Ethical expertise in medicine: from humanism to formalism

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Background: Everyone knows what ethical expertise is in medicine, but most often they understand it as an axiological component of clinical research, which is incorrect [1]. Firstly, the subject of expertise is not research, but testing. Secondly, not only clinical trials, but also the entire medical practice are subject to expert evaluation.

Aim: Understanding of the described situation allows us to formulate topical questions about the further development of the institute of ethical expertise and to propose for discussion options for this development in new medical and social conditions.

Methods: Statistical analysis of the data of examinations conducted by ethical committees (councils, commissions) shows a tendency to limit the subject of examination, the lack of connection between different types of examinations.

Results: Modern medicine requires new forms of control over ongoing research and testing in connection with new risks both in the individual human body and in the social organism as a whole. Ethical expertise responds to the challenges associated with these risks by specifying and multiplying its norms and rules, which leads to excessive formalization that does not correspond to the principles of the axiology of scientific knowledge and practice in medicine.

Conclusion: The transition from ethical to fully humanitarian expertise will reduce the level of formalization, which deprives the ethical approach of its essential intentions. The allocation of deontology as the basis of ethical assessments is illegitimate, axiological components are ignored. Humanitarian expertise makes it possible to restore the parity of norms and assessments as a criterion of expertise in medicine.

作者简介

Natalya Sedova

Volgograd State Medical University

编辑信件的主要联系方式.
Email: nns18@yandex.ru
ORCID iD: 0000-0001-6775-0787
Scopus 作者 ID: 378269

Doctor of Philosophy, Doctor of Law, Professor, Honored Scientist of the Russian Federation, Head of the Higher School of Medical Humanities of the Institute of Public Health, member of the Russian Unit of the International Network of UNESCO Bioethics Departments, member of the RBC at the Commission of the Russian Federation for UNESCO, member of the IFT (International Forum of Teachers Bioethics)

俄罗斯联邦, Volgograd

参考

  1. Ethical examination of biomedical research: a guide for ethics committees / under the general editorship of A.L. Khokhlov. 3rd ed., reprint. and additional. Moscow: Publishing House of OKI, 2021. 792 p. (in Rus.).
  2. Research ethics committees : basic concepts for capacity-building. Library Cataloguing-in-Publication Data. WHO. URL: https://www.who.int/ethics/publications/en/.
  3. Order of the Ministry of Health and Social Development of the Russian Federation dated August 26, 2010 No. 753n "On approval of the procedure for organizing and conducting an ethical review of the possibility of conducting a clinical trial of a medicinal product for medical use and the form of conclusion of the ethics council". Garant System. (in Rus.) URL: https://base.garant.ru/12178437.
  4. Order of the Ministry of Health of the Russian Federation of November 24, 2020 No. 1248 "On the Coordinating Council under the Ministry of Health of the Russian Federation on Bioethics". SPS ConsultantPlus. (in Rus.) URL: http://www.consultant.ru/cons/cgi/online.cgi?req=doc&base=EXP&n=755687#iKpgpLTI3opoXanV2.
  5. Sedova N. N. Bioethics: textbook. Moscow: KnoRus, 2016. 216 p.
  6. Order of the Ministry of Health of the Russian Federation dated July 10, 2015 No. 435n "On the Ethics Committee of the Ministry of Health of the Russian Federation (as amended on March 31, 2017)". Garant System. (in Rus.) URL: https://base.garant.ru/71148664.

补充文件

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1. JATS XML
2. Рис. 1. Заседания Совета по этике Минздрава России в 2019–2021 гг.

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3. Рис. 2. Количество одобренных / не одобренных Советом по этике заявок на проведение клинических испытаний за 2016–2021 гг.

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4. Рис. 3. Фазы клинических испытаний [5]

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