Boult Maggi, Fitzpatrick Kate, Maddern Guy, Fitridge Robert
Department of Surgery, The University of Adelaide, Woodville South, South Australia, Australia.
ANZ J Surg. 2011 Mar;81(3):132-6. doi: 10.1111/j.1445-2197.2010.05529.x. Epub 2010 Oct 12.
This paper describes existing inconsistencies as well as the disparate processes and logistics required when obtaining ethics approval in Australia and New Zealand in order to initiate a multi-centre bi-national surgical trial.
The endovascular aortic aneurysm repair trial is a large multi-centre trial that aims to obtain pre- and post-operative data from patients in hospitals across Australia and New Zealand. As the trial was research based, ethics applications were submitted to all hospitals where surgeons wished to be involved in the trial.
Few ethics committees have embraced attempts to simplify the application process for multi-centre trials. There was limited mutual review between Human Research Ethics Committees necessitating the submission of multiple applications. Though the use of the National Ethics Application Form in ethical review is increasing, some Human Research Ethics Committees do not accept it in its entirety; many require site-specific applications or sections of the Common Application Form modules.
Queensland, New South Wales and New Zealand were the easiest systems to prepare, submit and lodge ethics applications because of their understanding and accommodation of reviewing multi-centred trials. The time, expense and complexity of obtaining ethics approval for multi-centre research projects are impediments to their establishment and reduce the time available for research. Australia is working to implement a system named the Harmonisation of Multi-centre Ethical Review to ease the process of obtaining multi-centre ethics clearance. Our experience suggests there will be some teething problems with implementation and acceptance.
本文描述了在澳大利亚和新西兰开展一项多中心双边外科试验以获得伦理批准时存在的不一致之处，以及所需的不同流程和后勤工作。
血管内腹主动脉瘤修复试验是一项大型多中心试验，旨在获取澳大利亚和新西兰各地医院患者的术前和术后数据。由于该试验基于研究，伦理申请已提交给所有外科医生希望参与试验的医院。
很少有伦理委员会接受简化多中心试验申请流程的尝试。人类研究伦理委员会之间的相互审查有限，因此需要提交多份申请。尽管国家伦理申请表在伦理审查中的使用正在增加，但一些人类研究伦理委员会并不完全接受；许多委员会要求提供特定地点的申请或通用申请表模块的部分内容。
昆士兰州、新南威尔士州和新西兰是准备、提交和提交伦理申请最简便的系统，因为它们理解并接纳多中心试验的审查。为多中心研究项目获得伦理批准所需的时间、费用和复杂性阻碍了这些项目的建立，并减少了可用于研究的时间。澳大利亚正在努力实施一个名为多中心伦理审查协调的系统，以简化获得多中心伦理批准的过程。我们的经验表明，在实施和接受方面会出现一些初期问题。
