I believe my project is 'exempt', do I need to submit a protocol?
All research projects that will involve human subjects, even if they would qualify under one of the exemption categories, require a protocol submission.
Exempt determinations must be made by IRB staff. Some research qualifying as exempt under Categories 2 and 3 requires Limited IRB Review to ensure specific criteria in the Common Rule are met (e.g., privacy protections).
The federal eligibility criteria for exemptions can be complex. There may be situations where a project does not qualify for exemption, as an investigator had anticipated. In these situations, study procedures (including consent processes) may need to be adapted. The study will be reviewed via the appropriate review procedures (e.g., expedited or full review) to ensure adequate protection of subjects and compliance with federal regulations.