Many of us participated in an earlier project (#1-R01-HG003178) that offered analysis and recommendations addressing the responsibilities of researchers and Institutional Review Boards (IRBs) when the researcher collecting data and samples discovers IFs of potential health or reproductive importance to the research participant. That project resulted in consensus recommendations1 published as part of a journal symposium issue including a large number of individual papers offering additional analyses. This follow-on project (#2-R01-HG003178) broadens the focus in two respects: we consider management of IRRs as well as IFs, and we concentrate on the problem of how to identify and manage them in the increasingly important context of large-scale research involving biobanks.
