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获得人类临床研究的好处. 美德伦理与规范伦理对比
1Pontificia Università della Santa Croce. Pzza di S. Apollinare 49, 00186-Roma. requena@pusc.it, +39 348 03 10 227.
概括
临床试验的试验后访问 (PTA) 仍然有限,特别是在发展中国家. 本研究审查了目前的PTA实践和伦理准则,倡导改善研究公平.
科学领域:
- 临床研究伦理学
- 全球卫生平等全球卫生平等
- 制药政策 制药政策
背景情况:
- 临床试验参与者的试验后访问 (PTA) 是一个不断发展的伦理考虑,在赫尔辛基宣言中得到了正式的形式.
- 尽管有道德要求,但在过去二十年中,PTA的实际实施,特别是在发展中国家,进展有限.
- 现有的制药公司关于PTA的信息往往不反映实际可用性.
研究的目的:
- 提出关于临床研究中试验后访问当前可用性的经验数据.
- 批判性地分析有关PTA的国际伦理准则.
- 探讨在实现普遍遵守PTA任务方面的挑战,并为公平的研究提出道德框架.
主要方法:
- 对近期实证数据的分析,这些数据是关于审判后访问的实际可用性.
- 对国际知名临床研究基准指南的审查.
- 检查伦理框架及其对研究公平性的影响.
主要成果:
- 经验数据显示,PTA政策和实际实践之间存在很大的差距.
- 国际准则虽然在不断发展,但对普遍实施和执行提出了挑战.
- 在资源有限的环境中实现PTA的进展仍然不足.
结论:
- 对于临床研究来说,有必要超越规范性伦理原则,转向良性伦理范式.
- 促进公平和支持性的研究努力需要实际的解决方案,以确保有意义的审判后访问.
- 解决PTA稀缺问题对于道德全球健康研究和参与者福利至关重要.
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