Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Randomized, Controlled Surgical Trial

Brian T. Helfand, Anne K. Mongiu, Claus Roehrborn, Robert F. Donnell, Reginald Bruskewitz, Steven A. Kaplan, John W. Kusek, Laura Coombs, Kevin T. McVary

Research output: Contribution to journalArticle

30 Scopus citations

Abstract

Purpose: The primary responsibility of institutional review boards is to protect human research subjects and, therefore, ensure that studies are performed in accordance with a standard set of ethical principles. A number of groups have compared the responses of institutional review boards in multicenter clinical trials involving medical therapies. To our knowledge no such studies have been performed to date of trials investigating surgical intervention. We investigated the consistency of the recommendations issued by various institutional review boards in the Minimally Invasive Surgical Therapies study for benign prostatic hyperplasia, a multicenter trial with a uniform consent and study protocol. Materials and Methods: We obtained the institutional review board response from 6 of the 7 participating institutions after initial submission of the Minimally Invasive Surgical Therapies study protocol and classified the responses. We then redistributed the approved protocols to an institutional review board at another participating institution and analyzed that review of these protocols. Results: We found that the number and type of responses required for institutional review board approval of an identical study protocol varied significantly among participating institutions. We also found that institutional review board responses were inconsistent in the second review, although all protocols were ultimately approved. Conclusions: The current system of local institutional review board review in the context of a multicenter surgical trial is inefficient in the review process and may not provide expertise for overseeing surgical trials. Based on these results a central surgical institutional review board may be needed to improve the ethical review process in multicenter trials.

Original languageEnglish (US)
Pages (from-to)2674-2679
Number of pages6
JournalJournal of Urology
Volume181
Issue number6
DOIs
StatePublished - Jun 1 2009

Keywords

  • ethics committees
  • minimally invasive
  • prostate
  • randomized controlled trials as topic
  • research
  • research subjects
  • surgical procedures

ASJC Scopus subject areas

  • Urology

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    Helfand, B. T., Mongiu, A. K., Roehrborn, C., Donnell, R. F., Bruskewitz, R., Kaplan, S. A., Kusek, J. W., Coombs, L., & McVary, K. T. (2009). Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Randomized, Controlled Surgical Trial. Journal of Urology, 181(6), 2674-2679. https://doi.org/10.1016/j.juro.2009.02.032