【摘要】：近年來,隨著生物技術的發(fā)展,人類的基因密碼已隨著人類基因組圖的繪制成功而被破解,人類進入了一個疾病預測、預防、診斷的新時代。世界各國紛紛試圖通過建立人體基因數(shù)據(jù)庫來搜集本國國民的基因信息,來提高本國的醫(yī)療水平。但是人體基因數(shù)據(jù)庫在我國仍屬于新出現(xiàn)的事物,目前學者的理論研究不多、現(xiàn)實案例較少、實踐經(jīng)驗不足。人體基因數(shù)據(jù)庫建置涉及基本權利問題、人格權問題、財產(chǎn)權保護問題,值得探討。本文的研究視角是采用的合同的角度來保護各方主體的利益,具體完善與規(guī)范基因數(shù)據(jù)庫在建置的不同階段中所遇到的問題。采用的合同的角度來保護各方主體的利益符合自愿性的要求,并且具有合法性,促進性,全面性,更具效率。人體基因數(shù)據(jù)庫是指在醫(yī)學研究領域、以及臨床研究領域,以尋找致病基因或其他致病因子為目的,基于大規(guī)模人口群或特定群體之基因數(shù)據(jù)庫。而基因?qū)儆谌烁裎铩．斎梭w的器官或組織脫離人體之后,基因就獨立于人身而存在,具有獨立物之屬性。但由于基因上又帶有人的遺傳因子,因此本人對基因具有人格利益。人體基因數(shù)據(jù)庫建置過程中涉及到的利益關系中,受試者個人利益與生物醫(yī)藥產(chǎn)業(yè)之問的利益關系,醫(yī)學研究人員與生物醫(yī)藥產(chǎn)業(yè)之間的利益關系可以受到合同法的調(diào)整,主要體現(xiàn)為《知情同意書》以及《材料轉(zhuǎn)移協(xié)議》。受試者個人權利與公共利益之間的利益關系,也可以原則性的由知情同意書來做出規(guī)定。在以合同方式保護的基因數(shù)據(jù)庫建置實踐主要有美國阿帕奇族案例、美國國家癌癥研究院的合同安排,以及我國深圳國家基因庫的合同安排。人體基因數(shù)據(jù)庫建置合同關涉到四方合同主體。一是國家、政府,二是采集者,三是研發(fā)單位,四是資源提供者及利害關系人。文章分四個方面探討了人體基因數(shù)據(jù)庫建置的具體合同內(nèi)容。首先是合同中的“告知后同意”原則的運用,其次是對樣本再次利用的各方權利義務,再次是合同中的基因隱私權保護條款,最后是合同中相關法律主體對醫(yī)研成果利益分享的協(xié)商探討。文章還研究了人體基因數(shù)據(jù)庫建置中合同責任之承擔問題。違約責任承擔的情形主要包括損害樣本提供者的知情同意權,損害了樣本提供者的隱私權,以及可能造成樣本提供者不能公平的參與醫(yī)學研究成果的利益分配這一財產(chǎn)性損害后果。承擔責任的方式主要體現(xiàn)為損害賠償、強制實際履行。當事人在緊急情況下,公共利益需要的情況下、以及具有免責條款時,可以免責。此外,文章還討論了侵權責任與違約責任的民事責任的競合的情況。相比侵權責任方式主張救濟,違約責任在責任構成方面,從總體上看,并不要求違約人具有過錯。樣本提供者主張違約責任是更為容易及方便的選擇,只要證明違約方的行為違反了合同的約定即可主張相應的救濟。
[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.
【學位授予單位】：福建師范大學
【學位級別】：碩士
【學位授予年份】：2016
【分類號】：D923.6

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