Expedited review allows a single qualified IRB reviewer (rather than the full board) to approve research that involves no more than minimal risk and falls within one of the categories listed in 45 CFR 46.110 and 21 CFR 56.110.
When it applies
- Minimal-risk research only
- Minor changes to previously approved research during the approval period
- Studies in the OHRP/FDA-published expedited categories (e.g., specimen collection, surveys, secondary data analysis)
Expedited review is not 'lighter' review — the same ethical standards apply. It is simply a faster procedural path.