沙特阿拉伯的机构审查委员会:首份基于调查的关于其职能和运作的报告
Areej AlFattani1, Norah AlBedah2, Asma AlShahrani2
1Biostatistics, Epidemiology and Scientific computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. aralfattani@kfshrc.edu.sa.
沙特机构审查委员会 (IRB) 通常表现良好,但需要增强资源和组织改进. 新的IRB在伦理研究审查过程中显示出更高的分数和效率.
科学领域:
- 生物医学研究伦理学
- 医疗服务研究 医疗服务研究
背景情况:
- 机构审查委员会 (IRB) 对于监督生物医学研究伦理和保护人类参与者至关重要.
- 障碍物可能会延迟IRB流程并造成冲突,需要对其功能进行评估.
研究的目的:
- 评估沙特阿拉伯的IRB的职能,角色,资源和审查过程.
- 确定该国内部IRB运营需要改进的领域.
主要方法:
- 在沙特阿拉伯对53名IRB主席和管理人员进行了横截面调查.
- 该调查评估了IRB运营的八个方面,包括组织因素,会员资格,提交,审查程序和资源.
主要成果:
- 二十六个IRB参与了,平均得分为150/200. 新的IRB通常表现更好.
- 组织方面的评分最低,这表明需要有针对性的改进.
- 平均审查时间为加速审查7天,全面委员会审查20.5天.
结论:
- 沙特IRB在伦理研究监督方面表现良好.
- 显然需要加强资源和组织改进,由监管机构指导.
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