Institutional review board approval and innovation in urology: Current practice and safety issues

Varun Sundaram, Goutham Vemana, Sam B. Bhayani

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Objective To retrospectively review recent publications describing novel procedures/techniques, and describe the Institutional Review Board (IRB)/ethics approval process and potential ethical dilemmas in their reporting. Materials and Methods We searched PubMed for papers about innovative or novel procedures/techniques between 2011 and August 2012. A query of titles/abstracts in the Journal of Urology, Journal of Endourology, European Urology, BJU International, and Urology identified relevant papers. These results were reviewed for human studies that described an innovative technique, procedure, approach, initial series, and/or used new technology. Results In all, 91 papers met criteria for inclusion; 25 from the Journal of Endourology, 14 from the Journal of Urology, nine from European Urology, 15 from the BJU International and 28 from Urology. IRB/ethics approval was given for an experimental procedure or database in 24% and 22%, respectively. IRB/ethics approval was not mentioned in 52.7% of studies. Conclusions Published IRB/ethics approvals for innovative techniques are heterogeneous including database, retrospective, and prospective approvals. Given the concept that innovations are likely not in the legal or ethical standard of care, strong consideration should be given to obtaining IRB/ethics approval before the actual procedure, instead of approval to merely report database outcomes.

Original languageEnglish
Pages (from-to)343-347
Number of pages5
JournalBJU international
Issue number2
StatePublished - Feb 2014


  • Institutional Review Board approval
  • novel technique
  • standard of care
  • surgical innovation


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