Ethics of Pediatric Research

Of all types of research involving human subjects, research on children is the one which has undergone the most profound evolution: from the initial banning to prevent any exploitation of vulnerable subjects, to the widespread recognition of the need for this research in order to grant children treatments and drugs that have been specifically tested for that population. As a consequence of the moral and epistemological justification of pediatric research, the number of studies involving children is rapidly increasing all around the world. This phenomenon requires however the refinement of the traditional moral requirements of biomedical research (especially informed consent and risk assessment) in order to adapt them to the specific characteristics of children. Furthermore, these traditional moral requirements must be rethought to deal with the ethical challenges posed by new research developments such as, for example, enhancement pediatric research. This challenge must be taken up by all people involved in pediatric research (especially members of Research Ethics Committees) who wish to promote excellence in research while granting children the necessary protection, avoiding the risk that economical pressure compromises the moral and scientific soundness of the studies. Contents of the course include: (1) the evolution of the debate on the ethics of pediatric research; (2) research with children in a globalized world; (3) scientific justification of pediatric research; (4) methodological requirements of pediatric research; (5) the standard of minimal risk in pediatric research; (6) ethical and legal considerations on consent and assent in pediatric research; (7) guidelines on pediatric research; (8) ethical and social issues in vaccine research; (9) ethical issues in pediatric enhancement research; (10) ethical issues in pediatric transplantation research. As to the methods, the course will combine lectures, group discussions and workshops. All course activities and materials will be in English.