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药物临床试验机构伦理委员会委员核心能力评价指标体系构建及应用
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| 篇名： | 药物临床试验机构伦理委员会委员核心能力评价指标体系构建及应用 |
| TITLE： | Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution |
| 摘要： | 目的 构建药物临床试验机构伦理委员会委员的核心能力评价指标体系，为优化委员培训体系、提升伦理审查质量、充分保障受试者安全与权益提供依据。方法采用文献研究、专家咨询等方法初步构建核心能力评估指标体系，并使用德尔菲法对其进行修改和验证，最终形成伦理委员会委员核心能力评价指标体系。基于该体系对全国29家药物临床试验机构的90位伦理委员会委员进行问卷调查，并对其核心能力指标的重要性评分和自我能力评分进行比较。结果所建评价体系包含4个一级指标（伦理及专业知识、伦理审查能力、沟通表达能力、道德操守与工作作风）和39个二级指标（熟悉临床试验相关法律法规的内容、能在较短的时间内完成项目伦理审查并找出研究方案中的伦理缺陷、具备判断临床研究科学价值的审查能力等）。问卷调查结果显示，受访伦理委员会委员在法律法规知识、伦理规范、审查效率、风险判断、问题分析等方面存在明显的能力缺口，对应二级指标的重要性评分与自我能力评分的差值均不低于0.38。结论本研究构建了可量化、分层化的伦理委员会委员核心能力评价工具，可为委员培训、资质认证及伦理委员会规范化管理提供科学框架。 |
| ABSTRACT： | OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution， providing a basis for optimizing the training system for committee members， improving the quality of ethical review， and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation， a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it， ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system， a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide， comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators （ethics and professional knowledge， ethics review ability， communication and expression ability， moral integrity and work style） and 39 secondary indicators （familiarity with the content of clinical trial-related laws and regulations， ability to complete project ethics review and identify ethical defects in research protocols within a short period of time， ability to judge the scientific value of clinical research， etc.）. The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge， ethical norms， review efficiency， risk judgment， and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training， qualification certification， and standardized management of ethics committees. |
| 期刊： | 2025年第36卷第20期 |
| 作者： | 汤晓华；蒋清青；张海伟；毛巍然；尹园园；隋江东；李俊；陈霞 |
| AUTHORS： | TANG Xiaohua， JIANG Qingqing，ZHANG Haiwei，MAO Weiran，YIN Yuanyuan，SUI Jiangdong，LI Jun，CHEN Xia |
| 关键字： | 伦理委员会委员；核心能力；指标评价体系；德尔菲法；问卷调查 |
| KEYWORDS： | ethics committee member； core competencies； |
| 阅读数： | 1 次 |
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