浅析脑胶质瘤临床试验中知情同意的问题  

Analysis of Informed Consent in Clinical Trials of Glioma

作　　者：王婵媛 康庄 李生兰 李文斌 WANG Chanyuan;KANG Zhuang;LI Shenglan;LI Wenbin(Neurotumor Comprehensive Treatment Ward,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China)

机构地区：[1]首都医科大学附属北京天坛医院神经肿瘤综合治疗病区,北京100070

出　　处：《医学与哲学》2024年第1期16-19,共4页Medicine and Philosophy

基　　金：2020年北京天坛医院人才引进启动基金项目(RCYJ-2020-2025-LWB);2020年北京市自然科学基金项目(J200003);2020年北京市临床重点专科项目。

摘　　要：通过对医院目前开展的脑胶质瘤临床试验知情同意过程中的观察,综合科室脑胶质瘤临床试验的开展情况,针对不同类型脑胶质瘤病人尤其是功能区受损以及伴有认知功能受限的病人,分析签署知情同意过程中存在的问题,经探讨并提出整改及解决办法。通过规范的签署知情同意,针对病情不同的脑胶质瘤受试者采取个体化签署知情同意,充分尊重受试者意愿,保证临床试验顺利进行,使受试者权益得到充分保障,促进临床试验规范、安全、有序的开展。Through the observation of the informed consent process in the current clinical trials of glioma conducted in our hospital,and based on the overall development of glioma clinical trials in our department,this paper analyzes the issues encountered during the signing of informed consent,especially among patients with different types of gliomas,particularly those with impaired functional areas and limited cognitive function.Discussions are undertaken,and solutions for rectification are proposed.By standardizing the signing of informed consent and adopting personalized informed consent for glioma participants with different conditions,their wishes are fully respected.This standardized process ensures that the rights and interests of participants are adequately protected and promotes the standardized,safe,and orderly conduct of clinical trials.

关 键 词：脑胶质瘤 临床试验 知情同意 受试者权益 

分 类 号：R-05[医药卫生]