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Wiad Lek ; 76(11): 2525-2530, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-38112375

RESUMEN

OBJECTIVE: The aim: To find out the peculiarities of constitutional and legal principles of the limits of permissible intervention in conducting biomedical research with human participation. PATIENTS AND METHODS: Materials and methods: The methodological basis of the study was worldview dialectical, general scientific and specific scientific methods of learning the phenomena of state and legal reality. Common ones were widely used in the work principles of scientific knowledge - comprehensiveness, objectivity, historicism, unity of theory and practice and others. The most important methodological prerequisite was a systemic approach to the issue of protecting human rights when conducting biomedical experiments with his participation, which made it possible to form a holistic view of the object and subject of research. With its help, the human rights affected by biomedical research in the context of the general legal principle of humanism were analyzed, the limits of permissible intervention in the human body were identified, and conclusions were drawn regarding the need for the separation and normative legal regulation of the complex branch of medical law. In the study, general scientific methods were widely used: historical, systematic analysis of the studied phenomena and syn¬thesis of the obtained results, inductive and deductive reasoning; special: formal-logical, sociological, statistical; and also private-scientific: comparative-legal, normative-legal, and others. CONCLUSION: Conclusions: 1) A key point in the mechanism of protection of the subject's rights in the process of conducting biomedical research is the establishment of a number of limits (maxims) that allow interference in the human body and can limit the researcher and protect the subject. These maxims should be integral elements of the process of biomedical research with human participation and determine the basic criteria for the protection of citizens' rights when conducting biomedical research. 2) The limits of permissible intervention in the conduct of biomedical research with human participation are the legal and factual consequences of the activity of bodies authorized to conduct biomedical research, which is based on the law and aimed at achieving the goals set by the researcher for conducting biomedical research with human participation, as a result of which the options for permitted by the norms of the law of behavior of the subjects of biomedical research by establishing various limits of such behavior, which necessarily have an exclusively temporary and subjective nature.


Asunto(s)
Investigación Biomédica , Derechos Humanos , Humanos
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