【摘要】：知情同意是醫(yī)療行業(yè)必須遵循的一項(xiàng)制度�！夺t(yī)療事故處理?xiàng)l例》11條、《執(zhí)業(yè)醫(yī)師法》26條、《醫(yī)療機(jī)構(gòu)管理?xiàng)l例》33條、《醫(yī)療機(jī)構(gòu)管理?xiàng)l例實(shí)施細(xì)則》62條等一系列法律法規(guī)對(duì)知情同意制度做出了規(guī)定,但是各個(gè)法律法規(guī)之間的規(guī)定不統(tǒng)一。2010年施行的《侵權(quán)責(zé)任法》55條、56條對(duì)知情同意制度做出了更仔細(xì)完善的規(guī)定,但依然無(wú)法滿足實(shí)踐發(fā)展的需要。 本文主要運(yùn)用比較研究、分析歸納的方法,介紹了美國(guó)知情同意制度的內(nèi)容,結(jié)合我國(guó)立法分析知情同意制度的不足,希望對(duì)我國(guó)相關(guān)制度提供一點(diǎn)建議。 本文一共分為四部分。第一部分是美國(guó)知情同意制度的概述,主要介紹了知情同意的概念和功能。知情同意是指醫(yī)師在實(shí)施醫(yī)療行為前必須向患者披露實(shí)質(zhì)性信息,患者在理解的基礎(chǔ)上自愿做出決定。知情同意制度意在尊重患者的自主選擇權(quán),即每一個(gè)成熟的個(gè)人有權(quán)進(jìn)行影響他生活的選擇,社會(huì)不允許一個(gè)人的身體完整受到威脅,除非他知道并且自愿同意這個(gè)干預(yù)。 第二部分是知情同意制度在美國(guó)的歷史發(fā)展。簡(jiǎn)要描述了知情同意制度在美國(guó)發(fā)展的兩個(gè)階段。介紹了知情同意制度在美國(guó)產(chǎn)生的歷史背景,敘述了知情同意制度的社會(huì)基礎(chǔ)、倫理基礎(chǔ)、法律基礎(chǔ)。 第三部分是本文的重點(diǎn)。首先介紹美國(guó)知情同意制度中的信息披露義務(wù),闡述信息披露的內(nèi)容與判斷標(biāo)準(zhǔn),信息披露的例外與新發(fā)展。美國(guó)知情同意制度要求醫(yī)師披露“實(shí)質(zhì)性”信息。披露信息判斷的標(biāo)準(zhǔn)有兩種,第一種為醫(yī)師標(biāo)準(zhǔn),第二種為患者標(biāo)準(zhǔn)。其中患者標(biāo)準(zhǔn)又分為主觀標(biāo)準(zhǔn)說(shuō)與客觀標(biāo)準(zhǔn)說(shuō)。其次,介紹了知情同意制度中患者的同意,主要闡述了同意的主體、形式,以及同意構(gòu)成的有效要件。最后介紹了美國(guó)四位著名學(xué)者對(duì)知情同意制度的建議,并逐一進(jìn)行了評(píng)價(jià)。 第四部分主要介紹了我國(guó)知情同意制度立法現(xiàn)狀以及存在的不足,在此基礎(chǔ)上提出對(duì)我國(guó)知情同意制度的完善建議。首先對(duì)我國(guó)有關(guān)知情同意的法律法規(guī)進(jìn)行了介紹并做具體分析。然后參考美國(guó)知情同意制度給我國(guó)帶來(lái)的啟示,對(duì)我國(guó)現(xiàn)行相關(guān)制度提出了一些建議。
[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.
【學(xué)位授予單位】：浙江工商大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2013
【分類號(hào)】：D971.2;D922.16

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