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
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
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DOI：
10.1007/s11948-015-9723-4
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发表时间：
2016-12-01
影响因子：
3.7
通讯作者：
Famenka, Andrei
中科院分区：
文献类型：
--
作者：
Famenka, Andrei
本文探讨了中欧和东欧国家在日益全球化的生物医学研究领域确保研究参与者得到适当保护的能力。通过对中东欧4个国家--白俄罗斯、拉脱维亚、立陶宛和波兰--应用分析框架，确定人类受试者保护政策和方案的差距，发现相关政策的范围和内容存在重大差距，方案执行存在重大障碍。在这些国家，关于保护研究参与者的公共政策缺乏一致性和可靠的执行机制。项目绩效的障碍通常与国家研究伦理体系在组织结构、预算支持、监督和培训方面的不足有关。研究伦理能力的水平因国家而异，取决于后共产主义过渡时期的社会经济和政治因素。所查明的问题的广度和深度表明，目前对中欧和东欧研究参与者的保护水平可能不足以应对生物医学研究全球化带来的挑战。在中东欧国家，有必要通过修改相关政策和改善项目管理来加强研究伦理能力。各国之间的差异要求进一步研究，以确定填补旨在确保有效保护研究参与者的政策和方案空白的最佳方法。
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.