Adi Abramovici1, Ashley Salazar2, Tonya Edvalson3, Nancy Gallagher4, Karen Dorman5, Alan Tita6. 1. Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL. 2. Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX. 3. Department of Obstetrics and Gynecology, University of Utah School of Medicine and Intermountain Healthcare, Salt Lake City, UT. 4. Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY. 5. Department of Obstetrics and Gynecology, University of North Carolina School of Medicine at Chapel Hill, Chapel Hill, NC. 6. Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL. Electronic address: atita@uab.edu.
Abstract
OBJECTIVE: The objective of the study was to describe characteristics and outcomes of a review of multisite perinatal studies by individual institutional review boards (IRBs) and identify barriers and opportunities for streamlined IRB review. STUDY DESIGN: We compared the review of 5 collaborative protocols by individual IRBs at National Perinatal Research Consortium centers from 2007 through 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 = .024) and number of stipulations (P = .007) differed across protocols but not across IRBs. However, times from submission-to-IRB review (P = .011) and IRB review-to-initial letter (P < .007) differed across sites. Both overall submission-to-approval and initial review-to-approval times increased with the increasing number of IRB review stipulations (both values P < .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 multisite perinatal studies. This may help guide initiatives to streamline IRB review and reduce research delays and burdens.
OBJECTIVE: The objective of the study was to describe characteristics and outcomes of a review of multisite perinatal studies by individual institutional review boards (IRBs) and identify barriers and opportunities for streamlined IRB review. STUDY DESIGN: We compared the review of 5 collaborative protocols by individual IRBs at National Perinatal Research Consortium centers from 2007 through 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 = .024) and number of stipulations (P = .007) differed across protocols but not across IRBs. However, times from submission-to-IRB review (P = .011) and IRB review-to-initial letter (P < .007) differed across sites. Both overall submission-to-approval and initial review-to-approval times increased with the increasing number of IRB review stipulations (both values P < .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 multisite perinatal studies. This may help guide initiatives to streamline IRB review and reduce research delays and burdens.
Authors: Laura M Dember; Patrick Archdeacon; Mahesh Krishnan; Eduardo Lacson; Shari M Ling; Prabir Roy-Chaudhury; Kimberly A Smith; Michael F Flessner Journal: J Am Soc Nephrol Date: 2016-07-11 Impact factor: 10.121
Authors: Michael P Diamond; Esther Eisenberg; Hao Huang; Christos Coutifaris; Richard S Legro; Karl R Hansen; Anne Z Steiner; Marcelle Cedars; Kurt Barnhart; Tracy Ziolek; Tracey R Thomas; Kate Maurer; Stephen A Krawetz; Robert A Wild; J C Trussell; Nanette Santoro; Heping Zhang Journal: Clin Trials Date: 2018-10-24 Impact factor: 2.486