临床研究风险与受益的评估框架构建研究  

The evaluation framework of clinical research risk and benefit is constructed

作　　者：余中光[1] 陈虎[2] 盛艾娟[3] YU Zhongguang;CHEN Hu;SHENG Aijuan(Center for Respiratory,China-Japan Friendship Hospital,Beijing 100029,China;Department of Research,Cangzhou Central Hospital,Cangzhou 061001,China;Ethical Committee,Beijing YouanHospital Affiliated to Capital Medical University,Beijing 100069,China)

机构地区：[1]中日友好医院呼吸中心,北京100029 [2]沧州市中心医院科研处,河北沧州061001 [3]首都医科大学附属北京佑安医院伦理委员会,北京100069

出　　处：《中国医学伦理学》2024年第2期177-183,共7页Chinese Medical Ethics

基　　金：国家自然科学基金青年基金项目“临床研究伦理审查风险与受益评估指标体系研究”(72104255);中国医学科学院医学与健康科技创新工程项目“基于卫生健康体系学的健康中国建设战略研究”(2021-I2M-1-046);中日友好医院高水平项目“临床研究风险评估量表开发与应用研究——以呼吸领域项目为例”(2023-NHLHCRF-GLMS-14)。

摘　　要：目的当前医疗机构伦理委员会主要依靠经验来分析临床研究风险与受益,缺乏风险与受益评估框架。方法采用扎根理论法对国内29名伦理审查工作者进行访谈分析,通过开放式编码、主轴式编码、选择式编码,构建中国临床研究风险与受益框架;采用NVivo11软件对资料进行存储、整理、编码和分析。结果基于中国国情提出了临床研究风险与受益框架,临床研究风险由生理风险、心理风险、经济风险和社会风险构成,研究受益由研究参与者受益和社会受益构成。结论系统阐述临床研究风险与受益内涵,构建适用于中国的临床研究风险与受益框架,在理论研究方面具有一定创新性,也为研究人员、伦理委员会评估临床研究的风险和潜在受益提供借鉴。Objective:Currently,the medical Institutional Review Board(IRB)mainly rely on experience to analyse the risks and benefits of clinical research,lacking an assessment framework of risks and benefits.Methods:Using grounded theory,interviews were conducted on 29 ethical review workers in China.Through open coding,spindle coding,and selective coding,the framework of risks and benefits for clinical research in China was constructed.NVivo11 software was used for data storage,organization,encoding,and analysis.Results:A framework of risks and benefits for clinical research was proposed based on China’s national conditions.Clinical research risks consisted of physiological risk,psychological risk,economic risk,and social risk.Research benefits consisted of subject benefits and society benefits.Conclusion:This paper systematically explained the connotation of the risks and benefits of clinical research,and constructed a framework of the risks and benefits of clinical research applicable to China.It has certain innovations in theoretical research,and also provides use for reference for researchers and ethics committees to evaluate risks and potential benefits in clinical research.

关 键 词：临床研究 风险 受益 扎根理论 伦理视角 

分 类 号：R-052[医药卫生]