The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties

Journal of Law, Medicine & Ethics, Vol. 36, No. 2, pp. 361-383, 2008

23 Pages Posted: 30 Jun 2010 Last revised: 25 Dec 2010

Susan M. Wolf

University of Minnesota Law School

Jordan Paradise

Loyola University Chicago School of Law

Charlisse Caga Anan

Cleveland Clinic Foundation - Department of Bioethics

Date Written: July 27, 2009

Abstract

Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). hese are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defined set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately offer to disclose IFs of potential clinical or reproductive significance to research participants when they arise.

Keywords: incidental findings, genetics, research, informed consent, disclosure of results, law, ethics

Suggested Citation

Wolf, Susan M. and Paradise, Jordan and Caga Anan, Charlisse, The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties (July 27, 2009). Journal of Law, Medicine & Ethics, Vol. 36, No. 2, pp. 361-383, 2008. Available at SSRN: https://ssrn.com/abstract=1439762

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

Jordan K. Paradise

Loyola University Chicago School of Law ( email )

25 E. Pearson
Chicago, IL 60611
United States

Charlisse Caga Anan

Cleveland Clinic Foundation - Department of Bioethics ( email )

9500 Euclid Ave.
Cleveland, OH 44195
United States

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