Demonstration Project: Transitioning a Research Network to New Single IRB Platforms

Area of Science:

• Clinical research administration
• Human subjects protection
• Regulatory science

Background:

• The National Institutes of Health (NIH) mandated the use of a single Institutional Review Board (sIRB) for multicenter research in 2016.
• Academic institutions face challenges in operationalizing the sIRB process, including managing reliance agreements and documentation.

Purpose of the Study:

• To demonstrate a transition from individually negotiated reliance agreements to a new sIRB master agreement and informatics platform.
• To identify lessons learned for academic institutions and IRBs implementing sIRB processes.

Main Methods:

• A demonstration project was conducted at the University of Utah Trial Innovation Center.
• Assisted the Collaborative Pediatric Critical Care Research Network in adopting an sIRB master agreement and informatics platform.
• Shifted from paper-based documentation to an informatics platform for capturing reliance documentation.

Main Results:

• The project facilitated a transition to a more streamlined sIRB operational model.
• Key lessons include clarifying the distinction between site engagement/reliance and study activation.
• Understanding local review requirements remains a significant challenge.

Conclusions:

• Operationalizing sIRB requires clear understanding of reliance types and local review nuances.
• Further research is needed to optimize sIRB processes for efficiency and reduced administrative burden.
• The goal is to align with the NIH vision for improved study start-up times and human research protections.