临床试验受试者知情同意权研究

发布时间：2018-11-10 07:03

【摘要】：知情同意权是临床试验受试者最基本的权利之一,实践中侵犯受试者知情同意权的案例频频发生,我国现有的法律法规已无法满足保护受试者知情同意权的需要,这就促使对受试者知情同意权的相关问题进行分析完善,以达到保护受试者知情同意权的目的。本文在对知情同意权的来源与内涵进行叙述后,分析了受试者知情同意权在我国临床试验领域所面临的问题和原因。在此基础上,借鉴外国先进经验,针对我国实践中问题提出相应的完善建议,构建一整套保护受试者知情同意权的法律法规机制,使得知情同意权在临床试验领域能够有效贯彻实施,最终达到保护受试者知情同意权的效果。
[Abstract]:The right of informed consent is one of the most basic rights of the subjects in clinical trials. The cases of violating the right of informed consent of the subjects occur frequently in practice. The existing laws and regulations of our country can no longer meet the needs of protecting the right of informed consent of the subjects. This promotes the analysis and perfection of the subject's right of informed consent, in order to protect the subject's right of informed consent. After describing the origin and connotation of the right of informed consent, this paper analyzes the problems and causes of the right of informed consent in the field of clinical trials in China. On this basis, draw lessons from the advanced experience of foreign countries, in view of the problems in practice in our country, put forward the corresponding perfect suggestions, build a whole set of laws and regulations to protect the right of informed consent of the subjects. So that the right of informed consent can be effectively implemented in the field of clinical trials, and finally achieve the effect of protecting the right of informed consent.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D922.16;D923
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本文编号：2321727