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浅析脑胶质瘤临床试验中知情同意的问题
引用本文:王婵媛, 康庄, 李生兰, 李文斌. 浅析脑胶质瘤临床试验中知情同意的问题[J]. 医学与哲学, 2024, 45(1): 16-19. doi: 10.12014/j.issn.1002-0772.2024.01.04
作者姓名:王婵媛  康庄  李生兰  李文斌
作者单位: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
基金项目: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。



关 键 词:脑胶质瘤   临床试验   知情同意   受试者权益
收稿时间:2023-04-18
修稿时间:2023-06-15

Analysis of Informed Consent in Clinical Trials of Glioma
WANG Chanyuan, KANG Zhuang, LI Shenglan, LI Wenbin. Analysis of Informed Consent in Clinical Trials of Glioma[J]. Medicine & Philosophy, 2024, 45(1): 16-19. doi: 10.12014/j.issn.1002-0772.2024.01.04
Authors:WANG Chanyuan  KANG Zhuang  LI Shenglan  LI Wenbin
Affiliation:Neurotumor Comprehensive Treatment Ward, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China
Abstract: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.
Keywords:glioma  clinical trial  informed consent  rights and interests of participants
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