美国医疗知情同意制度研究
发布时间：2018-11-01 10:46
【摘要】：知情同意是医疗行业必须遵循的一项制度。《医疗事故处理条例》11条、《执业医师法》26条、《医疗机构管理条例》33条、《医疗机构管理条例实施细则》62条等一系列法律法规对知情同意制度做出了规定,但是各个法律法规之间的规定不统一。2010年施行的《侵权责任法》55条、56条对知情同意制度做出了更仔细完善的规定,但依然无法满足实践发展的需要。 本文主要运用比较研究、分析归纳的方法,介绍了美国知情同意制度的内容,结合我国立法分析知情同意制度的不足,希望对我国相关制度提供一点建议。 本文一共分为四部分。第一部分是美国知情同意制度的概述,主要介绍了知情同意的概念和功能。知情同意是指医师在实施医疗行为前必须向患者披露实质性信息,患者在理解的基础上自愿做出决定。知情同意制度意在尊重患者的自主选择权,即每一个成熟的个人有权进行影响他生活的选择,社会不允许一个人的身体完整受到威胁,除非他知道并且自愿同意这个干预。 第二部分是知情同意制度在美国的历史发展。简要描述了知情同意制度在美国发展的两个阶段。介绍了知情同意制度在美国产生的历史背景,叙述了知情同意制度的社会基础、伦理基础、法律基础。 第三部分是本文的重点。首先介绍美国知情同意制度中的信息披露义务,阐述信息披露的内容与判断标准,信息披露的例外与新发展。美国知情同意制度要求医师披露“实质性”信息。披露信息判断的标准有两种,第一种为医师标准,第二种为患者标准。其中患者标准又分为主观标准说与客观标准说。其次,介绍了知情同意制度中患者的同意,主要阐述了同意的主体、形式,以及同意构成的有效要件。最后介绍了美国四位著名学者对知情同意制度的建议,并逐一进行了评价。 第四部分主要介绍了我国知情同意制度立法现状以及存在的不足,在此基础上提出对我国知情同意制度的完善建议。首先对我国有关知情同意的法律法规进行了介绍并做具体分析。然后参考美国知情同意制度给我国带来的启示,对我国现行相关制度提出了一些建议。
[Abstract]:Informed consent is a system that the medical profession must follow. Articles 11 of the regulations on the handling of Medical Accidents, 26 of the Law on Medical Practitioners, 33 of the regulations on the Administration of Medical institutions, A series of laws and regulations, such as the detailed rules for the implementation of the regulations on the Administration of Medical institutions, and a series of laws and regulations provide for the informed consent system, but the provisions between the various laws and regulations are not uniform. In 2010, 55 articles of the Tort liability Law were enacted. Article 56 makes more detailed and perfect regulations on informed consent system, but still can not meet the need of practice development. This article mainly uses the comparative research, the analysis induction method, has introduced the American informed consent system content, unifies our country legislation to analyze the informed consent system insufficiency, hoped to provide the suggestion to our country correlation system. This paper is divided into four parts. The first part is an overview of American informed consent system, mainly introduces the concept and function of informed consent. Informed consent means that doctors must disclose material information to patients before implementing medical behavior, and patients make voluntary decisions on the basis of understanding. Informed consent is intended to respect the patient's right to choose freely, that is, every mature individual has the right to make choices that affect his life, and society does not allow a person's physical integrity to be threatened unless he knows and voluntarily consents to the intervention. The second part is the historical development of informed consent system in the United States. This paper briefly describes the two stages of the development of informed consent system in the United States. This paper introduces the historical background of the system of informed consent in the United States, and describes the social, ethical and legal basis of the system of informed consent. The third part is the focus of this paper. First of all, it introduces the obligation of information disclosure in the system of informed consent in the United States, expounds the content and judgment standard of information disclosure, the exception and new development of information disclosure. The United States informed consent system requires doctors to disclose "material" information. There are two criteria for judging disclosure of information, the first for physicians and the second for patients. The patient standard is divided into subjective standard theory and objective standard theory. Secondly, the author introduces the consent of patients in the system of informed consent, mainly expounds the subject, form and effective elements of consent. Finally, four famous American scholars' suggestions on informed consent system are introduced and evaluated one by one. The fourth part mainly introduces the current situation and shortcomings of the legislation of informed consent system in China, and then puts forward some suggestions on how to improve the system of informed consent system in China. First of all, the laws and regulations about informed consent are introduced and analyzed in detail. Then, referring to the enlightenment of American informed consent system to our country, this paper puts forward some suggestions to the current relevant system of our country.
【学位授予单位】：浙江工商大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：D971.2;D922.16
本文编号：2303677
[Abstract]:Informed consent is a system that the medical profession must follow. Articles 11 of the regulations on the handling of Medical Accidents, 26 of the Law on Medical Practitioners, 33 of the regulations on the Administration of Medical institutions, A series of laws and regulations, such as the detailed rules for the implementation of the regulations on the Administration of Medical institutions, and a series of laws and regulations provide for the informed consent system, but the provisions between the various laws and regulations are not uniform. In 2010, 55 articles of the Tort liability Law were enacted. Article 56 makes more detailed and perfect regulations on informed consent system, but still can not meet the need of practice development. This article mainly uses the comparative research, the analysis induction method, has introduced the American informed consent system content, unifies our country legislation to analyze the informed consent system insufficiency, hoped to provide the suggestion to our country correlation system. This paper is divided into four parts. The first part is an overview of American informed consent system, mainly introduces the concept and function of informed consent. Informed consent means that doctors must disclose material information to patients before implementing medical behavior, and patients make voluntary decisions on the basis of understanding. Informed consent is intended to respect the patient's right to choose freely, that is, every mature individual has the right to make choices that affect his life, and society does not allow a person's physical integrity to be threatened unless he knows and voluntarily consents to the intervention. The second part is the historical development of informed consent system in the United States. This paper briefly describes the two stages of the development of informed consent system in the United States. This paper introduces the historical background of the system of informed consent in the United States, and describes the social, ethical and legal basis of the system of informed consent. The third part is the focus of this paper. First of all, it introduces the obligation of information disclosure in the system of informed consent in the United States, expounds the content and judgment standard of information disclosure, the exception and new development of information disclosure. The United States informed consent system requires doctors to disclose "material" information. There are two criteria for judging disclosure of information, the first for physicians and the second for patients. The patient standard is divided into subjective standard theory and objective standard theory. Secondly, the author introduces the consent of patients in the system of informed consent, mainly expounds the subject, form and effective elements of consent. Finally, four famous American scholars' suggestions on informed consent system are introduced and evaluated one by one. The fourth part mainly introduces the current situation and shortcomings of the legislation of informed consent system in China, and then puts forward some suggestions on how to improve the system of informed consent system in China. First of all, the laws and regulations about informed consent are introduced and analyzed in detail. Then, referring to the enlightenment of American informed consent system to our country, this paper puts forward some suggestions to the current relevant system of our country.
【学位授予单位】：浙江工商大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：D971.2;D922.16
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