E-Learning of Informed Consent

知情同意电子学习

• 批准号: 6591003
• 负责人: WILLIAM R HENDEE
• 金额: $ 15万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591003
• 关键词: Internet; educational resource design /development; health science research; health science research support; informed consent; interactive multimedia; medical education

Growth in the number of clinical trials coupled with increasing demands to protect human research subjects, have strained Institutional Review Boards. Informed Consent, as embodied by the Study Consent Form, is a fundamental principle of human subject's research and therefore a major focus of IRB review and oversight. The content and structure of the form are a reflection of numerous federal regulations, ethical standards, and institutional policies. Errors and omissions in this document are the most common topic of discussion during IRB meetings and the most common reason why protocols are returned to the investigators for clarifications and modifications. Delays in IRB review delay patients' access to potentially life-saving experimental treatments, and frustrate investigators. Four teams (Content, Design, Technology, Testing/Assessment) will develop 21 short e-learning modules to train investigators to create Study Consent Forms. Beginning with MCW's Model Study Consent Form as a template, "standard" and "custom" language will be identified and linked with excerpts of the most relevant institutional IRB policies and regulations. Tutorials will be organized under specific sections of the Study Consent Form (Title, Purpose, Risks, etc.). The need to address frequent and high-impact errors will guide the selection and packaging of supplemental learning content, practice opportunities, and performance feedback provided to learners within each module. Modules will be delivered through a Web browser using Macromedia e-Learning Studio. Selected faculty will test the product and provide feedback for refining each learning module. Study Consent Forms submitted for IRB review will be evaluated for completeness, accuracy and compliance with guidelines using a performance checklist. We will also monitor the outcome of IRB review and a research nurse will audit the performance of the approved Study Consent Form when presented to human subjects enrolled in selected trials. Our educational approach is based on how and why adults learn. As they work through each section of the Study Consent Form, investigators can access context-related background and supplemental information on an as-needed basis. There is a reward for this task-specific "virtual mentoring" - a Study Consent Form that can be used as part of their IRB application. The modules will: (a) strengthen the protection of human subject rights and safety; (b) insure compliance with institutional policies, ethical standards, and federal regulations; and (c) by empowering investigators to produce a quality, approvable Study Consent Form, reduce the workload of IRB and investigators.

临床试验数量的增长，加上保护人类研究受试者的要求越来越高，使机构审查委员会感到紧张。知情同意，如研究同意书所体现的，是人类受试者研究的基本原则，因此是IRB审查和监督的主要重点。表格的内容和结构反映了众多的联邦法规、道德标准和机构政策。本文件中的错误和遗漏是IRB会议期间最常见的讨论主题，也是将方案返回给研究者进行澄清和修改的最常见原因。IRB审查的延误延误了患者获得可能挽救生命的实验性治疗的机会，并使研究人员感到沮丧。四个团队（内容、设计、技术、测试/评估）将开发21个简短的电子学习模块，以培训研究者创建研究同意书。从MCW的研究同意书范本开始， 将确定“标准”和“自定义”语言，并将其与最相关的机构IRB政策和法规的摘录联系起来。将根据研究知情同意书的特定章节（标题、目的、风险等）组织指导。解决频繁和高影响错误的需要将指导补充学习内容的选择和打包，实践机会，以及在每个 module.模块将通过使用Macromedia e-Learning Studio的Web浏览器提供。选定的教师将测试产品，并提供反馈，以完善每个学习模块。将使用性能检查表评价提交给IRB审查的研究知情同意书的完整性、准确性和对指南的依从性。我们还将监测IRB审查的结果，研究护士将稽查已批准研究的绩效 向入选选定试验的人类受试者提供知情同意书。我们的教育方法是基于成年人如何和为什么学习。在研究者完成研究知情同意书的每个部分时，他们可以根据需要访问上下文相关的背景和补充信息。这种特定任务的“虚拟指导”是有奖励的--一份研究同意书，可用作他们IRB申请的一部分。这些单元将：（a）加强对人类受试者权利和安全的保护;（B）确保遵守机构政策、伦理标准和联邦法规;（c）通过授权研究者制作高质量、可批准的研究同意书，减少IRB和研究者的工作量。