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Chunk #57 — 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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yes

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Recognizing that biobanks bear responsibilities to address the IFs and IRRs question and should anticipate potential IFs/IRRs from biobank and secondary research would have several major implications. First, biobanks would need appropriate policy-making capacity to address the question of whether to return IFs and IRRs at all. If they decided to offer some return, they would need governance and oversight structures as well as policies to fulfill this function. They would also need to have the capacity to evaluate potential IFs and IRRs, managing the scientific and ethical issues arising. Biobanks already conducting human subjects research will likely have an IRB already, but the challenge of the IFs and IRRs issues may suggest that other biobanks need an IRB (whether their own, or access to others’). The biobank’s IRB will need the capacity to interact with IRBs at primary research or collection sites, as offering findings back to an individual contributor may involve both IRBs. Biobanks may additionally want to create a specialized committee for management of return of IFs and IRRs (if any are offered), one model being the Informed Cohort Oversight Board (ICOB).47