| Objective:In this study,for its relatively mature,and significant value and needs for sharing,clinical data of oncology was selected as a typical case to analyze the common ethical problems of clinical data sharing of chronic diseases.To provide some ideas for promoting clinical data sharing in China,through comparing the similarities and differences in the policies,laws and regulations in this point between China and the United States(USA),and the sharing practice of some platforms.Methods:The ethical common problems of clinical data sharing of chronic diseases represented by tumor was analyzed through literature investigation and theoretical analysis.The typical ethical issues were extracted through keyword frequency analysis,and the potential ethical management and practicing system of data sharing between China and USA was explored from academic literatures.Polices,laws and regulations(here in after is also referred to as legal provisions)in recent years of China and USA were collected by multi-channel search,and the representative texts were selected.Then,the similarities and differences in the political and legal aspects were studied and compared between the two countries,especially those on tumor clinical data sharing.Finally,a sharing platform for tumor clinical data in China and USA was chosen.The platform both had complete practical framework with four aspects:functional modules,data acquisition conditions,data sharing degree and data characteristics was selected in both countries on basis of the feasibility of research,so as to discuss and analyze the impact of policies,laws and regulations on the data sharing practice.Results:Totally,326 ethical-related articles and 154 references of policies,laws and regulations were investigated.Among them,71 and 255 articles discussed data sharing ethical issues of China and USA,respectively;and there was 41 and 21 documents of data sharing including policies,laws and regulations in China and USA,respectively.The results are as follows:(1)The common ethical issues of clinical data sharing,privacy protection(64/326)and informed consent(76/326)was discussed most frequently.In terms of ethical management,there was 29 articles was found on broad informed consent in sharing in our study.And most(21/29)was about potential problems and solutions of broad informed consent.The articles showed that ethical management in the United States was relative fully discussed.(2)Results showed that similarities and differences was not only in the theme trend,content framework,but also emphasis of data sharing policies,laws and regulations between those in China and USA.(a)About the theme trend,the similarities included:in both countries,tumor registration had been taken into control of laws and regulations;gradually improved the mechanism of sharing;balancing between improving data sharing and rights and interests confirmation was always considered.The differences included:when compared with USA,the construction time of the policies and laws in China was relatively centralized due to late start.They most emphasized the national strategic orientation,however,weakly refinement,as shown in sharing practice of tumor clinical data still following the general rules.(b)As for the framework of policies and legal provisions,the similarities included:considerations of intellectual property protection was relatively less,;the content coverage was almost the same,etc.The difference showed that,China payed more attention to the dimension and balance of the content covered by the policies and legal provisions,and the framework is more comprehensive when compared with those of USA.In addition,China relatively attached importance to intellectual property protection,and acknowledgment for data re-use was more required.(c)To the primary coverage of the policies and legal provisions,,the similarities included:privacy protection and data security was regulated by general legal provisions.In addition,some detailed requirements of data security was provided in the laws and regulations.The difference showed that,China is still relatively general on the sharing management.In terms of sharing model,most was conditional sharing;the purpose and usage plan of data reuse should be clarified,an agreement was also required.Legal provision for privacy protection was included in general laws and regulations.(3)Sharing practice of representative platform for tumor data sharing:the similarities included:They both had relevant detailed standards or guidelines provided by data sharing platforms to data users;most of the data was classified shared,of which was obtained conditionally.In addition,the data information contained in the shared data is relatively similar.The differences showed that there had more functional modules in the platform in China;Data access and data acquisition was strict;providing metadata and some sample data in public area,and the acquisition of complete data would be provided after strictly reviewed for approval;Besides,the sharing data was characteristics with rich varieties,time spectra is narrow but high instantaneity.Conclusions:In the light of clinical data sharing of chronic diseases represented by tumor,the common ethical issues that Chinese and American scholars both paid more attention to privacy protection and informed consent.The experience of the performance of broad informed consent in USA could provide some useful ideas to practice in China.The system of policies and legal provisions exactly had some impacts on the sharing effectiveness during clinical data sharing practice.China should strengthen the refinement and specification of practical guidance documents for data sharing in different fields.The policies,laws and regulations of USA and experience of ethical management could also provide some useful suggestions for Chinese governments.Moreover,some advanced local experience of value to extension and application for data sharing in China should be realized. |
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