| Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives. | |
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MedLine Citation:
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PMID: 21732978 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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: TEDDY Network of Excellence and RESPECT set up an inventory of Ethics Committees existing in Europe and carried out a survey on paediatric trials approach among them. 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. |
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Authors:
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A Altavilla; C Manfredi; P Baiardi; M Dehlinger-Kremer; P Galletti; A Alemany Pozuelo; J Chaplin; A Ceci |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-7-6 |
Journal Detail:
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Title: Acta paediatrica (Oslo, Norway : 1992) Volume: - ISSN: 1651-2227 ISO Abbreviation: - Publication Date: 2011 Jul |
Date Detail:
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Created Date: 2011-7-7 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9205968 Medline TA: Acta Paediatr Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Acta Paediatrica © 2011 Foundation Acta Paediatrica. |
Affiliation:
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Université de la Méditerranée - Espace Ethique Méditerranéen, Marseille, France Consorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy Omnicare Clinical Research, Bad Soden a Ts., Germany, and Paediatric Working Group of EUCROF, Netherlands Pierrel Research Italy Spa, Sesto San Giovanni (MI), Italy TFS Trial Form Support, S.L., Madrid, Spain Göteborg Pediatric Growth Research Center, The Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden. |
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