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Chunk #126 — PART IV. RECOMMENDATIONS FOR NEW AND EXISTING BIOBANKS — B. Preexisting Biobanks

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Managing incidental findings and research results in genomic research involving biobanks and archived data sets.
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Retrofitting preexisting biobanks to cope with IFs and IRRs is more challenging. These biobanks vary in terms of the type of consent (if any) elicited from contributors. Some biobanks are comprised of data and/or samples collected without research consent (e.g., excess blood samples remaining after clinical laboratory analysis and then de-identified for research use). In these biobanks, contributors may not realize that their data or samples are being used in research. The literature debates whether recontact to elicit consent to return IFs and IRRs would be an unwelcome and inappropriate surprise.97,117(p619) In this no-consent case, researchers or the biobank may nonetheless encounter findings of high health significance and actionability. Thus, an emerging recommendation is to allow some return, where possible, but only of the most important findings, that is, those addressed in Recommendation 3(A) above. In some biobanks, however, the biobank (ideally in coordination with the primary researcher) may find it feasible and ethically appropriate to recontact the population of contributors (or those with potentially returnable IFs or IRRs) to ask whether they consent to recontact and return. In those