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. Importantly, biobanks will need to consider how to hold codes for re-identification or to establish a Trusted Intermediary to perform this function. They will also need to consider their access to clinical personnel (including genetic counselors) as needed to consult on IFs and IRRs and potentially perform re-contact. Clinical personnel could usefully collaborate in advance to establish a methodology and format for return of IFs and IRRs, considering those already described in the literature.47,106
