3H 4H7
Canada

Rebecca Fisher

Patient Advocate ( email )

Stephanie M. Fullerton

University of Washington - Department of Bioethics & Humanities ( email )

Box 356340
1925 N.E. Pacific Street
Seattle, WA 98195-6340
United States

Stacey Gabriel

Broad Institute of MIT and Harvard University ( email )

301 Binney Street
Cambridge, MA 02142
United States

Francine Gachupin

Southwest Tribal Epidemiology Center ( email )

5015 Prospect NE
Albuquerque, NM 87110
United States

Cynthia James

Johns Hopkins University - Department of Medicine/Cardiology ( email )

720 Rutland Avenue
Baltimore, MD 21205-2196
United States

Gail P. Jarvik

University of Washington - Division of Medical Genetics ( email )

Seattle, WA 98195
United States

Rick Kittles

University of Illinois Chicago - College of Medicine ( email )

1200 W Harrison St
Chicago, IL 60607
United States

Jennifer R. Leib

HealthFutures, LLC ( email )

600 Maryland Avenue, SW
Suite 835W
Washington, DC 20024
United States

Christopher O'Donnell

Framingham Heart Study - National Heart, Lung, and Blood Institute ( email )

73 Mr. Wayte Avenue
Framingham, MA 01702
United States

P. Pearl O'Rourke

Partners HealthCare ( email )

Boston, MA

Laura Lyman Rodriguez

National Institutes of Health (NIH) - National Human Genome Research Institute ( email )

Building 29, Room $a56
49 Convent Dr, MSC 4472
Bethesda, MD 20892
United States

Sheri D. Schully

National Institutes of Health (NIH) - National Cancer Institute ( email )

9000 Rockville Pike
Bethesda, MD 20892
United States

Alan R. Shuldiner

University of Maryland - School of Medicine ( email )

College Park, MD 20742
United States

Rebecca K.F. Sze

Charles B. Wang Community Health Center ( email )

125 Walker Street
NY 10013
United States

Joseph V. Thakuria

Massachusetts General Hospital - Genetics Unit

Boston, MA 02114
United States

Harvard Medical School - Department of Genetics ( email )

250 Longwood Avenue
Boston, MA 02115
United States

Susan M. Wolf

University of Minnesota Law School ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States
612-625-3406 (Phone)
612-624-9143 (Fax)

HOME PAGE: http://www.law.umn.edu/facultyprofiles/wolfs.html

Gregory L. Burke

Wake Forest University - School of Medicine ( email )

Medical Center Boulevard
Winston-Salem, NC 27157-1063
United States

Paper statistics

Downloads
165
Rank
146,450
Abstract Views
1,594