机构审查委员会对当地环境的评估:一种混合方法研究
Timothy C Guetterman1, Adrianne Haggins2, Sacha Montas2
1Assistant professor in the Department of Family Medicine at the University of Michigan.
Ethics & human research
|January 19, 2024
概括
机构审查委员会 (IRB) 在审查多中心试验的当地环境时面临挑战. 了解利益相关者的看法是改善单一IRB审查流程和确保一致的本地环境评估的关键.
科学领域:
- 临床研究 临床研究
- 监管科学 监管科学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 机构审查委员会 (IRB) 对当地环境的审查缺乏明确的定义.
- 针对多中心试验的单一IRB (sIRB) 审查任务需要更好地了解本地上下文审查的实施.
- 利益相关者对本地背景审查的观点对于优化集中审查流程至关重要.
研究的目的:
- 通过探索利益相关者的态度和看法,务实地理解IRB的当地环境审查.
- 确定如何在实践中解释和实施本地上下文审查.
- 探讨中央集中的地方背景审查的担忧和优势.
主要方法:
- 与26名IRB成员,工作人员,机构官员和调查人员进行了半结构化采访.
- 对类似的利益相关者群体进行了80项调查.
- 通过基于主题的文本分析分析定性数据和带有描述性统计数据的定量数据.
主要成果:
- 利益相关者定义了"本地环境",并在IRB审查中阐述了其价值.
- 确定实施本地上下文审查的关键流程,包括允许例外的紧急研究.
- 对中央集中的本地背景审查表示了担忧和潜在的优势.
- 揭示了利益相关者对当地背景审查的观点的变化.
结论:
- 地方上下文审查不是一个离散的,统一理解的过程.
- 观点的变化为定义单一IRB审查的更清晰途径提供了机会.
- 需要进一步的研究和标准化,以优化sIRB对当地环境的审查.
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