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人类挑战研究的伦理要求:对原因的系统审查
Matthias Katzer1, Sabine Salloch1, Christoph Schindler2
1Institute for Ethics, History, and Philosophy of Medicine, Hannover Medical School (MHH), Hannover, Germany.
人类挑战研究 (HCS) 涉及故意感染病原体的志愿者. 这些试验的伦理要求很复杂,关键问题包括参与者的安全,知情同意和撤回权.
科学领域:
- 医学伦理 医学伦理
- 临床试验设计 临床试验设计
- 传染病研究 传染病研究
背景情况:
- 人类挑战研究 (HCS) 越来越多地用于疾病研究,促使道德审查,特别是在COVID-19后.
- 最近的一场伦理辩论集中在进行HCS的可接受性和要求上.
- 了解这些伦理考虑对于负责任地推进HCS至关重要.
研究的目的:
- 对人类挑战研究的伦理要求进行分类和总结.
- 识别和分析这些道德要求背后的原因.
- 突出HCS中特别敏感和有争议的伦理问题.
主要方法:
- 从多个数据库 (PubMed,Google Scholar,BELIT,PhilPapers) 中对伦理学文献进行系统审查.
- 收录标准:关于HCS伦理的学术文章 (研究,评论,社论等). ) 的情况.
- 从161个出版物中提取10个主题类别的183个要求和理由的定性内容分析.
主要成果:
- 确定了183个伦理要求和HCS的理由,按主题分类.
- 出现了三个特定于HCS的敏感问题:撤回权,研究人员与公众的沟通和知情同意.
- 突出了四个有争议的问题,而不是特定于HCS:可接受的风险,参与者付款,弱势群体和国际合作标准.
结论:
- 人类挑战研究的伦理要求是多方面的,包括研究的具体和一般的研究伦理问题.
- 需要进一步讨论,以便为HCS制定更明确的伦理准则.
- 伦理指导文件中的精细指令可能是必要的,以解决当前的争议.
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