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

Abstract

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

“…Based on a review of public documents and a survey of RECs, Famenka, an alumnus of the Advanced Certificate Program, described the research ethics review system in Belarus and identified deficiencies in policy implementation and plausibility (Famenka, 2011(Famenka, , 2014.…”

Electromobility and Renewable Energy Sources: Comparison of Attitudes and Infrastructure in Poland and Germany

“…If the accession numbers have not yet been obtained at the time of submission, please state that they will be provided during review. They must be provided prior to publication [46][47][48][49][50].…”

Developing Quality and Efficiency of Institutional Review Board Review Under a Human Research Protection Program at a Leading Hospital in Central Southern China: A Descriptive Analysis of the First Three Years

“…In the decades since, many countries have used international guidelines as a starting point for constructing national research ethics systems, including IRBs to enforce research ethics review (Famenka, 2016). Despite an increasing number of countries following international research ethics guidelines, IRBs globally still face numerous obstacles in achieving their goal of improving the protection of research participants (Famenka, 2016).…”

“…Standard guidelines for research ethics involving human subjects were largely determined by international consensus following World War II, including the Nuremberg Code in 1947, the Declaration of Helsinki in 1964, and more recently, the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation (ICH). In the decades since, many countries have used international guidelines as a starting point for constructing national research ethics systems, including IRBs to enforce research ethics review (Famenka, 2016). Despite an increasing number of countries following international research ethics guidelines, IRBs globally still face numerous obstacles in achieving their goal of improving the protection of research participants (Famenka, 2016).…”