Exempt research is still human-subjects research, but it qualifies for one of the eight categories listed in 45 CFR 46.104 and is exempt from most Common Rule requirements.
Common exempt categories
- Normal educational practices in established educational settings
- Anonymous surveys, interviews, or observation of public behavior
- Secondary research using existing identifiable data when conditions are met
- Benign behavioral interventions with adult subjects
A qualified reviewer (not the investigator) must make the exemption determination. Exempt status does not remove the obligation to conduct research ethically.