涉及人的生物医学研究伦理审查标准化操作的实践与体会

The Practice and Experience of the Standardized Operation in Ethical Review in Human Involved Biomedical Research

针对目前医疗机构在医学科研中涉及人的生物医学研究的伦理审查在申报、实施和监督等环节较难同步的现状,探索医院伦理委员对生物医学研究伦理审查的标准化操作规程,认为在审查实践中应加强伦理委员会持续教育,抓关键环节的伦理监督,不断提高委员的伦理审查能力;重视信息化管理,建立多渠道的沟通方式,重视加强对科研人员伦理导航的重要性。

In cognizance of the current situation of that it is difficult to synchronize the links in declaration, implementation and supervision of ethical review in human involved biomedical research, this essay explore the standardized operation regulations arid rules for the ethical review of biomedical research of hospital ethics committee. During the review the experience has been obtained that the continuing education of the ethical commission should be enhanced; the ethical supervision of the key links be strengthened; the ethical review capacity of the commissioners be continuously improved; the information management be emphasized;the multi--channel communications be established and the importance be attached to the ethical direction to scientific researchers.