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Updated: Jul 12, 2025

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保护参与研究的人类受试者
Min-Fu Tsan1, J Thomas Puglisi1
1Research Service, McGuire Research Institute Richmond, VA, USA.
American journal of translational research
|October 19, 2023
概括
绩效指标显示,退伍军人事务部的人类研究保护计划有效地保护了受试者. 2010-2021年的数据显示,在保护人类研究参与者方面有显著的改善.
科学领域:
- 临床研究监督 临床研究监督
- 人类对象保护 人类对象保护
- 医疗保健服务研究 医疗服务研究
背景情况:
- 进行人类受试者研究的机构利用机构审查委员会 (IRB) 和人类研究保护计划 (HRPP) 来保护参与者.
- 评估这些保护措施的有效性对于维持研究伦理标准至关重要.
研究的目的:
- 开发和实施绩效指标,以评估HRPP在保护人类研究对象方面的有效性.
- 评估退伍军人事务部 (VA) 研究设施的IRB和HRPP的表现.
主要方法:
- 开发了一套五个关键绩效指标来衡量人类研究对象的保护.
- 通过对107个VA设施的知情同意文件和研究协议的年度审计收集数据.
- 分析了从2010年到2021年的数据.
主要成果:
- 所有五个绩效指标的事件率始终很低.
- 三个指标显示了统计学上显著的改善趋势,减少了70%至100%.
- 在研究期间,没有任何绩效指标显示有效性下降.
结论:
- 在2010年至2021年期间,VA HRPP在保护人类研究对象方面表现出有效性.
- 开发的绩效指标对于监测和提高HRPP有效性非常有价值.
- 使用这些指标的持续监测可以加强对人类研究参与者的保护.
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