A multisite study of performance drivers among institutional review boards

Journal of Clinical and Translational Science
Michael CaligiuriJohn Fontanesi

Abstract

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

References

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Citations

Feb 8, 2019·Epidemiology and Health·Liang-Yu LinPau-Chung Chen
Aug 8, 2018·Journal of Clinical and Translational Science·John FontanesiGary S Firestein
Oct 17, 2019·AJOB Empirical Bioethics·Genevieve L NesomTyler M Moore
Jun 29, 2021·Journal of Empirical Research on Human Research Ethics : JERHRE·Mwifadhi Mrisho, Zaynab Essack

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