Time to institutional review board approval with local versus central review in a multicenter pragmatic trial

Abstract

Background/aims:

Central institutional review board (IRB) review will be required for National Institutes of Health–funded multisite human subjects research as of January 2018, with similar requirements extending to most US multisite human research in 2020. Nonetheless, little is known regarding the relative efficiency of central versus local IRB review for multicenter studies. We compared the amount of time required for central versus local IRB review and approval for sites in one ongoing multicenter randomized trial.

Methods:

The REGAIN Trial (Regional versus General Anesthesia for Promoting Independence after Hip Fracture; clinicaltrials.gov number: NCT02507505) is an ongoing randomized trial comparing standard-care spinal anesthesia to standard-care general anesthesia for patients undergoing hip fracture surgery. After approval of the protocol by the sponsor IRB, each participating US site opted either to submit the protocol for local IRB review or to designate the sponsor IRB as the IRB of record (i.e. central IRB) via an authorization agreement after a limited local review. For each US REGAIN site approved through 18 April 2017, we assessed (1) the time in calendar days from protocol receipt to IRB submission, (2) the time in calendar days from IRB submission to IRB approval, and (3) the total time in calendar days from protocol receipt to IRB approval (i.e. time from protocol receipt to IRB submission plus time from IRB submission to IRB approval).

Results:

The main study protocol was submitted to the sponsor IRB on 25 May 2015 and approved on 8 July 2015 (44 days). Out of 34 sites, 9 received initial approval from the central (sponsor) IRB; 25 sought initial approval via local review. The median time from protocol receipt to IRB submission was 39 days for sites approved by the central IRB (interquartile range: 35–134) versus 58 days for sites approved via local review (interquartile range: 41–105; p = 0.711). The median time from IRB submission to IRB approval for sites approved by the central IRB was 27 days (interquartile range: 14–32) versus 66 days (interquartile range: 29–138) for sites approved via local review (p = 0.026). The median total time from protocol receipt to IRB approval was 100 days (interquartile range: 71–148) for centrally approved sites versus 132 days (interquartile range: 87–209) for locally approved sites (p = 0.191).

Conclusion:

While central IRB review was associated with a shorter time from IRB submission to IRB approval compared to local IRB review, the total time from protocol receipt to IRB approval varied markedly across sites.