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2023 PRIM&R Annual Conference

Single IRB

Flexibility and Innovation in Research Oversight Processes

HRPP/IRB Administration/Management and Process

C01 - [IN-PERSON/RECORDED] Single IRB (sIRB) Coordination Models: Innovative Approaches from Four Clinical and Translational Science Award (CTSA) Programs

Monday, December 4, 2023
3:45 PM – 4:45 PM ET
Location: Ballroom AB
Live Session Recorded Human Subjects Research Call for Session Proposal Networking Series CIP Accredited
This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

Academic IRBs serving as sIRB for multi-site research have developed several operational models and utilize key tools to adapt to this complex role. This session will outline coordination challenges faced by IRBs and study teams throughout the sIRB review process and describe operational models and essential tools employed in response to the NIH sIRB mandate, including how multiple CTSAs utilize IRB Reliance Exchange (IREx), developed by Vanderbilt, to support sIRB coordination. This includes a liaison model, study team coordination model, or a hybrid of both.

Learning Objectives:

  • Identify coordination challenges faced by IRBs and study teams throughout the sIRB review process and describe operational models and essential tools
  • Discuss metrics and outcomes of five years of Single IRB data and share outcomes gleaned from it
  • Define methods for centralizing study/reliance documentation and communication between site study teams, IRBs, HRPPs, etc., using tools like IREx and other electronic systems