DECISION CHARTS FOR DEFINING
THE NATURE OF IRB OVERSIGHT
OF HUMAN SUBJECTS RESEARCH

The decision charts below will help you decide whether your project meets the definitions for research involving human subjects and whether your planned research requires full board review, expedited review, or is exempt.  These charts are the charts developed by the Federal Office for Human Subjects Protection
(OHRP) and were last updated September 2004.

FROM OHRP GUIDANCE DOCUMENT 45 CFR 46:

CHART 1: Is an activity research involving human subjects covered by 45 CFR 46?

CHART 2: Is the research involving human subjects eligible for exemption under 45 CFR 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 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 under 45 CFR 46.110?

CHART 9: Can the continuing review be done by expedited procedures under 45 CFR 46.110?

CHART 10: Can the 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?