The Development of Ethical Review Practices in Eastern Europe and Central Asia

Abstract

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.