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http://ssrn.com/abstract=1721782
 
 

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Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations


Susan M. Wolf


University of Minnesota Law School

Frances P. Lawrenz, PhD


University of Minnesota - Twin Cities

Charles A. Nelson


Harvard Medical School

Jeffrey P. Kahn


Johns Hopkins University

Mildred K. Cho


Stanford University - Stanford Center for Biomedical Ethics (SCBE)

Ellen Wright Clayton


Vanderbilt University - Law School

Joel G. Fletcher


Mayo Clinic - College of Medicine

Michael K. Georgieff


University of Minnesota - Twin Cities

Dale Hammerschmidt


University of Minnesota - Twin Cities

Kathy Hudson


National Institutes of Health (NIH)

Judy Illes


University of British Columbia (UBC)

Vivek Kapur


Pennsylvania State University

Moira Keane, M.A.


University of Minnesota - Twin Cities

Barbara Koenig


University of California, San Francisco (UCSF)

Bonnie LeRoy


University of Minnesota - Twin Cities

Elizabeth McFarland


St. Luke's Hospital; Washington University in Saint Louis

Jordan Paradise


Seton Hall University - School of Law

Lisa Parker


University of Pittsburgh

Sharon Terry


Genetic Alliance

Brian Van Ness


University of Minnesota - Twin Cities

Benjamin Wilfond


University of Washington

June 2, 2008

Journal of Law, Medicine and Ethics, Vol. 36, No. 2, pp. 219-248, 2008

Abstract:     
Tremendous debate surrounds the question of whether researchers owe back to human subjects information about incidental findings of potential clinical and reproductive importance to the individual. Historically, law, ethics, and practice have drawn a bright line between the duties of clinicians and the duties of researchers, imposing on researchers no duty to return information of clinical importance. Indeed, bioethics and health law are built on a dichotomy between clinical care (the domain of the doctor-patient relationship) and research (the domain of the researcher-subject relationship). Yet the debate over whether researchers have any duty to return incidental findings (and the related debate over whether they have a duty to return individual research results) challenges that fundamental dichotomy.

This article offers analysis and recommendations from a two-year project funded by the National Institutes of Health (NIH) and led by Susan M. Wolf (Principal Investigator) to determine how to manage incidental findings (IFs) in human subjects research, focusing on genetic and genomic research, with comparison to imaging research. This is the first national project funded by NIH on this issue. IFs are defined as findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. IFs are frequently discovered in conducting research and can hold life-and-death importance (as when researchers stumble upon a genetic variant predicting life-threatening response to a commonly used anesthetic). The article argues that researchers have an obligation to address the possibility of discovering IFs and articulate how IFs will be managed. This information should be reflected in the researcher’s protocol and communications with the IRB, as well as in consent forms and communications with research participants. The article recommends a pathway for researchers to follow in addressing IFs. It categorizes IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.

This is the first comprehensive analysis and major set of recommendations on how to handle incidental findings in human subjects research including genomic research. It is the centerpiece of a symposium issue including sixteen articles from a multidisciplinary group of top scholars on this pressing issue.

Number of Pages in PDF File: 30

Keywords: incidental findings, human subjects research, bioethics, health law

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Date posted: December 8, 2010 ; Last revised: February 6, 2014

Suggested Citation

Wolf, Susan M. and Lawrenz, PhD, Frances P. and Nelson, Charles A. and Kahn, Jeffrey P. and Cho, Mildred K. and Wright Clayton, Ellen and Fletcher, Joel G. and Georgieff, Michael K. and Hammerschmidt, Dale and Hudson, Kathy and Illes, Judy and Kapur, Vivek and Keane, M.A., Moira and Koenig, Barbara and LeRoy, Bonnie and McFarland, Elizabeth and Paradise, Jordan and Parker, Lisa and Terry, Sharon and Van Ness, Brian and Wilfond, Benjamin, Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations (June 2, 2008). Journal of Law, Medicine and Ethics, Vol. 36, No. 2, pp. 219-248, 2008. Available at SSRN: http://ssrn.com/abstract=1721782

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
Frances P. Lawrenz, PhD
University of Minnesota - Twin Cities ( email )
56 East River Road
Minneapolis, MN 55455
United States
Charles A. Nelson
Harvard Medical School ( email )
250 Longwood Avenue
Boston, MA 02115
United States
Jeffrey P. Kahn, PhD, MPH
Johns Hopkins University ( email )
1809 Ashland Ave
Baltimore, MD 21205
United States
Mildred K. Cho
Stanford University - Stanford Center for Biomedical Ethics (SCBE) ( email )
1215 Welch Road
Modular A
Stanford, CA 94305
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)
Joel G. Fletcher
Mayo Clinic - College of Medicine ( email )
200 First Street S.W
Rochester, MN 55905
United States
Michael K. Georgieff
University of Minnesota - Twin Cities ( email )
420 Delaware St. SE
Minneapolis, MN 55455
United States
Dale Hammerschmidt
University of Minnesota - Twin Cities ( email )
420 Delaware St. SE
Minneapolis, MN 55455
United States
Kathy Hudson
National Institutes of Health (NIH) ( email )
9000 Rockville Pike
Bethesda, MD 20892
United States
Judy Illes
University of British Columbia (UBC) ( email )
2329 West Mall
Vancouver, British Columbia BC V6T 1Z4
Canada
Vivek Kapur
Pennsylvania State University ( email )
University Park
State College, PA 16802
United States
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
Bonnie LeRoy
University of Minnesota - Twin Cities ( email )
420 Delaware St. SE
Minneapolis, MN 55455
United States
Elizabeth McFarland
Saint Luke's Hospital
St. Louis, MO
United States
Washington University in Saint Louis ( email )
Campus Box 1133
One Brookings Drive
Saint Louis, MO 63130-4899
United States
Jordan K. Paradise
Seton Hall University - School of Law ( email )
One Newark Center
Newark, NJ 07102-5210
United States
Lisa Parker
University of Pittsburgh ( email )
Medical Arts Building, Suite 300
3708 5th Avenue
Pittsburgh, PA 15260
United States
Sharon Terry
Genetic Alliance ( email )
4301 Connecticut Ave. NW
Suite 404
Washington, DC 200008
United States
Brian Van Ness
University of Minnesota - Twin Cities ( email )
420 Delaware St. SE
Minneapolis, MN 55455
United States
Benjamin Wilfond
University of Washington ( email )
Seattle Children's Hospital
1100 Olive Way, Suite 1200
Seattle, WA 98101
United States
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Citations:  6
Footnotes:  128

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