Ethical balance of clinical trials in different socio-economic conditions of their implementation
- Authors: Kubar O.I.1
-
Affiliations:
- St. Petersburg Pasteur Institute
- Issue: Vol 15, No 3 (2025)
- Pages: 409-414
- Section: LECTURES
- URL: https://journals.rcsi.science/2220-7619/article/view/315125
- DOI: https://doi.org/10.15789/2220-7619-EBO-17826
- ID: 315125
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Abstract
The modern concept of international clinical trials (CT) has reached strict regulation in terms of norms and ethics and is convincingly reflected in a series of current legislative acts, at the global, regional and national levels. Of particular interest in this area are situations of dual loyalty related to moral, financial and legal gradation of research in countries with different levels in economic development and priorities for owning the investigational drug’s patent. Based on this, the new picture of the modern Russia geopolitical map on participation in international research requires adapting and revisiting the series of semantic characteristics. First of all, this concerns a fundamental change in Russia’s status that developed from a region for conducting research on foreign drugs to be further registered, to the position as the sponsor of research on domestic drugs in third countries, usually with limited economic and infrastructural resources. This metamorphosis is not only significant in terms of the qualitative redistribution of roles, but, in connection with the high rates of popularization and real increase in the volume of such research, for example, in Africa, it dictates a need to rethink the entire system of administrative and ethical approaches to their implementation. In this article, a targeted attention is first paid to the factor of special responsibility for the adoption and regulatory consolidation in the Russia the special ethical code for sponsor’s research in the context of their implementation in regions with limited resources. This task is coupled to introducing domestic experience as well as deep legal and information baggage accumulated by international practice into the protocol for the development of sponsor research in the Russia. The specificity is also of special importance because this work consists of the direct authorial involvement in the process for establishing and forming partnership ethical code based on the principles of justice, respect, care and honesty in research with unequal resources.
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##article.viewOnOriginalSite##About the authors
Olga I. Kubar
St. Petersburg Pasteur Institute
Author for correspondence.
Email: okubar@list.ru
DSc (Medicine), Leading Researcher, Department of Etiology and Control of Viral Infections
Russian Federation, St. PetersburgReferences
- Ассоциация организаций по клиническим исследованиям. Информационно-аналитический бюллетень № 29. I полугодие 2024. М., 2024. 25 c. [Association of Clinical Research Organizations. Information and analytical bulletin No. 29. Jan-Jun 2024. Moscow, 2024. 25 p. (In Russ.)] URL: http://acto-russia.org/files/bulletin_29.pdf
- Всемирная медицинская ассоциация. Хельсинкская декларация: Этические принципы проведения медицинских исследований с участием человека. Принята 18-й Генеральной ассамблеей ВМА, Хельсинки, Финляндия, июнь 1964 г.; с изменениями, внесенными на 75-й Генеральной ассамблее ВМА, Хельсинки, Финляндия, октябрь 2024 г. [World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964; last amended by the 75th WMA General Assembly, Helsinki, Finland, October 2024] URL: http://acto-russia.org/index.php?option=com_content&task=view&id=21
- ГОСТ Р. 1.0-2004. Национальный стандарт Российской Федерации. Стандартизация в Российской Федерации. Основные положения (утв. Приказом Ростехрегулирования от 30.12.2004. № 152-ст.) [GOST R. 1.0-2004. National standard of the Russian Federation. Standardization in the Russian Federation. Basic provisions (approved by Order of Federal Agency for Technical Regulation and Metrology dated 30.12.2004. No. 152-st.) (In Russ.)] URL: https://legalacts.ru/doc/gost-r-10-2004-natsionalnyi-standart-rossiiskoi-federatsii
- ГОСТ Р. 52379-2005. Национальный стандарт Российской Федерации. Надлежащая клиническая практика (утв. Приказом Ростехрегулирования от 27.09.2005. № 232-ст.) [GOST R. 52379-2005. National standard of the Russian Federation. Good clinical practice” (approved by Order of Rostekhregulirovanie dated September 27, 2005. No. 232-st.) (In Russ.)] URL: https://docs.cntd.ru/document/1200041147
- Михаил Мурашко рассказал о перспективных направлениях для сотрудничества с африканскими странам // Министерство здравоохранения РФ. [Mikhail Murashko spoke about promising areas for cooperation with African countries // Ministry of Health of the Russian Federation. (In Russ.)] 28.07.2023. URL: https://minzdrav.gov.ru/news/2023/07/28/20368-mihail-murashko-rasskazal-o-perspektivnyh-napravleniyah-dlya-sotrudnichestva-s-afrikanskimi-stranami
