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. 2017 Jul;12(3):131-139.
doi: 10.1177/1556264617704294. Epub 2017 Apr 16.

Effects of Regulatory Support Services on Institutional Review Board Turnaround Times

Pankaja Desai  1 , Priyanka Nasa  2 , Jackie Soo  2 , Cunhui Jia  2 , Michael L Berbaum  2 , James H Fischer  2 , Timothy P Johnson  2
Affiliations

Effects of Regulatory Support Services on Institutional Review Board Turnaround Times

Pankaja Desai et al. J Empir Res Hum Res Ethics. 2017 Jul.

Abstract

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.

Keywords: CTSA evaluation; Institutional Review Boards; clinical research; evaluation research; translational research.

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Conflict of interest statement

The Authors declare no other conflicts of interest.

Figures

Figure 1
Figure 1
Median Turnaround Times for Full and Expedited Reviews by CCTS Regulatory Support Receipt: August 2008 to June 2014. Note. CCTS = Center for Clinical and Translational Science; IRB = institutional review board; PI = principal investigator. *p < .05.
Figure 2
Figure 2
Median Turnaround Times for Full and Expedited Reviews Receiving CCTS Regulatory Support by Level of Support: August 2008 to June 2014. Note. CCTS = Center for Clinical and Translational Science; IRB = institutional review board; PI = principal investigator. *p < .05.
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References

    1. Abbott L, Grady C. 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. 2011;6:3–19. - PMC - PubMed
    1. Check DK, Weinfurt KP, Dombeck CB, Kramer JM, Flynn KE. Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature. Clinical Trials. 2013;10:560–567. - PubMed
    1. Cleaton-Jones P. 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. 2010;3:20–24.
    1. Cleaton-Jones P. 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. 2012;5:38–44.
    1. Clinical and Translational Science Awards Common Metrics Booklet. CTSA Program Annual Principal Investigator Meeting; Dec 16-17, 2015; Washington DC. 2015. Retrieved from https://ctsacentral.org/wp-content/uploads/CTSA-Common-Metrics-Booklet-1....

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