Division of Urology, Washington University School of Medicine, St. Louis, MO, USA.
BJU Int. 2014 Feb;113(2):343-7. doi: 10.1111/bju.12114. Epub 2013 Aug 13.
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.
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.
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.
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.
回顾最近发表的描述新程序/技术的文献，并描述机构审查委员会（IRB）/伦理批准过程及其报告中潜在的伦理困境。
我们在 PubMed 中搜索了 2011 年至 2012 年 8 月期间关于创新或新颖程序/技术的论文。在《泌尿外科杂志》、《内镜泌尿外科杂志》、《欧洲泌尿外科杂志》、《英国泌尿外科杂志国际版》和《泌尿学》中对标题/摘要进行查询，以确定相关论文。这些结果经过审查，以确定是否有描述创新技术、程序、方法、初始系列的人类研究，以及/或使用新技术的研究。
共有 91 篇论文符合纳入标准；其中 25 篇来自《内镜泌尿外科杂志》，14 篇来自《泌尿外科杂志》，9 篇来自《欧洲泌尿外科杂志》，15 篇来自《英国泌尿外科杂志国际版》，28 篇来自《泌尿学》。分别有 24%和 22%的实验性程序或数据库获得了 IRB/伦理批准。52.7%的研究未提及 IRB/伦理批准。
已发表的创新技术的 IRB/伦理批准是多种多样的，包括数据库、回顾性和前瞻性批准。鉴于创新可能不符合法律或伦理护理标准的概念，强烈建议在实际程序之前获得 IRB/伦理批准，而不是仅为了报告数据库结果而获得批准。
