AI is reshaping clinical trials—but current oversight mechanisms aren't prepared. In this episode, we unpack a newly released framework from the MRCT Center that helps IRBs and researchers navigate AI’s ethical, regulatory, and operational challenges.

We explore:

• How AI is expanding its role—from trial design to data interpretation.

• The oversight gaps challenging institutional review boards (IRBs).

• A practical, phased framework tailored for clinical AI research.

• Concrete examples and guiding checklist questions that safeguard participants and ensure ethical integrity.

This episode is essential listening for anyone involved in clinical research, compliance, or AI deployment in health.