Bona Jonathan P, Utecht Joseph, Kemp Aaron S, Gan Jennifer M, Caballero Alison, Trudeau Christopher R, Brochhausen Mathias, James Laura
Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Department of Psychiatry, University of Arkansas for Medical Sciences, USA.
J Clin Transl Sci. 2022 Dec 1;7(1):e3. doi: 10.1017/cts.2022.507. eCollection 2023.
BACKGROUND/OBJECTIVE: Informed consent forms (ICFs) and practices vary widely across institutions. This project expands on previous work at the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy to develop a plain language ICF template. Our interdisciplinary team of researchers, comprised of biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board (IRB) process, has developed the ICF Navigator, a novel tool to facilitate the creation of plain language ICFs that comply with all relevant regulatory requirements.
Our team first developed requirements for the ICF Navigator tool. The tool was then implemented by a technical team of informaticists and software developers, in consultation with an informed consent legal expert. We developed and formalized a detailed knowledge map modeling regulatory requirements for ICFs, which drives workflows within the tool.
The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator uses those responses to produce a clear and compliant ICF, displaying a real-time preview of the final form as content is added. Versioning and edits can be tracked to facilitate collaborative revisions by the research team and communication with the IRB. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand.
The ICF Navigator is an innovative, customizable, open-source software tool that helps researchers produce custom readable and compliant ICFs for research studies involving human subjects.
背景/目的：各机构的知情同意书（ICF）及操作差异很大。本项目是阿肯色大学医学科学中心（UAMS）健康素养中心此前工作的拓展，旨在开发一个使用通俗易懂语言的ICF模板。我们的跨学科研究团队由生物医学信息学家、健康素养专家以及机构审查委员会（IRB）流程中的利益相关者组成，已开发出ICF导航器，这是一种新颖的工具，可促进创建符合所有相关监管要求的通俗易懂的ICF。
我们的团队首先制定了ICF导航器工具的要求。然后，一个由信息学家和软件开发人员组成的技术团队在一位知情同意法律专家的咨询下实施了该工具。我们开发并正式确定了一个详细的知识图谱，对ICF的监管要求进行建模，该知识图谱驱动工具内的工作流程。
ICF导航器是一个基于网络的工具，在研究人员回答有关其项目的问题时，引导他们创建ICF。导航器利用这些回答生成一份清晰且合规的ICF，在添加内容时显示最终表格的实时预览。可以跟踪版本控制和编辑，以方便研究团队进行协作修订以及与IRB进行沟通。该导航器有助于指导创建特定研究的语言，确保符合监管要求，并确保生成的ICF易于阅读和理解。
ICF导航器是一款创新的、可定制的开源软件工具，可帮助研究人员为涉及人类受试者的研究生成定制的、可读且合规的ICF。
