Chunk #90 — PART II. CORE QUESTIONS — F. What is the Content of those Responsibilities? Four Issues and Who Should Address Them — Step 2: Analyzing a particular finding
Another question that will routinely arise is whether a particular finding is well-enough understood and established to return. This is an area of controversy. Some recommendations on return of IFs and IRRs require that findings have “established risk.”86 However, the Personal Genome Project, while treating some findings as not ready for return, is nonetheless exploring the option of return with information sheets that indicate the level of scientific confirmation, rather than treating the degree to which a finding is established as a binary yes/no matter.111 While the purpose of having a central authority clarify the roster of returnable findings in Step 1 above is partly to identify those findings sufficiently established to warrant return, there will inevitably be some findings discovered that are not on that roster and for which there is not a well established literature, that nonetheless raise serious concern (e.g., a deletion whose size and location raise high suspicion of strong clinical importance). These must be addressed on a case-by-case basis.
