PCCPs and the IRB: What IRBs Need (and DON'T need) to Know скачать в хорошем качестве

PCCPs and the IRB: What IRBs Need (and DON'T need) to Know

This presentation clarifies how Predetermined Change Control Plans (PCCPs) (FDA pre-authorizations) allowing AI device manufacturers to make defined future modifications without new marketing applications impact IRB oversight. Key insights include: PCCPs apply only when a device's intended use (what the tool does, for whom, and in what setting) remains constant. Any change in intended use requires full IRB protocol modification review, regardless of FDA PCCP approval. The "locked versus unlocked" algorithm distinction matters for FDA validation but doesn't determine human subject risk. IRBs must independently assess whether algorithmic changes affect consent validity, risk-benefit ratios, or subject understanding. Using the AI HSR Three-Stage Framework, the presentation maps when PCCPs become relevant: Minimal in Stage 1 (development/training), documentation preparation in Stage 2 (validation), and active consideration in Stage 3 (clinical deployment).