医疗责任中的告知同意理论
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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。医生为得到患者的有效承诺而应履行的告知义务在2002年以前一直未成为法定义务。2002年9月1日开始施行的《医疗事故处理条例》对医生的告知义务和患者的知情权作了明确规定,这对保护患者的权利有着重大的意义。但我们也应注意到,该《条例》对医生的告知义务这部分仍规定过粗,很多相关的问题都没有涉及到。但对医生来说,告知义务是他们应履行的一个重要义务;对患者来说,作出同意治疗的承诺是否有效也是与他们自身权益密切相关的问题。可见,医生的告知义务和患者的承诺是一个有研究价值而现阶段又研究不够的领域,这是笔者选此为论文题目的原因。
    本文将结合新颁布的《医疗事故处理条例》,通过介绍国际医疗责任领域比较成熟的告知同意理论(informed consent),对医生的告知、患者的承诺中涉及的法律问题作一较全面的分析和探讨。
    本文共分四个部分。第一部分是告知同意理论概述。本部分介绍了告知同意理论的概念和功能,并对告知同意理论的发展和沿革作了回顾。"告知同意"字面意思是指在被告知相关情况的前提下作出的同意的表示。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,就其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、德国和日本的发展情况。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。告知同意理论在美国的发展经历了两个阶段:第一个阶段是二十世纪70年代以前,这个时期该理论集中探讨的是以“身体侵害” 还是以“过失”为诉因来解决没有告知的医疗纠纷;第二个阶段是70年代以后,这个时期争议的焦点在于应该采用何种标准来确定医生的告知义务。
    第二部分探讨医生的告知义务,这是本文的重点。该部分分为六节。第一节是医生负有告知义务的法律依据。医生对患者负有告知义务的依据可以是双方签订的契约。但笔者认为,由于契约双方地位的不平等,对患者的保护必然不利。
    
    把医生的告知义务归入诚信义务(fiduciary duty)的调整范围,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。第二节讨论了告知义务的主体。主要结论是,如果治疗过程中出现了多个医生,并不是所有的医生都有告知的义务。提出建议等不直接对患者的身体进行处置的医生没有告知义务。第三节讨论了确定医生告知义务的标准。告知义务的标准一般来说有两种:专业标准和病人标准。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。第四节是医生告知义务的范围。在介绍了医生告知的一般范围后,本节着重介绍了告知范围的新发展,比如医生对个人信息的告知、对经济利益的告知等。第五节是医生告知义务的例外。该节介绍了紧急情况例外、治疗特权例外、已知风险例外、不可预测风险例外等。第六节是违反告知义务的法律构成。违反告知义务的法律构成包括:医生有过失;患者受到了损害;医生的过失和患者受到的损害之间有因果关系。
    第三部分是患者的承诺。第一节指出患者承诺的意义。患者的承诺是医疗行为合法化的最重要条件。第二节讨论患者承诺的要件。要使患者的承诺有效,除了获得足够的医生告知的信息外,还要满足两个条件:承诺是患者自愿做出的及患者有同意的能力。患者同意的能力因患者年龄、精神状态的不同而有所区别。第三节介绍患者承诺的方式。承诺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承诺的有效形式。
    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。第二节是对《医疗事故处理条例》的分析与建议。笔者在三方面提出了分析和建议。第一是关于告知义务的范围。笔者分析了《条例》中的相关条款,并提出应逐渐把转医、医生职业经验和资格、经济利益等列入医生应告知的范围内。第二是关于告知义务的例外。笔者结合我国实际,着重分析了紧急情况例外和治疗特权例外。第三是关于患者的民事救济。笔者认为,患者只以医生未履行告知义务为由请求损害赔偿,法院应予以支持。至于赔偿的范围,应根据患者受到的伤害确定医疗事故等级,然后按《条例》第50条规定的标准进行计算。这种赔偿应包括
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. The Statute on Medical Malpractice implemented on 1 September 2002 provides that physicians have duty to disclose pertinent information. However, the limitation of the Statute is obvious. Many legal issues are not mentioned in the Statute. Therefore, the purpose of this article is to introduce the world popular "informed consent doctrine". After the introduction, I will give some advice to our statute and practice.
    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. SectionⅡof this part introduces the evolution of informed consent in America, Germany and Japan. 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 six sections in this part. SectionⅠis 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. SectionⅡ argues the main body for the disclosure duty. The conclusion is that if there is more than one physician during treatment, not all the physicians have duty to disclose. SectionⅢ 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. SectionⅣ 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. SectionⅤ argues the exceptions of physician's duty to disclose. The exceptions include emergency exception, therapeutic privilege exception, unknown risk exception, and so on. SectionⅥ discusses legal elements of breaching physician's disclosure duty. The legal elements include negligence, damages and causation.
    Part Three concentrates on the patient's promise. SectionⅠargues the significance of patient's promise. SectionⅡdiscusses 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. SectionⅢ 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
引文
1、 龚赛红:《医疗损害赔偿立法研究》,法律出版社2001年9月版
    2、 邱仁宗、卓小勤、冯建妹:《患者的权利》,北京医科大学、中国协和医科大学 联合出版社1996年8月版。
    3、 段匡、何湘渝:《医生的告知义务和患者的承诺》,载梁慧星主编:《民商法论丛》第12 卷,法律出版社1999年6月版
    4、 王敬毅:《医疗过失责任研究》,载梁慧星主编:《民商法论丛》第9卷,法律出版社1998年版
    5、 程啸:《论医疗损害民事纠纷中医疗者的义务》,载梁慧星主编:《民商法论丛》第21卷,法律出版社2001年12月版
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    13、Dieter Giesen: International Medical Malpractice Law, 1988.
