D. E. Hall1,2, U. Feske1, S. Gao1, R. Stone1,2, S. Zhang1, R. Arnold2 1VA Pittsburgh Healthcare System,Pittsburgh, PA, USA 2University Of Pittsburg,Pittsburgh, PA, USA
Introduction: Although data demonstrate that VA investigators perceive the need to reduce the time required to secure IRB approval, little is known about the actual time required to secure IRB approval. Therefore, we measured IRB review times across the research portfolios of 10 large VHA IRBs.
Methods: We collected the IRB records pertaining to a random sample of research protocols from the research portfolio of 10 VA IRBs, stratified by review type (i.e., exempt, expedited, full board). We included IRBs operated by the VA, and based on the number of actively managed protocols, we sequentially approached the 26 largest IRBs to achieve our target sample of 10 participating IRBs, including the VA Central IRB. Using detailed maps of each site’s review process, two independent analysts abstracted time data from the IRB records from which we calculated the overall and incremental review times. Multivariable models assessed differences between site, review type and and increments of the IRB review process.
Results:We obtained documentation for 278 protocols: 48 exempt, 106 expedited and 124 full board. Raters agreed on 3038 of 3090 time points (98.3%) abstracted from a sub-sample of 72 (22.4%) protocols. Total review time ranged from 24 to 310 days, with means of 93±51, 107±54, and 131±63 days for expedited, exempt and full board protocols respectively. Multivariable models using robust variance estimation controlling for site and review level demonstrate that, on average, expedited reviews were 45 days faster than full board reviews ( 95% CI = 31-59 days). There was no significant difference between full board and exempt reviews. However, after subtracting the time required for Research and Development (R&D) Committee review, both exempt and expedited reviews were 21 (95% CI = 1-41) and 39 (95% CI = 23-55) days faster than full board reviews, respectively, in the subgroup of protocols for which we could determine the time for R&D Committee Review (N = 178). Finally, when compared to Site 1, full board reviews at Sites 3, 8 9 and 10 were 27 (6-48), 38 (12-63), 45 (20-69) and 24 (1-46) days faster, and Site 6 was 56 (28-84) days slower (ranges show 95% CI).
Conclusion:IRB review times differ significantly between sites and review types. Some sites approach a consensus panel goal of 60 days for IRB review, but other sites need improvement to reach this goal. Review times for exempt protocols are unexpectedly long due to delay with the R&D Committee review. These data could inform site-specific initiatives for reducing the time required for IRB review.