Institutional Review Board approval and innovation in urology: current practice and safety issues.
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.


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.
Division of Urology, Washington University School of Medicine, St. Louis, MO, USA.
Varun
V
Sundaram
Goutham
G
Vemana
Sam B
SB
Bhayani
D035843:Biomedical Research; D020811:Biomedical Technology; D028744:Ethics Committees, Research; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D061214:Patient Safety; D010506:Periodicals as Topic; D012189:Retrospective Studies; D013520:Urologic Surgical Procedures / Q000592:standards; D014572:Urology / Q000592:standards* / Q000639:trends
Institutional Review Board approval; novel technique; standard of care; surgical innovation