Developing National Systems for Ethical Review in Eastern Europe and Central Asia
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FOCUS ON EASTERN EUROPE AND CENTRAL ASIA
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Developing National Systems for Ethical Review in Eastern Europe and Central Asia Legitimacy and Responsibility Yurii I. Kundiiev,1 Peter N. Vitte,2 Nicolay Chashchin,3 Tatyana Mishatkina4,5 and Bakhyt Sarymsakova6 1 2 3 4 5 6
National Bioethics Committee of Ukraine, Kiev, Ukraine Information Centre on Bioethics, Kiev, Ukraine National Scientific Center for Medical and Biotechnical Research, National Academy of Science, Kiev, Ukraine National Bioethics Committee of the Republic of Belarus, Minsk, Belarus National Institute for High Education, Byelorussian State University, Minsk, Belarus National Research Centre of Mother and Child Health, Astana, Kazakhstan
Abstract
This article discusses the developing of national systems for ethical review and the possibility of harmonizing Good Clinical Practice (GCP) ethical principles and guidelines in Eastern Europe and Central Asia countries and across the region as a whole.
The objective of this article is to discuss the development of quality and consistency in ethical review in Eastern Europe and Central Asia on the national level in relation to human subjects protection. For the purposes of this article, ‘Eastern Europe and Central Asia’ is regarded as the Commonwealth of Independent States (CIS), a group made up of the following former Soviet block countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, the Russian Federation, Tajikistan, Uzbekistan and Ukraine. One of the main tasks of a joint effort such as this is to harmonize the approaches of different countries in order to create joint standards that take local peculiarities into consideration.[1] Currently, there is no legal or regulatory framework for ethical review at the international level within the CIS countries; however, the quality and consistency of ethical review within the region is rapidly being developed. Nonetheless, it is imperative that ethical review and moral responsibility is taken seriously by the executing organization. All clinical or animal studies, whether they involve experimental or marketed products and patients or healthy participants, must be approved by a supervising independent ethics committee (IEC) before permission can be granted to begin investigations. The local ethics committee has discretion on
how it will supervise noninterventional studies (observational or retrospective studies); in some countries this assessment is undertaken by a special body called an ‘institutional review board’ (IRB). Most IRBs are located at the local investigator’s hospital or institution. Unfortunately, the basic responsibilities of these IRBs are rather limited and not transparent. For the development of a sound ethics review structure within the region, it is important that CIS countries have examples of effective efforts in the creation of ethical and legal review systems through access to biology, medicine and veterinary science publications and dissertation projects
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