关于与研究伦理委员会沟通,通过软件尽量减少风险的案例研究:在二级数据分析中记录链接的应用
Cason Schmit1,2, Alva O Ferdinand2, Theodoros Giannouchos1,3
1Population Informatics Lab, Texas A&M University, College Station, TX 77843, United States.
JAMIA open
|March 1, 2024
概括
机构审查委员会 (IRB) 的专家共同创建了用于描述二级数据研究中的增强隐私软件的语言. 这旨在改善使用复杂软件进行回顾性研究的沟通和风险评估.
科学领域:
- 医疗信息学 医疗信息学
- 生物伦理学生物伦理学
- 数据 隐私 数据 隐私 数据
背景情况:
- 研究人员经常使用复杂的软件进行追溯的二次数据分析,寻求机构审查委员会 (IRB) 的同意豁免.
- 人们对IRB专家对涉及此类软件的风险减轻策略的观点知之甚少.
- 研究人员和IRB之间的有效沟通对于导航这些复杂的研究至关重要.
研究的目的:
- 为IRB共同创建适当的语言来描述增强隐私的软件.
- 了解IRB专家对二次数据研究软件相关风险,好处和信息需求的看法.
- 开发涉及隐私增强软件的IRB应用程序的模板材料.
主要方法:
- 两个结构化的焦点小组与IRB专家一起确定关键考虑因素.
- 开发一个模板IRB应用程序和使用隐私增强软件进行研究的响应.
- 与17名专家一起进行了三轮的Delphi研究,以根据反来改进模板材料.
主要成果:
- 焦点小组产生了13个关于风险,益处和信息需求的想法.
- 大多数专家都认为,增强隐私的软件可以最大限度地降低风险,但二次数据研究中仍然存在固有的披露风险.
- 大多数人 (84.6%) 认为,只有追溯数据的研究,没有与受试者接触,风险最小.
结论:
- 在IRB专家之间存在关于二次数据研究中的风险的分歧,这可能会影响审查结果.
- 隐私增强软件的风险和好处排名最高的是社会风险 (例如,促进研究,无效结果的风险).
- 有效的沟通和协作,在设计过程的早期 (隐私-by-design) 结合隐私专家,对于开发增强隐私技术至关重要.
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