Research with human subjects may qualify for exemption if, and only if, (a) all research procedures fall within the “Exemption Categories” listed in 45 CFR 46.101(b), AND (b) the project does not involve any of the populations or procedures listed under “Restrictions.”
Research cannot be exempt if any of the following are involved.
- prisoners, fetuses, pregnant women or human in vitro fertilization;
- survey or interview techniques with minors;
- research involving the observation of public behavior of minors if the researcher participates in the activities being observed;
- the review of health care records or other archival data records if information is recorded in such a way that individuals can be identified, either directly or through identifier linked to the individual;
- deception of participants; OR
- procedures which expose participants to greater than minimal risk.