A Theoretical And Empirical Study Of Biobank Sharing

A Theoretical and Empirical Study of Biobank Sharing[Background]Biobanks across China are having been constructed in small scales since the 1990s, which are relying on the hospitals, schools, health institutions mostly and expanding their sizes. Biobanks carry out different guidelines and are hard to control samples quality by lacking biobank national standard specification. The most realistic option is to integrate the existing domestic sample resources and share the network of biological samples. During the construction of biobanks, medical institutions have advantage of collect samples, and scientific research can use these samples to gain research output. Lacking cooperation and problems of benefit sharing, the two kind of institutions cannot use samples effectively and share the samples, many biobanks with good quality became dead biobanks because of samples cannot be fully applied in scientific research. Many areas in China have tried a variety of patterns to solve the problem of resource sharing, but so far they have not set up a complete set of implementation strategy and mechanism of the biobank resource sharing, to balance the interests of all parties to realize sharing of biological samples.[Objective]Based on literature research, qualitative research, quantitative research, theory and empirical research is putted forward with biobank sharing principle、sharing model、support conditions, and propose Shanghai biobank sharing model, which provide a scientific basis for the development and perfection of biobank sharing.[Meterial and method]According to the research content, research methods include literature research, qualitative research and quantitative research. The part of theoretical research is mainly based on the literature research, empirical researchis combined the specific provisions of qualitative research and quantitative research methods.20 top comprehensive and specialized subject hospital in Shanghai were investigated by the questionnaire survey, including the biological sample library management questionnaire, clinicians questionnaires and interviews for key persons, eventually 58 hospital questionnaires and 12 insider interviews were collected. This study used descriptive statistics, including univariate, bivariate and multivariate statistical analysis about the present situation of biobanks. With epidata software for data entry, and then data exported the SPSS database, statistical analysis is in SPSS software 20.[Results]Combining with literature survey, we find epistemic values of biobank sharing, and four kinds of biobank sharing ideas with the international general, corresponding to the four kinds of biobank sharing mode, respectively is virtual sample database sharing mode, national biobank sharing mode, biobank distributed hub structure, biobank charitable trust model. To introduce suitable biobank in Shanghai-Shanghai virtual samples for the construction of trust model. Through empirical research and qualitative interviews, we understand the hospital basic information, hospital biobank construction situation, capital investment, biological sample collecting and equipment, storage space, sample management and sharing, and then discuss the biobank sharing mechanism research, to find the Shanghai biological samples supporting conditions of the construction of the biobank.[Conclusion and suggestions]Shanghai hospitals have constructed the early stage of the biobank construction, infrastructure and freezing equipment are into the expansion phase, there is sample collection specification and rigorous process, biobank management information systems have been set up. But less than 50% of sample are usage, which means that the sample is still stay in. the sample storage stage that are not good use. Through questionnaire survey, we found that hospitals’ willingness to share sample is very strong, many hospitals have been trying to share sample with other hospitals and research institutions, in order to get higher scientific research output. There is no specification of the law governing the use of biological samples. In addition, each biobank information system cannot be connected to the Internet communication, sharing is also one of the challenges. How to handle the ethics, legal sharing and the use of sample, hospitals have been limited to enlarge the range of sample Sharing constraints. So reasonable biobank sharing model needs to be put forward.Biobank in Shanghai Sharing concept using virtual biobank trust idea, set up the third party virtual biobank as a headquarters coordinating center, promote cooperation between the two parts, which is not a storage of samples. In order to satisfy the samples of other regional biobanks join in Shanghai biobank, the third party set up several regional cooperation under the virtual library center, mainly recruiting other provinces around Shanghai, and promote cooperation provinces surrounding biobanks. hospital biobank set up the corresponding sample trustee, with the trust contract sample donors, donor may entrust a custodian management biological samples, the trustee has legal fiduciary duty, can save or use biological samples, at the same time manage the benefits of using biological sample. Adopt "progressive" informed consent mechanism, to adopt the contact sample donors, ensuring that informed consent is to be effective. The introduction of commercial capital support, and business capital distribution of intellectual property right agreement through negotiations, shall not interfere with the original design of scientific research. By establishing a forward-looking standard compatible mechanism, development and application of the rules and procedures of management are built to collect data, storage, and record all biological samples information. Sharing the benefit of biobank is changed to share power, donors become active participants in biomedical research, samples are supervised by the donors, clients and common management ethics committee according to the intention of the donor, data of the potential value to the research of participants are choosed to return donors.