南京市某妇产医院科研项目伦理审查管理现状与对策研究

Research on the current situation and countermeasures of ethics review management of scientific research projects in a maternity hospital in Nanjing

目的通过调研某医院(以下简称A院)医学伦理委员会科研项目的伦理审查现状,深入探讨伦理审查过程中存在的问题及对策,为进一步加强医院伦理委员会的建设,改善伦理审查管理提供依据。方法对2017—2021年在A院承担实施的涉及人的科研项目伦理审查情况进行统计性描述分析,并分析伦理审查管理的问题与不足。结果伦理审查管理工作中存在委员审查能力有限,难以独立审查;伦理审查周期较长,众多项目被积压;研究者伦理意识薄弱,伦理审查材料质量较低等问题。结论通过搭建委员学习交流平台,增强委员履职能力;配备足够专(兼)职人员,保障项目的审查和监管;提高项目负责人伦理意识,保证伦理审查材料的质量等措施可使医院伦理审查管理得到改善和规范。

Objective By investigating the current situation of ethics review of scientific research projects of the medical ethics committee of a hospital(hereinafter referred to as hospital A),and deeply discussing the problems and countermeasures in the process of ethics review,it can provide a basis for further strengthening the construction of hospital ethics committee and improving the management of ethics review.Methods Statistical description and analysis of the ethical review of scientific research projects involving human beings undertaken and implemented in the A hospital from 2017 to 2021,and analyze the problems and deficiencies of ethical review management.Results In the ethical review management work,there are problems such as the limited review ability of the committee members,and it is difficult to conduct independent review;the ethics review cycle is long,and many projects are backlogged;the researchers’ethical awareness is weak,and the quality of the ethical review materials is low.Conclusion By building a platform for committee members to learn and communicate,the ability of committee members to perform their duties can be enhanced;sufficient full-time(part-time)staff are provided to ensure project review and supervision;measures such as improving the ethical awareness of project leaders and ensuring the quality of ethical review materials can make hospital ethics review management possible be improved and standardized.