儿童药物临床试验的受试者保护问题研究——基于伦理审查视角
Study on subject protection in clinical trials of pediatric drugs:from the perspective of ethical review
方中坚 1沈家辉 2王彩依 3杜沛龙 2汪颖霞 2朱思琪 2邵明立 3樊玉录2
作者信息
- 1. 上海健康医学院药学院,上海 201318;中国药科大学,南京 211198
- 2. 上海健康医学院药学院,上海 201318
- 3. 中国药科大学,南京 211198
- 折叠
摘要
儿童是一类敏感的特殊群体,其身心状况与成人有着显著的不同.儿童药物临床试验的开展需要考虑到的因素众多.我国儿童药物临床试验体系尚处于萌芽阶段,存在一些不成熟的地方,这可能会威胁到受试者的安全与权益.本研究根据儿童临床试验的特点,结合儿童作为特殊受试者群体的权益保护需求,就知情同意、研究队伍建设、试验风险管理等方面进行探讨,以期为我国儿童药物临床试验体系完善提供理论参考.
Abstract
Children are a sensitive and special group,and their physical and mental conditions are significantly different from those of adults.There are many factors that need to be considered in the conduct of clinical trials of pediatric drugs.The clinical trial system of pediatric drugs in China is still in its infancy,with some immature aspects that may threaten the safety and rights of the subjects.Based on the characteristics of pediatric clinical trials and the protection needs of children as a special group of subjects,this study explored the aspects such as informed consent,research team building,and trial risk management,in order to provide theoretical references for the improvement of China's pediatric drug clinical trial system.
关键词
药物临床试验/伦理审查/儿童药物/隐私保护Key words
clinical trials of drugs/ethical review/pediatric drugs/privacy protection引用本文复制引用
基金项目
上海健康医学院2023年科研骨干校外学术导师制项目(AMSCP-23-07-01)
国家自然科学基金资助项目(81860179)
上海市教委教师发展工程产学研践习-上海交通大学项目(A1-2601-19-311219)
出版年
2024
NETL
NSTL
万方数据