Institutional Review Boards (IRBs) are federally mandated bodies that oversee research involving human subjects. In the evolving landscape of clinical research, IRBs play a critical role in ensuring ethical oversight and regulatory compliance in FDA-regulated research. This session will provide comprehensive overview of the common challenges IRBs encounter, such as ensuring compliance with FDA regulations, working with industry partners, and maintaining rigorous oversight amidst increasing research complexities. We will also explore emerging trends impacting IRB operations, including the integration of Artificial Intelligence and Machine Learning in research protocols, the rise of decentralized clinical trials, companion diagnostics in oncology research, and the FDA's proposed mandate for single IRB review in cooperative research. Attendees will gain insights into best practices for navigating these challenges and adapting to the dynamic regulatory environment, ensuring robust protection for research participants while facilitating scientific advancement.
Learning Objectives:
Identify and address common pitfalls in IRB oversight of FDA-regulated research.
Understand the implications of emerging trends, such as AI/ML integration and decentralized trials, on IRB responsibilities.
Prepare for the FDA's proposed single IRB mandate and its impact on cooperative research oversight.
