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回顾与展望:我国伦理委员会研究知识图谱分析

     

摘要

Through the development of close to 30 years,ethics committee has become an indispensable part of biomedical research involving human beings.The research into ethics committee is problem-orientated and has made rich research results from theoretical research to practical research.By using software CiteSpace Ⅲ and analytic visualization of CNKI literature as measuring and drawing tool,this paper made the mapping knowledge domain of ethics committee study since 1991 and found that the published articles amount showed a wave upward trend,the quantity increased sharply in recent years and the research focused on ethical review,clinical trial,informed consent,human subjects,etc.The research topics developed from macro level to micro level and fitted with the development of whole ethical practice.The existing research mainly focused on five aspects of the analysis of laws and regulation,multidisciplinary perspective analysis of ethics committees,the management and practice,the review mechanism and supervision and evaluation.The existing research lacked many summaries accordance with China's national condition;the theory was separate from practice;the research on the micro-level was less.With the development of ethics committee in China,the ethics research on micro-level will become the focus of next step.%历经近三十年发展,伦理委员会已成为涉及人的生物医学研究中不可或缺的角色.伦理委员会研究以问题为导向,从理论研究到实践研究,取得了丰硕的成果.综合运用CiteSpaceⅢ和CNKI文献可视化分析作为测量和绘制工具,绘制1991年至今的伦理委员会研究的知识图谱,发现其发文量呈现出波浪上升趋势,近几年数量激增,研究方向集中在伦理审查、临床试验、知情同意、受试者等方面.研究主题从宏观层面向微观层面深入,且与整个伦理实践的发展相契合.既有研究主要集中在法规政策分析、伦理委员会的多学科视角剖析、管理与实践、审查机制、监管与评价五个方面.现有研究缺乏符合我国国情的提炼总结、理论与实践分离、微观层面研究较少.随着我国伦理委员会的发展,微观层面的伦理研究将成为下一步研究的重点.

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