【作者】 张静；

【导师】 霍存福；

【作者基本信息】 吉林大学 ， 法学理论， 2014， 博士

【摘要】 当生成于西方的知情同意权成为现代医学的共同话语时，其在我国的临床实践中却遭遇了本土传统医学的挑战，甚至提出在本土医学中是否需要知情同意的问题。这样的质疑和挑战来自两个方面：一是知情同意权是否具有理论上的普适性；二是当知情同意权在中国特定的医疗环境中运行时，其理论是否切合本土医学的实践需要。基于此，本文从法哲学的视角，立足于分析具有普遍性的知情同意权与中医这个“特殊物品”之间存在的某些矛盾关系，并在此基础上探寻知情同意权在本土医学中的实现问题。本文的核心观点是：其一，患者知情同意权源于人的自主性，是自主性所内含的自由、理性、尊严、责任等基本价值的必然选择。中医患者知情同意权源于患者的自主性诉求，具有理论上的正当性。自主性奠定了知情同意权的理论基础，它不仅赋予知情同意权实质意义，也决定了知情同意权的形式规定性，使之呈现出权利享有的普适性和权利实现的程序性。其二，现行普遍主义立法模式指认以西医为样本的知情同意权的普适性，却忽视了中医患者知情同意权的特殊性，具有某种程度的非适切性：它不能有效回应中国传统医疗中的权利诉求，并引发了中医患者知情同意权适用中的现实危机。因此，应当建立一种能有效回应中医患者的自主性诉求，并能兼顾中西医差异的“兼容式”的知情同意权立法模式。其三，知情同意权规则体系的构建应本着实质与形式相统一的原则，坚持程序优于实体，着重于患者知情权的标准、内容、患者的同意能力、知情同意权的法律限度、共同决策程序以及表达性程序等方面，使得中医患者知情同意权由抽象走向具体，由应然走向实然。论文的创新之处主要体现在以下几方面：其一，本文从患者自主性的角度论证中医患者知情同意权的理论基础，阐明中医患者知情同意权存在的现实基础和法律基础，论证了中医患者知情同意权的正当性和必要性，深化了知情同意权的理论研究。其二，本文突破了传统理论研究偏重知情同意权内容、要素等实体内容的局限性，从形式规定性和程序性两个层面分析知情同意权的权利构成，将中医患者知情同意权纳入一个过程化分析的模式，通过一种“程序优于实体”的制度设计增进中医患者知情同意权的可操作性，将知情同意权的理论研究从实体范畴扩展到了程序范畴，丰富了权利体系。其三，本文分析现行知情同意权立法的“泛西医化”，考察中医患者知情同意权的适用现状，在批判普遍主义立法模式的非适切性的基础上，提出构建中西医兼容的知情同意权立法模式的观点，为完善中医患者知情同意权立法提供了明确的理论指引。其四，本文探寻中医患者知情同意权的特殊性，并以之为基础构建中医患者知情同意权实现的规则体系，对中医患者的知情权、同意权以及知情同意的程序进行体系性的构建，为中医患者知情同意权立法与实践提供了重要的理论支撑与明确的规则指引。其五，本文运用实证分析的方法，深入考察中医患者知情同意权的运行现状，突破了现有规范性研究的局限，增强了中医患者知情同意权制度构建的有效性。论文分四个部分论证上述观点：论文的第一部分论证知情同意权的理论基础。本文分析知情同意权法理形成与发展的历史流变，审视知情同意权利化背后的推动因素，认为知情同意权的源于人的自主性，是自主性所内含的自由、理性、尊严、责任等基本价值的必然选择。以自主性为基础，本文将知情同意权置于实体与形式两个向度之下深入考察：在实体方面，知情同意权包括知情权与同意权两项基本权利，具有信息的告知、理解、同意能力、自愿四个构成要素；在形式方面，知情同意权作为一种行为模式具有两个方面的规定性，一是权利享有上的普适性，二是权利实现上的程序性。而程序性又表现为共同决策的形成性程序和告知承诺的表达性程序。论文的第二部分审视中医的特殊品质与患者自主性的价值关系，论证中医知情同意权存在的正当性和必要性。本文探究中国患者自主性的存在状态，认为中医具有回应自主性的历史特质，中医患者知情同意权源于患者自主性的道德诉求，有其存在的正当性。中医患者知情同意权还来自于中医风险披露的现实诉求，以及中医违法阻却的法律诉求，有其存在的必要性。在此基础上，通过审视中西医的差异，本文深入挖掘中医背景下知情同意权的特殊性，确定中医视域下知情同意权利构建中的主要矛盾。论文的第三部分反思中医视域下知情同意权立法及实践中存在的问题，构建中西医兼容的知情同意权立法格局。本文认为，以西医为样本的普遍主义立法模式下，知情同意权有其内在危机：一是知情同意权价值目标与适用目标不一致，难以回应传统医疗中的权利诉求；二是知情同意权止步于宣示性价值，权利内容模糊。本文指出普遍主义立法模式下知情同意权在中医诊疗实践中的非适切性，批判因权利的形式与价值各自执着于自身而表现出的形式主义以及行善的绝对主义。因此，本文主张制定《患者权益保护法》兼容中西医患者知情同意权的共性与差异。论文的第四部分构建并论证知情同意权的权利规则体系，并说明其限度。在实体层面，本文确立“理性患者与具体患者的双重告知标准”，阐释中医师告知义务的两方面内容：一般患者合理预期之情况的说明和具体患者特殊需求之情况的说明，界定中药告知的内容，确定患者同意能力判定的“识别能力标准”，排除中医药领域保护性医疗。在形式层面，本文构建基于患者自主的医患共同决策程序，并明确限定书面表达形式，实行个性化告知。最后，本文提出“最低限度知情原则”、“最低限度品种保护原则”和“最低限度国家秘密原则”，明确中医患者知情同意权的法律限度。更多还原

【Abstract】 Though the informed consent, originated in eastern countries, has becomecommon in modern medicine, it encounters challenges from our local traditionalmedicine during the clinical practice, and some even doubts the need to protect theinformed consent in our country. Such questioning is mainly concerned about twoaspects, i.e. whether the informed consent is of universality theoretically, andwhether its theory caters to the practical need of local medicine when it operates inthe special medical environment of China. Considering that, this paper is intended toanalyze the paradoxical relationship between the universal informed consent and theunique Chinese medicine from a legal philosophy perspective, and further discussthe practice of the informed consent in local medicine.The core ideas of this paper are as bellow. Firstly, patients’ informed consentcomes from one’s autonomy, to be specific, it is an inevitable extension of freedom,reason, dignity, responsibility and any other basic value of autonomy. As for Chinesemedicine, there is a certain legitimacy in patients’ informed consent, which isderived from their autonomous appeal. Autonomy lays the foundation of theinformed consent’s theoretical bases, in which it not only gives the informed consenta substantive meaning, but also defines its form regulation, so that the informedconsent appears to have universality in right possession and procedural characteristicin right practice. Secondly, the current universalism legislative mode only admits theuniversality of informed consent based on the sample of western medicine, whileignoring the particularity