ETHICAL AND LEGAL FOUNDATIONS OF HUMAN MEDICAL RESEARCH: DEVELOPMENT, GLOBAL STANDARDS, AND APPLICATION IN UKRAINE

Abstract

The article is dedicated to a comprehensive analysis of the ethical and legal foundations of medical research involving human participants, particularly focusing on their historical development, international regulation, and implementation in Ukraine. The authors highlight key historical events that became turning points in the formation of modern standards for the ethics of medical experiments, starting with the tragic experience of medical experiments conducted by Nazi doctors during World War II. Special attention is given to the Nuremberg Doctors' Trial (1946–1947), which for the first time raised the issue of the ethicality of medical experiments, and the adoption of the Nuremberg Code in 1947—the first document to define key ethical principles such as voluntary consent of participants, minimization of risks, and researchers' responsibility. The article examines the subsequent development of international regulation, including the Declaration of Helsinki (1964), which became the foundation for the formation of global standards for the ethical conduct of biomedical research. The article also analyzes the Council of Europe’s Convention on Human Rights and Biomedicine (1997) and its additional protocols, which contain detailed requirements for protecting the rights of research participants, especially vulnerable populations. Particular attention is paid to the legal regulation of medical research in Ukraine, including the reflection of international standards in the country’s legislation. The main regulatory legal acts, such as the Law of Ukraine "Fundamentals of Ukrainian Legislation on Healthcare," the Law of Ukraine "On Medicinal Products," and subordinate acts regulating the procedure for conducting clinical trials, have been analyzed. Emphasis is placed on the importance of adapting Ukrainian legislation to modern international standards, particularly regarding the protection of the rights of research participants, especially in the context of new challenges related to biotechnology and genome research. The importance of ethical principles in scientific activities is underscored, particularly the prioritization of participants' interests over the interests of science and society, as well as ensuring the right to voluntary informed consent. The article examines challenges associated with the introduction of new technologies in medical research, such as the use of human-derived biomaterials and cloning. The need to strengthen legal regulation in this area and to create effective control mechanisms is emphasized. In the conclusions, attention is drawn to the necessity of further improving Ukraine's regulatory legal framework, taking into account international experience, which will help ensure a balance between the development of science and the protection of human rights.