Ethical approval for health research in central and eastern Europe: an international survey
Ethical approval for health research in central and eastern Europe: an international survey
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DOI：
10.7861/clinmedicine.1-3-197
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发表时间：
2001-05-01
影响因子：
4.4
通讯作者：
McKee, M
中科院分区：
文献类型：
--
作者：
Coker, R;McKee, M
中欧和东欧的研究伦理委员会的重要性与日俱增，因为该地区的机构主办的健康相关研究的范围和数量越来越多，资金来源也越来越广泛。目的：描述中东欧11个国家对研究进行道德监督的安排，以找出良好做法的范例和薄弱之处。方法：2000年10月，向阿尔巴尼亚、保加利亚、克罗地亚、捷克、中东欧、爱沙尼亚、匈牙利、立陶宛、波兰、罗马尼亚、俄罗斯和乌克兰等国的主要知情人士发送了一份问卷。它要求提供关于伦理委员会的组成和运作、其培训以及公众对与健康有关的研究的伦理问题的任何关切的信息。结果：除乌克兰外，所有国家都确认决策委员会结构的运作是为了监督人体研究的伦理。除阿尔巴尼亚外，所有国家的委员会都由医疗和非医疗成员组成。成员在爱沙尼亚、匈牙利和立陶宛接受了生物伦理方面的专门培训。各国在执行协调多地点研究和监测研究的安排方面取得了不同程度的进展。公众对健康相关研究引发的伦理问题的关注很少。结论：中欧和东欧对健康相关研究的伦理监督的发展差异很大。在一些国家，存在着需要解决的重大弱点。其他国家可以作为该区域良好做法的榜样。一大挑战是公众如何参与这一过程。
Research ethics committees in central and eastern Europe are increasing in importance as institutions in this region host a growing and more diverse range and volume of health-related research, with funding from an increasingly wide variety of sources.Aim: To describe the arrangements for ethical supervision of research in eleven countries of central and eastern Europe, so as to identify examples of good practice and areas of weakness.Methods: A questionnaire was sent to key informants known to be active in health-related research in Albania, Bulgaria, Croatia, Czech central and eastern Republic, Estonia, Hungary, Lithuania, Poland, Romania, Russia, and Ukraine in October 2000. It sought information on the composition and functioning of ethics committees, their training and any public concerns about the ethics of health-related research.Results: All countries except Ukraine confirmed that decision-making committee structures operate to oversee the ethics of research on human subjects. In all countries except Albania committees are comprised of medical and nonmedical members. Members received specific training in bioethics in Estonia, Hungary, and Lithuania. Countries had made different degrees of progress in implementing arrangements for coordinating multi-site research and for monitoring research once it had commenced. Public concern about ethical issues arising from health-related research was rare.Conclusion: The development of ethical supervision of health-related research in central and eastern Europe varies considerably. In some countries there are significant weaknesses that should be addressed. Other countries could serve as examples of good practice in the region. A major challenge is how the public can be involved in this process.