The article discusses the role of an ethical review in clinical research involving minors. It examines the historical aspect of the ethical component of clinical trials involving minors. The article analyzes the legislative regulation of clinical trials involving minors in Russia and internationally. Currently, the need in pediatric trials is not a point for dispute. It is the issues of optimization of planning and conducting pediatric trials concerning design and protection of minors’ rights that are being discussed. A detailed examination of how clinical trials with the participation of children are conducted today is provided. Special attention is paid to the use of “off-label” drugs in clinical practice. The authors predict further progress in creating favorable conditions for the participation of children in clinical trials and provide practical advice for achieving it.