提高医院伦理审查能力的实践与思考以南京医科大学附属泰州人民医院为例

Practice and thinking on improving the ability of hospital ethical review: Take the Affiliated Taizhou People′s Hospital of Nanjing Medical University as an example

目的探讨提高医院伦理审查能力的路径和方法, 保障伦理审查的质量和效率。方法通过查阅文献, 结合样本医院伦理委员会建设与伦理审查工作的实践经验, 分析我国伦理审查的现状, 深入剖析医院伦理审查工作存在的主要问题。结果通过实行归口管理、优化工作流程, 建立应急制度、开通绿色通道, 优化委员构成、加强伦理培训与考核, 统一文件清单、加强形式审查, 加强预审沟通、灵活审查方式, 加大宣传力度、提升伦理意识等举措, 能有效提高伦理审查质量和效率。结论明确责任分工, 强化多部门联动, 能有效提高伦理审查效率;优化伦理委员结构, 加强委员培训与考核, 能有效提升伦理委员审查能力;统一文件清单, 优化工作流程和审查方式, 能有效缩短伦理审查周期。建议进行持续伦理培训和考核评价、运用信息化平台系统实现动态监管、从国家层面建立对伦理委员会认证制度和考核机制, 以促进伦理审查能力进一步提升。

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.