We evaluated how regulatory support services provided by University of Illinois at Chicago’s Center for Clinical and Translational Science may reduce Institutional Review Board (IRB) turnaround times. IRB applications were categorized by receipt of any regulatory support and amount of support received. Turnaround time included total turnaround time, time for IRB review, and time for investigators to modify protocols. There were no differences in any turnaround times for supported versus nonsupported applications. However, for supported applications, those receiving more intensive support had total turnaround times 16.0 days (SE 7.62, p < .05) faster than those receiving less intensive support. Receiving higher regulatory support may be associated with faster approval of IRB submissions.
AbbottL.GradyC. (2011). A systematic review of the empirical literature evaluating IRBs: What we know and what we still need to learn. Journal of Empirical Research on Human Research Ethics, 6, 3-19.
2.
CheckD. K.WeinfurtK. P.DombeckC. B.KramerJ. M.FlynnK. E. (2013). Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature. Clinical Trials, 10, 560-567.
3.
Cleaton-JonesP. (2010). Process error rates in general research applications to the Human Research Ethics Committee (Medical) at the University of the Witwatersrand: A secondary data analysis. South African Journal of Bioethics & Law, 3, 20-24.
4.
Cleaton-JonesP. (2012). Applications and secretariat workload at the University of the Witwatersrand Human Research Ethics Committee (Medical) 2002-2011: A case study. South African Journal of Bioethics & Law, 5, 38-44.
Dixon-WoodsM.FoyC.HaydenC.Al-Shahi SalmanR.TebbuttS.SchroterS. (2016). Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project. BMJ Open, 6, e011973.
8.
DyrbyeL. N.ThomasM. R.MechaberA. J.EackerA.HarperW.MassieF. S.Jr.. . . ShanafeltT. D. (2007). Medical education research and IRB review: An analysis and comparison of the IRB review process at six institutions. Academic Medicine, 82, 654-660.
9.
GordonB. G.KessingerA.MannS. L.PrenticeE. D. (2003). The impact of escalating regulatory requirements on the conduct of clinical research. Cytotherapy, 5, 309-313.
10.
GreenL. A.LoweryJ. C.KowalskiC. P.WyszewianskiL. (2006). Impact of institutional review board practice variation on observational health services research. Health Services Research, 41, 214-230.
11.
GreeneS. M.GeigerA. M. (2006). A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval. Journal of Clinical Epidemiology, 59, 784-790.
12.
HallD. E.HanusaB. H.StoneR. A.LingB. S.ArnoldR. M. (2015). Time required for institutional review board review at one Veterans Affairs medical center. JAMA Surgery, 150, 103-109.
SilbermanG.KahnK. L. (2011). Burdens on research imposed by institutional review boards: The state of the evidence and its implications for regulatory reform. The Milbank Quarterly, 89, 599-627.
15.
TrochimW.KaneC.GrahamM.PincusH. A. (2011). Evaluating translational research: A process marker model. Clinical and Translational Science, 4, 153-162.
16.
TzengD. S.WuY. C.HsuJ. Y. (2015). Latent variable modeling and its implications for institutional review board review: Variables that delay the reviewing process. BMC Medical Ethics, 16, Article 57.
17.
VarleyP. R.FeskeU.GaoS.StoneR. A.ZhangS.MonteR.. . . HallD. E. (2016). Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards. Journal of Surgical Research, 204, 481-489.
