從合同角度論人體基因數(shù)據(jù)庫(kù)之建置
發(fā)布時(shí)間：2018-08-28 06:13
【摘要】：近年來(lái),隨著生物技術(shù)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(jìn)入了一個(gè)疾病預(yù)測(cè)、預(yù)防、診斷的新時(shí)代。世界各國(guó)紛紛試圖通過(guò)建立人體基因數(shù)據(jù)庫(kù)來(lái)搜集本國(guó)國(guó)民的基因信息,來(lái)提高本國(guó)的醫(yī)療水平。但是人體基因數(shù)據(jù)庫(kù)在我國(guó)仍屬于新出現(xiàn)的事物,目前學(xué)者的理論研究不多、現(xiàn)實(shí)案例較少、實(shí)踐經(jīng)驗(yàn)不足。人體基因數(shù)據(jù)庫(kù)建置涉及基本權(quán)利問(wèn)題、人格權(quán)問(wèn)題、財(cái)產(chǎn)權(quán)保護(hù)問(wèn)題,值得探討。本文的研究視角是采用的合同的角度來(lái)保護(hù)各方主體的利益,具體完善與規(guī)范基因數(shù)據(jù)庫(kù)在建置的不同階段中所遇到的問(wèn)題。采用的合同的角度來(lái)保護(hù)各方主體的利益符合自愿性的要求,并且具有合法性,促進(jìn)性,全面性,更具效率。人體基因數(shù)據(jù)庫(kù)是指在醫(yī)學(xué)研究領(lǐng)域、以及臨床研究領(lǐng)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(kù)。而基因?qū)儆谌烁裎�。�?dāng)人體的器官或組織脫離人體之后,基因就獨(dú)立于人身而存在,具有獨(dú)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(duì)基因具有人格利益。人體基因數(shù)據(jù)庫(kù)建置過(guò)程中涉及到的利益關(guān)系中,受試者個(gè)人利益與生物醫(yī)藥產(chǎn)業(yè)之問(wèn)的利益關(guān)系,醫(yī)學(xué)研究人員與生物醫(yī)藥產(chǎn)業(yè)之間的利益關(guān)系可以受到合同法的調(diào)整,主要體現(xiàn)為《知情同意書(shū)》以及《材料轉(zhuǎn)移協(xié)議》。受試者個(gè)人權(quán)利與公共利益之間的利益關(guān)系,也可以原則性的由知情同意書(shū)來(lái)做出規(guī)定。在以合同方式保護(hù)的基因數(shù)據(jù)庫(kù)建置實(shí)踐主要有美國(guó)阿帕奇族案例、美國(guó)國(guó)家癌癥研究院的合同安排,以及我國(guó)深圳國(guó)家基因庫(kù)的合同安排。人體基因數(shù)據(jù)庫(kù)建置合同關(guān)涉到四方合同主體。一是國(guó)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(guān)系人。文章分四個(gè)方面探討了人體基因數(shù)據(jù)庫(kù)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(yùn)用,其次是對(duì)樣本再次利用的各方權(quán)利義務(wù),再次是合同中的基因隱私權(quán)保護(hù)條款,最后是合同中相關(guān)法律主體對(duì)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(kù)建置中合同責(zé)任之承擔(dān)問(wèn)題。違約責(zé)任承擔(dān)的情形主要包括損害樣本提供者的知情同意權(quán),損害了樣本提供者的隱私權(quán),以及可能造成樣本提供者不能公平的參與醫(yī)學(xué)研究成果的利益分配這一財(cái)產(chǎn)性損害后果。承擔(dān)責(zé)任的方式主要體現(xiàn)為損害賠償、強(qiáng)制實(shí)際履行。當(dāng)事人在緊急情況下,公共利益需要的情況下、以及具有免責(zé)條款時(shí),可以免責(zé)。此外,文章還討論了侵權(quán)責(zé)任與違約責(zé)任的民事責(zé)任的競(jìng)合的情況。相比侵權(quán)責(zé)任方式主張救濟(jì),違約責(zé)任在責(zé)任構(gòu)成方面,從總體上看,并不要求違約人具有過(guò)錯(cuò)。樣本提供者主張違約責(zé)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(yīng)的救濟(jì)。
[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(xué)位授予單位】：福建師范大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：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.
【學(xué)位授予單位】：福建師范大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：D923.6
【相似文獻(xiàn)】
相關(guān)期刊論文 前2條
1 茅萬(wàn)良;執(zhí)意在國(guó)內(nèi)讀博士[J];江海僑聲;1997年01期
2 ;[J];;年期
相關(guān)會(huì)議論文 前1條
1 周遠(yuǎn);陳亮;陶怡;劉宏德;孫嘯;;利用生物信息技術(shù)構(gòu)建精神與行為相關(guān)基因數(shù)據(jù)庫(kù)[A];遺傳學(xué)進(jìn)步與人口健康高峰論壇論文集[C];2007年
相關(guān)重要報(bào)紙文章 前8條
1 邢遠(yuǎn)翔邋劉平 吳衛(wèi)紅;我國(guó)將建立重大疾病基因數(shù)據(jù)庫(kù)[N];健康報(bào);2007年
2 本報(bào)記者 鄭煥斌;免費(fèi)公開(kāi)基因數(shù)據(jù)庫(kù)遭遇挑戰(zhàn)[N];科技日?qǐng)?bào);2013年
3 吳佳s，
本文編號(hào)：2208499
本文鏈接：http://sikaile.net/kejilunwen/jiyingongcheng/2208499.html
最近更新
教材專著
