These materials are being prepared as updated guidance for investigators, IRB members, and the research community and will be submitted for certification by the Association for the Accreditation of Human Research Protection Programs.

We solicit your comments and feedback for usefulness and clarity. As documents are prepared and updated, this work in progress will be expanded.

  1. Human Research Protection Program
  2. IRB Oversight
  3. IRB Application Process
  4. Review Procedures
  5. Recruiting and Informed Consent Process
  6. IRB Documentation
  7. Special Conditions and Populations
    • Protection of Vulnerable Subjects and Special Populations SOP
      • Permitted Categories of Research in Children
        • Summary Table of Requirement Protections for Children in Research
        • General Consent Guidelines for Research Involving Children
        • Rationale for Inclusion of Children in Research
        • Waiver of Child's Assent
  8. Clinical Trials
  9. Conduct of Research
  10. Glossary of Lay Terms