Decision Trees

Is your activity actual research? Is your research considered exempt?

If you are running into some of these questions, run through these Decision Tree charts provided by the U.S. Department of Health & Human Services:

Chart 1: Is an Activity Research Involving Human Subjects?

Chart 2: Is the Human Subjects Research Eligible for Exemption? (Exempt Protocol Category 1)

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? (Exempt Protocol Category 2 or 3)

Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply? (Exempt Protocol Category 4)

Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply? (Exempt Protocol Category 5)

Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply? (Exempt Protocol Category 6)