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在COVID-19中,人类挑战试验的案例

George P Drewett^1,2

¹Melbourne Law School, University of Melbourne, Parkville, VIC, Australia. gdrewett@gmail.com.

Journal of bioethical inquiry

|September 18, 2023

概括

人类受控感染试验 (CHIT) 加快了对COVID-19的理解和治疗开发. 本综述审查了早期COVID-19挑战研究中CHIT历史,伦理和WHO标准的合规性.

科学领域:

传染性疾病传染性疾病
医学伦理医学伦理
临床试验临床试验

背景情况:

随着COVID-19的流行,人们迫切需要对疾病的理解和新型治疗方法的研究.
人类受控感染试验 (CHIT) 是快速研究的潜在途径.
在COVID-19时代之前,有故意感染人类和CHIT的历史先例存在.

研究的目的:

检查CHITs的历史和以前的使用情况.
在COVID-19大流行背景下分析CHIT的关键伦理考虑.
审查世界卫生组织 (WHO) 对道德COVID-19人类挑战研究的标准,并评估已开始试验的合规性.

主要方法:

蓄意感染人类和CHITs的历史审查.
分析伦理框架和指导方针,特别是世卫组织的标准.
对两个启动的COVID-19 CHIT的案例研究审查,评估它们遵守道德标准和世卫组织标准.

主要成果:

在COVID-19大流行之前,CHIT有历史基础.
在COVID-19 CHITs的背景下,出现了特定的伦理挑战.
对两家COVID-19 CHIT的评估表明它们符合世卫组织的标准和伦理考虑.

结论:

CHIT为加速COVID-19研究提供了一个有价值的模型.
在COVID-19 CHIT的设计和执行中,道德考虑至关重要.
世卫组织的标准为确保这些研究的伦理可接受性提供了一个框架.

关键词:

这是一个奇特的奇特.新冠病毒新冠病毒新冠病毒.人类挑战试验试验这是SARS-CoV-2病毒.疫苗接种疫苗接种

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