【作者】 雷蕾；

【导师】 房绍坤；

【作者基本信息】 烟台大学 ， 民商法， 2007， 硕士

【摘要】 近年来,医疗纠纷的不断增加使医疗责任成为全社会关注的焦点,也成为法学界探讨的热门话题。但总体来说,这种探讨还处于不太成熟的阶段,医疗责任中的许多问题或者还没有触及,或者论述还不够充分,患者关于治疗的知情权就是其中之一。我们知道,只有患者才有权处置自己的身体,因此医生在对患者实施治疗之前,必须在充分告知患者相应情况的前提下得到患者的有效承诺,这也是医疗行为合法化的一个必要条件。长期以来,我国的医疗立法和实践都偏向于对医生、医疗机构的保护,对患者的利益保护较为不利。本文将结合我国的立法和实践的现状,通过介绍国际医疗责任领域比较成熟的知情同意理论(informed consent)对医生的说明、患者的同意中涉及的法律问题作比较全面的分析和探讨。本文共分四个部分。第一部分是知情同意理论概述。本部分介绍了知情同意理论的概念和功能,并对知情同意理论的发展作了回顾。知情同意的字面意思是指在被告知相关情况的前提下作出的同意的意思表示。具体到医疗责任领域,是指医生在对患者实施手术等医疗行为时,首先要针对向患者提出的医疗处置方案,医疗风险以及其它可以考虑采取的措施等做出详细的说明,并在此基础上得到患者的同意。该理论的功能在于,它能有效地抑制医生武断地替患者做出决定的做法,并在制度上保证患者自主决定权的实现。本部分第二节介绍了该理论在美国、德国、加拿大、日本、台湾的发展情况。其中,关于美国的介绍占了较大篇幅,因为该理论主要是在美国的法律土壤里成长起来的。第二部分探讨医生的说明义务,这是本文的重点。该部分分为四节。第一节是医生说明义务的法律性质。在英美法中,一般将“诚信义务”应用于医生的说明义务。这样可以使医生承担高度注意的义务,从而实现患者的最大利益。在大陆法系国家,有的学者认为,医生的说明义务是基于医院和患者之间的契约;也有的学者认为,医生的说明义务是一种法定义务。第二节讨论了医生说明义务的标准问题。说明义务的标准一般来说有两种:职业标准和病人标准。病人标准中又分为主观的具体病人标准和客观的合理病人标准。该节列举了较多的案例对上述几种标准的优劣进行评析。笔者的看法是,合理病人标准比较好的平衡了患者和医生的利益,也有比较好的实际操作性,并能有效地防止医生独断专行。第三节是医生说明义务的范围。在介绍了医生说明的一般范围后,本节着重介绍了说明范围的新发展,比如医生对个人信息的说明,对经济利益的说明等。第四节主要论述的是医生说明义务的例外。该节介绍了紧急情况例外,为社会公共利益的例外,患者本人放弃,已知风险的说明例外,不可预测风险例外等。第三部分是关于患者的同意。第一节指出患者同意的有效要件。患者的承诺是医疗行为合法化的最重要条件,要使患者的承诺有效,除了获得足够的医生告知的信息外,还要满足几个条件:同意是患者自愿做出的;患者有同意的能力;患者理解被告知信息的内容;第二节主要介绍患者的同意能力问题。患者同意的能力因患者年龄、精神状态的不同而有所区别。第三节介绍患者同意的方式。同意不以书面形式为必要,但对于某些重大的医疗行为,医患双方应合意以书面形式作为同意的有效形式。第四部分是对我国相关立法、实践的分析与建议。第一节介绍了我国相关的立法、实践现状。第二节指出我国目前关于知情同意的立法缺陷。针对我国知情同意理论的立法缺陷,笔者在第三部提出了分析和建议。如应逐渐把转医,医生职业经验和资格,经济利益等列入医生应说明的范围内等。更多还原

【Abstract】 Medical malpractice has become a serious social problem in recent years. Although scholars have done some research in this field, many questions are still not been settled in our country. The physician’s duty of disclosure is one of them. As we know, every human being of adult years and sound mind has a right to determine what shall be done with his own body. So a physician must provide enough information in order to achieve a truly informed consent. But few people paid attention to this question before.This article is divided into four parts. Part One introduces the informed consent doctrine generally, including its concept and functions. The general rule for informed consent is that a physician must, except in certain situations, obtain the consent of a patient before treatment. However, mere consent to treatment does not suffice: the patient must receive a clear and honest explanation of the proposed treatment so that he or she can give an informed consent. The consent norm had occupied a prominent an honored place in legal thought. The most important function for informed consent doctrine is that it will promote the realization of individual autonomy. Section of this part introduces the evolution of informed consent in America, Germany , Canada Japan and Taiwan .The informed consent doctrine mainly comes from America, so the author plays much emphasis on the evolution in America.Part Two discusses a physician’s duty to disclose. There are four sections in this part. Section one is the legal foundation for physician’s duty to disclose. Physician and patient can sign a contract to regulate their legal relationship. However, the two parties have different statuses. In the author’s opinion, it’s better to adjust physician’s disclosure duty according to fiduciary duty, for this will help to achieve patients’best interests. Section two discusses the standard of physician’s duty to disclose. There are two standards in this doctrine: professional standard and patient standard. The patient standard includes objective standard and subjective standard. In the author’s opinion, the objective patient standard is easy to practice. At the same time it can balances the interests between physicians and doctors well. Section three reviews the scope of physician’s duty to disclose. After the general introduction, this section lays emphasis on the new development of physician’s disclosure scope, such as the personal information and economic interests. The scope of disclosure required by the informed consent doctrine under both case law and statutes will be reviewed. Section four argues the exceptions of physician’s duty to disclose. The exceptions include emergency exception, therapeutic privilege exception, unknown risk exception, and so on.Part Three concentrates on the patient’s promise. Section one argues the required elements of patient’s promise. In order to make a patient’s promise effective, the patient must have ability to promise and promise willingly. In addition, achieving enough pertinent information provided by the physician is necessary. Section three introduces the form of patient’s promise. The written promise is not necessary in all situation. However, patient and physician had better sign a written contract before an important treatment is put into practice.Part Four analyzes the pertinent legislation and practice. Section one introduces the pertinent legislation and practical situation. Section analyzes the defect of legislation in our country and section three gives some advice on it. As to the scope of physician’s duty to disclose, the author analyzes the concerning clauses in the Statute. At the same time, in the author’s opinion, the physician’s duty to disclose shall also include alternative treatment, physician’s qualifications and economical interests.更多还原