IRB Challenges and Updates for 2024

In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHRP, and the need for greater federal agency involvement. They also cover the impact of new guidance, the Trump administration, and the FDA's relationship with IRBs.We discuss: 1. The FDA’s Finalized Guidance on Decentralized Clinical Trials (DCTs): The recent FDA guidance formalizing decentralized elements in clinical trials raises crit...