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。
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.
出处
《中国医学伦理学》
2014年第4期449-452,共4页
Chinese Medical Ethics
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
Declaration of Helsinki
Ethical Guideline
Bioethics
Medical Ethics Review
Subiect Protection
Biological Medicine Clinical Research
作者简介
springholiday@ qq. com
