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

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.