Ethical key issues and fundamental rights in paediatric research.

Purpose: This article is aimed at describing the methodology of "ethical reasoning" that finally led TEDDYNoE (Task-force in Europe for Drug Development for the Young) to propose the integration of international human rights law to develop coherent and exhaustive ethical recommendations on paediatric research at a European level.

Methods: A large number of ethical guidelines and texts of varying legal force existing in the field of clinical research and in particular related to paediatrics are analysed. Differences and non-coordinated implementation are pointed out.

Results: Differences, tensions or outright contradictions among the provisions of these texts can generate confusion leading to the adoption of different ethical standards across Europe. In this context, the real challenge is to ensure that each child involved in a clinical trial in the EU territory may rely directly on the same principles and rights. Taking international human rights law as the main starting point to develop a coherent framework for paediatric research that incorporates all the relevant ethical considerations and existing guidelines is a way of achieving this objective.

Conclusions: The implementation, at national and local level, of the "European Ethical Recommendations" (Eudralex 2008 vol. 10), based on international human rights law, seems to be the next step in facilitating a coordinated approach to the application of the Directive 2001/20/EC, as well as developing quality and ethically sound paediatric research.