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在医学上脆弱的人身上进行危险的首次人体临床试验:承担道德成本
1College of Medicine, Central Michigan University, Mt. Pleasant, MI, USA. cabobier@gmail.com.
Theoretical medicine and bioethics
|September 11, 2024
概括
首次在人体 (FIH) 试验优先考虑社会利益而不是参与者收益,这带来了伦理困境. 该研究主张对参与风险性FIH临床试验的参与者进行公平的补偿,以承认这种道德紧张.
科学领域:
- 临床研究伦理学
- 这是第一次对人类进行试验.
- 参与者的安全和赔偿.
背景情况:
- 首次在人身上 (FIH) 临床试验对于评估药物/设备的安全性,副作用和人类的剂量至关重要.
- FIH试验的首要目标是产生知识 (基线人体安全),而不是直接的参与者利益.
- 一些FIH试验涉及显著可预见的风险与最小可预见的参与者利益.
研究的目的:
- 探索高风险,低收益的FIH研究中的伦理紧张关系.
- 倡导对参与风险高的FIH临床试验的参与者提供公平的补偿.
- 提出解决FIH研究中的伦理不平衡的机制.
主要方法:
- 在FIH试验中风险-收益的伦理分析.
- 基于道德原则的参与者补偿的论证.
- 讨论社会利益对有风险的研究的理由.
主要成果:
- FIH试验在社会利益和参与者风险之间存在着固有的伦理紧张关系.
- 风险性FIH研究的当前理由依赖于潜在的社会利益.
- 参与者补偿是作为一种以道德方式解决这种紧张局势的手段.
结论:
- 对参与高风险的FIH试验的参与者进行公平的补偿是道德上合理的.
- 补偿不会改变风险/收益比率,但承认道德妥协.
- 这种方法促进了对FIH研究的伦理挑战的集体考虑.
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