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