Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives
Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives
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DOI：
10.1111/j.1651-2227.2011.02401.x
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发表时间：
2012-01-01
期刊：
影响因子：
3.8
通讯作者：
Ceci, A.
中科院分区：
文献类型：
--
作者：
Altavilla, A.;Manfredi, C.;Ceci, A.
目的：评估新的欧洲儿科监管框架对欧洲伦理委员会活动的影响，并评估其对儿科研究的参与和兴趣。方法：任务-欧洲青年药物开发卓越网络以及与儿童参与和授权临床试验项目的期望和需求相关的力量，建立了欧洲现有伦理委员会的清单，结果：在22个欧洲国家的伦理委员会参与了这项调查。结果表明，目前欧洲儿科监管框架的知识，理解和认识高度缺乏，缺乏参与儿科研究的伦理委员会，特别是在培训和教育方面，也证明了详尽地回答整个问卷的伦理委员会的数量减少。大多数参与的伦理委员会表示有兴趣在未来的举措有关儿科research.Conclusions：尽管有限的知识和了解，目前的儿科监管框架，在欧洲运作的伦理委员会的显着数量显示在有关儿科research. Conclusions的举措感兴趣。网络可能是一个必不可少的工具，用于加强伦理委员会在支持儿科研究的作用。任何倡议都应在欧洲一级与欧洲联盟机构合作进行。
Aim: To evaluate the impact of the new European paediatric regulatory framework on the activities of Ethics Committees operating in Europe and to assess their involvement and interest in paediatric research.Methods: Task-force in Europe for Drug Development for the Young Network of Excellence and Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials project set up an inventory of Ethics Committees existing in Europe and conducted a survey on their approach to paediatric trials.Results: Ethics Committees operating in 22 European Countries participated in this survey. Results showed a high lack of knowledge, understanding and awareness of the current European paediatric regulatory framework and a lack of involvement of Ethics Committees in paediatric research, especially in terms of training and education, demonstrated also by the decreasing number of Ethics Committees answering exhaustively to the whole questionnaire. The majority of participating Ethics Committees expressed interest in future initiatives related to paediatric research.Conclusions: Despite a limited knowledge and understanding of the current paediatric regulatory framework, a significant number of Ethics Committees operating in Europe show interest in initiatives related to paediatric research. Networking may be an essential tool to be used to enhance Ethics Committees role in supporting paediatric research. Any initiative should be undertaken at European level in collaboration with European Union Institutions.