Ethical aspects of clinical trials in Russia and BRICS countries: an overview
Authors
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Sergey Y. Simeniv
I.M. Sechenov First Moscow State Medical University
https://orcid.org/0000-0002-2867-2840
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Alexander L. Khokhlov
Yaroslavl State Medical University
https://orcid.org/0000-0002-0032-0341
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Olga N. Soldatova
Sanatorium Buran - branch of the joint-stock company Russian Railways-Health
https://orcid.org/0009-0007-2454-989X
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Nathalia V. Pyatigorskaya
I.M. Sechenov First Moscow State Medical University
https://orcid.org/0000-0003-4901-4625
DOI:
https://doi.org/10.18413/rrpharmacology.10.496Abstract
Introduction: In the context of the globalization of the clinical trials market, the rapid growth in their number, the fast development of biomedical research using new technologies, and insufficient control over their conduct by state regulatory authorities and independent ethics committees, ethical aspects of conducting clinical trials and the issue of protecting patients’ rights remain relevant. The aim of the study: To review and compare the legislative frameworks and regulations of ethical aspects of clinical trials in Russia and the BRICS countries, which possess significant scientific, industrial, and economic potential – China, India, and Brazil.
Material and Methods: The search was conducted using PubMed, Medline, and Google Scholar databases, with descriptors including ethics in clinical trials, legislative regulation of clinical trials, and ethic committee. The selection criteria included publications from 2010 to 2024 and articles focusing on the regulation of clinical trials in Russia, China, India, and Brazil, along with their histories and evaluation forms.
Results and Discussion: In Russia, the work of Ethics Committees is based on the European model, grounded in modern international ethical norms and regulatory documents of the Russian Federation and the Eurasian Economic Union (EAEU). A drawback is the lack of structured interaction between Ethics Committees at both national and local levels. The work of Ethics Committees in China and India faces several problems, such as weak organizational structure, unjustified membership composition, low training, incompetence, weak control and management mechanisms, and flawed systems for obtaining informed consent. The Brazil’s ethical and regulatory system meets global requirements and ethical standards, aimed at protecting the rights of clinical trials participants. However, in all developing countries, there remains a potential danger for clinical trial participants with a low socio-economic standard of living.
Conclusion: The experience of BRICS countries, which are intensively developing in the field of clinical trials, is interesting in terms of developing possible approaches to monitoring activities, ensuring interaction, certifying Ethics Committees, and centrally training Ethic Committee members in Russia.
Graphical Abstract
Keywords:
clinical trials, developing countries, ethic committee, ethical principles, rights of participants, safetyReferences
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Copyright (c) 2024 Sergey Y. Simeniv, Alexander L. Khokhlov, Nathalia V. Pyatigorskaya, Olga N. Soldatova
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