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.

Objective:To explore the ways and methods to improve the ability of hospital ethical review and ensure the quality and efficiency of ethical review.Methods:By consulting the literature and combining the practical experience of the construction of the ethics committee and the ethical review work in the hospital, analyze the present situation of ethical review in our country, and deeply analyze the main problems existing in the work of ethical review in hospitals.Results:The quality and efficiency of ethical review can be effectively improved by implementing centralized management, optimizing work processes, establishing emergency response systems, opening green channels, optimizing the composition of committee members, strengthening ethical training and assessment, establishing emergency response systems, opening green channels, strengthening pre-review communication, establishing emergency response systems, opening green channels, strengthening formal review, increasing publicity, and improving ethical awareness.Conclusions:Clarifing the division of responsibilities and strengthen multi-department interaction can effectively improve the efficiency of ethics review. Optimizing the structure of ethics committee, strengthen the training and assessment of members, can effectively enhance the ability of ethics committee review. Unifing the list of documents, optimizing the work flow and the way of examination can effectively shorten the period of ethical examination. It is suggested that continuous ethical training and assessment should be carried out, that an information-based platform system should be used to achieve dynamic supervision, and that a certification system and assessment mechanism for ethics committees should be established at the national level, to promote the improvement of the ability of ethical review.