Institutional review board variability in minimal-risk multicenter urogynecology studies

Heidi S. Harvie, Lior Lowenstein, Tola B. Omotosho, Tatiana Sanses, Stephanie Molden, Janet Hardy, Linda Brubaker

Research output: Contribution to journalReview article

Abstract

Objectives: To investigate variability among local institutional review boards (IRBs) in the review process of standardized multicenter urogynecologic studies with common protocols. Methods: Descriptive study of the IRB review and approval process for common urogynecologic protocols of 4 minimal-risk multicenter studies conducted within the Fellow's Pelvic Research Network (FPRN), including prospective cohort, retrospective review, and case-control studies. Results: Most of the 22 network sites (73%) were in academic institutions. The level of IRB review varied by site and study design. Institutional review boards had local requirements regarding standard format and language that resulted in 86% of consent documents and 33% of protocols being changed before submission. Institutional review boards queried most (55%) submissions, with significantly more queries for prospective studies compared to retrospective studies (78.6% vs 35.3%; P = 0.03). After submission, IRB requirements necessitated changes for 71% of consents and 28% of protocols. There were no substantive changes made to any consent document or 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). Conclusions: We detected considerable variability in IRB review of standardized multicenter protocols across minimal-risk study designs. Reduction in variability may improve expediency of multicenter studies while maintaining the highest level of protections for research participants.

Original languageEnglish (US)
Pages (from-to)89-93
Number of pages5
JournalFemale Pelvic Medicine and Reconstructive Surgery
Volume18
Issue number2
DOIs
StatePublished - Jan 1 2012

Keywords

  • Bioethics
  • IRB variability
  • Institutional review board
  • Multicenter studies
  • Research standards

ASJC Scopus subject areas

  • Surgery
  • Obstetrics and Gynecology
  • Urology

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  • Cite this

    Harvie, H. S., Lowenstein, L., Omotosho, T. B., Sanses, T., Molden, S., Hardy, J., & Brubaker, L. (2012). Institutional review board variability in minimal-risk multicenter urogynecology studies. Female Pelvic Medicine and Reconstructive Surgery, 18(2), 89-93. https://doi.org/10.1097/SPV.0b013e318249bd40