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Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations

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Abstract:

No consensus yet exists on how to handle incidental fnd-ings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1748-720X.2008.00266.x

Affiliations: 1: (University of Minnesota) 2: (Harvard University) 3: (Stanford University) 4: (Vanderbilt University) 5: (Mayo Clinics) 6: (Johns Hopkins University) 7: (University of British Columbia) 8: (Pennsylvania State University) 9: (Mayo Medical School) 10: (St. Luke's Hospital and Washington University) 11: (University of Pittsburgh) 12: (Genetic Alliance) 13: (University of Washington).

Publication date: June 1, 2008

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