ABSTRACT
This chapter refers specifically to 'non-communicative' infants, and focuses on the issue of their involvement in clinical studies. The chapter introduces some of the most significant international regulations about research involving minors. The regulation explicitly addresses also ethical issues. The ethical principles associated to research with human subjects were defined largely in the wake of the serious violations of human rights perpetrated during the Second World War, some of which involved children. Documents adopted by eminent national, international, and supranational institutions are highly relevant for bioethics. The ethics of clinical trials are dealt with both in general documents that refer also to minors and in others that apply specifically to minors. According to the American Academy of Pediatrics, the ethical issues of particular concern in drug investigation in paediatric research are determination of benefit and risks. Consent embodies the principle of autonomy, which in turn is one of the cornerstones of bioethics.
