Research Ethics in the Context of Transition: Gaps in Policies and Programs on the Protection of Research Participants in the Selected Countries of Central and Eastern Europe.

This paper examines the ability of countries in Central and Eastern Europe (CEE) to ensure appropriate protection of research participants in the field of increasingly globalizing biomedical research. By applying an analytical framework for identifying gaps in policies and programs for human subjects protection to four countries of CEE-Belarus, Latvia, Lithuania, and Poland, substantial gaps in the scope and content of relevant policies and major impediments to program performance have been revealed. In these countries, public policies on the protection of research participants lack consistency and reliable mechanisms for their implementation. Impediments to program performance most often relate to inadequacies in the national research ethics systems with regard to organizational structure, budgetary support, supervision, and training. The level of research ethics capacity varies from country to country and depends on socio-economic and political factors of post-communist transition. The breadth and depth of the problems identified suggest that the current level of protection for research participants in CEE might be inadequate to the challenges posed by the globalization of biomedical research. In CEE countries, there is a need for strengthening research ethics capacity through modification of relevant policies and improvement of program management. The differences among the countries call for further research on identifying the best approaches for filling the gaps in the policies and programs aimed at ensuring effective protection of research participants.

Research ethics review: identifying public policy and program gaps.

We present an analytical framework for use by fellows of the Fogarty International Center-sponsored Advanced Certificate Program in Research Ethics for Central and Eastern Europe to identify gaps in the public policies establishing research ethics review systems that impede them from doing their job of protecting human research subjects. The framework, illustrated by examples from post-Communist countries, employs a logic model based on the public policy and public management literature. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum program.

Belarus: health system review.

This analysis of the Belarusian health system reviews the developments in organization and governance, health financing, healthcare provision, health reforms and health system performance since 2008. Despite considerable change since independence, Belarus retains a commitment to the principle of universal access to health care, provided free at the point of use through predominantly state-owned facilities, organized hierarchically on a territorial basis. Incremental change, rather than radical reform, has also been the hallmark of health-care policy, although capitation funding has been introduced in some areas and there have been consistent efforts to strengthen the role of primary care. Issues of high costs in the hospital sector and of weaknesses in public health demonstrate the necessity of moving forward with the reform programme. The focus for future reform is on strengthening preventive services and improving the quality and efficiency of specialist services. The key challenges in achieving this involve reducing excess hospital capacity, strengthening health-care management, use of evidence-based treatment and diagnostic procedures, and the development of more efficient financing mechanisms. Involving all stakeholders in the development of further reform planning and achieving consensus among them will be key to its success.

ETHICAL REVIEW OF BIOMEDICAL RESEARCH IN BELARUS: CURRENT STATUS, PROBLEMS AND PERSPECTIVES.

The paper provides description of the system of ethical review for biomedical research in Belarus, with special emphasis on its historical background, legal and regulatory framework, structure and functioning. It concludes that the situation with research ethics in Belarus corresponds to the tendency of bureaucratic approach to establishment of systems of ethical review for biomedical research, observed in a number of countries of Central and Eastern Europe. Different social, economical and political factors of transition have major impact on capacities of the Belarusian RECs to ensure adequate protection of human subjects. Among the main problems identified are non-equivalent stringency of ethical review for different types of biomedical research; lack of independence, multidisciplinarity, pluralism and lay representation experienced by RECs; low level of research ethics education and transparency of RECs activities. Recommendations are made to raise the issue of research ethics on the national agenda in order to develop and maintain the research ethics system capable to effectively protect research participants and promote ethical conduct in research.