The law of incidental findings in human subjects research: Establishing researchers' duties

Susan M Wolf, Jordan Paradise, Charlisse Caga-Anan

Research output: Contribution to journalArticlepeer-review

75 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)361-383
Number of pages23
JournalJournal of Law, Medicine and Ethics
Volume36
Issue number2
DOIs
StatePublished - 2008

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