生物样本库共享理论与实证研究
发布时间：2018-08-17 11:09
【摘要】：[背景]中国的生物样本库在上世纪90年代开始小规模建设,至今已逐渐发展,多是依托医院、学校、卫生机构建成。因没有全国性质的生物样本库规范指南做指导,各地生物样本库的生物样本管理标准不同,质量参差不齐,样本使用率低下。整合国内现有的生物样本库资源,形成集成、共享的网络化生物样本库是当前最现实的选择。生物样本库建设中,医疗机构因其特殊的职能而具备生物样本搜集的最大便利,科研机构因其自身的科研能力而具备最佳的生物样本利用能力,然而双方缺乏合作信任及生物样本使用后利益分配的问题,使得长期以来无法真正实现生物样本资源的共享,一些生物样本质量好,临床资料全面的精品库因为不能被充分应用于科学研究而成为死库,我国不少地区尝试了多种模式来解决资源共享的问题,但目前为止尚未建立一套完整的实现生物样本库资源共享的策略和机制,来均衡各方利益已实现生物样本的共享。[目的]基于文献研究、定性调查、定量研究,围绕生物样本库共享理念、共享模式、共享的支撑条件三方面内容展开理论及实证研究,提出上海市生物样本库共享模型,为上海市生物样本库共享的发展和完善提供科学依据。[资料与方法]根据研究内容,研究方法包括文献研究、定性研究和定量研究。其中理论研究部分主要基于文献研究,实证研究部分则联合应用了定性研究方法和定量研究方法。对上海市20家三甲综合和专科医院进行问卷调查,调查内容包括生物样本库管理人员调查问卷,临床医生调查问卷以及对关键知情者的访谈,最终获得58份医院调查问卷,另针对性的选取9家与生物样本库密切相关的单位进行了12位知情人访谈,本研究主要应用描述性统计,包括单变量、双变量、多变量统计分析,对生物样本库现状进行分析。用epidata软件进行数据录入,然后导出SPSS数据库,在SPSS 20软件中进行统计分析。[结果]结合文献调查,找到国际生物样本库共享理念,结合四种生物样本库共享模式：虚拟样本数据库共享模式、国家样本库共享模式、样本库分布式轮毂结构、样本库慈善信托模型,分析各模型对应理念的优势和劣势,通过实证研究和定性访谈,了解各医院基本情况、医院生物样本库启动建设情况、资金投入情况、生物样本收集情况及设备数量、储存空间、样本库管理情况及共享情况,进而探讨生物样本库共享机制研究,结合上海市各医院生物样本库共享现状研究结果,引出适合上海市生物样本库共享建设的上海虚拟样本信托模型。[结论与建议]问卷调查的20家上海市各医院生物样本库的初期建设基本落实,基础设施和冷冻设备进入扩大化阶段,样本收集规范、流程严谨、各自都建立了自己的生物样本库管理信息系统。但样本使用情况不到50%的比例,这意味着样本库目前还停留在样本储存阶段,并没有很好的利用样本。通过问卷调查发现各家医院希望样本共享的意愿非常强烈,不少医院已经开始尝试与其他医院或研究机构共享样本,以期获得更高科研产出。目前没有规范的法律条文来约束生物样本的使用。除此之外,各样本库信息系统不能联网沟通,这也是共享面临的难题之一。该如何对共享制定伦理规范,合法的使用样本也是限制各家医院扩大样本共享范围的约束条件。因此合理的生物样本库共享模型需要被提出。上海市生物样本库共享理念采用虚拟样本库信托理念,设立第三方虚拟库作为总部协调中心,起到嫁接供方和需方的作用,促进两者间的合作,不储存样本。为满足其他地域的样本库加入上海市生物样本库,在第三方虚拟库下面设立几个区域合作中心,主要工作是考察招募上海周围其他省份优秀的样本库,促进周边省份样本库的合作。在各医院样本库中设立相应的样本托管人,通过与样本捐献者签署信任合同,捐献者可以委托一位托管人管理生物样本,这位托管人具有法定受托责任,可以保存或使用生物样本,同时管理生物样本使用带来的利益。采纳“进行时”知情同意机制,采取再联系样本捐献者来保证起初的知情同意仍发挥效用。引进商业资本的支持,与商业资本通过谈判签署合适的知识产权分配协议,不得干扰原来的科学研究设计。通过设立前瞻性标准解决数据兼容问题,开发和应用统一的规则和程序管理数据收集、存储和记录所有生物样本信息。将生物样本库的利益共享转变为权利共享,捐献者在生物医学研究中变成积极的参与者,样本由捐献者、委托人、伦理委员会根据捐献者的意图共同管理。选择具有潜在价值的研究数据返还给参与者。
[Abstract]:[BACKGROUND] China's biological sample banks began to be constructed on a small scale in the 1990s and have been gradually developed, mostly relying on hospitals, schools and health institutions. It is the most realistic choice to integrate the existing domestic biological sample database resources and form an integrated and shared network biological sample database. In the construction of biological sample database, medical institutions have the greatest convenience for collecting biological samples because of their special functions, and scientific research institutions have the best ability to utilize biological samples because of their own scientific research capabilities. However, the lack of cooperation and trust between the two sides and the distribution of benefits after the use of biological samples have made it impossible to really share biological sample resources for a long time. To solve the problem of resource sharing, but so far no complete strategy and mechanism has been set up to realize the resource sharing of biological sample banks, so as to balance the interests of all parties and realize the sharing of biological samples. According to the research contents, the research methods include literature research, qualitative research and quantitative research. The theoretical research part is mainly based on literature research. Qualitative and quantitative research methods were used in the empirical study. A questionnaire survey was conducted in 20 tertiary general and specialized hospitals in Shanghai. The questionnaire included the questionnaire of biological sample bank managers, the questionnaire of clinicians and interviews with key insiders. 