Abstract

http://ssrn.com/abstract=2029261
 
 

Citations (1)



 
 

Footnotes (1)



 


 



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


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 University

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

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

January 25, 2012

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

Number of Pages in PDF File: 24

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

Accepted Paper Series


Download This Paper

Date posted: March 26, 2012 ; Last revised: April 27, 2012

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: http://ssrn.com/abstract=2029261

Contact Information

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 University ( email )
1809 Ashland Ave
Baltimore, MD 21205
United States
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 ( email )
1001 Sherbrooke St. W
Montreal, Quebec H3A 1G5
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
Feedback to SSRN


Paper statistics
Abstract Views: 646
Downloads: 88
Download Rank: 171,599
Citations:  1
Footnotes:  1

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo3 in 0.875 seconds