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从2013年版《赫尔辛基宣言》的变化生命伦理学研究的新进展
引用本文:郑金,曲雁.从2013年版《赫尔辛基宣言》的变化生命伦理学研究的新进展[J].中国医学伦理学,2014(4):449-452.
作者姓名:郑金  曲雁
作者单位:河北医科大学第三医院科研处,河北石家庄050051
摘    要:通过对2013年版《赫尔辛基宣言》和旧版本进行比较,分析生命伦理学发展的新进展:一是对受试者的保护工作进一步加强,表现在从研究设计的源头管控保障受试者利益和从知情同意的过程管控维护受试者权利两方面.二是对研究医生的管理进一步规范,涉及研究医生的定义问题、资质问题、职责问题.三是对伦理委员会的定位进一步明确.此外,新版宣言更加重视对生态环境的保护.

关 键 词:赫尔辛基宣言  伦理指南  生命伦理学  医学伦理审查  受试者保护  生物医学临床研究

New Trends of Bioethics from the Change and Interpretation of the Edition of the 2013 Declaration of Helsinki
ZHENG Jin,Qu Yan.New Trends of Bioethics from the Change and Interpretation of the Edition of the 2013 Declaration of Helsinki[J].Chinese Medical Ethics,2014(4):449-452.
Authors:ZHENG Jin  Qu Yan
Institution:( The Department of Scientific Research, the Third Hospital of Hebei Medical University, Shijiazhuang 050051, China)
Abstract:This paper tried to compare the old version of " Declaration of Helsinki" with the new one, the new progress of the development of bioethies were analysed: the first is to further strengthen the protection to the subjects, that is, protect the interests of the subjects from research design control and the informed consent control. The second is to further standardize the management of the research doctors, making clearing about their definitions, qualifications and duties. The last, the localization of the ethics committee is further defined. In addition, the new edition pays more attention to the protection of the ecological environment.
Keywords:Declaration of Helsinki  Ethical Guideline  Bioethics  Medical Ethics Review  Subiect Protection  Biological Medicine Clinical Research
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