Models of Consent to Return of Incidental Findings in Genomic Research

Appelbaum, Paul S.; Parens, Erik; Waldman, Cameron R.; Klitzman, Robert L.; Fyer, Abby; Martinez, Josue Natanael; Price II, W. Nicholson; Chung, Wendy K.

Genomic research has the capacity to generate a wide array of findings that go beyond the goals of the study—usually referred to as “incidental findings.” The evolving consensus of researchers, participants, and expert panels is that at least some incidental results should be made available to participants. However, there are a number of challenges to discussing these issues with participants and ascertaining their preferences, including the complexity and magnitude of the relevant information. Believing that usual models of informed consent are not likely to be effective in this context, we identify four approaches that investigators and IRBs might consider: traditional consent, staged consent, mandatory return, and outsourcing. Each has advantages and disadvantages compared with the other options, and which one is selected for a given project will depend on a mix of practical and normative considerations that are described in this paper.


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The Hastings Center Report

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June 8, 2020