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Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives

Journal article
Authors A. Altavilla
C. Manfredi
P. Baiardi
M. Dehlinger-Kremer
P. Galletti
A. A. Pozuelo
John Chaplin
A. Ceci
Published in Acta Paediatrica
Volume 101
Issue 1
Pages e27–e32
ISSN 1651-2227
Publication year 2012
Published at Institute of Clinical Sciences, Department of Pediatrics
Pages e27–e32
Language en
Keywords Ethics; Ethics committees; Paediatric clinical research; RESPECT; Survey; TEDDY
Subject categories Clinical Medicine


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.

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