Chunk #69 — 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
Another consent-related debate is whether to abstain from offering return of IFs and IRRs or limit return to only the most important findings when the individual contributors gave no consent for return because they gave no consent for research at all. As noted above, some biobank research and secondary research on data and/or samples from biobanks are conducted without consent, as the data and samples used were collected in clinical care and de-identified before biobank and secondary research, so the research is not considered human subjects research. In these research designs, the contributor has not consented to the research and thus has not consented to return of IFs or IRRs. How to handle return in this scenario is another hard question. Options include refraining from any return, returning only the most important and clinically actionable findings, or contacting contributors to seek consent for return. The recent DHHS ANPRM2 raises the possibility that in the future contributors will be asked for consent to research on data and samples collected in clinical care, and thus could be asked at that point if they wish to be recontacted in the future about findings of potential clinical importance.
