中国医学伦理学2024，Vol.37Issue(2)：177-183,7.DOI:10.12026/j.issn.1001-8565.2024.02.09
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
摘要
Abstract
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Key words
clinical research/risk/benefit/grounded theory/ethical perspective引用本文复制引用
余中光,陈虎,盛艾娟..临床研究风险与受益的评估框架构建研究[J].中国医学伦理学,2024,37(2):177-183,7.基金项目
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) （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) （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) （2023-NHLHCRF-GLMS-14）
