Charles River Campus (CRC) Institutional Review Board (IRB) Forms

• IRB New Protocol Application (iPDF) (required for new submissions)
• IRB New Protocol Application (DOC) (required for new submissions)
• BU Conflict of Interest Form (PDF) (required for all non-funded submissions)
• Single IRB Review Request (iPDF) (optional for cross-campus collaborative projects)
• Single IRB Review Request (DOC) (optional for cross-campus collaborative projects)

Boston University Policies for the Protection of Human Subjects

• CRC Assurance of Compliance with DHHS Regulations (PDF)
• Conflict of Interest Policy (PDF)
• IRB Memorandum on Stamped Recruitment Materials/Consent Forms (PDF)
• Single IRB Review Policy (PDF)

Federal Policies for the Protection of Human Subjects

• 45CFR46 - Protection of Human Subjects
• 56FR28002 - Protection of Human Subjects; Notices and Rules
• 63FR60364 - Categories of Research Reviewed via Expedited Review Procedures
• Belmont Report

Guidance for Human Subjects Researchers and IRB Applicants

• 21CFR812 - FDA Regulations - Investigational Device Exemptions
• FDA Information Sheet - Investigational Use of Drugs, Biologics, and Medical Devices
• DHHS Engagement in Research Memo
• DHHS Policies, Regulations and Guidance for Human Subjects Protection