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Related Experiment Videos

Variation in Institutional Review processes for a multisite observational study.

Catherine C Vick1, Kelly R Finan, Catarina Kiefe

  • 1Deep South Center on Effectiveness, Birmingham Veterans Administration Medical Center, Birmingham, AL, , USA.

American Journal of Surgery
|October 18, 2005
PubMed
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Multisite Institutional Review Board (IRB) approval for observational studies in the Veterans Affairs (VA) system is time-consuming and costly. A centralized VA national IRB could reduce these burdens.

Area of Science:

  • Health Services Research
  • Observational Studies
  • Clinical Trial Management

Background:

  • The Veterans Affairs (VA) system is a suitable environment for conducting multisite research.
  • However, each site requires individual Institutional Review Board (IRB) approval, posing a significant administrative hurdle.
  • This study specifically investigates the burden of this process on a Health Services Research and Development (HSRD) study focused on ventral hernia outcomes.

Purpose of the Study:

  • To quantify the financial and temporal burden associated with obtaining multisite IRB approval within the VA.
  • To identify factors contributing to delays and increased costs in the IRB approval process.
  • To evaluate the potential benefits of a centralized VA national IRB for multisite observational studies.

Main Methods:

Related Experiment Videos

  • Data collection included time for application completion, staff training, and IRB approval at each study site.
  • IRB affiliation (VA vs. university) and required consent letter modifications were recorded.
  • Statistical analysis utilized Wilcoxon rank sum tests to compare median times; financial and temporal expenses were calculated.

Main Results:

  • Significant differences were observed in the median time to complete applications based on IRB affiliation (P < .01).
  • Median time to IRB approval was significantly affected by required changes to the consent letter (P < .05).
  • The overall IRB process for this multisite study incurred substantial financial and temporal costs.

Conclusions:

  • The current multisite IRB approval process within the VA is resource-intensive, demanding significant time and financial investment.
  • Implementing a VA national IRB for multisite studies could substantially alleviate these financial and temporal burdens.
  • Streamlining the IRB process is crucial for efficient conduct of multisite observational research in the VA.