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Managing incidental findings in human subjects research: analysis and recommendations.
Authors:Susan M Wolf  Frances P Lawrenz  Charles A Nelson  Jeffrey P Kahn  Mildred K Cho  Ellen Wright Clayton  Joel G Fletcher  Michael K Georgieff  Dale Hammerschmidt  Kathy Hudson  Judy Illes  Vivek Kapur  Moira A Keane  Barbara A Koenig  Bonnie S Leroy  Elizabeth G McFarland  Jordan Paradise  Lisa S Parker  Sharon F Terry  Brian Van Ness  Benjamin S Wilfond
Institution:University of Minnesota, MN, USA.
Abstract:No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings 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.
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