A comparison of institutional review board models and study efficiency in the Environmental influences on Child Health Outcomes Cohort Consortium.

BACKGROUND: Institutional review board (IRB) approval is a key step in site activation and study initiation. Single IRBs aim to improve the timeliness of IRB review through centralization and standardization, whereas local IRBs conduct reviews only for specific sites. In Cycle 1 of the Environmental influences on Child Health Outcomes (ECHO) Cohort Consortium, 110 sites chose either single or local IRB review, providing the opportunity to compare the efficiency of single versus local IRBs within one multicenter observational study. OBJECTIVES: Data were collected from the ECHO Coordinating Center at the Duke Clinical Research Institute. Primary outcomes included: 1) time from IRB submission to approval and 2) time from regulatory pack receipt to first participant enrollment. Secondary outcomes included: 1) time from regulatory pack receipt to IRB submission, 2) time from IRB approval to site activation, and 3) time from site activation to first participant enrollment. We compared these outcomes between sites using local versus single IRBs. RESULTS: No significant differences were identified between the local and single IRB groups for the primary and secondary outcomes. The time from IRB submission to approval was similar for local and single IRBs (median [IQR]: 20 days [10-33]; 19 days [11-27]; p = 0.71, respectively). The time from regulatory pack receipt to first participant enrollment was similar for local and single IRBs (median [IQR]: 243 days [16-309]; 191 days [137-233]; p = 0.50, respectively). CONCLUSION: Multiple factors influence review timelines. Single IRBs do not guarantee faster review; additional work is needed to evaluate their impact on study timelines.

Duke Scholars

Author Phillip Brian Smith Pediatrics, Neonatology