The Empirical Study on the Construction of Ethics Committee in Municipal Hospitals in Shanxi Province / 中国医学伦理学

To analyze the main factors influencing the ethical review work of municipal hospitals in Shanxi Province by investigating the current situation of the construction and operation of ethics committees, and to put forward reasonable suggestions for improving the work of ethics committees. Questionnaire surveys and interviews were used to investigate the composition of ethics committees, systems and standard operating procedures, personnel training, review project methods, time limits, etc. of 24 hospitals at municipal levels in Shanxi Province. The establishment and system of ethics committees in tertiary hospitals at prefecture and city level were basically reasonable, and they could actively play the role of ethics committees. At present, most hospitals do not pay enough attention to the work of ethics committees, lack of full-time staff and systematic training, resulting in insufficient ethics review capabilities. The construction of the ethics committee of the second-level hospital is a mere formality, and no substantive work has been carried out. It is recommended to strengthen the supervision, increase the training of ethics committees and researchers, improve the information management of ethics committees, and establish regional ethics committees to further improve the ability and efficiency of ethics review.

Requirement for Ethics Committee after China Food and Drug Administration Join ICH-GCP / 中国医学伦理学

Objective:To summarize the opportunities,challenges and countermeasures that China Food and Drug Administration (CFDA) joining ICH-GCP will bring to the construction of ethics committee,so as to provide reference for the standardization construction and review ability of ethical committee in China.Methods:We reviewed and comprehensively analyzed the domestic literatures about the requirement for ethics committee after CF-DA join ICH-GCP.Results:CFDA joining ICH-GCP was conducive to speeding up the construction of Chinese ethics committee.Aiming at the challenge of the standardization construction of ethics committee,it could use the revised policy regulations and guidelines to integrate with ICH-GCP,establish ethics certification system in line with the national condition,clear the composition of members,standardize operational procedures,and establish regional ethics committee and leader the review of the unit system;to improve the review ability,it could strengthen reviewing requirement from the aspects of sponsor responsibilities,researchers qualification,research protocols,informed consent,researcher brochures and documents management.Conclusion:CFDA joining ICH-GCP brings a rapid development opportunity for the ethics committee as well as challenges.We can solve problems from standardization construction and the improvement of review ability,to speed up the construction of ethics committee that meets the requirements of ICH-GCP.