科技伦理审查制度建设中的主体、程序与方法优化

Subjects,Procedures and Method Optimization in the Construction of Science and Technology Ethical Review System

充分发挥伦理审查在科技伦理治理中的作用,必须重视伦理审查相关机制构建与完善。目前我国伦理委员会建设、伦理审查程序运行、伦理审查方式方法应用等方面的机制还存在一些欠缺和不足,影响科技伦理审查质量和效率,亟需寻求对策加以优化。通过案例探讨、数据分析、域外经验借鉴等方法与途径进行研究,得到如下结果:一是在伦理委员会建设上,构建相关认证机制,提高准入门槛,以全面均衡地提升伦理委员会综合实力,通过人员聘用、单独建制、财务支持等路径增强伦理委员会独立性,通过制度约束、业务培训、指导监督,不断提高伦理委员会审查能力;二是在伦理审查程序运行上,完善利益冲突回避机制,合理确定回避主体范围等,根据研究风险等级启用相应审查程序,实行分级分类管理;三是在伦理审查方式方法上,优化审查结果互认机制,通过结果互认提高审查效率和质量,并加强伦理审查信息化建设,推进伦理数据标准化,健全信息系统权限管理制度。

The rapid development of science and technology,especially the emergence of new technologies,has brought benefits to the whole society.However,the ethical risks it brings have become increasingly prominent.The ethical and moral issues are mainly related to nuclear technology,biotechnology and information technology.How to promote scientific and technological ethical governance and prevent scientific and technological ethical risks have become the new mission.For this reason,it is of great significance to strengthen the ethical review of science and technology.Ethical review is an effective means of scientific and technological ethics governance,and ethical review of science and technology follows the concept of“science and technology for good”.Ethical review is served as gatekeeper and has a very important normative effect on research and innovation in cutting-edge scientific and technological fields.In order to give full play to the role of ethical review in the governance of scientific and technological ethics,attention should be paid to the construction and improvement of relevant mechanisms for ethical review.There are still some deficiencies in China's construction mechanisms of the ethics committee,the operation of the ethical review procedures and the application of the ethical review methods.For example,the standardization and homogeneity of the ethics committee construction are still insufficient,which affects the overall level of the ethics committee construction.The procedures and mechanisms for avoiding conflicts of interest are far from satisfactory,and this may lead to unfair ethical review results.Due to the lack of homogeneous review standards,mutual recognition of the ethical review results is highly affected.The mechanism for the construction of information technology for ethical review is not good enough,leading to a generally low level of information management.These problems will influence the quality and efficiency of the ethical review of science and technology.Therefore,it is necessary to find the countermeasures and optimize relevant mechanisms.By using the research methodology of case study,data analysis,overseas experience,and other methods and approaches,this study concludes the following countermeasures for further improvement and optimization.(1)Regarding the construction of the ethics committee,the relevant certification mechanism should be built,and the entry threshold should be raised to comprehensively improve the strength of the committee.The independence of the ethics committee should be enhanced from three aspects of personnel recruitment,independent establishment and financial support.The review capacity of the ethics committee should be continuously strengthened through system constraints,business training,guidance and supervision.(2)As to the operation of ethical review procedures,the conflict of interest avoidance mechanism should be improved,and the scope of the avoidance subject should be reasonably determined.Scientific and technological ethical risk assessment standards should be set to define the risk classification and its connotation,and corresponding review procedures should be used according to the risk levels of research projects in the hierarchical and classified management.(3)With regarding to the ethical review methods,the mutual recognition mechanism of review results should be optimized to improve review efficiency and quality through mutual recognition.It is necessary to strengthen the construction of ethical review information,promote the standardization of electronic data,and improve the authority management system of the information system.In conclusion,the above research can solve the specific problems existing in the practice of the ethical review of science and technology in China.By multi-party exploration,especially by drawing on the successful experience abroad,the corresponding countermeasures with strong feasibility and certain novelty are proposed.Ethical review of science and technology can effectively avoid scientific and technological ethics and safety risk.By optimizing the related mechanism of ethical review of science and technology,the good governance of science and technology can be realized.