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Chunk #50 — 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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If IFs or IRRs are to be returned at all, the conventional view has been that the biobank has no responsibilities. Instead, primary investigators (or collection sites) should be responsible for identifying and contacting contributors, because primary researchers have the identification information and have had direct contact with contributors.24(p34) According to NHGRI, if a secondary researcher “does generate results of immediate clinical significance,” that researcher “can only facilitate their return by contacting the contributing investigator who holds the key to the code that identifies the participant. In such cases, the contributing investigator would be expected to comply with all laws and regulations and consider the benefits and risks associated with the return of individual research results to participants and follow established institutional procedures (e.g., consultation with and approval by the IRB) to determine whether return of the results is appropriate and, if so, how it should be accomplished.”83(p12)