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对拟议的知情同意的视觉关键信息页面进行定性评估
Krista E Cooksey1, Eliana Goldstein1, Clara Lee2
1Department of Surgery, Division of Public Health Sciences, Washington University School of Medicine, St. Louis, MO, USA.
Journal of clinical and translational science
|January 10, 2025
概括
视觉关键信息 (KI) 模板可以提高对研究研究的理解. 参与者发现视觉AI是有益的,尽管像IRB解释和风险沟通这样的挑战需要解决,以便更广泛地使用.
科学领域:
- 健康素养和患者参与临床研究.
- 人与计算机在医疗保健中的互动.
- 监管科学和研究伦理学.
背景情况:
- 2018年共同规则的修订旨在通过简短的关键信息 (KI) 部分来加强知情同意.
- 有限的指导存在于有效地呈现KI,特别是在视觉设计和健康素养方面.
研究的目的:
- 开发和评估创新的,视觉关键信息 (KI) 模板,以获得知情同意.
- 探索最终用户的态度,信仰和影响视觉AI页面实施的机构因素.
主要方法:
- 在三个学术机构中,与40名参与者 (主要调查员,研究人员,IRB人员,社区合作伙伴) 进行了半结构化访谈.
- 参与者审查了视觉AI页面的示例,并提供了反.
- 采访成绩单使用基于COM-B框架和主题分析的归纳和演编码进行分析.
主要成果:
- 参与者对视觉人工智能示例做出了积极反应,引用了诸如改进信息处理,理解研究程序以及对研究的信任增强等好处.
- 发现的潜在挑战包括IRB对指导方针的解释,对提交流程的影响,开发工作以及沟通研究风险.
- 在所有研究类型中,在同意和可行性期间对视觉AI使用的最佳时间缺乏共识.
结论:
- 视觉人工智能提出了一种有希望的方法来应对知情同意方面的挑战.
- 需要进一步的研究来开发资源和培训,以克服实施障碍,并促进视觉AI的更广泛采用.
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