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- The Institutional Review Board at Stanford
- Ethical Principles & Regulations
- Code of Federal Regulations. TITLE 45 Public Welfare. Department of Health and Human Services. Part 46 Protection of Human Subjects
- Stanford Human Research Protection Program
- Criteria for Approval & Informed Consent
- Protocol Review Cycle & Reviewer Role
- Review Type: What is it and why do I need to know?
- Reviewing Quick Guide – using “The Blues” online AID – E2
- Human Subject Regulations Decision Charts
- Chart 1: Is an Activity Research Involving Human Subjects Covered by 45 CFR part 46?
- Chart 2: Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.101(b)?
- Chart 3: Does Exemption 45 CFR 46.101(b)(1)(For Educational Settings) Apply?
- Chart 4: Does Exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?
- Chart 5: Does Exemption 45 CFR 46.101(b)(4)(for Existing Data Documents and Specimens) Apply?
- Chart 6: Does Exemption 45 CFR 46.101(b)(5)(for Public Benefit or Service Programs) Apply?
- Chart 7: Does Exemptions 45 CFR 46.191(b)(6)(for Food Taste and Acceptance Studies) Apply?
- Chart 8: May the IRB Review Be Done by Expedited Procedures Under 45 CFR 46.110?*
- Chart 9: Can Continuing Review be Done by Expedited Procedures Under 45 CFR 46.110?
- Chart 10: Can Informed Consent Be Waived or Consent Elements Be Altered Under 45 CFR 46.116(c) or (d)?**
- Chart 11: Can Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?
- 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)
- Chart 13: When Can Informed Consent Be Waived or Altered Under 45 CFR 46.116(f)
- Chart 14: Can Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)
- IRB Related Issues
- Resource: eProtocol Reviewing and Commenting
- Resources: 15_Resources MemBinder