Activity of Ethics Committees in Europe on issues related to clinical trials in paediatrics: Results of a survey

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: [email protected]

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