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控制的人类感染研究的伦理与C型肝炎病毒
Annette Rid1, Jordan J Feld2, T Jake Liang3
1Department of Bioethics, The Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
概括
开发一种型肝炎病毒 (HCV) 疫苗需要进行受控人类感染 (CHI) 研究. 评估HCV CHI研究的伦理对于全球HCV消除工作至关重要.
科学领域:
- 病毒学 病毒学
- 疫苗学 疫苗学 疫苗学
- 医学伦理 医学伦理
背景情况:
- 全球消除C型肝炎病毒 (HCV) 是由于缺乏有效的HCV疫苗而受到阻碍.
- 高效的HCV治疗的近期进展使得人体受控感染 (CHI) 研究成为可行的考虑因素.
- 成功治疗故意的HCV感染的可行性需要对建立HCV CHI研究计划的伦理评估.
研究的目的:
- 评估开发一种型肝炎病毒 (HCV) 控制的人类感染 (CHI) 模型的伦理考虑.
- 在全球HCV消除策略的背景下,评估HCVCHI研究的伦理可接受性.
主要方法:
- 基于10个关键考虑因素进行的伦理评估:社会价值,风险-收益概况,地点选择,参与者选择,知情同意,补偿,利益相关方参与,合作,独立审查和综合伦理研究.
- 在研究环境中进行故意的HCV感染的伦理影响的分析.
主要成果:
- 伦理评估表明,开发HCV CHI模型可以在伦理上被接受.
- 该研究确定了必须满足负责任的HCV CHI研究的具体伦理标准.
结论:
- 在适当的道德监督和遵守既定道德原则的情况下,建立HCV CHI模型在道德上是允许的.
- 开发一种HCV CHI模型是推动全球HCV消除工作的优先事项.
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