Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets

Genetics in Medicine, Vol. 14, No. 4, pp. 361-384, 2012

24 Pages Posted: 26 Mar 2012 Last revised: 27 Apr 2012

Susan M. Wolf

University of Minnesota Law School

Brittney N. Crock

University of Minnesota - Twin Cities

Brian Van Ness

University of Minnesota - Twin Cities

Frances P. Lawrenz, PhD

University of Minnesota - Twin Cities

Jeffrey P. Kahn

Johns Hopkins Berman Institute of Bioethics

Laura M. Beskow

Duke University - Institute for Genome Sciences & Policy

Mildred K. Cho

Stanford University - Stanford Center for Biomedical Ethics (SCBE)

Michael F. Christman

Coriell Institute for Medical Research

Robert C. Green

Harvard Medical School

Ralph Hall, JD

University of Minnesota, Twin Cities - School of Law

Judy Illes

University of British Columbia (UBC)

Moira Keane, M.A.

University of Minnesota - Twin Cities

Barbara Koenig

University of California, San Francisco (UCSF)

Bartha Maria Knoppers

McGill University - Centre for Genomics and Policy

Isaac S. Kohane

Harvard Children's Hospital

Bonnie LeRoy

University of Minnesota - Twin Cities

Karen J. Maschke

The Hastings Center

Pilar Ossorio

University of Wisconsin-Madison, School of Law; Morgridge Institute for Research

William McGeveran

University of Minnesota Law School

Lisa Parker

University of Pittsburgh

Gloria M. Petersen

Mayo Clinic College of Medicine

Henry S. Richardson

Georgetown University - Department of Philosophy

Joan A. Scott

National Coalition for Health Professional Education in Genetics

Sharon Terry

Genetic Alliance

Benjamin Wilfond

University of Washington

Wendy A. Wolf

Harvard Children's Hospital

Date Written: January 25, 2012

Abstract

Biobanks and archived data sets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors (using “biobank” here to refer both to collections of samples and collections of data). This article reports recommendations from a 2-year project funded by the National Institutes of Health. We analyze the responsibilities involved in managing the return of incidental findings and individual research results in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). We suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When reidentification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities to (1) clarify the criteria for evaluating findings and the roster of returnable findings, (2) analyze a particular finding in relation to this, (3) reidentify the individual contributor, and (4) recontact the contributor to offer the finding. We suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors. This article specifies 10 concrete recommendations, addressing new biobanks as well as those already in existence.

Keywords: biobanks, bioethics, genetics, genomics, incidental findings, research ethics, return of results

Suggested Citation

Wolf, Susan M. and Crock, Brittney N. and Van Ness, Brian and Lawrenz, PhD, Frances P. and Kahn, Jeffrey P. and Beskow, Laura M. and Cho, Mildred K. and Christman, Michael F. and Green, Robert C. and Hall, JD, Ralph and Illes, Judy and Keane, M.A., Moira and Koenig, Barbara and Knoppers, Bartha Maria and Kohane, Isaac S. and LeRoy, Bonnie and Maschke, Karen J. and Ossorio, Pilar and McGeveran, William and Parker, Lisa and Petersen, Gloria M. and Richardson, Henry S. and Scott, Joan A. and Terry, Sharon and Wilfond, Benjamin and Wolf, Wendy A., Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets (January 25, 2012). Genetics in Medicine, Vol. 14, No. 4, pp. 361-384, 2012. Available at SSRN: https://ssrn.com/abstract=2029261

Susan M. Wolf (Contact Author)

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

Brittney N. Crock

University of Minnesota - Twin Cities ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States

Brian Van Ness

University of Minnesota - Twin Cities ( email )

420 Delaware St. SE
Minneapolis, MN 55455
United States

Frances P. Lawrenz, PhD

University of Minnesota - Twin Cities ( email )

56 East River Road
Minneapolis, MN 55455
United States

Jeffrey P. Kahn

Johns Hopkins Berman Institute of Bioethics ( email )

1809 Ashland Ave
Baltimore, MD 21205
United States
410-614-5679 (Phone)

Laura M. Beskow

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

240 North Building
Box 90141
Durham, CA 27708
United States

Mildred K. Cho

Stanford University - Stanford Center for Biomedical Ethics (SCBE) ( email )

1215 Welch Road
Modular A
Stanford, CA 94305
United States

Michael F. Christman

Coriell Institute for Medical Research ( email )

403 Haddon Avenue
Camden, NJ 08103
United States

Robert C. Green

Harvard Medical School ( email )

250 Longwood Avenue
Boston, MA 02115
United States

Ralph Hall, JD

University of Minnesota, Twin Cities - School of Law ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States

Judy Illes

University of British Columbia (UBC) ( email )

2329 West Mall
Vancouver, British Columbia BC V6T 1Z4
Canada

Moira Keane, M.A.

University of Minnesota - Twin Cities ( email )

420 Delaware St. SE
Minneapolis, MN 55455
United States

Barbara Koenig

University of California, San Francisco (UCSF) ( email )

Third Avenue and Parnassus
San Francisco, CA 94143
United States

Bartha Maria Knoppers

McGill University - Centre for Genomics and Policy ( email )

740 Dr. Penfield Avenue, Suite 5200
Montreal, Quebec H3A 0G1
Canada

Isaac S. Kohane

Harvard Children's Hospital

300 Longwood Avenue, Enders-6
Boston, MA 02115
United States

Bonnie LeRoy

University of Minnesota - Twin Cities ( email )

420 Delaware St. SE
Minneapolis, MN 55455
United States

Karen J. Maschke

The Hastings Center ( email )

Garrison, NY 10524
United States

Pilar Ossorio

University of Wisconsin-Madison, School of Law; Morgridge Institute for Research ( email )

716 Langdon Street
Madison, WI 53706-1481
United States

William McGeveran

University of Minnesota Law School ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States

HOME PAGE: http://blogs.law.harvard.edu/infolaw

Lisa Parker

University of Pittsburgh ( email )

Medical Arts Building, Suite 300
3708 5th Avenue
Pittsburgh, PA 15260
United States

Gloria M. Petersen

Mayo Clinic College of Medicine ( email )

200 First Street S.W
Rochester, MN 55905
United States

Henry S. Richardson

Georgetown University - Department of Philosophy ( email )

205 New North
37th & 0 Street NW
Washington, DC 20057
United States

Joan A. Scott

National Coalition for Health Professional Education in Genetics ( email )

2360 West Joppa Road
Lutherville, MD 21093

Sharon Terry

Genetic Alliance ( email )

4301 Connecticut Ave. NW
Suite 404
Washington, DC 200008
United States

Benjamin Wilfond

University of Washington ( email )

Seattle Children's Hospital
1100 Olive Way, Suite 1200
Seattle, WA 98101
United States

Wendy A. Wolf

Harvard Children's Hospital ( email )

300 Longwood Avenue
Boston, MA 02115
United States

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