The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations for the protection of human subjects recognize that not all research warrants review by the full IRB at a convened meeting. Accordingly, DHHS regulations at 45 CFR 46 and FDA regulations at 21 CFR 56 permit certain types of research to be reviewed and approved by expedited review.· A submission eligible for Expedited Review can be reviewed solely by one of the IRBMED co-chairs or their designee.
- An Expedited Review is not the same thing as a "rush" review.
- To be eligible for Expedited Review, the risk to the research subjects must be no more than minimal.
- Additional institutional restrictions may prohibit certain types of research from qualifying for expedited review.
- At the reviewer's discretion, submissions eligible for Expedited Review may still be referred to the full IRB for a vote.
- IRBMED staff evaluate all incoming applications to determine those that are eligible for expedited review.
For your reference, the categories of research that may be reviewed by the IRB through an expedited review procedure can be found at the Department of Health and Human Services (HHS) website.