Study On The Sharing Problems Of Bio-bank Of Medical Research In Public Institutions In China

Objective:Through using a variety of research methods,this paper analyzes what restricts the bio-bank sharing human biological sample resource which belongs to our public institution.Combining with domestic and foreign bio-bank experience,this paper proposes the policy suggestion that can improve our bio-bank sharing.Contents:First of all,by combing the relevant concepts and theories of human biological sample resource sharing,this paper constructs the theoretical analysis framework of this research;then researching the present situation of sharing the biological sample database of medical research in our country to summarize the existing problems in the sharing activities;this paper analyzes the reasons for the formation of sharing problems;the last,paper gives relevant policy recommendations for China to promote the sharing of biological sample resources.Methods:The paper uses literature research method to summarize and sort out the concept and theoretical research of sharing problems of the biological sample resource,to construct the analysis framework,to investigate the practice of sharing bio-bank of public institutions in China.The paper uses content analysis method and personal in-depth interviews method to summarize the specific problems in the sharing of biological samples.The paper uses expert discussion method and fish bone map method to further analyze the deep-seated causes of these problems.Results:1,Establishing China's bio-bank sharing problem analysis framework.The framework consists of technology and standards,management and organization,industry and economy,society and culture.2,China's bio-bank sharing has made some progress,as the representative of the biological sample database sharing network have been established,the national planning level also proposed bio-bank sharing requirements and ideas,some of the bio-banks construction standards have been introduced,which is a good start to the nationwide sample resource sharing.3,Although there is a certain sharing effect,the overall situation is still difficult to share,the specific aspects of the problem there are six aspects:biological samples are incomplete,difficult to meet the diverse needs;most biological samples are limited to the use of internal organs;the quality of the sample is uneven,difficult to meet the needs of research;supply and demand information is asymmetry;the sample is not associated with the clinical data;changes in sample use,infringement of privacy and"biological plagiarism" events happened frequently.4,The causes of these problems have deep-seated reasons:the lack of top-level design,supervision,legal,capital and service platform and other security behind;the lack of effective biological sample resource sharing benefit distribution mechanism,participation in the interests of the main can not be balanced and security;bio-bank has not yet achieved a unified standardized management,resource sharing met technical problems;the lack of sharing culture,ethics and biosecurity protection.5,Putting forward the proposal to promote the sharing of biological samples in China.With the above problems and causes as the starting point,combined with the experience of the United States and the European Union,it is put forward that the implementation of biological sample sharing should focus on building an open and sharing network of bio-bank;promote the standardization of stock resources;build the open and shared information platform of national biological sample database;form a multi-win-win sharing system.Conclusion:Many biological samples are limited to the use of internal organs,the lack of shared power,the quality of the sample is uneven,biological sample information is opaque;the supply and demand information is asymmetry,biological sample data is not comprehensive,the sample information and clinical data is not associated,change the use of samples,violations of privacy and "biological plagiarism" incident happened frequently.The causes of these problems are the lack of top-level design,supervision,legal,capital and service platform and other security behind,the lack of effective biological sample resource sharing benefit distribution mechanism,the interests of the participants can not be balanced and security,the bio-bank has not yet achieved a unified standardization management,resource sharing and utilization are facing technical problems,lack of shared culture,ethics and biosecurity protection.