Human Research Protections Program Office
Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Bethesda, MD 20814
Phone: (301) 295-9534
Human Research Decision Charts
Please refer to the appropriate Human Subject Regulations Decision Charts for guidance in determining whether your study is research and what type of review is needed. The official determination will be made by the Exemption Determination Official (EDO).
Text Version of OHRP Human Research Decision Charts
- Chart 1: Is an Activity Research Involving Human Subjects?
- Chart 2: Is the Human Subjects Research Eligible for Exemption?
- 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, Records and Specimens) Apply?
- Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply?
- Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply?
- Chart 8: May the IRB Review Be Done by Expedited Procedures?
- Chart 9: May the IRB Continuing Review Be Done by Expedited Procedures?
- Chart 10: May Informed Consent Be Waived or Consent Elements Be Altered under 45 CFR 46.116(d)?
- Chart 11: May Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?