The IRB will make the final determination on level of review. Research that qualifies as non-research or exempt must receive formal exemption from the IRB. A request for exemption will be reviewed by the IRB chair. If the chair agrees, a formal exemption will be provided. If not, the chair will request that the primary investigator submit a full application including an Informed Consent Form for IRB approval.

Exemption Guidelines

The Office for Human Research Protections has provided decision charts to determine if a research project involving human subjects must be reviewed by an institutional research board. These charts are quite useful in determining whether to submit a Request for Exemption with the IRB.

  • A Request for Exemption must be filed with the IRB if you are conducting research with human participants. An exemption approval from IRB is a safeguard that protects research participants, the investigators, and the institution.
  • Exemptions are not allowed for research with vulnerable populations. Vulnerable populations include: pregnant women, fetuses, prisoners, minors/children (less than 18 years) and persons with cognitive disabilities.

Exemption Categories

The following exempt conditions have been developed and described within the Federal Common Rule (45 CFR 46):

Exemption 1

Exemption 2

Exemption 3

Exemption 4

Exemption 5

Exemption 6

Exemptions 7 and 8