Human Subjects

IRB Policies and Procedures   USA Policies/Guidelines -IRB SOPs (April 2011) -IRB Guidelines (Updated 8/2008) -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