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Review
. 2008 Summer;36(2):361-83, 214.
doi: 10.1111/j.1748-720X.2008.00281.x.

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

Susan M Wolf  1 , Jordan Paradise, Charlisse Caga-anan
Affiliations
Review

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

Susan M Wolf et al. J Law Med Ethics. 2008 Summer.

Abstract

Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These 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.

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References

    1. The Common Rule governs research on human beings funded by the federal government or conducted by institutions providing the federal government with an assurance that all research conducted there will follow the federal rules. See 45 C.F.R. § 46.101 (2007).Sixteen federal agencies subscribe to that rule. See Office for Human Research Protections (OHRP) Common Rule Agencies/Departments, available at <http://www.hhs.gov/ohrp/related.html#com> (last visited January 14, 2008). The Food and Drug Administration (FDA) follows a variant. See 21 C.F.R. Parts 50, 56 (2007).

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