Ethical aspects of clinical trials in Russia and BRICS countries: an overview
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, ethica...
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| Format: | Article |
| Language: | English |
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Belgorod National Research University
2024-09-01
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| Series: | Research Results in Pharmacology |
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| Online Access: | https://rrpharmacology.ru/index.php/journal/article/view/496 |
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| author | Sergey Y. Simeniv Alexander L. Khokhlov Olga N. Soldatova Nathalia V. Pyatigorskaya |
| author_facet | Sergey Y. Simeniv Alexander L. Khokhlov Olga N. Soldatova Nathalia V. Pyatigorskaya |
| author_sort | Sergey Y. Simeniv |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-87bb1acf26f148a9a494ee2ebd9f71c4 |
| institution | Kabale University |
| issn | 2658-381X |
| language | English |
| publishDate | 2024-09-01 |
| publisher | Belgorod National Research University |
| record_format | Article |
| series | Research Results in Pharmacology |
| spelling | doaj-art-87bb1acf26f148a9a494ee2ebd9f71c42025-01-08T12:24:53ZengBelgorod National Research UniversityResearch Results in Pharmacology2658-381X2024-09-01103435110.18413/rrpharmacology.10.496Ethical aspects of clinical trials in Russia and BRICS countries: an overviewSergey Y. Simeniv0https://orcid.org/0000-0002-2867-2840Alexander L. Khokhlov1https://orcid.org/0000-0002-0032-0341Olga N. Soldatova2https://orcid.org/0009-0007-2454-989XNathalia V. Pyatigorskaya3https://orcid.org/0000-0003-4901-4625I.M. Sechenov First Moscow State Medical UniversityYaroslavl State Medical UniversitySanatorium Buran - branch of the joint-stock company Russian Railways-HealthI.M. Sechenov First Moscow State Medical UniversityIntroduction: 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.https://rrpharmacology.ru/index.php/journal/article/view/496clinical trialsdeveloping countriesethic committeeethical principlesrights of participantssafety |
| spellingShingle | Sergey Y. Simeniv Alexander L. Khokhlov Olga N. Soldatova Nathalia V. Pyatigorskaya Ethical aspects of clinical trials in Russia and BRICS countries: an overview Research Results in Pharmacology clinical trials developing countries ethic committee ethical principles rights of participants safety |
| title | Ethical aspects of clinical trials in Russia and BRICS countries: an overview |
| title_full | Ethical aspects of clinical trials in Russia and BRICS countries: an overview |
| title_fullStr | Ethical aspects of clinical trials in Russia and BRICS countries: an overview |
| title_full_unstemmed | Ethical aspects of clinical trials in Russia and BRICS countries: an overview |
| title_short | Ethical aspects of clinical trials in Russia and BRICS countries: an overview |
| title_sort | ethical aspects of clinical trials in russia and brics countries an overview |
| topic | clinical trials developing countries ethic committee ethical principles rights of participants safety |
| url | https://rrpharmacology.ru/index.php/journal/article/view/496 |
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