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IRB同意指南:研究多样性的潜在障碍
Evan Decker1, Tana Chongsuwat1
1University of Wisconsin, Madison, WI, USA.
Health promotion practice
|August 2, 2024
概括
机构审查委员会 (IRB) 的指导方针可能会阻碍边缘化群体参与研究. 替代性口头同意流程提高了低识字率的多样化人口的效率和包容性.
科学领域:
- 临床研究 临床研究
- 健康 公平 卫生 公平
- 卫生社会学 卫生社会学
背景情况:
- 在历史上,少数民族和种族少数群体在研究研究中的参与率很低.
- 现有的机构审查委员会 (IRB) 准则虽然对于道德实践来说是必要的,但可能会无意中为这些人群创造障碍.
- 对于具有不同语言背景和不同识字水平的社区来说,标准的同意翻译过程可能是低效和不切实际的.
研究的目的:
- 探索与非英语语言和边缘化群体的研究中传统同意过程的挑战.
- 提出和评估替代的,更具包容性的同意方法.
- 倡导对IRB指导方针进行调整,以减少障碍并促进研究中的多样性.
主要方法:
- 威斯康星大学的IRB批准了一种替代的口头同意程序,用于涉及赫蒙族,卡伦族,卡伦族和缅甸族群的研究.
- 经过翻译的同意材料以每个参与者的母语以录制形式提供.
- 在参与之前,在研究地点获得了口头同意,容纳无法阅读母语的参与者.
主要成果:
- 由于母语书面语言的识字率较低,标准的书面同意程序被发现是困难和不切实际的.
- 获得翻译人员的机会和同意翻译过程本身都带来了显著的时间和资源限制.
- 替代性口头同意过程,包括录制材料和口头同意,对于参与者和研究人员来说都是有效的.
结论:
- 调整与同意相关的IRB指南可以消除研究中的时间和资源障碍.
- 更具包容性的同意方法可以提高研究设计和推广的效率.
- 强调口头语言和适应的同意流程可以增强文盲程度较低的人群之间的研究多样性.
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