Cooksey Krista E, Goldstein Eliana, Lee Clara, Mozersky Jessica, Kaphingst Kimberly A, Gallegos Victor Catalan, Politi Mary C
Department of Surgery, Division of Public Health Sciences, Washington University School of Medicine, St. Louis, MO, USA.
Department of Surgery, Division of Plastic and Reconstructive Surgery, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
J Clin Transl Sci. 2024 Nov 21;8(1):e218. doi: 10.1017/cts.2024.662. eCollection 2024.
The 2018 Common Rule revision intended to improve informed consent by recommending a concise key information (KI) section, yet provided little guidance about how to describe KI. We developed innovative, visual KI templates with attention to health literacy and visual design principles. We explored end users' attitudes, beliefs, and institutional policies that could affect implementing visual KI pages.
From October 2023 to April 2024, we conducted semi-structured interviews with principal investigators, research staff, and Institutional Review Board (IRB) personnel, including those in oversight/management, and community partners. Forty participants from three academic institutions (in the Midwest, Southeast, and Mountain West) viewed example KI pages and completed interviews. We coded written transcripts inductively and deductively based on the capability, opportunity, and motivation to change behavior (COM-B) framework. Data were analyzed using content analysis and organized thematically.
Participants responded positively to the visual KI examples. They discussed potential benefits, including improving information processing and understanding of study procedures, diversity in research, trust in research, and study workflow. They also described potential challenges to consider before widespread implementation: IRBs' interpretations of federal guidelines, possible impacts on IRB submission processes, the effort/skill required to develop visuals, and difficulty succinctly communicating study risks. There was no consensus about when to use visual KI during consent, and some wondered if they were feasible for all study types.
Visual KI offers a promising solution to long-standing informed consent challenges. Future work can explore resources and training to address challenges and promote widespread use.
2018年《通用规则》修订旨在通过推荐一个简洁的关键信息（KI）部分来改善知情同意，但对于如何描述关键信息提供的指导很少。我们开发了创新的可视化关键信息模板，同时关注健康素养和视觉设计原则。我们探讨了最终用户可能影响实施可视化关键信息页面的态度、信念和机构政策。
2023年10月至2024年4月，我们对主要研究者、研究人员和机构审查委员会（IRB）人员进行了半结构化访谈，包括监督/管理人员和社区合作伙伴。来自三个学术机构（中西部、东南部和山区西部）的40名参与者查看了关键信息页面示例并完成了访谈。我们根据行为改变的能力、机会和动机（COM-B）框架对书面记录进行了归纳和演绎编码。使用内容分析对数据进行分析并按主题进行整理。
参与者对可视化关键信息示例反应积极。他们讨论了潜在的好处，包括改善信息处理和对研究程序的理解、研究的多样性、对研究的信任以及研究工作流程。他们还描述了在广泛实施之前需要考虑的潜在挑战：IRB对联邦指南的解释、对IRB提交过程的可能影响、开发可视化所需的努力/技能以及简洁传达研究风险的困难。对于在同意过程中何时使用可视化关键信息没有达成共识，一些人怀疑它们是否适用于所有研究类型。
可视化关键信息为长期存在的知情同意挑战提供了一个有前景的解决方案。未来的工作可以探索资源和培训，以应对挑战并促进广泛使用。
