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Review of multicenter studies by multiple Institutional Review Boards: characteristics and outcomes for perinatal studies implemented by a multicenter network.
MedLine Citation:
PMID:  25088862     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: To describe characteristics and outcomes of review of multisite perinatal studies by individual Institutional Review Board (IRBs), and identify barriers and opportunities for streamlined IRB review.
METHODS: We compared the review of 5 collaborative protocols by individual IRBs at National Perinatal Research Consortium (NPRC) centers from 2007-2012. Three randomized trials, 1 observational study and 1 follow-up study of a trial were selected. IRB logs and communications were reviewed and abstracted by trained team members.
RESULTS: Seven or 8 IRBs reviewed each protocol. Monthly IRB meeting frequency varied from 1 to 6. Full board review was required by all IRBs for the primary trials but not by all for the observational protocols. The overall duration from submission to approval (p=0.024) and number of stipulations (p=0.007) differed across protocols but not across IRBs. However, times from submission-to-IRB review (p=0.011) and IRB review-to-initial letter (p<0.007) differed across sites. Both overall submission-to-approval and initial review-to-approval times increased with increasing number of IRB review stipulations (both p-values<0.001). Significant delays (>60 days) were few and not consistent across IRBs or protocols. Most stipulations were stylistic or editorial modifications rather than regulatory requests. All protocols were approved without changes and no more than 1 IRB meeting was needed at each site.
CONCLUSION: Findings confirm unnecessary duplication and variability and some similarities in IRB review processes and outcomes for multi-site perinatal studies. This may help guide initiatives to streamline IRB review and reduce research delays and burdens.
Authors:
Adi Abramovici; Ashley Salazar; Tonya Edvalson; Nancy Gallagher; Karen Dorman; Alan Tita;
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-7-31
Journal Detail:
Title:  American journal of obstetrics and gynecology     Volume:  -     ISSN:  1097-6868     ISO Abbreviation:  Am. J. Obstet. Gynecol.     Publication Date:  2014 Jul 
Date Detail:
Created Date:  2014-8-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370476     Medline TA:  Am J Obstet Gynecol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2014 Mosby, Inc. All rights reserved.
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