Chunk #96 — 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)
Variation in degrees of de-identification and who holds the key to the code for re-identification is a challenge for return of IFs and IRRs from biobank research. When only the primary researcher (or collection site) holds the key, the capacity to return IFs and IRRs may be limited by research funding at the primary research (or collection) site, whether the original investigator or someone else capable of performing re-identification remains there, whether the key for re-identification can be found and used for re-identification even after a potentially significant lapse of time, and the policy of that particular IRB on re-identification and return of results. This will likely produce multiple different outcomes within a single biobank research system when the biobank contributor population derives from multiple primary research or collection sites. It also means that the particulars of individual researchers and 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
