Chunk #68 — PART II. CORE QUESTIONS — F. What is the Content of those Responsibilities? Four Issues and Who Should Address Them — Step 1: Clarifying the criteria and roster
A second general criterion garnering significant, though not complete, agreement is that the contributor or research participant has consented to receipt of this information.76,86,95,97 Ideally researchers and IRBs will anticipate the question of whether to return IFs and IRRs before data and samples are initially collected and the collecting researchers will ask contributors whether they wish to be recontacted in the future to receive such findings. Contributors may also be asked what kinds of IFs and IRRs they wish to receive, depending on the major categories expected in anticipated research.86,98 Debate surrounds the question of whether researchers should or may return results when the contributor has not given earlier consent to return or has earlier refused return, if the finding has high health importance and is clinically actionable (e.g., when return of a finding of a genetic variant associated with catastrophic reaction to a commonly used drug would allow avoidance of that drug).86 This question is hard to answer in the abstract and may require consideration in the context of the particular biobanks, study population, and study type in question, ideally with involvement of representatives from the study population and research on contributor preferences for return, as discussed further below.
