While the simpler example on which we focused in our earlier project, that of a researcher discovering IFs and IRRs in what we will call “primary” research, raises difficult questions that are still under debate, the more complex example of IFs and IRRs discovered by a biobank or by a researcher obtaining and analyzing biobank data or samples (in what we will call “secondary research”) raises still further questions. Literature and guidance are sparse on the responsibilities of biobanks when IFs or IRRs of significance are identified, and how to address IFs and IRRs consistently across research networks spanning multiple institutions. Core questions include: What information, if any, about IFs and IRRs should be offered back to individuals whose genetic data and samples are stored in biobanks and archived datasets? Who has the responsibility of offering genetic/genomic research results to those individuals? What policies should be in place governing the research practices of both existing biobanks (which may have been assembled without attention to return of IFs and IRRs) and new biobanks?
