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Institutional Review Board

Policy Material (Institutional Review Board & HIPAA)

Pepperdine University
Protection of Human Participants in Research:
Policies and Procedures Manual

MS Word document of the entire manual

Dr. Doug Leigh & Dr. Steven Rouse

Sections from the Policies and Procedures Manual

  • Exempted Research Activities    (MS Word)
  • Expedited Review Activities    (MS Word)
  • Informed Consent Instructions    (MS Word)

Human Participants Policies & Procedures Amendment Process

  • Amendment Guidelines    (MS Word)
  • Changes to the IRB Manual - 2004
  • Changes to the IRB Manual - 2005
Human Subjects Regulations/Statutes
  • Federal Regulation Code - Title 45, Part 46    (en espaƱol)
  • California Health & Safety Code
  • CA - Experimental Subjects Bill of Rights     (MS Word)
  • Belmont Report

Agency Specific Statutes

  • Department of Education
    • 34 CFR Part 97
    • 34 CFR Part 98 - Protection of Pupil Rights Amendment (PPRA)
    • 34 CFR Part 99 - Family Education Rights and Privacy Act (FERPA)
  • National Science Foundation
    • 45 CFR 690
  • Food and Drug Administration
    • 21 CFR Part 50
    • 21 CFR Part 56
  • Department of Veterans Affairs
    • 38 CFR 16

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  • IRB Links
  • Investigator Education
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