ABSTRACT
Objective:Taking into account of the current situation that domestic laws and regulations of medical technology ethics review are not perfect, we put forward practical suggestions on ethical review supervision of the clinical application of new medical technologies from the perspective of standardization.Methods:Referring to the relevant laws, regulations and specific implementation guidelines of ethical review of clinical research, combined with the practical experience of the ethics committee of the host Hospital, this paper systematically summarizes the concept and characteristics and existing problems of new clinical applied medical technology, optimizes the working steps of technology access and ethical review, and establishes an ethical continuing review model.Results:A series of measurements are proposed, which including formulate the access process, improve the management system, optimize ethical review methods, etc. At the same time, pay more attention to the annual continuing review, adverse event report review, suspension/termination of approved research, closure report review, as well as site visit to improve the initiative and efficiency of ethical review. At last, it ensures the continuing of ethical review.Conclusions:It is very important to regulate new medical technology project entry and ethical review supervision in the practice. On one hand, it can effectively make up for the possible shortcomings of current laws and regulations and promote the introduction of new regulatory requirement. On the other hand, it can effectively reduce the medical technology risks and build good medical quality management, improve the system to better safeguard people′s health rights and interests.