The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties
Susan M. Wolf
University of Minnesota Law School
Seton Hall University - School of Law
Charlisse Caga Anan
Cleveland Clinic Foundation - Department of Bioethics
July 27, 2009
Journal of Law, Medicine & Ethics, Vol. 36, No. 2, pp. 361-383, 2008
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.
Number of Pages in PDF File: 23
Keywords: incidental findings, genetics, research, informed consent, disclosure of results, law, ethics
Date posted: June 30, 2010 ; Last revised: December 25, 2010
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