Clinical Research Observations & IRB Expectations For 2026

By Raffaella Hart and Linda Reuter

Clinical research oversight is entering a transformative phase in 2026, driven by rapid technological adoption and evolving regulatory expectations. Institutional Review Boards (IRBs) are navigating a landscape where informed consent is no longer a static process. The rise of digital tools and AI means participants approach consent with varying levels of technological fluency, challenging sponsors to balance clarity and inclusivity across demographics.

Artificial intelligence is also reshaping research methodologies and review processes. While AI promises efficiency in data analysis and administrative tasks, ethical oversight remains firmly human-led. IRBs are preparing for hybrid review models that integrate AI without compromising judgment and participant protection.

Regulatory uncertainty adds another layer of complexity. Shifts in FDA guidance on diversity planning, resource constraints, and new transparency rules underscore the need for adaptability. Sponsors must anticipate potential delays and maintain proactive communication with IRBs to safeguard compliance.

As multi-site studies await the single IRB mandate, flexibility and meticulous documentation will be critical. In this dynamic environment, success hinges on collaboration, ethical rigor, and readiness to embrace innovation without losing sight of participant safety.

Access the full resource to explore strategies for navigating these changes and preparing for the future of clinical research oversight.