Harmonisation of ethics committees' practice in 10 European countries
Harmonisation of ethics committees' practice in 10 European countries
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DOI：
10.1136/jme.2009.030551
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发表时间：
2009-11-01
影响因子：
4.1
通讯作者：
Carne, X.
中科院分区：
文献类型：
--
作者：
Hernandez, R.;Cooney, M.;Carne, X.
背景：2001/20/EC指令是欧洲临床试验要求和流程一致性的重要第一步。然而，通过将相同的规则应用于所有类型的药物试验，并将该指令的原则转换为先前存在的国家立法，该指令在某种程度上未能实现其促进和协调目标。在伦理领域，2001/20/EC指令规定了理解和转换每个国家“单一意见”过程的方式。这导致了研究伦理委员会组织系统存在两种模式的情况，其中“单一意见”被认为是由单一伦理委员会做出的决定，在行政和后勤工作量方面更有效和更简单。方法：在欧洲10个国家进行调查。欧洲临床研究基础设施网络第1工作组的成员，具有伦理领域的专业知识，作出了回应。结果：在被调查国家中，基于成员数量、专家与非专业成员的比例以及科学成员的专业知识，伦理委员会的组成存在主要的异质性。大多数国家建议在共同课程基础上对伦理委员会成员进行统一教育。结论：尽管努力协调欧洲临床试验指令，但从伦理的角度来看，欧洲仍然存在多个伦理委员会系统。重要的是要了解各个国家的制度，了解它们所面临的问题。
Background: The Directive 2001/20/EC was an important first step towards consistency in the requirements and processes for clinical trials across Europe. However, by applying the same rules to all types of drug trials and transposing the Directive's principles into pre-existing national legislations, the Directive somewhat failed to meet its facilitation and harmonisation targets. In the field of ethics, the Directive 2001/20/EC conditioned the way of understanding and transposing the "single opinion'' process in each country. This led to a situation in which two models of research ethics committees organisation systems exist, being the model in which the "single opinion'' is considered to be the decision made by a single ethics committee more effective and simpler in terms of administrative and logistic workload.Method: A survey was conducted in 10 European countries. Members of the European Clinical Research Infrastructures Network working party number 1, with expertise in the field of ethics, responded.Results: There is a major heterogeneity in the composition of ethics committees among the surveyed countries based on the number of members, proportion of experts versus lay members and expertise of the scientific members. A harmonised education of the ethics committees' membership based in common curricula is recommended by the majority of countries.Conclusions: Despite the efforts for harmonisation of the European Clinical Trial Directive, from an ethical point of view, there remains a plurality of ethics committees' systems in Europe. It is important to comprehend the individual national systems to understand the problems they are facing.