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 greater than minimal risk AND
- Fit into one (or more) of the following nine specific expedited review categories.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j))(Common Rule).
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