Variation in Institutional Review processes for a multisite observational study

Catherine C. Vick, Kelly R. Finan, Catarina Kiefe, Leigh Neumayer, Mary T. Hawn

Research output: Contribution to journalArticle

40 Scopus citations

Abstract

Background: The Veterans Administration is an ideal setting for multisite studies; however, individual VA Institutional Review Board (IRB) approval is necessary. This study examines the burden of multisite IRB approval on a Health Services Research and Development (HSRD) ventral hernia outcomes observational study. Methods: Data gathered on the IRB process per site included time required for application completion, staff training and compliance, IRB affiliation (VA or university), approval status, and time to IRB approval. Wilcoxon rank sum tests were used to determine differences in median times for application completion and approval. Financial and temporal expenses were calculated. Results: Significant differences were found in median time to complete applications by IRB affiliation (P < .01) and median time to approval by changes required to the consent letter (P < .05). Conclusions: The IRB process for a multisite observational study is expensive in both time and money. A VA national IRB for multisite studies would significantly decrease the financial and temporal burden for observational studies.

Original languageEnglish (US)
Pages (from-to)805-809
Number of pages5
JournalAmerican journal of surgery
Volume190
Issue number5
DOIs
StatePublished - Nov 2005
Externally publishedYes

Keywords

  • Informed consent
  • Institutional Review Board
  • Multisite
  • Observational
  • Processes
  • Variation

ASJC Scopus subject areas

  • Surgery

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