Quantifying IRB Process Variability Across Departments
Data-driven evidence for IRB process standardization across 5 departments.
The Challenge
A research university's IRB approval time ranged from 2 weeks to 4 months for equivalent protocols, depending on the department. Faculty complained, but the IRB office had no process data to diagnose the variability.
The Approach
H-Synth modeled the IRB submission-to-approval workflow as practiced in each of 5 departments. Monte Carlo simulation quantified the variability contribution of each step. Comparison views showed where departmental processes diverged from the documented standard.
The Results
The analysis revealed that 60% of variability came from 2 steps: initial review assignment and committee scheduling. The IRB office standardized these steps and reduced median approval time from 8 weeks to 3 weeks.