If biobanks determine to engage in return, they will also need appropriate procedures and informatics capacity to deal with re-identification. Biobanks could approach re-identification in one of three ways. They could rely on primary researchers or collection sites to re-identify contributors when appropriate, they could themselves hold the key to the codes to re-identify contributors, or they could create an entity (such as a “trusted intermediary” or “honest broker”) to hold the key and perform re-identification. 26(p42),87(p1013) Note that if biobanks themselves hold the key to the codes (the second option), then the biobank would likely be conducting a research activity that would require an IRB-approved protocol and informed consent, unless the Common Rule criteria for waiver of consent are met. Yassin et al.87(p1013) elaborate on the option of using a trusted intermediary, saying that “The trustee’s role can be filled by a biospecimen resource, an entity within an academic institution not involved in the research, a subcontracted third party, or an informatics system.” Researchers are currently exploring automated informatics options to facilitate return of IFs and IRRs, including the biobank using electronic interfaces to make detailed offers of data return so that contributors can elect what to receive. 47,88,89
