Research On Administrative Permission And Regulation Of Human Gene Editing Clinical Trial

In recent years,the research on gene editing technology has become a hot activity in biological science and technology.In the early stage,gene editing technology was mostly used in bacterial research,and then gradually applied to plants,animals,human body cells,and then to human reproductive cells.There are many gaps in the legislative system of gene editing technology,especially in human gene editing technology,which needs to be improved and difficult to determine scientific and social risks.However,as a legal person,we should treat the development of this technology dialectically with a rational attitude.We should not only consider the advantages and disadvantages of this technology,but also put forward the legal supervision and regulation of this technology The new technology should control the social risk reasonably.The administrative licensing of human gene editing clinical trials should follow the theories of medical technology development,risk prevention and control,legal regulation,administrative control,and administrative relief.We should integrate the above theories to build the human gene editing clinical licensing system: first,the principles of setting up,mainly including the principles of protecting human rights,scientific integrity,appropriate intervention,and public interest;second,the end Good legislation: the implementation of the administrative licensing system is determined through legislation,and on this basis,a number of integrated review mechanisms are established;the third is to ensure law enforcement,the state should establish a special management department and management organization,and the administrative licensing authority should establish a review expert pool to select experts to form a review team for review,and in the process of review,the on-the-spot review should be implemented through the linkage mechanism;the fourth is to supplement In order to protect the rights and interests of the subjects,we should establish a compensation mechanism.