All research projects that will involve human subjects, even if they would qualify under one of the exemption categories, require a protocol submission.  Determinations of exemption are made by IRB staff.  Some research qualifying as exempt under Categories 2 and 3 require 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 expedited or full review procedures in order to ensure adequate protection of subjects and compliance with federal regulations.