我国伦理委员会管理制度调研与结果分析

Report of Questionaire Survey on Ethics Committee Management System in China

从各国的监管经验来看,伦理委员会在临床试验管理中发挥着重要的作用。为理清我国伦理委员会管理制度的现状及存在的问题,在前期文献研究的基础上,通过问卷调研和专家访谈,对伦理委员会的监管问题、影响伦理审查的"质量"因素、影响伦理审查的"效率"因素等关键问题进行了调研。调研结果表明,多数调研对象认为应不断完善我国的伦理委员会管理制度,进一步提高伦理审查的质量和效率。

From the regulatory experience of various countries,Ethics Committee plays an important role in clinical trial management.In order to clarify the current situation and existing problems of Ethics Committee management system in China,based on the previous literature research,this paper investigates key issues such as the supervision of Ethics Committee,the"quality"factors that affect ethical review,and the"efficiency"factors that affect ethical review through questionnaire survey and expert interview.Results show that most respondents believe that China’s Ethics Committee management system should be continuously improved for higher quality and efficiency of ethical review.