Abstract
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.
Highlights
In the 19th century, when pediatrics has already become a separate branch of medicine, children in hospitals and orphanages have become a good resource for experiments
Until the 1960s of the XX century, pediatric trials continued without any regulation
In 1964, the World Medical Association developed and implemented the Nuremberg Code successor document, the Declaration of HelsinkiThe Declaration of Helsinki admits that clinical trials involving minors can be conducted in case when consent of parents or legally authorized representatives is provided [4]
Summary
Teplova NV1 , Gratsianskaya АN1, Kostyleva МN1,2 1 Pirogov Russian National Research Medical University, Moscow, Russia 2 Russian Children’s Clinical Hospital, Moscow, Russia. Clinical trials involving children as subjects are still the matter attracting a great attention of the society, especially as far as the ethical aspect goes. As an experiment is an essential part of any science development, experimental work in medicine has always been there, involving patients of any age. Edward Jenner (1798) conducted one of the first recorded medical experiments where children of different age groups had smallpox vaccination [1]. In the 19th century, when pediatrics has already become a separate branch of medicine, children in hospitals and orphanages have become a good resource for experiments. This didn’t provoke any indignation in the society considering standards and norms of those times related to biomedical trials
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