The Office of Human Research Protections (OHRP) provides these decision charts to guide those involved with human-subject research in making decisions regarding whether the activity must be reviewed, what type of review might be performed and whether informed consent can be waived or altered.
The decision charts can also be found at the OHRP decision chart site.
- Chart 1: Is an activity research involving human subjects?
- Chart 2: Is the human-subject research eligible for exemption?
- Chart 3: Does exemption Category 1 (for educational settings) apply?
- Chart 4: Does exemption Category 2 or 3 (for tests, surveys, interviews, public-behavior observation) apply?
- Chart 5: Does exemption Category 4 (for existing data, documents, records and specimens) apply?
- Chart 6: Does exemption Category 5 (for public benefits or service programs) apply?
- Chart 7: Does exemption Category 6 (for food taste and acceptance studies) apply?
- Chart 8: Can the IRB review be done through expedited procedures?
- Chart 9: Can the IRB continuing review be done through expedited procedures?
- Chart 10: Can informed consent be waived or consent elements be altered?
- Chart 11: Can documentation of informed consent be waived?