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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

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

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

IRB Policies and Procedures

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

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

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


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© 2012 University of South Alabama - Mobile Alabama 36688-0002
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Date last changed: May 13, 2015 12:38 PM
http://www.southalabama.edu/researchcompliance/irb.html

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