Ethics of Pediatric Research

The Department of Philosophy, Sociology, Education and Applied Psychology, and the Department of Woman and Child Health, University of Padova, announce the advanced European Bioethics Course ‘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. 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 in particular the risk that economical pressure compromise the moral and scientific soundness of the studies. Contents of the course include: (1) economical and social pressure on international biomedical research involving children; (2) the evolution of the debate on pediatric research; (3) the scientific justification of pediatric research; (4) methodological and ethical 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 using databases and population registers. As to the methods, the course will combine lectures, group discussions and workshops. All course activities and materials will be in English. Our faculty includes: Annagrazia Altavilla (“Espace Ethique Méditerranéen”, Aix-Marseille University, France), Marina Cuttini (“Bambino Gesù” Children’s Hospital, IRCCS, Roma, Italy), Paolo De Coppi (Department of Woman and Child Health, University of Padova and Great Ormond Street Hospital for Children, London, UK), Paola Facchin (Department of Woman and Child Health, University of Padova, Italy), Carlo Giaquinto (Department of Woman and Child Health, University of Padova, Italy), Susanna Livadiotti (“Bambino Gesù” Children’s Hospital, IRCCS, Roma, Italy), Esther Munalula Nkandu (Zambia National Research Ethics Committee), Mariassunta Piccinni (University of Padova, Italy), Martina Pigazzi (Institute of Pediatric Research, Padova, Italy), Tatjana Poplazarova (GlaxoSmithKline Biologicals, Wavre, Belgium), Michela Pozzobon (Institute of Pediatric Research, Padova, Italy), Francesca Rocchi (Pharmacologist expert in pediatric clinical trials, Roma, Italy), Rodolfo Saracci (National Research Centre, Pisa, Italy), Rosella Tomanin (Department of Woman and Child Health, University of Padova, 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. Location: University of Padova, Italy. Language: English. Price: Euro (€) 600 for early registration before March 31, 2013, Euro (€) 700 for registration after March 31, 2013 (from April 1 to May 6, 2013). For more information, please visit our website: www.masterbioethics.org, under Intensive courses, or write to Silvia Tusino: emmbpadova@gmail.com. The intensive course Ethics of Pediatric Research is part of the Erasmus Mundus Master of Bioethics program.