摘要
随着人口老龄化情况的加剧,针对老年人的临床研究日益增多,如何保障临床研究中老年人的健康和权益,降低其风险,是老年医学研究工作中亟待解决的问题。针对老年临床研究纳入年龄限制、知情同意履行、多重用药的方案设计以及审查专业性等主要问题进行分析,提出保护老年人权益的相应方法及措施,以期提升老年临床研究质量,保障老年受试者的权益。
With the aggravation of aging population in China, clinical research on the elderly is increasing. How to protect the health and rights of the elderly as vulnerable groups in clinical research and reduce their risks is an urgent problem to be solved in the research of geratology. This paper analyzed the main problems including the inclusion of age limits, the performance of the informed consent, the scheme design of multiple drugs and the professionalism of review in geriatric clinical research, and proposed corresponding countermeasures to protect the rights and interests of the elderly, in order to improve the quality of geriatric clinical research and protect the rights and interests of elderly subjects.
作者
王世婷
陈其
贾仁兵
王艳
WANG Shiting;CHEN Qi;JIA Renbing;WANG Yan(Department of Scientific Research,Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200011,China)
出处
《中国医学伦理学》
2022年第9期1007-1011,共5页
Chinese Medical Ethics
基金
上海交通大学医学院科技创新项目“医院研究者发起的临床研究项目质量评价体系研究”(wk2113)。
关键词
老年医学
临床研究
伦理审查
知情同意
Geratology
Clinical Research
Ethical Review
Informed Consent