Preparing Your Action Plan for the FDA sIRB Mandate

FDA’s anticipated sIRB mandate at the end of this year will mean broad changes for the entire research community.

Watch our webinar for practical guidance from IRB thought leaders on what to include in your sIRB reliance preparations. Presenters will share real-world learnings and experiences gained from navigating current sIRB mandates in preparing IRB offices for possible FDA sIRB requirements. This includes ideas for restructuring HRPP resources, and actionable insights for coordinating with external partners and improving critical timelines.

• Outline key tasks to include when developing an sIRB reliance plan for your institution/site
• Assess current HRPP infrastructure for gaps and other potential impacts of FDA’s proposed sIRB mandate
• Discuss the impact of local study activation requirements on sIRB timelines and processes
• Review potential organizational changes to improve sIRB reliance and overall local research support services

• Presenters

Joshua Fedewa

Director, Consulting – Institutional Research, Advarra

Adam McClintock

Director, Office of the Institutional Review Board, University of Alabama at Birmingham