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基于实践浅谈临床课题研究“申报前伦理审查”问题

Discussion on the Ethical Review Issues before Application of Clinical Scientific Research Based on the Practice

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【作者】 陈勇川杨竟

【Author】 CHEN Yongchuan;YANG Jing;Pharmacy Department of Southwest Hospital,Third Military Medical University;

【机构】 第三军医大学西南医院药剂科

【摘要】 西南医院伦理委员会结合伦理审查经验和课题申报的特殊性,建立了伦理"三审制"。但在"三审制"的实际工作中容易发生以下常见问题:立题依据不充分,缺乏必要的研究背景;研究基础不充分,缺乏必要的临床前实验数据;研究条件不充分,缺乏必要的质量保证体系。对此,伦理委员会应开展项目申报前审查,并使其制度化;并加强对委员的培训,提升其审查能力;同时应严把质量关,避免成为"橡皮图章",还要针对研究者开展伦理培训,提高其伦理意识。

【Abstract】 Combined with previous experience in ethical review and the particularity of application,Ethics Committee of Southwest Hospital has established three-level system of ethical review. But in the actual work there mighthave the following common problems: the foundation is not sufficient and lack of the necessary research background; the research basis is not sufficient and lack of necessary preclinical experimental data; the research conditions are not sufficient and lack of necessary quality assurance system. In this regard,the ethics committee should carry out the review before application and make it institutionalized,strengthen the training of members and improve the review ability,strictly control the quality and avoid becoming a rubber stamp,and carry out ethical training for researchers to improve their ethical consciousness.

  • 【文献出处】 中国医学伦理学 ,Chinese Medical Ethics , 编辑部邮箱 ,2016年06期
  • 【分类号】R-052
  • 【被引频次】10
  • 【下载频次】223
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