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Chunk #51 — PART II. CORE QUESTIONS — E. Should the Biobank Itself Have Responsibilities for Managing Return?

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Managing incidental findings and research results in genomic research involving biobanks and archived data sets.
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Placing responsibility for deciding whether and how to return IFs and IRRs on the original, collecting researcher, also comports with NIH policy on GWAS.84 Under that policy, “The NIH does not anticipate that participants will be able to obtain individual results of secondary analyses on data obtained from their participation in primary studies. Because the NIH GWAS data repository and secondary data users will not have access to identifying information or to the link to the keycode within the data, neither will be able to return individual results directly to subjects. Secondary investigators may share their findings with primary investigators, who may determine whether it is appropriate to return individual or aggregate research results to participants whose health may be affected….”84(p49293)