Biomedical Experimental Research with Human Participation: Ethical and Legal Aspects
( Pp. 28-33)
More about authors
Helen I. Volkova
Cand. Sci. (Law), Associate Professor of Department of constitutional law named after N.V. Vitruka
Russian State University of Justice (RSUJ)
Moscow, Russian Federation Helen A. Khapsirokova Cand. Sci. (Law), Associate Professor, Associate Professor of Department of constitutional law named after N.V. Vitruka
Russian State University of Justice (RSUJ)
Moscow, Russian Federation
Russian State University of Justice (RSUJ)
Moscow, Russian Federation Helen A. Khapsirokova Cand. Sci. (Law), Associate Professor, Associate Professor of Department of constitutional law named after N.V. Vitruka
Russian State University of Justice (RSUJ)
Moscow, Russian Federation
Abstract:
The article is devoted to the possibility and conditionality of legal and ethical restrictions in regulating the sphere of biomedical experimental research in order to respect human rights. Based on the analysis of theoretical views regarding the biomedical experiment, its essence, conditions, features of implementation and risks of consequences, as well as legal regulation at the international and national level identify problems of ethics and law in conducting such medical research. The authors substantiate the position that national legal acts must ensure full knowledge and the need for the voluntary consent of those participating in the experiment. It is emphasized that raising awareness of ethical issues and clear legal regulation of relevant procedures will help to maintain public confidence in research activities and minimize the likely risks for participants.
How to Cite:
Volkova H. I., Khapsirokova H. A. Biomedical Experimental Research with Human Participation: Ethical and Legal Aspects // ECONOMIC PROBLEMS AND LEGAL PRACTICE. 2024. Vol. 20. № 4. P. 28-33. (in Russ.) EDN: MOCXUN
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Bernard K. Course of general physiology, per. c Franz. —SPb., —1878.
Gardia J. M. History of medicine from Hippocrates to Brusset and his followers, per. Franz. —Kazan, 1892.
Danisuk N.B., Glushkov V.A. On the legal regulation of medical experiment // Clinical surgery. —1984. —6.
Kovner S. G. History of ancient medicine, Ch. 1, v. 3. —Kiev, 1888. —687 p.
Krasovsky V.S., Yermolaev D.O., Yermolaeva Y.N. Biomedical experiment with human participation: Russian view on the problem // Scientific almanac. —2015. 11-4(13).
Moll A. Medical ethics. Doctor’s duties in all branches of his activity: for doctors and the public: per. with him. / A. Moll ; per. J. I. Levenson. —SPb.: Marx, 1903. —414 p.
Gunpowder V.I., Zatypkina E.V. Ethical-legal problems of modern biomedical research // Legal policy and legal life. —2011. —1. —P. 68.
Hapsirokova E.A. Protection of human rights in the field of biomedical experimental research // Legislation. —2020. —5. —P. 44–49.
Chernysheva Y.A. Concept, essence, problems of biomedical experimental research with human participation in the Russian Federation // Historical, philosophical, political and legal sciences, cultural studies and art. Questions of theory and practice. —2011. —5-3 (11).
Shkurlatovskaya K.M., Kisteneva O.A., Chernavin D.A. History of biological experiments // European Research. —2016. —12 (23). —P. 97–99.
Aurey X. The Nuremberg Doctors' Trial: Looking Back 70 Years Later // INTERNATIONAL CRIMINAL LAW REVIEW7 —2017. —17 (6). —P. 1049–1069.
Chenaud C., Merlani P., Luyasu S., Ricou B. Informed consent for research obtained during the intensive care unit stay // Crit Care Med. —2006. —10. —P. 168–173.
Gaille, M. For a new «Nuremberg Code»: some contemporary issues of consent // M S-MEDECINE SCIENCES. —2019. —35 (8-9). —P. 603–604.
Magendie F. Précis élémentaire de physiologie. —Paris. —1816. —Vol. 1-2.
Muller, M. Medical Ethics in the 70 Years after the Nuremberg Code, 1947 to the Present // WIENER KLINISCHE WOCHENSCHRIFT. —2018. —№ 6 (130). —P. 161.
Pisani M.A., McNicoll L., Inouye S.K. Cognitive impairment in the intensive care unit // Clin Chest Med. —2003. —24. —P. 727–737.
Poli, L. International law as the «engine» of bio-law and the emergence of an «international biolaw» // Biolaw journal-rivista di biodiritto. —2019. —2. —P. 287–301.
Silverman, H. Protecting Vulnerable Research Subjects in Critical Care Trials: Enhancing the Informed Consent Process and Recommendations for Safeguards. // Annals of Intensive Care. Springer Open Journal. —2011. —4. —P. 1072–1077.
Smithline H.A., Mader T.J., Crenshaw B.J. Do patients with actue medical conditions have the capacity to give informed consent for emergency medicine research? // Ann Emerg Med. —1999. —6. —P. 776–780.
Keywords:
biomedical experimental research, medical experiment, human rights, legal regulation, restrictions on human rights, personal dignity..
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