- О техническом регулировании: Федеральный закон РФ от 27 декабря 2002 г. № 184-ФЗ (с изменениями на 2 июля 2021 года) (редакция, действующая с 23 декабря 2021 года). [On technical regulation: Federal Law of the Russian Federation of December 27, 2002 No. 184-FZ. (as amended on July 2, 2021) (version effective from December 23, 2021) (In Russ.)] URL: https:// docs.cntd.ru/document/901836556
- Об утверждении положения о совете по этике, порядка его создания и деятельности, требований к квалификации и опыту работы по экспертной оценке научных, медицинских и этических аспектов клинических исследований лекарственных препаратов для медицинского применения, предъявляемых к экспертам совета по этике, порядка организации и проведения этической экспертизы, форм заключений совета по этике, порядка размещения информации о составе совета по этике, планах его работы и текущей деятельности: Приказ Минздрава РФ от 31.10.2024 № 586н. Зарегистрировано в Минюсте России 28.11.2024 № 80360. [On approval of the Ethics Council regulation, the procedure for its establishment and activities, requirements for the qualifications and experience of work on expert assessment of scientific, medical and ethical aspects of clinical trials of medicinal products for medical use, presented to experts of the Ethics Council, the procedure for organizing and conducting ethical examination, forms of conclusions of the Ethics Council, the procedure for posting information on the composition of the Ethics Council, plans for its work and current activities: Order of the Ministry of Health of the Russian Federation dated October 31, 2024 No. 586n. Registered in the Ministry of Justice of Russia on November 28, 2024 No. 80360 (In Russ.)] URL: https://www.consultant.ru/document/cons_doc_LAW_492267
- Об утверждении Правил надлежащей клинической практики Евразийского экономического союза. Решение Совета Евразийской экономической комиссии № 79 от 06.11.2016. [On approval of the Rules of Good Clinical Practice of the Eurasian Economic Union. Decision of the Council of the Eurasian Economic Commission No. 79 of 06.11.2016. (In Russ.)] URL: https://docs.cntd.ru/document/456026110
- Об утверждении правил проведения фармацевтических инспекций: Решение Совета Евразийской экономической комиссии от 3 ноября 2016 года № 83 (с изменениями на 06.09.2024) [On approval of the rules for conducting pharmaceutical inspections: Decision of the Council of the Eurasian Economic Commission of November 3, 2016 No. 83 (as amended on September 6, 2024) (In Russ.)] URL: https://docs.cntd.ru/document/456026119?marker=64U0IK
- Россия и Африка: от помощи – к партнерству // Комсомольская правда. [Russia and Africa: from aid to partnership. Komsomolskaya Pravda. (In Russ.)] 30.07.2023. URL: https://www.kp.ru/daily/27535.5/4801181
- Трапкова А.А. Проведение фармацевтических инспекций на соответствие требованиям GCP ЕАЭС в Российской Федерации является осознанной необходимостью // Безопасность и риск фармакотерапии. 2023. Т. 11, № 2. С. 127–130. [Trapkova A.A. Conducting pharmaceutical inspections for compliance with the requirements of the EAEU GCP in the Russian Federation is a conscious need. Bezopasnost’ i risk farmakoterapii = Safety and Risk of Pharmacotherapy, 2023, vol. 11, no. 2, pp. 127–130. (In Russ.)] doi: 10.30895/2312-7821-2023-11-2-127-130
- Центр им. Гамалеи заявил о готовности поставлять странам Африки вакцины // ТАСС. Саммит Россия – Африка. [The Gamaleya Center has announced its readiness to supply vaccines to African countries. TASS. Russia – Africa Summit. (In Russ.)] 28.07.2023. URL: https://tass.ru/obschestvo/18394227
- Экспорт оригинальных препаратов позволит нам обеспечить и себя, и другие страны новыми эффективными лекарствами и развивать технологический суверенитет страны // Коммерсант. Иннопром. Приложение № 123. [Export of original drugs will allow us to provide ourselves and other countries with new effective drugs and develop the technological sovereignty of the country. Kommersant. Innoprom. Appendix No. 123. (In Russ.)] 11.07.2023. URL: https://www.kommersant.ru/doc/6081959
- African Union. African Medicine Agency (AMA) Treaty. 05.02.2020. URL: https://au.int/en/pressreleases/20200205/african-medicine-agency-ama-treaty
- Appiah D., Teye-Adjei D., Auagah C. Ethics Dumping: Case Studies from Global North and South Research Collaborations: Book Review. Research Ethics: Journal of Multidisciplinary Research, 2024, vol. 2, no. 1. URL: https://www.researchgate.net/profile/Research-Ethics/publication/378525257_Ethics_Dumping_Case_Studies_from_North-South_Research_Collaborations_Edited/links/65deb5e1e7670d36abe30848/Ethics-Dumping-Case-Studies-from-North-South-Research-Collaborations-Edited.pdf?_tp=eyJjb250ZXh0Ijp7ImZpcnN0UGFnZSI6InB1YmxpY2F0aW9uIiwicGFnZSI6InB1YmxpY2F0aW9uIn19
- Bolstering Vaccine Manufacturing Capacity in Africa: a move towards self-sufficiency. The Brown Journal of World Affairs, 2020, vol. XXVIII, iss. 1, 16 p.
