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构建有效,透明和有弹性的"适合目的"的国家卫生研究伦理体系的变革性解决方案
Manju Rani1, Neha Chawla2, Nitya Wadhwa2
1Research and Innovation, South-East Regional Office of WHO (SEARO), New Delhi, India. ranim@who.int.
Health research policy and systems
|September 20, 2024
概括
拟议的研究伦理委员会 (REC) 国家在线平台旨在通过在全国范围内标准化数字流程和文档来简化伦理审查,降低成本并加速多站点研究.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 生物医学研究伦理学
- 医疗信息学 医疗信息学
背景情况:
- 目前的研究伦理审查系统依赖于孤立的机构研究伦理委员会 (RECs),其数字解决方案分散.
- 这种碎片化导致效率低下,包括延迟,成本增加和在多个地点进行研究时的挑战.
研究的目的:
- 为所有REC提出一个统一的,全国性的在线平台来管理提交和审查流程.
- 提高效率,减少行政负担,协调各机构的审查程序.
主要方法:
- 根据国家政策,开发一个具有共同审查流程和文档要求的国家在线平台.
- 利用现有的概念验证系统,如印度的e-EC和世卫组织的区域卫生研究门户.
主要成果:
- 该平台有望将数字解决方案扩展到所有REC,减少行政负担并协调审查程序.
- 它将通过协调的程序和单次提交能力促进多个地点的研究.
- 该系统可以生成国家REC和临床试验注册表等输出,避免单独干预.
结论:
- 拟议的国家在线研究伦理平台是对国家卫生基础设施的雄心勃勃但可行的投资.
- 它将加强研究生态系统,加速医疗保健创新,并通过资源共享提高REC的弹性.
- 在研究人员能力建设和提高人体审查质量的同时努力,对于最大限度地提高收益至关重要.
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