Expedited review studies typically are reviewed by a small number of IRB reviewers. Expedited review is appropriate for studies that according to 45 CFR 46.110 and 21 CFR 56.110:
- Involve no more than minimal risk and
- Fit into one (or more) of the following nine specific expedited review categories.
Expedited Review Categories
Category 1: Approved drug or device being used for its approved indication
Category 2: Blood sampling (limited amounts)
Category 3: Noninvasive specimen collection
Category 4: Noninvasive, routine clinical procedures, such as MRI or EKG (no sedation, general anesthesia, x-rays or microwaves)
Category 5: Use of data or specimens collected for non-research or research purposes (e.g. chart reviews)
Category 6: Collection of data from voice, video, digital, or image recordings
Category 7: Low-risk behavioral research
Category 8: Continuing review of inactive research or studies that are essentially complete
Category 9: Continuing review of other minimal risk research studies