Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution
- VernacularTitle: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
- Author:
Xiaohua TANG
1
;
Qingqing JIANG
1
;
Haiwei ZHANG
1
;
Weiran MAO
1
;
Yuanyuan YIN
1
;
Jiangdong SUI
1
;
Jun LI
1
;
Xia CHEN
1
Author Information
1. Chongqing Key Laboratory for the Mechanism and Intervention of Cancer Metastasis，Chongqing University Cancer Hospital，Chongqing 400030，China
- Publication Type:Journal Article
- Keywords:
ethics committee member;
core competencies
- From:
China Pharmacy
2025;36(20):2489-2494
- CountryChina
- Language:Chinese
-
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.
