Udział w badaniach klinicznych osob małoletnich
The participation of minors in clinical trials
In the paper the conditions that must be met to carry out a clinical trial involving minors were discussed. Provides the legal basis for regulating the conduct of such research, and role of the Bioethical Committee. In addition, the factors taken into account in preparing the study protocol in each pediatric age group are discussed, and the idea of European Pediatric Research Network was presented.
Keywords: pediatric study, the Bioethical Committee, protocol.