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Medical IRBs

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  1. The Institutional Review Board at Stanford
    1. Charge to the Administrative Panels on Human Subjects in Medical Research-IRB  CHG-1
    2. Charge to the Administrative Panel on Human Subjects in Medical Research-IRB/SCRO  CHG-3
    3. Excerpt from HRPP Policy Manual, Ch. 6.3 IRB Composition and Membership
  2. Ethical Principles & Regulations
    1. Code of Federal Regulations. TITLE 45 Public Welfare. Department of Health and Human Services. Part 46 Protection of Human Subjects
  3. Stanford Human Research Protection Program
    1. Stanford HRPP (Goals & Objectives)
    2. Stanford HRPP Manual (Documentation of IRB Policies)
    3. AAHRPP:  AAHRPP: Enhancing Quality, Protection
  4. Criteria for Approval & Informed Consent
    1. Criteria for IRB Approval of Research: 45 CRF 46.111 [OHRP] GUI-40
    2. General Requirements for Informed Consent: 45 CRF 46.116 [OHRP] & 21 CRF 50.25 [FDA] GUI-C41
  5. Protocol Review Cycle & Reviewer Role
    1. Review Type: What is it and why do I need to know?
    2. Reviewing Quick Guide – using “The Blues” online AID – E2
    3. Human Subject Regulations Decision Charts
      1. Chart 1: Is an Activity Research Involving Human Subjects Covered by 45 CFR part 46?
      2. Chart 2: Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.101(b)?
      3. Chart 3: Does Exemption 45 CFR 46.101(b)(1)(For Educational Settings) Apply?
      4. Chart 4: Does Exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?
      5. Chart 5: Does Exemption 45 CFR 46.101(b)(4)(for Existing Data Documents and Specimens) Apply?
      6. Chart 6: Does Exemption 45 CFR 46.101(b)(5)(for Public Benefit or Service Programs) Apply?
      7. Chart 7: Does Exemptions 45 CFR 46.191(b)(6)(for Food Taste and Acceptance Studies) Apply?
      8. Chart 8: May the IRB Review Be Done by Expedited Procedures Under 45 CFR 46.110?*
      9. Chart 9: Can Continuing Review be Done by Expedited Procedures Under 45 CFR 46.110?
      10. Chart 10: Can Informed Consent Be Waived or Consent Elements Be Altered Under 45 CFR 46.116(c) or (d)?**
      11. Chart 11: Can Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?
      12. Chart 12: Waiver or Alteration of Informed Consent in Research Involving Public Benefit and Service Programs Conducted by or Subject to the Approval of State or Local Government Officials (45 CFR 46.116(e) 
      13. Chart 13: When Can Informed Consent Be Waived or Altered Under 45 CFR 46.116(f) 
      14. Chart 14: Can Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c) 
  6. IRB Related Issues
    1. Research Policy Handbook - Document 18.4: Confidentiality of Administrative Panel Proceedings
  7. Resource: eProtocol Reviewing and Commenting
  8. Resources: 15_Resources MemBinder