- Bwire G., Ario A.R., Eyu P., Ocom F., Wamala J.F., Kusi K.A., Ndeketa L., Jambo K.C., Wanyenze R.K., Talisuna A.O. The COVID-19 pandemic in the African continent. BMC Med., 2022, vol. 20, no. 1: 167. doi: 10.1186/s12916-022-02367-4
- Chatfield K., Schroeder D., Guantai A., Bhatt K., Bukusi E., Odhiambo J.-A., Cook J., Kimani J. Preventing ethics dumping: the challenges for Kenyan research ethics committees. Research Ethics, 2021, vol. 17, no. 1, pp. 23–44. doi: 10.1177/1747016120925064
- Extraordinary Session of the IBC/Join Session of the IВС and IGBC/11th (Extraordinary) Session of COMEST. 23 and 24 February 2021. URL: http://www.events.unesco.org
- Grüner S., Krüger F. The intention to be vaccinated against COVID-19: stated preferences before vaccines were available. Appl. Econ. Lett., 2021, vol. 28, pp. 1847–1851. doi: 10.1080/13504851.2020.1854445
- Guideline for good clinical practice E6(R3): ICH harmonised guideline. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Final version Adopted on 06 January 2025. URL: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
- Kelly A.H. The Territory of Medical Research: Experimentation in Africa’s Smallest State. In: Geissler P.W., editor. Para-States and Medical Science: Making African Global Health. Durham (NC): Duke University Press; 2015. Chapter 10.
- Molyneux S., Geissler P.W. Ethics and the ethnography of medical research in Africa. Soc. Sci. Med., 2008, vol. 67, no. 5, pp. 685–695. doi: 10.1016/j.socscimed.2008.02.023
- Nachega J.B., Sam-Agudu N.A., Mellors J.W., Zumla A., Mofenson L.M. Scaling Up Covid-19 Vaccination in Africa - Lessons from the HIV Pandemic. N. Engl. J. Med., 2021, vol. 385, no. 3, pp. 196–198. doi: 10.1056/NEJMp2103313
- Nature addresses helicopter research and ethics dumping. Nature, 2022, vol. 606, no. 7912: 7. doi: 10.1038/d41586-022-01423-6
- Ncube B.M., Dube A., Ward K. Establishment of the African Medicines Agency: progress, challenges and regulatory readiness. J. Pharm. Policy Pract., 2021, vol. 14, no. 1: 29. doi: 10.1186/s40545-020-00281-9
- Ndomondo-Sigonda M., Miot J., Naidoo S., Dodoo A., Kaale E. Medicines Regulation in Africa: Current State and Opportunities. Pharmaceut. Med., 2017, vol. 31, no. 6, pp. 383–397. doi: 10.1007/s40290-017-0210-x
- Ozawa S., Evans D.R., Bessias S., Haynie D.G., Yemeke T.T., Laing S.K., Herrington J.E. Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. JAMA Netw Open, 2018, vol. 1, no. 4: e181662. doi: 10.1001/jamanetworkopen.2018.1662
- Paul E., Steptoe A., Fancourt D. Attitudes towards vaccines and intention to vaccinate against COVID-19: Implications for public health communications. Lancet Reg Health Eur., 2021, vol. 1: 100012. doi: 10.1016/j.lanepe.2020.100012
- Peeters Grietens K., Ribera J.M., Erhart A., Hoibak S., Ravinetto R.M., Gryseels C., Dierickx S., O’Neill S., Muela S.H., D’Alessandro U. Doctors and vampires in sub-Saharan Africa: ethical challenges in clinical trial research. Am. J. Trop. Med. Hyg., 2014, vol. 91, no. 2, pp. 213–215. doi: 10.4269/ajtmh.13-0630
- Schroeder D., Chatfield K., Chennells R., Herissone-Kelly P., Singh M. Equitable Research Partnerships: A Global Code of Conduct to Counter Ethics Dumping. Cham: Springer Verlag, 2019. 122 p.
- The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. DHEW Publication No. (OS) 78-0012, Washington D.C., U.S. Government Printing Office, 1978.
- World Health Organization. The health of the people: what works. The African Regional Health Report 2014. URL: https://www.afro.who.int/publications/african-regional-health-report-2014-health-people-what-works#:~:text=Fuelled%20by%20rapid%20urbanization%20and,have%20been%20shown%20to%20work
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