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

Journal of Law, Medicine and Ethics 36 (2):361-383 (2008)

Authors
Susan Wolf
University of North Carolina, Chapel Hill
Abstract
Research technologies can now produce so much information that there is signifcant potential for incidental fndings . 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
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DOI 10.1111/j.1748-720X.2008.00281.x
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Empirical Analysis of Current Approaches to Incidental Findings.Frances Lawrenz & Suzanne Sobotka - 2008 - Journal of Law, Medicine and Ethics 36 (2):249-255.

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