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科学与良知。

Science and conscience.

作者信息

Javashvili G, Kiknadze G, Kurtanidze T

出版信息

Georgian Med News. 2010 Jul-Aug(184-185):7-20.

PMID:20834070
Abstract

Many historical facts, describing exploitation and discrimination of research subjects which have been justified by the importance of research aims, are known. Today the protection of the rights and safety of persons involved in biomedical research (research subjects) is the necessary precondition for contemporary biomedical researches and correspondingly, development of the science. An integral responsibility of researchers working in the field of biomedicine is to ensure the protection of safety and rights of research subjects. In Europe, as well as other countries of developed and partly in developing world, there is a relevant legislative basis of international agreements and national legislation which aims at protecting the research subject. Georgia possesses considerable legislative basis in this field which includes two obligatory instruments of Council of Europe and two national laws. Relevant legislation and ethical evaluation of biomedical research protocols involving human subjects by research ethics committees is an effective mechanism for protection of a research subject's safety and rights. In Georgia there already exist biomedical research ethics committees. Further, their amalgamation is necessary to increase their competence and regularity of activities through increasing the number of submitted research protocols as well as re-distribution of expertise (3-5 committees instead of existing 15-20 or more committees). All the researchers participating in biomedical research shall be educated on the issues of protection of rights of research subjects and contemporary principles of bioethics. The latter shall become an inseparable part of professional competence of researchers for which it is necessary to prepare and put into practice special training programmes (mural as well as distant courses).

摘要

许多历史事实表明,以研究目标的重要性为由对研究对象进行剥削和歧视的情况屡见不鲜。如今,保护参与生物医学研究的人员(研究对象)的权利和安全,是当代生物医学研究以及相应的科学发展的必要前提。在生物医学领域工作的研究人员的一项重要职责,就是确保研究对象的安全和权利得到保护。在欧洲以及其他发达国家和部分发展中国家,都有旨在保护研究对象的国际协定和国家立法的相关法律依据。格鲁吉亚在这一领域拥有相当完善的法律依据,其中包括欧洲委员会的两项强制性文书和两部国家法律。研究伦理委员会对涉及人类受试者的生物医学研究方案进行相关立法和伦理评估,是保护研究对象安全和权利的有效机制。在格鲁吉亚已经存在生物医学研究伦理委员会。此外,有必要对它们进行整合,通过增加提交的研究方案数量以及重新分配专业知识(由现有的15 - 20个或更多委员会合并为3 - 5个委员会)来提高其能力和活动的规范性。所有参与生物医学研究的研究人员都应接受关于保护研究对象权利和当代生物伦理原则的教育。后者应成为研究人员专业能力不可分割的一部分,为此有必要制定并实施专门的培训计划(面授课程和远程课程)。

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