of informed consent in Chinese medicine. Consequently, itis somehow inappropriate in Chinese medicine, as it cannot effectively satisfy thedemand of right in Chinese traditional medicine, which causes the latent risks ofpractical use of informed consent in Chinese medicine. Therefore, we need acompatible informed consent legislative mode that can effectively respond to theautonomous demand of patient who seek Chinese medicine, and meanwhile, take thedifference of Chinese and western medicine into consideration. Thirdly, the construction of informed consent right system should stick to the principle of theunity of content and form, and insist the priority of procedure over entity. Besides, itshould emphasize the standards and content for Chinese medicine practitioners tofulfil their duty of informing, as well as, patients’ agreement ability, the legal limit ofinformed consent right, codetermination and expression procedures and so on, whichwill make informed consent right of patient who seeks for Chinese medicine begin toalter from abstract to concrete, and from idealistic to legal.The novelty of this paper is as follows. Firstly, the theoretical base of informedconsent right in Chinese medicine is reasoned from a patient’s autonomy angle, inwhich it illustrates the realistic and legal basis of informed consent right in Chinesemedicine and verifies the legitimacy and necessity of informed consent right inChinese medicine, thus deepening the theory research of informed consent right.Secondly, this paper breaks the limitation of traditional theory research, whichstresses the content, element and other entity information of informed consent right.Instead, it analyze the right structure of informed consent at the form regulation andprocedure level, in which it puts the informed consent in Chinese medicine into aprocedure analysis mode. Hence, by a “priority of procedure over entity”institutional design, it improves the operability of informed consent right in Chinesemedicine and extends the theoretical research of it from the category of entity to thecategory of procedure, which enriches the right system. Thirdly, this paper analyzesthe “being similar to pan-western medicine” of the current informed consent rightlegislation and studies the application of it. Then based on the criticism of theinappropriateness of the universalism legislation mode, it puts forward the idea ofbuild an informed consent right legislation mode in which Chinese medicine iscompatible with western medicine, thus providing a clear theoretical guidance ofimproving the informed consent legislation in Chinese medicine. Fourthly, this paperexplores the particularity of the informed consent legislation in Chinese medicine.Based on that, this article builds a rule system for the realization of the informedconsent in Chinese medicine and constructs the system for the informing duty ofChinese medicine practitioners and herbs, as well as patients’ consent right, thusproviding an important theoretical support and clear rule guidance for legislation and practice of the informed consent in Chinese medicine. Fifthly, this paper takes a deepdemonstration study on the current situation of the informed consent in Chinesemedicine, which breaks the limitation of the present regularity research and enhancesthe effectiveness of the system building of the informed consent in Chinesemedicine.This paper is organized as follows:The first part discusses the theoretical basis of the informed consent. Throughthe panoptic analysis of the formation and development of the informed consent, itexamines the propelling factor behind the informed consent, believing that theinformed consent comes from one’s autonomy, to be specific, it is an inevitableextension of freedom, reason, dignity, responsibility and any other basic value ofautonomy. Based on autonomy, this paper makes a thorough investigation of