• Definition of Terms
• Statement of Principles
• Institutional Review Board
• Types of IRB Reviews
• Submission and Review Procedures
• Requirement of Informed Consent
• Alterations and Waivers of Informed Consent
• Alternative to Written Informed Consent
• Storage of Informed Consent Forms
• Submission of Annual Update
• Submission of Injury Reports
• Reporting Changes in Research Protocol
• Forms