Chunk #36 — 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 ethics of return in individual studies
In our prior project, we analyzed ethical arguments on return of IFs in individual studies, concluding that researchers do indeed bear duties to manage IFs and offer a subset of them back to research participants consenting to return.1 We based that conclusion on several grounds. First, when the federal regulations stating standards for human subjects research (preeminently DHHS’s Common Rule11) apply, they impose requirements that are germane, even though the regulations do not explicitly address IFs and IRRs.11 For one, the regulations provide that consent must address research risks and potential benefits; IFs and IRRs may be seen as both risks and potential benefits, as they may impart crucial and even life-saving clinical information, but also may impose anxiety and the burdens of follow-up, with some IFs and IRRs turning out to be benign or even false positives.43 As IFs and IRRs do impose risks, the provisions calling for minimization of risk and that risks must be reasonable in relation to anticipated benefits are also germane.
