Glossary Term

Exempt Research

Review & Determinations

Also known as: exempt research determination, exempt category, exempt determination, exempt study

Human-subjects activities that meet one of eight exemption categories in 45 CFR 46.104 and are exempt from most IRB requirements.

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.

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