Informed consent for paediatric clinical trials in Europe.
Informed consent for paediatric clinical trials in Europe.
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DOI：
10.1136/archdischild-2015-310001
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发表时间：
2016-11
影响因子：
5.2
通讯作者：
de Wildt S
中科院分区：
文献类型：
--
作者：
Lepola P;Needham A;Mendum J;Sallabank P;Neubauer D;de Wildt S
儿科临床试验通常作为多国试验进行。知情同意或同意是伦理委员会批准临床试验的一部分。由于国家法律和法规的不同，各国的同意要求也各不相同，而欧洲的法律和法规并不统一。这些差异可能对儿科临床试验提出挑战。本研究的目的是在整个欧洲经济区收集这些同意和同意要求。尽管真实的需要这些数据，但整理后的国家要求以前从未公开过。截至2014年底，对25个欧盟成员国和2个欧洲自由贸易联盟国家的儿科临床试验的国家同意和同意要求进行了分析和整理。这些数据是从现有数据库中检索的，并通过与主管部门和选定的伦理委员会进行沟通。将国际或国家指南、宣言和公约以及学术团体出版物的文献检索结果作为比较材料。这些国家的同意和同意要求各不相同。我们在“知情同意和同意工具包”中汇编了我们的调查结果，该表格包括27个国家的同意和同意要求。儿科知情同意书的广泛差异为欧洲的多国儿科试验带来了挑战。该工具包可供所有参与儿科临床试验和伦理委员会的人员使用，为主动反馈知情同意要求提供了一个新的平台，并可能最终导致所需的协调过程，包括整个欧洲接受的统一标准。
Paediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due to national laws and regulations, which are not harmonised in Europe. These discrepancies can present challenges for paediatric clinical trials. The aim of this study was to assemble these consent and assent requirements across the European Economic Area. The collated national requirements have not been publicly available before, despite a real need for this data. National consent and assent requirements for paediatric clinical trials were analysed and collated for 25 European Union Member States and 2 European Free Trade Association countries until the end of 2014. The data were retrieved from existing databases and through communication with the competent authorities and selected ethics committees. Results from a literature search for international or national guidelines, declarations and conventions and academic societies' publications served as comparison material. Consent and assent requirements are heterogeneous across these countries. We compiled our findings in ‘The Informed Consent and Assent Tool Kit’, a table including 27 national consent and assent requirements listed by individual country. Wide variation in paediatric consents and assents presents challenges for multinational paediatric trials in Europe. The toolkit is available for all those involved in paediatric clinical trials and ethics committees, providing a new platform for proactive feedback on informed consent requirements, and may finally lead to a needed harmonisation process, including uniform standards accepted across Europe.
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4.1
作者：
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