Skip to main content
×
Home
    • Aa
    • Aa

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.

  • View HTML
    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      A multisite study of performance drivers among institutional review boards
      Available formats
      ×
      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your Dropbox account. Find out more about sending content to Dropbox.

      A multisite study of performance drivers among institutional review boards
      Available formats
      ×
      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your Google Drive account. Find out more about sending content to Google Drive.

      A multisite study of performance drivers among institutional review boards
      Available formats
      ×
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)
Linked references
Hide All

This list contains references from the content that can be linked to their source. For a full set of references and notes please see the PDF or HTML where available.

3. DM Dilts , AB Sandler . Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. Journal of Clinical Oncology 2006; 24: 45454552.

7. TP Ryan . Statistical Methods for Quality Improvement, 3rd edition. Hoboken, NJ: John Wiley & Sons, Inc., Publication, 2011.

8. J Zhang . Tests for multiple upper or lower outliers in an exponential sample. Journal of Applied Statistics 1998; 25: 245255.

9. GZ Retsch-Bogart , et al. Highly effective cystic fibrosis clinical research teams: critical success factors. Journal of General Internal Medicine 2014; 29(Suppl. 3): S714S723.

10. JA Catania , et al. Survey of U.S. human subjects research protection organizations: workload and membership. Journal of Empirical Research on Human Research Ethics 2008; 3: 5769.

11. R McWilliams , et al. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA 2003; 290: 360366.

12. CC Polito , et al. Navigating the institutional review board approval process in a multicenter observational critical care study. Critical Care Medicine 2014; 42: 11051109.

13. H Silverman , S Chandros Hull , J Sugarman . Variability among institutional review boards’ decisions within the context of a multicenter trial. Critical Care Medicine 2001; 29: 235241.

Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

Journal of Clinical and Translational Science
  • ISSN: -
  • EISSN: 2059-8661
  • URL: /core/journals/journal-of-clinical-and-translational-science
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Keywords:

Metrics

Full text views

Total number of HTML views: 22
Total number of PDF views: 58 *
Loading metrics...

Abstract views

Total abstract views: 154 *
Loading metrics...

* Views captured on Cambridge Core between 24th July 2017 - 24th September 2017. This data will be updated every 24 hours.