How Emerging Technologies Are Challenging Traditional IRB Oversight

Emerging technologies such as artificial intelligence (AI), connected wearables, and Software-as-a-Medical-Device (SaMD) are transforming how clinical research defines and evaluates “devices.” As innovation accelerates, traditional frameworks for risk assessment and regulatory review are being reexamined to keep pace with software-driven, adaptive, and data-centric tools.

This article explores how sponsors, CROs, and study monitors can navigate evolving FDA expectations and Institutional Review Board (IRB) requirements when integrating AI and SaMD into clinical trials. It highlights the growing importance of distinguishing physical, data, and algorithmic risks, ensuring informed consent and data security, and maintaining rigorous validation throughout development.

By understanding intent, functionality, and change management within these technologies, research leaders can better safeguard participant safety while enabling ethical innovation. As the FDA continues refining its guidance for AI-enabled devices, the intersection of technology, regulation, and human oversight remains central to the responsible advancement of modern clinical research.