Chunk #86 — 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
clinical significance that may result from the study, including genetic findings, and propose how these will be handled, including reporting to participants and their physicians and providing recommendations for follow up. This includes incidental findings, such as pathology identified from an imaging study that is not the focus of the study.”110