The evaluation framework of clinical research risk and benefit is constructed
10.12026/j.issn.1001-8565.2024.02.09
- VernacularTitle:临床研究风险与受益的评估框架构建研究
- Author:
Zhongguang YU
1
;
Hu CHEN
;
Aijuan SHENG
Author Information
1. 中日友好医院呼吸中心,北京 100029
- Keywords:
clinical research;
risk;
benefit;
grounded theory;
ethical perspective
- From:
Chinese Medical Ethics
2024;37(2):177-183
- CountryChina
- Language:Chinese
-
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.
