Neither of these policies recognizes a role for the biobank itself. Instead, they place on primary researchers and their IRB the responsibility for determining whether to return IFs and IRRs at all, deciding which to return, and performing any actual return. In both cases, however, this approach is premised on the biobank and secondary researchers having no access to identifying information because primary researchers and institutions de-identified the data before submission to the biobank. It is important to recognize, though, that this is not the only model of biobank research. Biobanks can receive data and samples that are not de-identified, even if the biobank then removes identifiers before releasing the data and samples to secondary researchers. Indeed, a biobank – especially biobanks set up to study individuals with a particular disease or condition -- may follow contributors prospectively, collecting additional information for research. When the biobank itself receives identifying information, the premise of these NHGRI and NIH policies does not apply. This re-opens the question of what responsibilities the biobank should shoulder for deciding whether to return IFs and IRRs at all, determining which to return, and then managing the return process.
