Clinical research with children: the European legal framework and its implementation in French and Italian law.

According to the International Convention of the Rights of the Child, an improvement of the protection of the rights of children in Europe should be accomplished by inserting the principle of best interests and evolving capacities in the legal framework related to paediatric clinical research. In this article, an overview is given of the European legal framework governing clinical research on minors in a comparative approach. The lack of coordination between different International and European ethical/ legal statements and its impact on national legislations is evaluated by analyzing provisions that have been foreseen in Italy and in France as a result of the ratification/implementation process. A presentation of the perspectives of paediatric research in Europe is provided.