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Office of Research Compliance and Assurance

 

 
Human Subjects
 
IRB Forms, Policies, Guidelines and Ethical Principles
 
 
Forms (Word Format)
-Biomedical Research Application Form (Revised 12/2008)
-Social/Behavioral/Educational Research Application Form (Revised 12/2008)
-Exempt Application (Updated 3/2009)
-Guide to Exempt Review Process (Updated 12/2008)
-IRB Continuing Review Form / Renewal Form (Updated 12/2008)
-IRB Amendment/Revision Form (Updated 11/2007)
-IRB Final Report Form (Posted 11/2007)
-Protocol Deviation/Violation Reporting (Updated 1/2007)
-Adverse Event: Investigator's Report Form (Updated 11/2006)
-Storage of Biological Materials (Updated 10/2004)
 
 
USA Policies/Guidelines
-IRB SOPs (December 2008)
-IRB Guidelines (Updated 8/2008)
-Federal Wide Assurance of Protection for Human Subjects (pdf file)
-Guidelines for Quality Improvement Research (February 2009)
-HIPAA Information
-Statement of Regulatory Compliance (pdf file)
-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)
-Regulatory Compliance Statement (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
 
 
 
 
 
 

University of South Alabama - Mobile Alabama 36688-0002
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Date last changed: November 17, 2009 3:55 PM
http://www.southalabama.edu/researchcompliance/irb.html
University of South Alabama