Study On Operating Status And Countermeasures Of The Ethics Committee Of One Specialized Hospital

OBJECTIVESThis article is intended to have a comprehensive understanding of running status of the ethics committee of one specialized hospital which is the research object, to find out and analyze problems in its operation, and to study countermeasures in order that a practical and popular quality continuous improvement of hospital ethics committee suitable to specialized hospitals can be established to provide reference for hospital administrators as well as the ethics committee workers.METHODOLOGY(1) Documents analysis, personal interview, and other methods were used to set the survey range of the research.(2) Reviewing and researching documents of the specialized hospital ethics committee, including review records, meeting minutes, membership documents, protocol documents, etc. Using assessment tools to analyze the problems of the object ethic committee.(3) Adopting questionnaire survey on the specialized hospital ethics committee members, researchers, clinical research coordinators (CRC). Going through the articles and researches about the hospital EC review, and preparing3different questionnaires according to the object EC in order to find out the awareness and evaluation of ethics committees from different populations.RESULT AND ANALYSIS(1) The running status of the object ethics committee, including object EC Structure and Composition, adherence to specific policies, completeness of the review process, etc. were described.(2) Problems were discovered from the inventory survey:professional backgrounds of the ethics committee members of one specialized hospital are limited which can not cover expertise for existing accepted review projects; the review capacity of committee members needs upgrading; Education and training functions of the ethics committee needs to be strengthened; field visit needs to be implemented(3) Problems form other evaluation were found as follows:lack of SOPs about tissue bank Ethic review, and SOPs of research from government funding ethic review.(4) Problems by analyzing the result of the questionnaire survey were found as follows:the education and consulting functions of the ethics committee are not exerted very well; Promotion of the ethics committee needs to be strengthened; Personnel structure of the ethics committee need to be improved.(5) Countermeasure research:making suggestion about the amendment of SOPs, improving the existing management system of ethics committee, and providing management system of ethics committee.DISCUSSION AND RECOMMENDATION(1) Re-structure relationship between Ethics Committee with the researchers and clinical research coordinators (CRC).(2) Adopting PDSA/PDCA Cycle (Deming Cycle) to support continuous improvement of ethics committee.(3) Exploring the path of the construction of ethics committee based on the ethical assessment and emphasizing the continuous optimization of evaluation tool.(4) Suggestion on the time limit for amending SOP of ethics committee.