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

药事管理

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中图分类号R95；R-052 文献标志码A 文章编号1001-0408（2025）20-2489-06

DOI 10.6039/j.issn.1001-0408.2025.20.01

Development and application of core competency evaluation index system for ethics committee members of drugclinical trialinstitution

TANG Xiaohua，JIANG Qingqing， ZHANG Haiwei，MAO Weiran， YIN Yuanyuan，SUI Jiangdong，LI Jun， CHEN Xia（Chongqing Key Laboratory for the Mechanism and Intervention of Cancer Metastasis，Chongqing University Cancer Hospital， Chongqing 40o030，China）

ABSTRACTOBJECTIVETo construct anevaluation index system for thecore competencies of ethics commitee members of drugclinicaltrialinstitution，provdingabasisforoptiizingthetrainingsystemforcommiteemembers，improvingthequalityof ethicalreview，andfullysafeguarding thesafetyandrightsofsubjects.METHODSUsing methodssuchasliteratureresearchand expertconsultation，apreliminarycorecompetencyevaluation index system wasconstructed.TheDelphi methodwas employed to reviseandvalidateit，ultimatelyforminganevaluationindexsystemforthecorecompetenciesofethicscommiteemembers.Based onthissystem，aquestionnairesurveywasconductedamong9Oethicscommiteemembers from29drugclinical trial institutions nationwide，comparing theirimportanceratingandself-assessment scoresofthecorecompetencyindexes.RESULTsThe evaluationsystemconstructedincluded4primaryindicators（ethicsandprofesionalknowledge，ethicsreviewability， communicationandexpressionabilitymoralintegrityandworkstyle）and39secondaryindicators（familiaritywiththeontentof clinicaltrial-relatedlawsandregulations，abilitytocompleteprojectethicsreviewandidentifyethicaldefectsinrsearhprotocols withinashortperiodof time，abilitytojudgethescientificvalueofcliicalresearch，etc.）.Theresultsofquestionnairesurvey showed thattheinterviewed ethicscommitee members hadsignificantcapabilitygapsindimensionssuchasregulatory knowledge， ethical norms，eviewefciency，riskjudgment，andproblemanalysisThedierencesbetweentheimportanceratingscorsof correspondingsecondaryindicatorsandtheself-asessment scoreswereallno less than0.38.CONCLUsIONs Thisstudyhas developedaquantifiableandstratifiedcorecompetencyassssmenttoolforethicscommiteemembers.Itcanprovideascientific

framework for committee member training，qualification certification， and standardized management of ethics committees.

KEYWORDSethics committee member;core competencies; evaluation index system； Delphi method; questionnaire survey

临床试验是新药从实验室走向市场的必经环节，是生物医药创新的核心引擎。（剩余8514字）