E-Learning of Informed Consent

临床试验数量的增长，加上保护人类研究对象的要求不断增加，给机构审查委员会带来了压力。研究同意书所体现的知情同意是人类研究的一项基本原则，因此也是IRB审查和监督的主要焦点。该形式的内容和结构反映了许多联邦法规、道德标准和制度政策。本文件中的错误和遗漏是IRB会议期间最常见的讨论主题，也是将协议退回调查人员进行澄清和修改的最常见原因。IRB审查的延迟推迟了患者获得可能挽救生命的实验治疗的机会，并使调查人员感到沮丧。四个小组(内容、设计、技术、测试/评估)将开发21个简短的电子学习模块，以培训调查人员创建研究同意书。以妇幼保健会的示范研究同意书为模板， 将确定“标准”和“习惯”语言，并将其与IRB最相关的机构政策和法规摘录联系起来。教程将在研究同意书的特定部分(标题、目的、风险等)下组织。解决频繁且影响较大的错误的需要将指导选择和打包补充学习内容、练习机会和向学习者提供的每个 模块。模块将通过使用Macromedia e-Learning Studio的网络浏览器提供。选定的教职员工将对产品进行测试，并为完善每个学习模块提供反馈。提交给IRB审查的研究同意书将使用绩效检查表评估其完整性、准确性和对指南的遵从性。我们还将监督IRB审查的结果，一名研究护士将审计批准的研究的表现 在向参加选定试验的人类受试者出示同意书时。我们的教育方法是基于成年人学习的方式和原因。在研究同意书的每个部分时，调查人员可以根据需要访问与背景相关的背景和补充信息。这种针对特定任务的“虚拟辅导”是有奖励的--一份研究同意书，可以作为他们IRB申请的一部分。这些单元将：(A)加强对人权和安全的保护；(B)确保遵守机构政策、道德标准和联邦法规；(C)通过授权调查人员出具高质量、可批准的研究同意书，减少IRB和调查人员的工作量。

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.