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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.

DOI:10.1007/BF02914559
PMID:15540705
Abstract

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.

摘要

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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Ethical approval for national studies in Ireland: an illustration of current challenges.爱尔兰全国性研究的伦理批准:当前挑战的一个例证
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本文引用的文献

1
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.欧洲议会和理事会2001年4月4日关于协调各成员国有关在人用药品临床试验实施中适用良好临床实践的法律、法规及行政规定的第2001/20/EC号指令。
Med Etika Bioet. 2002 Spring-Summer;9(1-2):12-9.
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Implications of the EU directive on clinical trials for emergency medicine.欧盟临床试验指令对急诊医学的影响。
BMJ. 2002 May 18;324(7347):1169-70. doi: 10.1136/bmj.324.7347.1169.
Impact of briefly-assessed depression on secondary prevention outcomes after acute coronary syndrome: a one-year longitudinal survey.
短暂评估的抑郁对急性冠脉综合征后二级预防结局的影响:一项为期一年的纵向调查。
BMC Health Serv Res. 2006 Feb 13;6:9. doi: 10.1186/1472-6963-6-9.
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Nine-year comparison of presentation and management of acute coronary syndromes in Ireland: a national cross-sectional survey.爱尔兰急性冠状动脉综合征的临床表现与治疗的九年比较:一项全国性横断面调查。
BMC Cardiovasc Disord. 2005 Feb 11;5(1):5. doi: 10.1186/1471-2261-5-5.