A multisite study of performance drivers among institutional review boards

Area of Science:

• Clinical trial management
• Regulatory affairs
• Health services research

Background:

• Delays in Institutional Review Board (IRB) approval impede clinical trial initiation.
• Efforts to reduce these delays are ongoing.
• This study focuses on identifying factors influencing IRB approval timelines.

Purpose of the Study:

• To understand operational and clinical trial characteristics affecting IRB approval times.
• To inform the development of a quality improvement framework for IRB processes.
• To identify specific ancillary reviews contributing to delays.

Main Methods:

• Analysis of 807 IRB-approved clinical trials across 5 University of California campuses.
• Identification of operational and study-specific factors influencing approval duration.
• Comparison of approval times based on funding, site count, and review types.

Main Results:

• High workloads, low staff ratios, and limited training correlate with longer approval times.
• Ancillary reviews, particularly biosafety and billing coverage analysis, significantly increase delays.
• Federally funded and multisite trials generally experience shorter approval durations.
• Accreditation status did not demonstrate a significant association with reduced approval times.

Conclusions:

• A quality improvement framework is essential for reducing IRB approval delays.
• This framework must integrate operational, study-specific, and institutional regulatory factors.
• Targeting specific ancillary reviews and optimizing operational efficiency can expedite trial initiation.