论非法人体试验的刑法规制

发布时间：2018-02-10 10:18

本文关键词： 人体试验非法人体试验罪 “告知后同意”法则　出处：《山东大学》2014年硕士论文　论文类型：学位论文

【摘要】：人体试验是现代医学研究的基本手段和必经环节,《赫尔辛基宣言》第四条明确指出“医学进步取决于对人体对象进行实验的研究”。人体试验的意义可概括为三点：探索疾病的病因和发病机理,改善疾病诊断的方法；维护和促进人类的健康利益；提高患者个体的生存质量。然而,人体试验是把“双刃剑”,因其试验中所用的药物本身存在着可预见的或者不可预见的风险,如用之不当则会导致医学与受试验者双受其害。二战时期的非法人体试验带来的惨痛教训还让人心有余悸。当前我国也存在着大量的非法人体试验,如不对其进行刑法规制,必将侵害许多民众的生命健康法益,并会对伦理观念、医学管理秩序、社会的公序良俗等造成严重侵害。因此,将非法人体试验行为入罪,凸显了刑法规制的必要性和紧迫性。本文第一部分对人体试验的基本内容进行阐释,对于人体试验的外延作出明确界定,就其与常规医疗行为的区别进行说明。对人体试验的正当化根据进行探讨,包括被害人承诺、受试验者的自主决定权、容许的风险等学说。虽每种学说都有其合理之处,但鉴于人体试验的特殊性,均无法足以阻却人体试验的违法性。第二部分切入本文的研究对象“非法人体试验”,就“非法”的涵义进行了限缩,本文的“非法人体试验”仅指触犯了刑法规定的人体试验。从伦理标准、医学标准和法律标准三个层面就非法人体试验作了进一步的说明。第三部分重点在于说明我国当前刑法缺乏对非法人体试验的规定。并且,由于“告知后同意”法则并未真正在实践中得以运用,也使得受试验者的权益保障欠佳。而之所以出现这种困境,主要有立法缺少前瞻性、过度提倡非犯罪化、缺乏医学互动等三方面原因。第四部分对非法人体试验的域外刑事立法进行梳理,从中可以看出许多国际规约和主要国家已就非法人体试验在刑法中加以规定,对我国就这一领域的刑事立法具有借鉴价值。第五部分是本文的核心部分。我国刑法在应对非法人体试验方面应当有所作为,将非法人体试验纳入刑法的保护范畴,在入罪的过程中也要秉持刑法谦抑和提前预防的理念,不能盲目扩大刑法的打击面,以免出现“防御性医疗”。同时,也应当构建起“告知后同意”法则,对研究者的告知义务和受试验者的同意分别加以说明,从而更有力地保障受试验者的合法权益。非法人体试验的刑法规制,不仅涉及到刑法的一些基本理论,也牵涉到医学方面的理论知识。为更好地发挥刑法保护法益的机能,切实保障受试验者的合法权益,希望本文能够通过对非法人体试验的刑法规制实现医学领域和刑法的对话,能对人体试验的实践有所裨益。
[Abstract]:Human body experiment is the basic means and necessary link of modern medical research. Article 4th of the Helsinki Declaration clearly points out that "medical progress depends on the experimental study of human body objects". The significance of human body experiment can be summarized as three points. To explore the etiology and pathogenesis of the disease, To improve the methods of disease diagnosis; to maintain and promote the health interests of human beings; to improve the quality of life of individual patients. However, human trials are a "double-edged sword" because the drugs used in their trials involve foreseeable or unpredictable risks. If it is used improperly, it will result in both the medicine and the subjects being harmed by it. The painful lessons brought about by the illegal human body experiments during World War II are still daunting. At present, there are also a large number of illegal human trials in our country, such as not regulating them under criminal law. It will infringe upon the life and health interests of many people, and will cause serious infringement on ethics, medical management order, public order and good customs. Therefore, criminalizing illegal human trial behavior highlights the necessity and urgency of criminal law regulation. In the first part of this paper, the basic contents of human trials are explained, the extension of human trials is clearly defined, the differences between human trials and routine medical behaviors are explained, and the justification of human trials is discussed. Although each theory has its rationality, but in view of the particularity of human body experiment, it is not enough to prevent the illegality of human body test. The second part cuts into the research object of this article, "illegal human body experiment", and limits the meaning of "illegal human body test". The "illegal human body test" in this paper only refers to the human body test that has violated the criminal law. Three levels of medical standards and legal standards on illegal human experiments are further explained. The third part focuses on the lack of provisions on illegal human body testing in China's current criminal law. Moreover, the law of "consent after notification" has not really been applied in practice. These difficulties are mainly due to the lack of foresight in legislation, the excessive promotion of decriminalization and the lack of medical interaction. Part 4th combs the extraterritorial criminal legislation of illegal human body test, from which we can see that many international statutes and major countries have stipulated illegal human body test in criminal law. It has reference value to our country's criminal legislation in this field. Part 5th is the core part of this paper. China's criminal law should do something to deal with the illegal human body test, bring it into the protection category of the criminal law, and also uphold the concept of modesty of criminal law and prevention in advance in the process of incrimination. We should not blindly expand the scope of criminal law to avoid "defensive medical treatment". At the same time, we should construct the rule of "informed consent" and explain the researcher's duty of informing and the subject's consent separately. Thus, the legal rights and interests of the subjects can be protected more effectively. The criminal law regulation of illegal human body experiment involves not only some basic theories of criminal law, but also the theoretical knowledge of medicine. It is hoped that this paper can realize the dialogue between the field of medicine and criminal law through the regulation of criminal law on illegal human body experiment, and it will be beneficial to the practice of human body experiment.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D924.3

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