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Office of Research Compliance and Assurance

Human Subjects   

IRB Policies and Procedures
USA Policies/Guidelines   
- IRB SOPs   
- 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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