In structuring the biobank’s own operations, the facility will need to establish policies, committees and advisory resources, procedures, staff, and funding to support fulfillment of the responsibilities suggested in Recommendations 1–10 above. Committees and other advisory resources should include a dedicated committee on return of IFs and IRRs (such as an ICOB), an IRB, a DAC to manage access by secondary researchers, and a means of community consultation such as a Community Engagement Committee. Some biobanks may be able to combine some of these functions into a smaller number of committees, but for large and complex biobank research systems, all may be needed. Biobanks will also need to consider informatics challenges posed by IFs and IRRs, including how to annotate data and samples to track the primary research institution (or collection site), how to note that the consent process addressed handling of IFs and IRRs, and how to track contributor consent to or refusal of recontact with respect to IFs and IRRs. Biobanks will further need to consider their use of or access to CLIA-certified labs to generate returnable findings.