58 hospital questionnaires were obtained and another needle was given. In this study, descriptive statistics, including univariate, bivariate and multivariate statistical analysis, were used to analyze the status quo of biological sample banks. Data were entered by EpiData software, and then SPSS database was derived to carry out the system in SPSS 20 software. [Results] Combining with literature survey, we found the concept of international bio-sample database sharing, and combined four bio-sample database sharing modes: virtual sample database sharing mode, national sample database sharing mode, sample database distributed hub structure, sample library charitable trust model, analyzed the advantages and disadvantages of each model corresponding to the concept, through empirical analysis. Research and qualitative interviews were conducted to understand the basic situation of hospitals, the start-up and construction of biological sample banks, capital investment, collection of biological samples and the number of equipment, storage space, management and sharing of biological sample banks, and then to explore the sharing mechanism of biological sample banks, and to study the sharing status of biological sample banks in Shanghai hospitals. [Conclusion and Suggestions] The initial construction of bio-sample banks in 20 hospitals in Shanghai has been basically implemented, infrastructure and refrigeration equipment have entered the stage of expansion, sample collection is standardized, and the process is rigorous. Bio-Sample Bank Management Information System. However, the proportion of sample usage is less than 50%. This means that the sample bank is still in the sample storage stage and does not make good use of the sample. There is no standard law to restrict the use of biological samples. In addition, the information systems of sample banks can not communicate with each other on line, which is also one of the difficulties faced by sharing. The concept of Shanghai Bio-Sample Bank Sharing adopts the concept of Virtual Sample Bank Trust and establishes a third-party virtual library as the headquarters coordinating center, which plays the role of grafting suppliers and demanders, promotes cooperation between them and does not store samples. The main work is to investigate and recruit excellent sample banks from other provinces around Shanghai and promote cooperation among sample banks of surrounding provinces. Under any contract, the donor may entrust a custodian to manage the biological samples. The custodian has a statutory fiduciary duty to preserve or use the biological samples and to manage the benefits arising from the use of the biological samples. With the support of introducing commercial capital and negotiating appropriate intellectual property rights distribution agreements with commercial capital, the original scientific research design shall not be disturbed. Data compatibility issues shall be solved by setting forward-looking standards, uniform rules and procedures shall be developed and applied to manage data collection, storage and recording of all biological sample information. Benefit sharing in the sample bank translates into rights sharing. Donors become active participants in biomedical research. Samples are managed jointly by donors, clients, and ethics committees according to the intention of the donors. Potentially valuable research data are selected and returned to the participants.
