The rights of minor children in clinical trials

Introduction. The article substantiates the objective need for a systematic understanding of constitutional, civil, and international guarantees of respect for the rights of minors in clinical research, in order to ensure a balance between protecting the rights of the child (their dignity, health, and well-being) and developing pediatric clinical pharmacology (the development of evidence-based medicine, which is impossible without conducting clinical research). Materials and Methods. The following general scientific methods of cognition were used in the study: analysis, synthesis, induction, deduction, etc. Special attention was paid to the use of special legal methods (formal legal and comparative legal methods, the method of interpretation of legal norms, legal analogy, etc.). The materials for writing the scientific article were based on the legal acts of the Russian Federation and foreign countries, as well as the principles and norms of international law. Special attention was paid to the analysis of statistical data on clinical studies involving minors. Analysis. The authors compared international and domestic experience in legal regulation and implementation of the rights of minors in clinical research, highlighting the fundamental difference in approaches to determining the age of the assent in different countries. Results. The authors concluded that Russian legislation is characterized by a high degree of fragmentation and inconsistency, which is associated with a number of problems and gaps in the legislation. As a solution, the authors proposed a number of amendments to various legal acts, as only a comprehensive and systematic approach can create an environment that simultaneously protects minors while providing them with access to high-quality medical care with minimal risks. 

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