Effective collaboration between principal investigators (PIs) and institutional review boards (IRBs) is critical to protecting participants and ensuring efficient study conduct, yet misalignment between these groups remains a persistent challenge.

This session offers dual perspectives from an IRB reviewer and an experienced PI/IRB chair on how decisions are made, interpreted, and sometimes contested across the research lifecycle. Using real-world, case-based scenarios, attendees will be walked through high-friction moments in IRB–PI interactions, including disagreements about informed consent in complex or time-sensitive settings, protocol design concerns and risk-benefit assessments, and responses to deviations, noncompliance, and evolving safety signals.

This session will emphasize how regulations are implemented in practice, highlighting the underlying reasoning, assumptions, and common communication breakdowns in order to anticipate IRB concerns during study design and submission, improve communication, reduce iterative review cycles, and navigate disagreements constructively while maintaining participant protections.

CEU: 1.0 ACRP

Speakers:

• Muhammad Waseem, MD, MS, Research Director, Emergency Medicine, Lincoln Medical Center

• Ribu Goyal, IRB Specialist and Scientific Reviewer, Mayo Clinic