生物樣本庫(kù)共享理論與實(shí)證研究
發(fā)布時(shí)間：2018-08-17 11:09
【摘要】：[背景]中國(guó)的生物樣本庫(kù)在上世紀(jì)90年代開(kāi)始小規(guī)模建設(shè),至今已逐漸發(fā)展,多是依托醫(yī)院、學(xué)校、衛(wèi)生機(jī)構(gòu)建成。因沒(méi)有全國(guó)性質(zhì)的生物樣本庫(kù)規(guī)范指南做指導(dǎo),各地生物樣本庫(kù)的生物樣本管理標(biāo)準(zhǔn)不同,質(zhì)量參差不齊,樣本使用率低下。整合國(guó)內(nèi)現(xiàn)有的生物樣本庫(kù)資源,形成集成、共享的網(wǎng)絡(luò)化生物樣本庫(kù)是當(dāng)前最現(xiàn)實(shí)的選擇。生物樣本庫(kù)建設(shè)中,醫(yī)療機(jī)構(gòu)因其特殊的職能而具備生物樣本搜集的最大便利,科研機(jī)構(gòu)因其自身的科研能力而具備最佳的生物樣本利用能力,然而雙方缺乏合作信任及生物樣本使用后利益分配的問(wèn)題,使得長(zhǎng)期以來(lái)無(wú)法真正實(shí)現(xiàn)生物樣本資源的共享,一些生物樣本質(zhì)量好,臨床資料全面的精品庫(kù)因?yàn)椴荒鼙怀浞謶?yīng)用于科學(xué)研究而成為死庫(kù),我國(guó)不少地區(qū)嘗試了多種模式來(lái)解決資源共享的問(wèn)題,但目前為止尚未建立一套完整的實(shí)現(xiàn)生物樣本庫(kù)資源共享的策略和機(jī)制,來(lái)均衡各方利益已實(shí)現(xiàn)生物樣本的共享。[目的]基于文獻(xiàn)研究、定性調(diào)查、定量研究,圍繞生物樣本庫(kù)共享理念、共享模式、共享的支撐條件三方面內(nèi)容展開(kāi)理論及實(shí)證研究,提出上海市生物樣本庫(kù)共享模型,為上海市生物樣本庫(kù)共享的發(fā)展和完善提供科學(xué)依據(jù)。[資料與方法]根據(jù)研究?jī)?nèi)容,研究方法包括文獻(xiàn)研究、定性研究和定量研究。其中理論研究部分主要基于文獻(xiàn)研究,實(shí)證研究部分則聯(lián)合應(yīng)用了定性研究方法和定量研究方法。對(duì)上海市20家三甲綜合和�？漆t(yī)院進(jìn)行問(wèn)卷調(diào)查,調(diào)查內(nèi)容包括生物樣本庫(kù)管理人員調(diào)查問(wèn)卷,臨床醫(yī)生調(diào)查問(wèn)卷以及對(duì)關(guān)鍵知情者的訪談,最終獲得58份醫(yī)院調(diào)查問(wèn)卷,另針對(duì)性的選取9家與生物樣本庫(kù)密切相關(guān)的單位進(jìn)行了12位知情人訪談,本研究主要應(yīng)用描述性統(tǒng)計(jì),包括單變量、雙變量、多變量統(tǒng)計(jì)分析,對(duì)生物樣本庫(kù)現(xiàn)狀進(jìn)行分析。用epidata軟件進(jìn)行數(shù)據(jù)錄入,然后導(dǎo)出SPSS數(shù)據(jù)庫(kù),在SPSS 20軟件中進(jìn)行統(tǒng)計(jì)分析。[結(jié)果]結(jié)合文獻(xiàn)調(diào)查,找到國(guó)際生物樣本庫(kù)共享理念,結(jié)合四種生物樣本庫(kù)共享模式：虛擬樣本數(shù)據(jù)庫(kù)共享模式、國(guó)家樣本庫(kù)共享模式、樣本庫(kù)分布式輪轂結(jié)構(gòu)、樣本庫(kù)慈善信托模型,分析各模型對(duì)應(yīng)理念的優(yōu)勢(shì)和劣勢(shì),通過(guò)實(shí)證研究和定性訪談,了解各醫(yī)院基本情況、醫(yī)院生物樣本庫(kù)啟動(dòng)建設(shè)情況、資金投入情況、生物樣本收集情況及設(shè)備數(shù)量、儲(chǔ)存空間、樣本庫(kù)管理情況及共享情況,進(jìn)而探討生物樣本庫(kù)共享機(jī)制研究,結(jié)合上海市各醫(yī)院生物樣本庫(kù)共享現(xiàn)狀研究結(jié)果,引出適合上海市生物樣本庫(kù)共享建設(shè)的上海虛擬樣本信托模型。