Ethical Issues Concerning the Informed Consent Process in Paediatric Clinical Trials: European Guidelines and Recommendations on Minor's Assent and Parental Permission

Appreciation for minors’ involvement in clinical trials and for children’s au-tonomy is growing, but has to be combined with the parental and social duty to pro-tect them. In recent years the ethical debate had shifted to specifically encouraging children’s inclusion in trials, taking into account the benefit they can obtain, both di-rect and indirect. Nevertheless, there is a risk concerning the protection of children’s rights and the proper acquisition of informed consent could become a legal and ethi-cal issue. The article examines the ethical framework concerning informed consent in paediatric clinical trials at European level, with special reference to guidelines, rec-ommendations and opinions issued by national, European and international bioeth-ics/research ethics committees, scientific societies, European institutions and inter-national organizations. The review aims at pointing out key issues regulated by com-mon ethical standards and grey areas in which soft law regulation is still evolving. The focus is devoted to the topics of assent, parental permission and shared decision-making, analysed in the light of the general principle of child’s best interest