Ethics of Pediatric Research

Background and objectives 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 growing awareness that we should protect children and young people through research not from research. As a consequence, 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 re-thought to deal with the ethical challenges posed by new research developments. Contents of the course include: (1) the evolution of the debate on the ethics of pediatric research; (2) scientific and methodological requirements of pediatric research; (3) normative requirements of research with children; (4) the concept of child’s best interest; (5) consent and assent in pediatric research; (6) ethical and social issues in pediatric transplantation research, in pediatric rare diseases research and in in risky-behavior studies with adolescents; (7) the challenge of prioritizing research: hidden ethical challenges. As to the methods, the course will combine lectures, group discussions and workshops. Course activities and materials are in English. Our faculty includes: Katharine Wright (Nuffield Council on Bioethics, UK), Mara Cananzi (Padova University Hospital, Italy), Carlo Giaquinto (University of Padova, Italy), Ioana Hiriscau (University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj-Napoca, Romania), Jan Piasecki (Jagiellonian University, Kraków, Poland), Maurizio Scarpa (University of Padova, Italy), Alessio Vedovetto (Padova University Hospital, Italy). The course should be of interest for: health professionals working with children; children’s health investigators; members of Research Ethics Committees (or IRBs); members of Research Institutions; government policy makers and legislators.