In the context of a biobank research system, biobanks should analyze whether a particular finding qualifies as an IF or IRR that should be offered to a consenting contributor or contributors. An exception to this is when the IF or IRR arises in the primary research and the primary research constitutes human subjects research overseen by an IRB, in which case the primary researcher and researcher’s institution should generally bear this responsibility. Collection agreements between biobanks and collection sites or primary researchers should specify the division of responsibility for handling IFs and IRRs, including analysis of particular findings.
