从合同角度论人体基因数据库之建置
发布时间：2018-08-28 06:13
【摘要】：近年来,随着生物技术的发展,人类的基因密码已随着人类基因组图的绘制成功而被破解,人类进入了一个疾病预测、预防、诊断的新时代。世界各国纷纷试图通过建立人体基因数据库来搜集本国国民的基因信息,来提高本国的医疗水平。但是人体基因数据库在我国仍属于新出现的事物,目前学者的理论研究不多、现实案例较少、实践经验不足。人体基因数据库建置涉及基本权利问题、人格权问题、财产权保护问题,值得探讨。本文的研究视角是采用的合同的角度来保护各方主体的利益,具体完善与规范基因数据库在建置的不同阶段中所遇到的问题。采用的合同的角度来保护各方主体的利益符合自愿性的要求,并且具有合法性,促进性,全面性,更具效率。人体基因数据库是指在医学研究领域、以及临床研究领域,以寻找致病基因或其他致病因子为目的,基于大规模人口群或特定群体之基因数据库。而基因属于人格物。当人体的器官或组织脱离人体之后,基因就独立于人身而存在,具有独立物之属性。但由于基因上又带有人的遗传因子,因此本人对基因具有人格利益。人体基因数据库建置过程中涉及到的利益关系中,受试者个人利益与生物医药产业之问的利益关系,医学研究人员与生物医药产业之间的利益关系可以受到合同法的调整,主要体现为《知情同意书》以及《材料转移协议》。受试者个人权利与公共利益之间的利益关系,也可以原则性的由知情同意书来做出规定。在以合同方式保护的基因数据库建置实践主要有美国阿帕奇族案例、美国国家癌症研究院的合同安排,以及我国深圳国家基因库的合同安排。人体基因数据库建置合同关涉到四方合同主体。一是国家、政府,二是采集者,三是研发单位,四是资源提供者及利害关系人。文章分四个方面探讨了人体基因数据库建置的具体合同内容。首先是合同中的“告知后同意”原则的运用,其次是对样本再次利用的各方权利义务,再次是合同中的基因隐私权保护条款,最后是合同中相关法律主体对医研成果利益分享的协商探讨。文章还研究了人体基因数据库建置中合同责任之承担问题。违约责任承担的情形主要包括损害样本提供者的知情同意权,损害了样本提供者的隐私权,以及可能造成样本提供者不能公平的参与医学研究成果的利益分配这一财产性损害后果。承担责任的方式主要体现为损害赔偿、强制实际履行。当事人在紧急情况下,公共利益需要的情况下、以及具有免责条款时,可以免责。此外,文章还讨论了侵权责任与违约责任的民事责任的竞合的情况。相比侵权责任方式主张救济,违约责任在责任构成方面,从总体上看,并不要求违约人具有过错。样本提供者主张违约责任是更为容易及方便的选择,只要证明违约方的行为违反了合同的约定即可主张相应的救济。
[Abstract]:In recent years, with the development of biotechnology, human gene code has been successfully deciphered with the drawing of human genome map. Human beings have entered a new era of disease prediction, prevention and diagnosis. Countries all over the world try to improve their medical treatment by setting up human gene database to collect genetic information of their own people. However, human gene database is still a new thing in our country. At present, there are few theoretical studies, few practical cases and insufficient practical experience. The establishment of human genetic database involves basic rights, personality rights and property rights. The research angle of this paper is to protect the interests of all parties from the perspective of contract, and to perfect and standardize the problems encountered in the different stages of construction of gene database. The contract adopted to protect the interests of the parties conforms to the voluntary requirements, and has legitimacy, promotion, comprehensiveness and efficiency. Human gene database is a gene database based on large population or specific population in the field of medical research and clinical research in order to find pathogenic genes or other pathogenic factors. Genes belong to personality. When the organ or tissue of the human body is detached from the human body, the gene is independent of the human body and has the property of an independent object. However, because of the genetic factor, I have personality interests to the gene. In the interest relationship involved in the establishment of human gene database, the relationship between the personal interests of the subjects and the interests of the biomedical industry, the interest relationship between medical researchers and the biomedical industry can be adjusted by the contract law. Mainly reflected in the informed consent form and the material transfer Agreement. The relationship between individual rights and public interest can also be regulated in principle by informed consent. In the construction of the gene database protected by contract, there are mainly the case of Apache, the contract arrangement of the National Cancer Research Institute and the contract arrangement of the national gene bank in Shenzhen, China. The construction contract of human gene database is related to the main body of the four-party contract. One is the country, the government, the collector, the third is the R & D unit, the fourth is the resource provider and the stakeholder. This paper discusses the specific contract content of the establishment of human gene database in four aspects. The first is the application of the "informed consent" principle in the contract, the second is the rights and obligations of the parties reusing the sample, and the third is the gene privacy protection clause in the contract. The last part is the negotiation and discussion on the benefit sharing between the relevant legal subjects in the contract. This paper also studies the assumption of contract liability in the establishment of human gene database. The cases of liability for breach of contract mainly include damage to the right of informed consent of the sample provider, and damage to the privacy of the sample provider. And it may result in the unfair participation of sample providers in the distribution of benefits of medical research, as a result of property damage. The main way to assume responsibility is to compensate for damages and enforce the actual performance. The parties are exempt from liability in case of emergency, public interest need, and exemption clause. In addition, the article also discusses the concurrence of tort liability and civil liability for breach of contract. Compared with tort liability, liability for breach of contract does not require the fault of the defaulter on the whole. The sample provider claims that the liability for breach of contract is a more convenient and convenient choice, so long as it proves that the defaulting party's behavior has violated the contract agreement, it can claim the corresponding remedy.
