Protocol Design Choices That Trigger IRB And Regulatory Requirements

Protocol design decisions can shape the complexity, timing, and regulatory path of IRB review. In this video, BRANY experts Raffaella Hart and Linda Reuter explain how institutional review boards protect research participants by evaluating risk, informed consent, and ethical safeguards throughout the study lifecycle.

Learn how decentralized and adaptive trials, novel interventions, special populations, AI, and software-enabled medical devices may introduce additional questions, submissions, or consent requirements. The discussion also examines the experience and processes behind BRANY’s central IRB services, including its certified professionals, quality assurance practices, regulatory education, and post-approval monitoring.

Viewers will gain practical insight into planning protocols for smoother review, maintaining compliance as requirements evolve, and building an effective working relationship with an IRB. Watch the full video to understand how early communication and thoughtful protocol development can help research teams anticipate requirements, protect participants, and keep clinical studies moving forward.