【作者】 朱伟；

【导师】 邱仁宗； 殷正坤；

【作者基本信息】 华中科技大学 ， 马克思主义哲学， 2007， 博士

【摘要】 知情同意是生命伦理学的基本原则,它被视为保护病人和受试者的有效途径。然而,在生物医学临床和研究实践中,知情同意原则的贯彻未尽如人意,它不能有效地起到保护病人和受试者的作用。因此,知情同意原则在理论上受到质疑:一是知情同意原则在一般意义上是否具有理论的合理性;二是,当知情同意原则在特定的文化环境中贯彻时,其理论基础能否与所运用的文化环境相适应。在中国,知情同意原则的贯彻也面临同样的问题。许多学者把它归结为文化的原因,认为知情同意原则是以西方个体论为理论基础,而不适合中国强调和谐和社会本位的文化背景。本论文分析了知情同意原则所面临的困境,系统阐述知情同意的理论合理性,并从三个方面发展论文的观点:第一,中国在知情同意原则贯彻中遇到的问题,不是文化特有的,而是普遍的问题。第二,以个体论为基础的西方知情同意的理论基础,并不与中国的文化完全对立。中国文化并不否认个人的作用。第三,中西方在知情同意问题上的困惑,实质都是如何在强调医生和研究者保护病人或受试者的义务和主张病人和受试者的自主权利之间找到平衡。最后,论文得出结论:知情同意原则在非西方情境中遇到的挑战,其根本原因不在于文化根源上的差异,其实质仍在于对知情同意的理论辩护存在着偏差。无论是西方还是中国,对知情同意原则的理论辩护仍应以个体论为基础。因而,知情同意原则在中国这样的非西方国家中的运用,没有必要对其理论基础进行重新的构建,其文化的敏感性更应该着眼于操作层面。论文分七个部分来论证以上观点。第一章将着重论述知情同意的历史、概念和构成的要素。指出西方知情同意的历史一条由家长主义向要求个人自主性和权利的历史。同时,分析知情同意的含义,以及构成知情同意内容的四个要素。第二章主要分析来源于西方的知情同意的道德基础。主要论述西方哲学对知情同意理论的不同解释。着重分析契约论、义务论、功利主义的观点在对知情同意的解释上的共同点、不足及相互间的矛盾;证明自主性对构成知情同意理论内涵的必要性和重要性。第三章主要论述知情同意在中国所面临的困惑,对目前国内研究中的一些观点作梳理总结,并进行批判性的论证。对是否可以不要个人的自主性、是否可以家长主义和自主性之间找到平衡、知情同意原则是否可以在家长主义面前妥协,进行分析和论证。提出临床和研究中的根本问题是个人自主性的不足。第四章主要阐述知情同意在中国的发展历史和现状。说明中国的历史也从经历家长主义到强调病人、受试者的权利和自主性的过程,并因此与西方的发展相类似。但在如何保护病人和受试者利益的问题上,中国与西方在决策模式上的不同。第五章分析在中国文化中的个人与自主性的表现。本章通过对儒家文化中的个人、个体本位还是社会本位,以及医学文化情景中的人与人的关系(医生、病人和家庭)的论述,来论证中国文化并非是否定个人及其自主性的文化;中国儒家文化以独特的方式表达处于一定社会关系中的个人与社会。第六章是基于以上各章的分析得出结论:知情同意是一个合作的过程,它需要参与合作和协调的人具有自主的地位,还需要达到同意的结果----一个协议或盟约。知情同意的实现,既要具有自主性的前提,又要有协商的过程,还要有达到协议或作决定的结果。第七章主要从国内外有关知情同意法规着手,分析国内目前在知情同意法规上存在的不足和问题,并提出建设性的政策建议。更多还原

【Abstract】 Informed consent, one of the fundamental principles in bioethics, is long considered an effective means in protecting the best interest of both patients and human subjects. However, the role of informed consent in real situation, whether at the level of biomedical research or clinical practice, is far from being satisfacory. Hence doubts have been raised concerning the application of informed consent. Some critics begin to challenge the theoretical support of informed consent. Others tend to draw attention to the incompatibility between theory and practice when informed consent is carried out in the context of a non-Western culture. In China we are faced with similar problems in this respect. For many professionals, these problems are caused by the cultural difference. They argue that the principle of informed consent is built on individualism which is the quintessential element of the Western philosophy. But the core value for the Chinese culture is harmony which is in conflict with the Western culture.This doctoral dissertation, based on a detailed analysis of the problems involved in the implemntation of the principle of informed consent in China, attempts to prove its theoretical justifiability. The author is to approach the issue from three perspectives. In the first place, she will point out that the problems China encounters in the process of applying informed consent is not a China-only phenomenon but problems with universal meaning. Secondly, she will further discuss that individualism which is the theoretical basis of informed consent, is not entirely in conflict with the Chinese culture because the Chinese culture also lays emphasis on the importance of individuals. Finally, she will conclude that the nature of all these problems related to the application of informed consent is actually about how to balance the physician/researcher’s obligation for safeguarding the interest of the patient/subject with the patient/subject’s autonomous right for protecting itself.To sum up, the author presents her major points as follows: 1) The problems resulting from the application of informed consent in a non -Western cultural situation are caused not by the cultural differences between the West and the East but by misunderstanding of the theoretical support of informed consent. 2) Whether in the West or in the East, the theoretical support of informed consent is always the focus on individualism. 3) In China what is needed is not a restructuring of the theoretical basis of informed consent but more attention to the operational details.The dissertation is made up of seven chapters altogether. Chapter one is about the origin, historical development and content of informed consent. Chapter two is a detailed discussion of the theoretical support of informed consent. After studying the representative philosophical interpretations of the principle of informed consent in the West, the author emphasizes that autonomy or autonomous choice constitutes the essence of informed consent. Chapter three mainly touches upon the problems involved in the application of informed consent in China. The author in this section tries to address issues related to individualism, paternalism and autonomy. She declares that the major concern in the application of informed consent is the lack of respect for autonomy. Chapter four is a comparative study between China and the Western culture. While emphasizing similarities in the application of informed consent in both cultures, the author also points out that the major difference is in the mode of decision-making. Chapter five introduces the topic of individuality or autonomy in the context of the Chinese culture. The author holds that the Chinese culture is not one that negates autonomy. Chapter six summarizes all the major points covered in the previous chapters. In chapter seven the author proposes some suggestions concerning the legalization of informed consent in China.更多还原