Human subjects research may qualify for an exemption from ongoing IRB review if it is no more than minimal risk and all research procedures fit within one or more of the exemption categories as outlined in the federal regulations. Exempt research cannot be FDA-regulated, involve prisoners and in some cases, may not include minors.
Common types of research that may meet the criteria for an exemption include:
- Educational tests
- Interviews and focus groups
- Surveys
- Observation of public behavior
- Secondary use of existing data or specimens (if the information is either publicly available or is recorded so that the data cannot be linked to the subjects and the investigator does not contact the subjects.)
How do you apply for an exemption?
From the IRBIS home screen (irbis.research.unc.edu), select “New Study” and in the next screen select “Exempt” (application type).
The Exempt application walks you through the exempt categories and prompts you for the information required in each category.
Why should you apply for an exemption?
- The exempt application is abbreviated, requiring less time to complete than a full form application.
- Exempt research permits the use of a Research Information Sheet in lieu of a full consent form, which reduces burden on participants.
- Exempt research does not require annual review.
What else do you need to know about applying for an exemption?
- Exempt research is subject to review by the IRB for determination of exemption status.
- Exempt applications can/should be modified if your study changes
- If your study changes so that a full application is required, your responses will transfer over to the full form.
- The reliance process does not apply to exempt research. In some cases, UNC may agree to provide IRB oversight for Independent Investigators.