Chunk #85 — PART II. CORE QUESTIONS — F. What is the Content of those Responsibilities? Four Issues and Who Should Address Them — Step 1: Clarifying the criteria and roster
criteria for returnability to their IRB or conceivably their Data Access Committee (DAC). Some biobanks will find it useful to have all three entities, with the IFs/IRRs committee focusing on that issue, the IRB integrating those concerns with broader human subjects concerns, and the DAC addressing the question of how secondary researchers seeking to access biobank data and samples should handle IFs/IRRs and report them back to the biobank. Indeed, biobanks should consider writing into their contractual agreements with collection sites on one end of the process and secondary researchers on the other end (i.e., into collection agreements, MTAs, and DAAs or DUAs) provisions on how IFs and IRRs will be addressed. We see evidence of this already. For example, the Framingham Heart Study provides in its secondary (or “ancillary”) research application procedures that the secondary researcher must anticipate possible clinical findings and plan for the return of results to participants: “The proposing investigator must clearly delineate any findings of clinical significance that may result from the study, including genetic findings, and propose how these will be handled, including reporting to participants and their physicians and providing recommendations for follow up. This includes incidental findings, such as pathology identified from
