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 journalArticle

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 - 2012
Externally publishedYes

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Research Ethics Committees
Multicenter Studies
Consent Forms
Research
Case-Control Studies
Language
Retrospective Studies
Prospective Studies

Keywords

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

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Surgery
  • Urology

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

Institutional review board variability in minimal-risk multicenter urogynecology studies. / Harvie, Heidi S.; Lowenstein, Lior; Omotosho, Tola B.; Sanses, Tatiana; Molden, Stephanie; Hardy, Janet; Brubaker, Linda.

In: Female Pelvic Medicine and Reconstructive Surgery, Vol. 18, No. 2, 2012, p. 89-93.

Research output: Contribution to journalArticle

Harvie, HS, Lowenstein, L, Omotosho, TB, 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, vol. 18, no. 2, pp. 89-93. https://doi.org/10.1097/SPV.0b013e318249bd40
Harvie, Heidi S. ; Lowenstein, Lior ; Omotosho, Tola B. ; Sanses, Tatiana ; Molden, Stephanie ; Hardy, Janet ; Brubaker, Linda. / Institutional review board variability in minimal-risk multicenter urogynecology studies. In: Female Pelvic Medicine and Reconstructive Surgery. 2012 ; Vol. 18, No. 2. pp. 89-93.
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