Cargando…

A multisite study of performance drivers among institutional review boards

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Caligiuri, Michael, Allen, Karen, Buscher, Nate, Denney, Lisa, Gates, Cynthia, Kantelo, Kip, Magit, Anthony, Sak, Rachael, Firestein, Gary S., Fontanesi, John
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5652635/
https://www.ncbi.nlm.nih.gov/pubmed/29093967
http://dx.doi.org/10.1017/cts.2017.8
_version_ 1783273093807996928
author Caligiuri, Michael
Allen, Karen
Buscher, Nate
Denney, Lisa
Gates, Cynthia
Kantelo, Kip
Magit, Anthony
Sak, Rachael
Firestein, Gary S.
Fontanesi, John
author_facet Caligiuri, Michael
Allen, Karen
Buscher, Nate
Denney, Lisa
Gates, Cynthia
Kantelo, Kip
Magit, Anthony
Sak, Rachael
Firestein, Gary S.
Fontanesi, John
author_sort Caligiuri, Michael
collection PubMed
description 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.
format Online
Article
Text
id pubmed-5652635
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher Cambridge University Press
record_format MEDLINE/PubMed
spelling pubmed-56526352017-10-30 A multisite study of performance drivers among institutional review boards Caligiuri, Michael Allen, Karen Buscher, Nate Denney, Lisa Gates, Cynthia Kantelo, Kip Magit, Anthony Sak, Rachael Firestein, Gary S. Fontanesi, John J Clin Transl Sci Implementation, Policy and Community Engagement 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. Cambridge University Press 2017-07-24 /pmc/articles/PMC5652635/ /pubmed/29093967 http://dx.doi.org/10.1017/cts.2017.8 Text en © The Association for Clinical and Translational Science 2017 http://creativecommons.org/licenses/by/4.0/ 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.
spellingShingle Implementation, Policy and Community Engagement
Caligiuri, Michael
Allen, Karen
Buscher, Nate
Denney, Lisa
Gates, Cynthia
Kantelo, Kip
Magit, Anthony
Sak, Rachael
Firestein, Gary S.
Fontanesi, John
A multisite study of performance drivers among institutional review boards
title A multisite study of performance drivers among institutional review boards
title_full A multisite study of performance drivers among institutional review boards
title_fullStr A multisite study of performance drivers among institutional review boards
title_full_unstemmed A multisite study of performance drivers among institutional review boards
title_short A multisite study of performance drivers among institutional review boards
title_sort multisite study of performance drivers among institutional review boards
topic Implementation, Policy and Community Engagement
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5652635/
https://www.ncbi.nlm.nih.gov/pubmed/29093967
http://dx.doi.org/10.1017/cts.2017.8
work_keys_str_mv AT caligiurimichael amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT allenkaren amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT buschernate amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT denneylisa amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT gatescynthia amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT kantelokip amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT magitanthony amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT sakrachael amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT firesteingarys amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT fontanesijohn amultisitestudyofperformancedriversamonginstitutionalreviewboards
AT caligiurimichael multisitestudyofperformancedriversamonginstitutionalreviewboards
AT allenkaren multisitestudyofperformancedriversamonginstitutionalreviewboards
AT buschernate multisitestudyofperformancedriversamonginstitutionalreviewboards
AT denneylisa multisitestudyofperformancedriversamonginstitutionalreviewboards
AT gatescynthia multisitestudyofperformancedriversamonginstitutionalreviewboards
AT kantelokip multisitestudyofperformancedriversamonginstitutionalreviewboards
AT magitanthony multisitestudyofperformancedriversamonginstitutionalreviewboards
AT sakrachael multisitestudyofperformancedriversamonginstitutionalreviewboards
AT firesteingarys multisitestudyofperformancedriversamonginstitutionalreviewboards
AT fontanesijohn multisitestudyofperformancedriversamonginstitutionalreviewboards