Famenka Andrei
Legal medicine specialist, the State Service of Legal Medicine, Minsk, Belarus,
Rev Rom Bioet. 2011 Apr;9(2):74-83.
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.
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。