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Institutional R eview B oard approval and innovation in urology: current practice and safety issues
Author(s) -
Sundaram Varun,
Vemana Goutham,
Bhayani Sam B.
Publication year - 2014
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.12114
Subject(s) - institutional review board , medicine , urology , ethics committee , pediatric urology , editorial board , inclusion (mineral) , library science , political science , general surgery , surgery , computer science , sociology , social science , public administration
Objective To retrospectively review recent publications describing novel procedures/techniques, and describe the I nstitutional R eview B oard ( 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 A ugust 2012. A query of titles/abstracts in the J ournal of U rology , J ournal of E ndourology , E uropean U rology , BJU I nternational , and U rology 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 J ournal of E ndourology , 14 from the J ournal of U rology , nine from E uropean U rology , 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.