The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties
Abstract:Research technologies can now produce so much information that there is signifcant potential for incidental fndings (IFs). These are fndings generated in research that are beyond the aims of the study. Current law and federal regulations ofer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defned 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 ofer to disclose IFs of potential clinical or reproductive signifcance to research participants when they arise.
Document Type: Research Article
Affiliations: 1: The McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre & Benson Professor of Law; and Professor of Medicine at the University of Minnesota. 2: Associate Director of Research & Education for the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences and Joint Degree Program in Law, Health & the Life Sciences. 3: Research Assistant to the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences and expects her J.D. from the University of Minnesota Law School in May 2008.
Publication date: June 1, 2008