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.
