Article type: Research Article
Authors: Altavilla, A. | Giaquinto, C. | Giocanti, D. | Manfredi, C. | Aboulker, J.-P. | Bartoloni, F. | Cattani, E. | Lo Giudice, M. | Mellado Peña, M.J. | Nagler, R. | Peterson, C. | Vajnerova, O. | Bonifazi, F. | Ceci, A.
Affiliations: Mediterranean University – Espace Ethique
Méditerranéen, Bioethics Research Centre, Marseille, France | Department of Paediatrics, University of Padova,
Padova, Italy | Mediterranean University – Division of Legal
Medicine, Marseille, France | Consorzio per Valutazioni Biologiche e Farmacologiche,
Pavia, Italy | Institut National de la Sante et Recherche Medicale,
Villejuif, France | I.RI.D.I.A. srl, Health Care Engineering, Bari,
Italy | Family paediatrician, AUSL 6 Palermo, Palermo,
Italy | Department of Paediatrics, Hospital Carlos III,
Madrid, Spain | Department of Oral and Maxillofacial Surgical and Oral
Biochemistry Laboratory, Rambam Medical Center and Rappaport, Faculty of
Medicine, Israel Institute of Technology-Technion, Haifa, Israel | Department of Clinical Pharmacology, Linkopings
Universitet, Linkopings, Sweden | Department of Neurophysiology of Memory and
Computational Neuroscience, Institute of Physiology, Academy of Sciences,
Prague, Czech Republic
Note: [] Corresponding author: Adriana Ceci, Consorzio per Valutazioni
Biologiche e Farmacologiche, Via Palestro, 26 – 27100 Pavia, Italy. Tel.: +39
0382 25075; Fax +39 0382 536544; E-mail: aceci@cvbf.net
Abstract: The rights and well-being of children involved in clinical research
in Europe should be assured by the respect of ethical considerations and legal
rules. Specific provisions are included in the Directive 2001/20/EC (CT-Dir)
aimed at providing a homogeneous ethical and legal context to perform clinical
trials in Europe. The TEDDY Network of Excellence carried out a "Survey on the
ethical and legal frameworks existing in Europe for paediatric clinical
trials" to examine the measures enforced by Member States to implement the
CT-Dir and other relevant ethical norms. The results showed that many differences exist in the protection of
children enrolled in clinical trials. Such differences are especially due to a
non-coordinated implementation of the Directive's Article 4 and a lack of
public awareness on ethical issues in this field. The recently approved 'Ethical considerations for clinical trials on
medicinal products conducted with the paediatric population' should speed up
the implementation of an 'ad hoc set of ethical rules' and increase the level
of minors' protection. Nevertheless, in lack of 'binding rules', a coordination
at European level is still needed. Public initiatives aiming at promoting
in-depth debates have to be supported in order to encourage this process of
coordination.
Keywords: TEDDY, ethics, paediatrics, clinical trials, informed consent, children assent
DOI: 10.3233/PPL-2009-0208
Journal: Pharmaceuticals, Policy and Law, vol. 11, no. 1-2, pp. 79-87, 2009
Received 3 March 2009
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Accepted 3 March 2009
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Published: 2009
