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Chunk #122 — PART IV. RECOMMENDATIONS FOR NEW AND EXISTING BIOBANKS — A. New Biobanks

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Managing incidental findings and research results in genomic research involving biobanks and archived data sets.
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To be more specific, in structuring biobank interaction with primary researchers or collection sites, biobanks should make sure that primary researchers (or collection sites) specify how they plan to handle the issue of IFs and IRRs, and indicate that they have consulted their IRB in erecting this plan. Biobanks will need to establish an agreement with primary researchers (or collection sites) on the respective roles the biobank and primary research (or collection site) will play in the CARR process. Together they will need to consider whether key codes will be housed not just at the primary research (or collecting) institution but also at the biobank or a trusted intermediary, as discussed above. They will also need to consider how any consent process will address whether any IFs/IRRs identified in the biobank research system will be offered back to contributors, what type of findings will potentially be returned, whether individual contributors consent to return, and whether contributors are willing to share contact information and update that information over time to facilitate recontact.