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Office of Research Compliance and Assurance

Human Subjects

IRB Policies and Procedures
USA Policies/Guidelines
- IRB SOPs (2014)
- Guidelines for Quality Improvement Research (February 2009)
- HIPAA Information
- Consent Form Elements (pdf file)
- Consent Process Document (Word doc)
- Informed Consent Certificate (Word doc)
- Guidance for Conflicts Disclosure in Informed Consent (Word doc)
- Requirements for Humanitarian Use Device (HUD) (pdf file)
- Regulatory Requirements: Human Gene Transfer (pdf file)
- Protocol Deviation/Violation Reporting Policy (Word doc)
- Guidance on Conducting Computer-Based Research (pdf file)
- Medical Research Subject's Bill of Rights (pdf file)

Ethical Principles of Human Subjects Research
- The Belmont Report
- The Nuremberg Code
- The Declaration of Helsinki

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