The countries of Eastern Europe and Central Asia are the heirs to Soviet history, public healthcare and education systems, values and research ethics. In healthcare and healthcare research, the disintegration of the Soviet Union and subsequent formation of independent states has been accompanied by the appearance of foreign pharmaceutical manufacturers, research companies and international multicentre projects in the medical markets of these countries. To fully participate in the international research environment, it was a necessity for the Eastern European and Central Asian countries to introduce the international rules of Good Clinical Practice (GCP) into medical research. It was also necessary to develop ethics review practices that adhered to international standards through the development of bioethics legislation, the organization of independent ethical committees at the national and local level and the training of physicians and research scientists in bioethics and GCP. These changes, along with the democratic transformation to post-Soviet political systems, began in the early 1990s and have enabled the formation of the current ethics review practices in the Eastern European and Central Asian countries. The shared history of countries in this region has made regional collaboration particularly effective and productive. This regional collaboration has lead to the formation of the Forum of Ethics Committees in the Confederation of Independent States (FECCIS), supported by the World Health Organization, and the Good Clinical Practice Alliance — Europe, which forms the organizational basis for such cooperation.
This article analyses the characteristics of the current ethics review processes within Eastern European and Central Asia, and then looks at the problems with the current system and tries to identify ways that these can be resolved.
The success of the ethical review process in Eastern Europe and Central Asia is dependent on the joint efforts of all its individual members, member states and public bodies. These issues are considered by the authors to be fundamental to progress in this sphere.
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1The CIS is made up of the following countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, the Russian Federation, Tajikistan, Uzbekistan and Ukraine.
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Dr Alexei S. Sozinov is the Vice-Rector of Education, Head of Department of Medical Ethics and Law, Kazan State Medical University, Tatarstan, Russia and Chairman of the Forum of Ethics Committees in the Confederation in the Independent States (FECCIS). Francis P. Crawley is the Executive Director of the Good Clinical Practice Alliance — Europe and co-founder of the FECCIS and the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). Dr Aizhan Sadykova is the Chairman of the Association of Medical Doctors and Pharmacists of Kazakhstan and the Chairman of the International Committee of Euro-Asia Forum of Medical Associations.
The authors would like to thank the FECCIS Steering Committee members, WHO-TDR, GCPA, the European Commission, UNESCO, and OHRP DHHS USA for their support of the activities and materials supplied in producing this article.
No sources of funding were used to assist in the preparation of this review article. The authors have no conflicts of interest that are directly relevant to the content of this review.
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Sozinov, A.S., Crawley, F.P. & Sadykova, A. The Development of Ethical Review Practices in Eastern Europe and Central Asia. Pharm Med 22, 277–284 (2008). https://doi.org/10.1007/BF03256716
- Biomedical Research
- Central Asian Country
- Voluntary Consent
- Research Ethic Review
- Nuremberg Code