Managing Incidental Findings in Human Subjects Research: From Imaging to Genomics

5 Pages Posted: 9 Jan 2011

See all articles by Susan M. Wolf

Susan M. Wolf

University of Minnesota Law School

Jeffrey P. Kahn

Johns Hopkins Berman Institute of Bioethics

Frances P. Lawrenz, PhD

University of Minnesota - Twin Cities

Charles A. Nelson

Harvard University - Harvard Medical School

Date Written: Summer 2008

Abstract

This 18-article symposium publishes a breakthrough set of interdisciplinary articles on the highly controversial question of whether researchers bear duties to return to research participants incidental findings of potential clinical or reproductive importance. Past practice in genetic and genomic research has been to avoid return of incidental findings, drawing a sharp distinction between clinician duties and less expansive researcher duties. Past practice in imaging research (neuroimaging and CT colonography) has included some return. However, empirical work reported in this symposium shows no consistent practice, guidance, or even terminology addressing the management of incidental findings in human subjects research.

The symposium grows out of a 2-year, NIH-funded project (grant #1-R01-HG003178) on "Managing Incidental Findings in Human Subjects Research" (Susan M. Wolf, Principal Investigator (PI); Co-Investigators: Jeffrey Kahn, Frances Lawrenz, Charles Nelson, and Jordan Paradise). The centerpiece of the symposium is a major new consensus document on identifying and managing incidental findings, including the ethical and regulatory obligations devolving on researchers. (Susan M. Wolf et al., Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations, 36 J.L. MED. ETHICS 219 (2008)). The symposium includes the work of more than 25 authors on the legal, ethical, clinical, and scientific issues. The problem of incidental findings deeply challenges current approaches to human subjects research and the conventional divide in health law and bioethics between research and clinical obligations.

Keywords: Incidental findings, return of research results, human subjects research, genetics, genomics, neuroimaging, CT colonography, research ethics, health law, law and science, empirical studies

Suggested Citation

Wolf, Susan M. and Kahn, Jeffrey P. and Lawrenz, PhD, Frances P. and Nelson, Charles A., Managing Incidental Findings in Human Subjects Research: From Imaging to Genomics (Summer 2008). Journal of Law, Medicine and Ethics, Vol. 36, No. 2, p. 211, Summer 2008. Available at SSRN: https://ssrn.com/abstract=1735394

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

Jeffrey P. Kahn

Johns Hopkins Berman Institute of Bioethics ( email )

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

Frances P. Lawrenz, PhD

University of Minnesota - Twin Cities ( email )

56 East River Road
Minneapolis, MN 55455
United States

Charles A. Nelson

Harvard University - Harvard Medical School ( email )

25 Shattuck St
Boston, MA 02115
United States

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