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A multisite study of performance drivers among institutional review boards

  • Michael Caligiuri (a1), Karen Allen (a2), Nate Buscher (a3), Lisa Denney (a4), Cynthia Gates (a5), Kip Kantelo (a6), Anthony Magit (a1), Rachael Sak (a3), Gary S. Firestein (a1) (a3) and John Fontanesi (a1)...
Abstract
Introduction

The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework.

Methods

807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times.

Results

High workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times.

Conclusions

Reducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.

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Copyright
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Corresponding author
*Address for correspondence: J. Fontanesi, Ph.D., School of Medicine, University of California San Diego, 200 W Arbor Drive, San Diego, CA 8415, USA. (Email: jfontanesi@ucsd.edu)
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