1例聋哑文盲乳腺癌患者参与临床研究的伦理学分析  

Ethical analysis of a deaf-mute and illiterate breast cancer patient participating in clinical research

作　　者：李康琪[1] 魏宇梅 沈一峰 LI Kangqi;WEI Yumei;SHEN Yifeng(Clinical Trial Institution Office,Yantai Yuhuangding Hospital,Yantai 264001;Medical Institution conducting Clinical Trial,Shanghai mental health center,Shanghai Jiao Tong University School of Medicine,Shanghai 200032,China)

机构地区：[1]烟台毓璜顶医院药物临床试验机构办公室,山东烟台264001 [2]上海交通大学医学院附属精神卫生中心临床试验机构,上海200032

出　　处：《中国医学伦理学》2024年第8期915-918,共4页Chinese Medical Ethics

基　　金：上海市科委科技创新行动计划“医院制剂达营片治疗抗精神病药致泌乳素升高引起月经不调的临床前有效性与安全性研究”(22S21902300);上海申康医院发展中心医企融合创新支撑技能培训专项“旨在优化服务研究者、受试者和申办者的临床研究软环境建设集成”(SHDC2022CRS032)。

摘　　要：弱势研究参与者参与临床试验会引发一定的伦理学挑战,他们需要得到研究者、伦理委员会和管理部门的特别关注。以1例聋哑文盲研究参与者参与一项乳腺癌临床试验为例,探讨针对该研究参与者知情同意能力不足的特点进行的伦理学思考,以及为保障其合规地参加临床试验所采取的措施,进而为这一类伦理问题的应对提供思路。在临床试验实施过程中,研究者应评估研究参与者知情同意能力的水平,落实研究参与者的知情权和选择权,合乎规范地履行知情同意。对于存在弱势因素导致知情同意困难的研究参与者,不应将其过度地排除在研究之外,而应该采取针对性的保障措施,促进临床试验在遵守各项伦理原则的前提下高效实施。Vulnerable research participants participating in clinical trials pose certain ethical challenges,and they require special attention from researchers,ethics committees,and management departments.Taking a deaf-mute and illiterate research participants participating in a clinical trial of breast cancer as an example,this paper discussed the ethical considerations regarding the research participants’s insufficient capacity for informed consent,as well as the measures taken to ensure their compliance in the clinical trial,further provided ideas for dealing with this type of ethical issues.During the implementation of clinical trials,researchers should assess the level of informed consent ability of research participants,implement the research participants’rights to know and choose,and perform informed consent in a standardized manner.For research participants whose vulnerable factors make it difficult for them to give informed consent,they should not be excessively excluded from the research.Instead,targeted safeguards should be taken to promote the efficient implementation of clinical trials on the premise of complying with various ethical principles.

关 键 词：弱势研究参与者 临床研究 医学伦理学 聋哑人 文盲 

分 类 号：R-052[医药卫生]