Chunk #35 — PART II. CORE QUESTIONS — D. If Data and Samples Can Be Re-identified, Are There Any Biobank Research System Responsibilities to Offer Return of IFs and IRRs?
The published literature reveals a growing number of commentators concluding that if return is possible, some findings should indeed be considered for return. Few commentators argue that there should be zero return, no matter how urgent and clinically actionable the finding. Our project members nonetheless discussed whether a biobank that could re-identify participants and thus offer results might decide as a blanket matter to offer no return at all. In the end, we decided to urge biobanks to address the IFs/IRRs issue and consider what findings would warrant an offer of return. There is considerable controversy over this last question -- what findings merit an offer of return. Most of the literature to date, however, addresses return in individual studies or what we are calling “primary research,” not biobank research systems. We first briefly summarize the work on individual studies, the necessary starting point for considering the ethics of return in the more complex case of a biobank research system.
