Chunk #93 — PART II. CORE QUESTIONS — F. What is the Content of those Responsibilities? Four Issues and Who Should Address Them — Step 2: Analyzing a particular finding
In proposing that this function be discharged at the level of the biobank or biobank network, we are suggesting that this will generally be preferable to leaving this function to collection sites or multiple secondary researcher sites. By locating at the biobank level the Step 1 responsibility of developing general criteria for return as well as the Step 2 responsibility for evaluating a particular finding, you maximize uniformity of decision-making about IFs and IRRs across the whole 3-stage process of biobank research. Biobanks are further in a position to use their bargaining power and contractual documents with collection sites and secondary researchers to require that IFs and IRRs for biobank contributors go through the biobank committee or processes using biobank-accepted criteria. Biobanks may also be best positioned to fund this function and sustain it over the prolonged period of use of the data and samples. Finally, biobanks are probably best positioned to document how they are handling IFs and IRRs, feed that into a database, conduct research to improve this process over time, and engage with the biobank contributor population
