在实施研究中,什么构成风险? 从定性关键信息人研究的角度来看
Emmanuel K Tetteh1, Gifty Aboagye-Mensah2, Nwaliweaku Anidi2
1School of Public Health, Washington University in St. Louis, 1 Brookings Dr., St. Louis, MO, 63130, USA. emmanuel.tetteh@wustl.edu.
Implementation science communications
|February 27, 2026
概括
研究人员发现,在实施研究中定义最小风险是复杂的. 需要在与战略相关的风险和研究人员责任方面更加明确,以保护社区和系统.
科学领域:
- 实施科学 实施科学
- 生物伦理学生物伦理学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 在日常护理中实施研究需要适当的道德监督.
- 目前对最小风险的定义可能无法捕捉独特的实施研究风险.
- 研究人员对实施研究中最小风险的解释的经验数据有限.
研究的目的:
- 探索实施研究人员如何解释最小风险.
- 在实施研究中识别与风险相关的问题.
- 了解研究人员对风险评估的监管审查的经验.
主要方法:
- 与11名经验丰富的实施研究人员进行了半结构化的定性访谈.
- 针对参与者招募的有目的抽样.
- 使用接地理论方法进行主题分析.
主要成果:
- 研究人员发现,最小风险的应用复杂且取决于环境.
- 关键主题包括定义通常护理的模糊性,区分战略与干预风险,澄清谁有风险,以及理解风险类型.
- 人们对策略相关风险 (例如,员工负担) 的报告不足和审查不一致表示担忧.
结论:
- 需要加强伦理审查的清晰度,以实现与战略相关的风险和研究人员的责任.
- 建议系统地记录和公布实施策略造成的意外伤害.
- 开发特定的伦理框架和培训对于实施科学至关重要.
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