Chunk #97 — PART II. CORE QUESTIONS — F. What is the Content of those Responsibilities? Four Issues and Who Should Address Them — Step 3: Re-identifying the contributor(s)
institutions will determine how the system discharges ethical responsibilities. We recommend development of approaches to re-identification that allow greater consistency and predictability within a biobank research system. For biobanks that currently conduct research on identified data and/or samples or themselves hold the key and can readily re-identify contributors, it is no stretch to say they bear responsibilities for re-identification. Under the Common Rule, they are conducting human subjects research and assigning them responsibility for re-identification to return IFs and IRRs deemed important to return does not change that. However, for biobanks that do not hold the key and cannot readily re-identify contributors, it is a different matter. Such biobanks are not considered to be conducting human subjects research under the Common Rule. Asking them to hold the key themselves would change that. However, when re-identification and recontact is indeed possible, at least at the primary research or collection site, an alternative to having the biobank itself hold the key is to create an independent, “trusted intermediary” to hold it. 87,113 This means that after ascertaining in Steps 1 and 2 that an IF or IRR worthy of return has been found, the re-identification responsibility would rest on the “trusted intermediary.”
