Chunk #71 — 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
We suggest that those IFs and IRRs that should be offered back to contributors are those of high importance and likely net benefit to the contributor. These include findings revealing substantial risk of a serious health condition, a criterion that addresses both the likelihood of developing the condition and the seriousness of the condition. Note that this criterion for return is more inclusive than the “should disclose” criterion stated in our earlier project’s recommendations, which required “significant risk of a condition likely to be life-threatening…[or] grave.”1(Table 5) Our revision strives to establish more consistency with the subsequent group recommendations from Fabsitz et al.86 under NHLBI auspices (“important health implications…and the associated risks are established and substantial”). This broadening of the criterion for “should be offered back” prompted debate in our author group. Some would continue to restrict “should offer back” to conditions that are life-threatening or grave. A significant majority of our group, however, supported moving to “substantial risk of a serious health condition,” in greater alignment with Fabsitz et al. In any case, the core question, as we suggested
