INFORMED CONSENT IN PEDIATRIC PRACTICE: ETHICAL AND LEGAL PRINCIPLES, GOVERNMENT REGULATION, JUDICIAL AND LEGAL PRACTICE

Abstract

The article examines the legal nature of informed consent in pediatric practice as a necessary precondition for the lawfulness of medical intervention and as an element of proper state regulation in the field of healthcare. The correlation between Articles 39 and 43 of the Fundamentals of the Legislation of Ukraine on Health Care, Articles 284 and 285 of the Civil Code of Ukraine, as well as special provisions on preventive vaccinations, is analyzed. Particular attention is paid to the conflicting issues of obtaining consent from minor patients aged 14 to 18, the participation of legal representatives in medical decision-making, and the limits of a child’s autonomy in the healthcare sphere. It is substantiated that genuine informed consent is not limited to signing a standardized form but requires providing complete, comprehensible, and individualized information regarding the health condition, purpose of the intervention, risks, alternatives, and consequences of refusal. Based on an analysis of the case law of the European Court of Human Rights, open approaches in legal support of medical disputes, and relevant academic publications, it is established that the key evidentiary elements in disputes concerning informed consent include not only signed documents but also proper documentation of the content of communication between the physician, the parents, and the child. The article proposes directions for improving state regulation: the introduction of local standard operating procedures, individualized consent and refusal forms, mechanisms for resolving conflicts between the will of an adolescent and the position of the parents, as well as regular staff training in medical law. Scientific and practical recommendations for healthcare institutions, pediatricians, and parents are formulated.