河北省医疗机构伦理委员会运行现状评价及其影响因素研究

A Study on Operation Status Evaluation and Influencing Factors of Medical Institution Ethics Committee in Hebei Province

目的:以河北省为例,对其医疗机构伦理委员会制度、管理、审查等方面进行评价,分析其影响因素,发现医疗机构伦理委员会运行中的问题并提出建议。方法:通过专家咨询确定伦理委员会评价指标与方法,对河北省44家医疗机构伦理委员会进行评价并采用线性回归分析法分析其影响因素。结果:确定3个一级指标、11个二级指标、29个三级指标,44家医疗机构伦理委员会的评分总分平均为74.75分,不同级别医院差异较大。接受过GCP等伦理培训的成员比例、委员职称、伦理委员会审查范围三个因素是影响伦理委员会运行的相关因素,P <0.05。结论:河北省医疗机构伦理委员会运行情况良好,但仍有较大提升空间,管理水平和审查能力有待进一步提高。

Objectives:This study evaluated the system,management,review and other aspects of the Ethics Committee of Medical Institutions in Hebei province,which is expected to analyze the influencing factors,and find out the problems in the operation of the Ethics Committee of Medical Institutions and put forward suggestions. Methods:The evaluation indexes and methods of the Ethics Committee of Medical Institutions were determined by expert consultation. TheEthics Committee of 44 Medical Institutions in Hebei province was evaluated and its influencing factors were analyzed by linear regression. Results:3 first-level indicators,11 second-level indicators and 29 third-level indicators were finally determined. The total score of the Ethics Committee of 44 Medical Institutions was74.75 points on average,and there was a great difference between different levels of hospitals. The proportion of members who have received ethics training such as GCP,the professional title of members,and the scope of review ofthe Ethics Committees are the relevant factors affecting the operation of the Ethics Committees(P < 0.05). Conclusion:The Ethics Committee of Medical Institutions in Hebei provinceoperates well,but there is still room for progress,and the management level and review ability need to be further improved.