[結(jié)論與建議]問(wèn)卷調(diào)查的20家上海市各醫(yī)院生物樣本庫(kù)的初期建設(shè)基本落實(shí),基礎(chǔ)設(shè)施和冷凍設(shè)備進(jìn)入擴(kuò)大化階段,樣本收集規(guī)范、流程嚴(yán)謹(jǐn)、各自都建立了自己的生物樣本庫(kù)管理信息系統(tǒng)。但樣本使用情況不到50%的比例,這意味著樣本庫(kù)目前還停留在樣本儲(chǔ)存階段,并沒(méi)有很好的利用樣本。通過(guò)問(wèn)卷調(diào)查發(fā)現(xiàn)各家醫(yī)院希望樣本共享的意愿非常強(qiáng)烈,不少醫(yī)院已經(jīng)開(kāi)始嘗試與其他醫(yī)院或研究機(jī)構(gòu)共享樣本,以期獲得更高科研產(chǎn)出。目前沒(méi)有規(guī)范的法律條文來(lái)約束生物樣本的使用。除此之外,各樣本庫(kù)信息系統(tǒng)不能聯(lián)網(wǎng)溝通,這也是共享面臨的難題之一。該如何對(duì)共享制定倫理規(guī)范,合法的使用樣本也是限制各家醫(yī)院擴(kuò)大樣本共享范圍的約束條件。因此合理的生物樣本庫(kù)共享模型需要被提出。上海市生物樣本庫(kù)共享理念采用虛擬樣本庫(kù)信托理念,設(shè)立第三方虛擬庫(kù)作為總部協(xié)調(diào)中心,起到嫁接供方和需方的作用,促進(jìn)兩者間的合作,不儲(chǔ)存樣本。為滿足其他地域的樣本庫(kù)加入上海市生物樣本庫(kù),在第三方虛擬庫(kù)下面設(shè)立幾個(gè)區(qū)域合作中心,主要工作是考察招募上海周圍其他省份優(yōu)秀的樣本庫(kù),促進(jìn)周邊省份樣本庫(kù)的合作。在各醫(yī)院樣本庫(kù)中設(shè)立相應(yīng)的樣本托管人,通過(guò)與樣本捐獻(xiàn)者簽署信任合同,捐獻(xiàn)者可以委托一位托管人管理生物樣本,這位托管人具有法定受托責(zé)任,可以保存或使用生物樣本,同時(shí)管理生物樣本使用帶來(lái)的利益。采納“進(jìn)行時(shí)”知情同意機(jī)制,采取再聯(lián)系樣本捐獻(xiàn)者來(lái)保證起初的知情同意仍發(fā)揮效用。引進(jìn)商業(yè)資本的支持,與商業(yè)資本通過(guò)談判簽署合適的知識(shí)產(chǎn)權(quán)分配協(xié)議,不得干擾原來(lái)的科學(xué)研究設(shè)計(jì)。通過(guò)設(shè)立前瞻性標(biāo)準(zhǔn)解決數(shù)據(jù)兼容問(wèn)題,開(kāi)發(fā)和應(yīng)用統(tǒng)一的規(guī)則和程序管理數(shù)據(jù)收集、存儲(chǔ)和記錄所有生物樣本信息。將生物樣本庫(kù)的利益共享轉(zhuǎn)變?yōu)闄?quán)利共享,捐獻(xiàn)者在生物醫(yī)學(xué)研究中變成積極的參與者,樣本由捐獻(xiàn)者、委托人、倫理委員會(huì)根據(jù)捐獻(xiàn)者的意圖共同管理。選擇具有潛在價(jià)值的研究數(shù)據(jù)返還給參與者。
[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.
【學(xué)位授予單位】：復(fù)旦大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R446
本文編號(hào)：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.
【學(xué)位授予單位】：復(fù)旦大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R446
【參考文獻(xiàn)】
相關(guān)期刊論文 前1條
1 趙娟;李鋒;李思源;左彭湘;何玲;劉偉;黃瑾;;生物樣本庫(kù)的建立與管理[J];現(xiàn)代生物醫(yī)學(xué)進(jìn)展;2010年05期
，本文編號(hào)：2187419
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