爱尔兰全国性研究的伦理批准：当前挑战的一个例证
Ethical approval for national studies in Ireland: an illustration of current challenges.
作者信息
Smith M, Doyle F, McGee H M, De La Harpe D
机构信息
Health Services Research Centre, Department of Psychology, Royal College of Surgeons in Ireland, Dublin, Ireland.
出版信息
Ir J Med Sci. 2004 Apr-Jun;173(2):72-4. doi: 10.1007/BF02914559.
BACKGROUND
Ethical approval of research projects is, appropriately, an essential prerequisite in health settings.
AIMS
This paper outlines difficulties encountered with procedures for gaining ethical approval for two multicentre surveys in Ireland.
METHODS
The experiences of two national surveys were documented.
RESULTS
Delays in processing ethics applications led to substantial delays in both surveys. Research ethics committees (RECs) assessed applications in an idiosyncratic manner.
CONCLUSION
In Ireland, there is currently no accepted mechanism for single location ethical approval for multicentre studies. Instead, they require separate approval from all participating centres. The challenges of this system of application to multiple committees are outlined in this paper, and possible solutions presented.
背景
研究项目的伦理批准恰当地说是医疗卫生机构中的一项基本前提条件。
目的
本文概述了在爱尔兰为两项多中心调查获取伦理批准的程序中所遇到的困难。
方法
记录了两项全国性调查的经历。
结果
伦理申请处理过程中的延迟导致两项调查都出现了大幅延误。研究伦理委员会（RECs）以一种独特的方式评估申请。
结论
在爱尔兰，目前不存在针对多中心研究在单一地点进行伦理批准的公认机制。相反，它们需要获得所有参与中心的单独批准。本文概述了这种向多个委员会申请的系统所面临的挑战，并提出了可能的解决方案。
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