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    17、Halle Fine Terrion:Informed Choice: Physicians' Duty To Disclose Nonreadily Available Alternatives,Case Western Reserve Law Review ,Winter, 1993
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    21、Jeffrey W. Guise:Expansion Of The Scope Of Disclosure Required Under The Informed Consent Doctrine: Moore V. The Regents Of The University Of California,San Diego Law Review April/May, 1991
    22、Laurel R. Hanson:Informed Consent And The Scope Of A Physician's Duty Of Disclosure,North Dakota Law Review,2001
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    1 王凯戎:《目前医疗纠纷的现状及特点》,载于http://www.cca.org.cn/。
    2 郭小景:《本市医疗事故鉴定全状》,载《北京青年报》,1999年1月28日。
    3 Black's Law Dictionary, 1989, West Publishing Co., p701.
    4 95 Minn. 261, 104 N.W. 12 (1905).
    5 79 N.E. 562 (Ill. 1906).
    6 211 N.Y. 125, 105 N.E. 92 (1914).
    7 Katz, Informed Consent--A Fairy Tale? Law's Vision, 39 U.Pitt.L.Rev. 137 (1977).
    8 154 Cal. App. 2d 560, 317 P.2d 170 (1957).
    9 Cobbs v. Grant, 8 Cal. 3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (1972).
    10 464 F.2d 772 (D.C. Cir.), 409 U.S. 1064 (1972).
    11 邱仁宗、卓小勤、冯建妹:《患者的权利》,北京医科大学、中国协和医科大学联合出版社1996年8月版,第56页。
    12 Dieter Giesen: International Medical Malpractice Law, 1988, p260.
    13 判例时报660号,日本判例时报社,第62页。转引自段匡、何湘渝:《医生的告知义务和患者的承诺》,载梁慧星主编:《民商法论丛》第12卷,第159页。
    14 Black's Law Dictionary,1990, West Publishing Co., p625.
    15 396 F.2d 931 (D.C. Cir. 1967).
    16 390 Mass. 540, 458 N.E. 2d 710 (1983).
    17 See, e.g., Guebard v. Jabaay, 452 N.E.2d 751, 757 (Ill. App. Ct. 1983) (采用了国家标准而不是本地规则); Bruni v. Tatsumi, 346 N.E.2d 673, 679 (Ohio 1976) (根据一致性的要求,本地规则不再被适用); Scaria v. St. Paul Fire & Marine Ins. Co., 227 N.W.2d 647, 656 (Wis. 1975) (抛弃了本地规则).
    18 464 F.2d 772 (D.C. Cir. 1972), 409 U.S. 1064 (1974).
    19 Mehlman, Fiduciary Contracting: Limitations on Bargaining Between Patients and Health Care Providers, 51 U.Pitt.L.Rev. 365 (1990).
    20 Alan J. Weisbard, Informed Consent: The Law's Uneasy Compromise with Ethical Theory, 65 Neb. L. Rev. 749, 751 (1986).
    21 606 P.2d 554 (Okla. 1979).
    22 287 S.E.2d 892 (N.C. 1982).
    23 稻田龙树:《说明义务(1)》,第195页,转引自王敬毅:《医疗过失责任研究》,载于《民商法论丛》第9卷,梁慧星主编,法律出版社1998年版。
    24 Whiteside v. Lukson, 947 P.2d 1263, 1265 (Wash. Ct. App. 1997).
    25 199 Wis. 2d 615, 545 N.W.2d 495 (1996).
    26 793 P.2d 479 (Cal. 1990).
    27 45 C.F.R. § 46.116(a)(1)-(8) (1988).
    28 570 N.W.2d 168 (Minn. Ct. App. 1997).
    29 Minn. Stat.§147.091, subd.1 (p)(1) (1996).
    30 Medicaid/Medicare Anti-Kickback statute, 42 U.S.C. § 1320a- 7b(b) (1996).
    31 234 Cal. Rptr. 579 (Ct. App. 1987).
    32 Alan Meisel:The "Exceptions" to the Informed Consent Doctrine: Striking a Balance Between Competing Values in Medical Decisionmaking, 1979 ,Wis.L.Rev. 436-16 (1979).
    33 473 P.2d 116 (Haw. 1970).
    34 Okla. Unif. Civil Jury Instructions, Instruction 14.15 (2d.1993).
    35 856 P.2d 998 (Okla. Ct. App. 1990).
    36 641 P. 2d 93.
    37 971 F.2d 1487, 1499 (10th Cir. 1992).
    38 (台)邱聪智:《医疗过失与侵权行为》,载郑玉波:《民法债编论文选辑》,第593页。
    39 625 A 2d 778 (R.I. 1993).
    40段匡、何湘渝:《医生的告知义务和患者的承诺》,载梁慧星主编:《民商法论丛》第12卷,第185页。
    41邱仁宗、卓小勤、冯建妹:《患者的权利》,北京医科大学、中国协和医科大学联合出版社1996年8月版,62页。
    42郭小景:《本市医疗事故鉴定全状》,载《北京青年报》,1999年1月28日。
    43王小星:《凭什么切了我的卵巢》,载《晨报》,2000年6月11日。
    44详细情况参见《徐世朴诉中科院高能所、北京肿瘤所损害赔偿一案的案情介绍》,转引自程啸:《论医疗损害民事纠纷中医疗者的义务》,载梁慧星主编:《民商法论丛》第21卷,法律出版社2001年12月版。

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