Caligiuri Michael, Allen Karen, Buscher Nate, Denney Lisa, Gates Cynthia, Kantelo Kip, Magit Anthony, Sak Rachael, Firestein Gary S, Fontanesi John
School of Medicine, University of California San Diego, La Jolla, CA, USA.
School of Medicine, University of California Irvine, Irvine, CA, USA.
J Clin Transl Sci. 2017 Jun;1(3):192-197. doi: 10.1017/cts.2017.8. Epub 2017 Jul 24.
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 regulatory environment.
获得机构审查委员会（IRB）批准所需的时间是减少启动临床试验不必要延迟的努力中经常涉及的主题。本研究由IRB主任开展并为其进行，旨在更好地理解影响批准时间的因素，作为制定质量改进框架的第一步。
对来自加利福尼亚大学5个校区的807项经IRB批准的临床试验进行分析，以确定影响IRB批准时间的操作和临床试验特征。
高工作量、低人员配比、有限的培训以及辅助审查的数量和类型导致批准时间延长。生物安全审查和计费覆盖分析需求是导致最长延迟的辅助审查。联邦资助的和多中心临床试验的批准时间较短。各机构中审查3期多中心临床试验的各个委员会之间的差异也导致一些方案出现延迟。认证与较短的批准时间无关。
减少获得IRB批准过程中的不必要延迟将需要一个质量改进框架，该框架要考虑操作和研究特征以及更大的机构监管环境。
