Chunk #66 — 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
Table 4 updates the prior list of major U.S. consensus recommendations on criteria for return in Wolf et al.1 (Table 3) It adds our prior project’s 2008 recommendations and those subsequent. It also removes those not focused directly on return of IFs and IRRs or now superseded. As this Table suggests, two separate but interrelated issues are emerging: what criteria should ground an obligation or option to return and who should formulate those criteria, revise them over time with refinement of genetic and genomic knowledge, and recommend a roster of returnable results. On criteria, there is wide agreement that findings should be analytically valid and comply with applicable law. The requirement of analytic validity assures that the test results accurately reveal whether a particular genotype is present.91 Compliance with applicable law means that the finding was generated in compliance with the Clinical Laboratory Improvements Amendments of 1988 (CLIA).92 CLIA and its accompanying regulations impose a number of test quality assurance requirements when test results are being generated and returned for clinical purposes, including measures to ensure that the test result
