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Oral Presentation 19: Irb Variability In Multicenter Studies

Harvie, H. S.1; Lowenstein, L.7; Omotosho, T.3; Sanses, T.4; Molden, S.5; Hardy, J. R.6; Brubaker, L.2

Female Pelvic Medicine & Reconstructive Surgery: March-April 2010 - Volume 16 - Issue 2 - p S12-S13
doi: 10.1097/01.spv.0000370775.46818.bc
SGS Abstracts

1Obstetrics and Gynecology, Univ of Pennsylvania, Philadelphia, PA; 2Obstetrics and Gynecology, Loyola University Medical Center, Maywood, IL; 3Obstetrics and Gynecology, John Hopkins, Baltimore, MD; 4Obstetrics and Gynecology, GBMC/ University of Maryland Center, Baltimore, MD; 5Obstetrics and Gynecology, The Institute for Female Pelvic Medicine, Allentown, PA; 6Medicine, University of Massachusetts Medical School, Worcester, MA; 7Department of Obstetrics and Gynecology, Rambam Medical Center, Haifa, Israel

DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS: Stephanie Molden:Ethicon:honorarium:preceptor, Linda Brubaker:Yes;Allergan:Research Funding:Investigator;Pfizer:Research Funding:Investigator;Pfizer:Honorarium:Research Consultant

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To investigate qualitative and quantitative variability among local Institutional Review Boards (IRBs) in the approval of research protocols and informed consent documents for a standardized a multicenter study with a common protocol

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Descriptive study of the variability of local IRB review and approval process for four multicenter studies with common protocols conducted within the Fellow's Pelvic Research Network (FPRN). The local IRBs follow all applicable federal guidance including the DHHS at 45 CFR Part 46 and the FDA at 21 CFR Part 50 and 56 pertaining to human subjects research and the applicable regulations pertaining to privacy in research under the Health Information Portability and Accountability Act (HIPAA) at 45 CFR Part 160 and 164.

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Most of the 22 unique network sites (68%) were in academic institutions and (63%) had ABOG-ABU accredited fellowships. The four multicenter network studies included two prospective cohorts, one retrospective review and one retrospective case-control study. Sites participated in 1 (55%), 2 (18%) or 3 (27%) studies. Local IRBs varied in their requirements for identical research study protocols. Many IRBs had varied local requirements regarding standard format and language of consent forms that resulted in most sites (86%) changing consent document prior to IRB submission. Nonetheless, the IRB required changes to 71% of consent documents for the prospective studies. Required changes to consent documents primarily comprised alterations in wording with the intent of improving subject understanding of study risk and privacy safeguards. Thirty-three percent of sites were required to make minor format changes to the common protocol to meet local institution requirements. Despite federal guidelines for review of research, the level of review varied across sites (Table 1). Local IRB's had queries for most (55%) submissions with a significantly more queries for the prospective cohorts compared to retrospective studies [78.6% vs. 35.3% (P = 0.03)]. IRBs required changes to 29% of protocols, but there were no substantive changes made to any protocol. There was considerable variability in time between IRB submission and approval [10 ± 3 days, range 7–12 days for exempt; 22 ± 17 days, range 1–57 days for expedited and 34 ± 32 days, range 13–81 days for full board reviews]. Length of time to approval was longer for prospective than retrospective studies 30 ± 22 vs. 16 ± 15 days but failed to reach significance (P = 0.08).

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We detected considerable variability in local IRB review of standardized multicenter network protocols across a range of minimal-risk study designs. The reasons for this variability may include varied local interpretation in federal guidelines. Reduction in this variability may improve the expediency of multicenter studies while maintaining the highest level of protections for research participants.


IRB variability; Multicenter studies; Fellows Pelvic Research Network

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