theinformed consent from two angles: entity and form. For entity part, the informedconsent includes two fundamental rights, i.e. the right to know and the consent right,which is composed of4factors involving the informing, understanding, consentability and voluntariness of information. For form part, as a behavior pattern, theinformed consent has its prescriptions in two aspects, one is the universality in rightpossession, and the other is the procedural characteristic in right practice. In addition,the procedural characteristic is also embodied in the forming procedure ofcodetermination and expression procedure of informing and promise.The second part examines the value relation in the Chinese medicine’sparticular quality and patients’ autonomy, and verifies the legitimacy and necessityof the informed consent in Chinese medicine. By reviewing the development ofdoctor-patient relationship in China, we think that Chinese medicine has thehistorical quality of responding to autonomy, and the informed consent in Chinesemedicine has the legitimacy of existence as it is originated from the patients’autonomy and moral pursuit. At the same time, the informed consent in Chinesemedicine also comes from the realistic appeal from the expose of the risks ofChinese medicine and the legal appeal from illegal acts of Chinese medicine, thusproving its necessity of existence. Therefore, by examining the difference of Chineseand western medicine, this paper delves deeply to find the particularity of the informed consent against the Chinese medicine background and determines theprincipal contradiction in the construction of the informed consent from a Chinesemedicine angle.The third part reflects the problems existing in the legislation and practice of theinformed consent in Chinese medicine and constructs the informed consentlegislation pattern in which Chinese and western medicine are compatible with eachother. Under the universalism legislation mode that is based on the sample ofwestern medicine, the informed consent encounters interior crises, one is thedistinction between value goal and fitness goal of the informed consent, so theinformed consent is hard to respond to the right appeal in the traditional medical.Another crisis is that the informed consent stops at oath value with its fuzzy content.During the diagnosis and treatment of Chinese medicine, the informed consentappears to be inappropriate under the universalism mode, and owing to thepersistence of form and value to itself respectively, the informed consent in Chinesemedicine presents formalism and benefic absolutism. Consequently, this paperproposes to build Patient Rights Protection Law that makes similarities anddifferences of the informed consent in Chinese and western medicine compatiblewith each other.The fourth part construct and discuss the right rule system of the informedconsent and define its threshold. At the entity level, this paper sets “the doubleinforming standard for rational patients and concrete patients”, which embodies theinforming duty of Chinese medicine into two aspects, one is the rationally expectedcondition description of normal patients and the other is the special need conditiondescription of certain patients, so that it clearly defines the informing content ofChinese medicine and “the recognition ability standard” for judging the patients’consent ability, thus excluding the protective medical care in the Chinese medicinefield. At the form level, this paper constructs the doctor-patient codeterminedprocedure based on the patients’ autonomy, and clearly define the writing expressionform to inform in a personalized way. At last, this paper puts forward “the lowestlimit for knowing principle”,“the lowest limit for variety protection principle” and“the lowest limit for national secret principle”, which clarifies the legal limit in the informed consent in Chinese medicine.更多还原