基于定性访谈的深圳市医疗卫生机构人体研究伦理现状调查

Survey on Ethical Status of Human Research in Shenzhen Medical and Health Institutions: A Qualitative Interviews Study

目的了解深圳市各医疗机构已设立的伦理委员会实际运行、审查现状及挑战。方法采用目的抽样中的最大差异抽样方法,对130名来自15家不同医院的管理者(42位),伦理委员会委员以及秘书(69位)及研究者(19位)进行了半结构式的小组访谈,为定性研究。采用NVivo软件,用框架分析法进行资料的分析。结果访谈者们认为最重要的是科研项目伦理审查能力不足,主要挑战包括:机构伦理建设意识不足、科研项目审查流程及制度不完善、缺乏能胜任的委员、缺乏支持与监管体系等。结论为了有效保护受试者权益并控制研究风险,需要医疗卫生机构和行业主管部门重视顶层设计,开展伦理体系建设外部监管与支持建设。

Objective:To understand the actual operation,review status and challenges of the established ethics committees of medical institutions in Shenzhen.Methods:In this study,130 individuals who are taking the role as the hospital managers(42),ethics committee members,secretaries(69)and researchers(19)from 15 different hospitals were interviewed in a semi-structured group by using the maximum difference sampling method of objective sampling.This study is a qualitative study.NVivo software and frame analysis were used to analyze the data.Results:Interviewees expressed major concerns on the weak capacities regarding scientific research ethical review and approval in hospitals in Shenzhen.The main challenges include:the insufficient awareness of institutional ethics construction,the imperfect review process and system of scientific research projects,the lack of qualified human resources,the lack of support and supervision system.Conclusion:In order to effectively protect the rights and interests of subjects and control research risks,medical and health institutions and industry authorities need to pay attention to top-level design,carry out the construction of ethical system,and external supervision and support.