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Chunk #10 — (1) Blurring the Boundary between Research and Treatment — (a) Returning Incidental Findings

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What research ethics should learn from genomics and society research: lessons from the ELSI Congress of 2011.
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In a panel [D-1] that examined the ELSI implications for genomics of issues arising in neuroscience, a paper by Judy Illes discussed the treatment of incidental findings in neuroimaging and considered the similar issues arising from incidental findings in genomics research. The familiar problem of incidental findings in clinical research more generally is increased greatly in scope in biospecimen research, owing to its much greater magnitude and scale. The collection of large numbers of biospecimens, and the technologies that permit identification of multiple mutations potentially associated with common complex disorders like cancer, make the identification of genetic variants that are not being looked for but that may have clinical meaning far more likely. Thus there is both (1) a need to determine in advance appropriate protocols for handling a high volume of incidental findings, and (2) an expectation on the part of research subjects that information of potential clinical significance is likely to be found.