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白俄罗斯生物医学研究的伦理审查:现状、问题与展望

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

作者信息

Famenka Andrei

机构信息

Legal medicine specialist, the State Service of Legal Medicine, Minsk, Belarus,

出版信息

Rev Rom Bioet. 2011 Apr;9(2):74-83.

PMID:22701397
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3372927/
Abstract

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.

摘要

本文介绍了白俄罗斯生物医学研究伦理审查体系,特别强调了其历史背景、法律法规框架、结构和运作情况。结论指出,白俄罗斯的研究伦理状况与中东欧一些国家在建立生物医学研究伦理审查体系时采用的官僚主义做法趋势相符。转型期不同的社会、经济和政治因素对白俄罗斯伦理审查委员会确保充分保护人类受试者的能力产生了重大影响。所确定的主要问题包括对不同类型生物医学研究的伦理审查缺乏同等严格程度;伦理审查委员会缺乏独立性、多学科性、多元性和外行代表;研究伦理教育水平较低以及伦理审查委员会活动缺乏透明度。建议将研究伦理问题提上国家议程,以发展和维护能够有效保护研究参与者并促进研究中的伦理行为的研究伦理体系。

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Research ethics review: identifying public policy and program gaps.研究伦理审查:识别公共政策与项目差距。
J Empir Res Hum Res Ethics. 2014 Apr;9(2):3-11. doi: 10.1525/jer.2014.9.2.3.
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Building research ethics capacity in post-communist countries: experience of two Fogarty training programs.在后共产主义国家建设研究伦理能力:两项福格蒂培训项目的经验
J Empir Res Hum Res Ethics. 2013 Dec;8(5):28-39. doi: 10.1525/jer.2013.8.5.28.
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Publication ethics in biomedical journals from countries in Central and Eastern Europe.中东欧国家生物医学期刊的出版伦理
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Failures in clinical trials in the European Union: lessons from the Polish experience.欧盟临床试验失败:波兰经验教训。
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本文引用的文献

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Dev World Bioeth. 2011 Apr;11(1):48-54. doi: 10.1111/j.1471-8847.2010.00288.x. Epub 2010 Dec 7.
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Research ethics committees in Europe: trials and tribulations.欧洲的研究伦理委员会:试验与磨难
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How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review.我们如何知道研究伦理委员会真的在发挥作用?结果评估在研究伦理审查中被忽视的作用。
BMC Med Ethics. 2008 Mar 28;9:6. doi: 10.1186/1472-6939-9-6.
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Research ethics committees in Europe: implementing the directive, respecting diversity.欧洲的研究伦理委员会:执行指令,尊重多样性。
J Med Ethics. 2006 Aug;32(8):483-6. doi: 10.1136/jme.2005.013888.
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Ethics committees and countries in transition: a figleaf for structural violence?伦理委员会与转型国家:结构性暴力的遮羞布?
BMJ. 2005 Jul 23;331(7510):229-30. doi: 10.1136/bmj.331.7510.229.
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Ethics and the structures of health care in the European countries in transition: hospital ethics committees in Croatia.转型期欧洲国家的医疗保健伦理与结构:克罗地亚的医院伦理委员会
BMJ. 2005 Jul 23;331(7510):227-9. doi: 10.1136/bmj.331.7510.227.
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The globalization of clinical trials: a growing challenge in protecting human subjects: executive summary (2001).临床试验的全球化:保护人类受试者方面日益严峻的挑战:执行摘要(2001年)
J Int Bioethique. 2003 Mar-Jun;14(1-2):165-9.