【学位授予单位】：福建师范大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：D923.6
[Abstract]:In recent years, with the development of biotechnology, human gene code has been successfully deciphered with the drawing of human genome map. Human beings have entered a new era of disease prediction, prevention and diagnosis. Countries all over the world try to improve their medical treatment by setting up human gene database to collect genetic information of their own people. However, human gene database is still a new thing in our country. At present, there are few theoretical studies, few practical cases and insufficient practical experience. The establishment of human genetic database involves basic rights, personality rights and property rights. The research angle of this paper is to protect the interests of all parties from the perspective of contract, and to perfect and standardize the problems encountered in the different stages of construction of gene database. The contract adopted to protect the interests of the parties conforms to the voluntary requirements, and has legitimacy, promotion, comprehensiveness and efficiency. Human gene database is a gene database based on large population or specific population in the field of medical research and clinical research in order to find pathogenic genes or other pathogenic factors. Genes belong to personality. When the organ or tissue of the human body is detached from the human body, the gene is independent of the human body and has the property of an independent object. However, because of the genetic factor, I have personality interests to the gene. In the interest relationship involved in the establishment of human gene database, the relationship between the personal interests of the subjects and the interests of the biomedical industry, the interest relationship between medical researchers and the biomedical industry can be adjusted by the contract law. Mainly reflected in the informed consent form and the material transfer Agreement. The relationship between individual rights and public interest can also be regulated in principle by informed consent. In the construction of the gene database protected by contract, there are mainly the case of Apache, the contract arrangement of the National Cancer Research Institute and the contract arrangement of the national gene bank in Shenzhen, China. The construction contract of human gene database is related to the main body of the four-party contract. One is the country, the government, the collector, the third is the R & D unit, the fourth is the resource provider and the stakeholder. This paper discusses the specific contract content of the establishment of human gene database in four aspects. The first is the application of the "informed consent" principle in the contract, the second is the rights and obligations of the parties reusing the sample, and the third is the gene privacy protection clause in the contract. The last part is the negotiation and discussion on the benefit sharing between the relevant legal subjects in the contract. This paper also studies the assumption of contract liability in the establishment of human gene database. The cases of liability for breach of contract mainly include damage to the right of informed consent of the sample provider, and damage to the privacy of the sample provider. And it may result in the unfair participation of sample providers in the distribution of benefits of medical research, as a result of property damage. The main way to assume responsibility is to compensate for damages and enforce the actual performance. The parties are exempt from liability in case of emergency, public interest need, and exemption clause. In addition, the article also discusses the concurrence of tort liability and civil liability for breach of contract. Compared with tort liability, liability for breach of contract does not require the fault of the defaulter on the whole. The sample provider claims that the liability for breach of contract is a more convenient and convenient choice, so long as it proves that the defaulting party's behavior has violated the contract agreement, it can claim the corresponding remedy.
【学位授予单位】：福建师范大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：D923.6
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