【学位授予单位】：复旦大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R446
本文编号：2187419
[Abstract]:[BACKGROUND] China's biological sample banks began to be constructed on a small scale in the 1990s and have been gradually developed, mostly relying on hospitals, schools and health institutions. It is the most realistic choice to integrate the existing domestic biological sample database resources and form an integrated and shared network biological sample database. In the construction of biological sample database, medical institutions have the greatest convenience for collecting biological samples because of their special functions, and scientific research institutions have the best ability to utilize biological samples because of their own scientific research capabilities. However, the lack of cooperation and trust between the two sides and the distribution of benefits after the use of biological samples have made it impossible to really share biological sample resources for a long time. To solve the problem of resource sharing, but so far no complete strategy and mechanism has been set up to realize the resource sharing of biological sample banks, so as to balance the interests of all parties and realize the sharing of biological samples. According to the research contents, the research methods include literature research, qualitative research and quantitative research. The theoretical research part is mainly based on literature research. Qualitative and quantitative research methods were used in the empirical study. A questionnaire survey was conducted in 20 tertiary general and specialized hospitals in Shanghai. The questionnaire included the questionnaire of biological sample bank managers, the questionnaire of clinicians and interviews with key insiders. 58 hospital questionnaires were obtained and another needle was given. In this study, descriptive statistics, including univariate, bivariate and multivariate statistical analysis, were used to analyze the status quo of biological sample banks. Data were entered by EpiData software, and then SPSS database was derived to carry out the system in SPSS 20 software. [Results] Combining with literature survey, we found the concept of international bio-sample database sharing, and combined four bio-sample database sharing modes: virtual sample database sharing mode, national sample database sharing mode, sample database distributed hub structure, sample library charitable trust model, analyzed the advantages and disadvantages of each model corresponding to the concept, through empirical analysis. Research and qualitative interviews were conducted to understand the basic situation of hospitals, the start-up and construction of biological sample banks, capital investment, collection of biological samples and the number of equipment, storage space, management and sharing of biological sample banks, and then to explore the sharing mechanism of biological sample banks, and to study the sharing status of biological sample banks in Shanghai hospitals. [Conclusion and Suggestions] The initial construction of bio-sample banks in 20 hospitals in Shanghai has been basically implemented, infrastructure and refrigeration equipment have entered the stage of expansion, sample collection is standardized, and the process is rigorous. Bio-Sample Bank Management Information System. However, the proportion of sample usage is less than 50%. This means that the sample bank is still in the sample storage stage and does not make good use of the sample. There is no standard law to restrict the use of biological samples. In addition, the information systems of sample banks can not communicate with each other on line, which is also one of the difficulties faced by sharing. The concept of Shanghai Bio-Sample Bank Sharing adopts the concept of Virtual Sample Bank Trust and establishes a third-party virtual library as the headquarters coordinating center, which plays the role of grafting suppliers and demanders, promotes cooperation between them and does not store samples. The main work is to investigate and recruit excellent sample banks from other provinces around Shanghai and promote cooperation among sample banks of surrounding provinces. Under any contract, the donor may entrust a custodian to manage the biological samples. The custodian has a statutory fiduciary duty to preserve or use the biological samples and to manage the benefits arising from the use of the biological samples. With the support of introducing commercial capital and negotiating appropriate intellectual property rights distribution agreements with commercial capital, the original scientific research design shall not be disturbed. Data compatibility issues shall be solved by setting forward-looking standards, uniform rules and procedures shall be developed and applied to manage data collection, storage and recording of all biological sample information. Benefit sharing in the sample bank translates into rights sharing. Donors become active participants in biomedical research. Samples are managed jointly by donors, clients, and ethics committees according to the intention of the donors. Potentially valuable research data are selected and returned to the participants.
【学位授予单位】：复旦大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R446
【参考文献】
相关期刊论文 前1条
1 赵娟;李锋;李思源;左彭湘;何玲;刘伟;黄瑾;;生物样本库的建立与管理[J];现代生物医学进展;2010年05期
，本文编号：2187419
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