Exempt Protocol

Many educational, behavioral, and social science studies present little or no risk to the participants. Research involving existing data, medical records, and pathological specimens usually has little, if any, associated risk, particularly if subject identifiers are removed from the data. Although the rights and welfare of subject in those studies still require protection, there is usually no need for a detailed IRB review, the equivalent of the kind performed at a full committee IRB. In compliance with the Department of Health and Human Services (DHHS) regulations, certain research activities can qualify as exempt.

There are six categories of research that may qualify for exempt status. The regulations do not address a maximum risk level, it is implicit within the concept of exempt research that there must be very little, if any, associated risk.

Request for IRB Exemption Form

Categories of Exempt Research

How to Request an IRB Exemption

Exemption for Emergency Use