What happens if my “Expedited Review” project turns out not to qualify for Expedited Review?

Expedited Category Review | What is Expedited Review | What are the Criteria | What is the definition of minimal riskWho decides whether or not a project has “minimal risk” | What Research Categories fall under Expedited Category Review | What is the application process | How will I know that a Protocol has been approved | Who receives these IRB Action Notices | What happens if my Expedited Review does not qualify

In some cases, a protocol that was first thought to be “expedited review category” may actually meet the federal regulations to be classified as Exempt from IRB review. If that happens, you will be notified of this change and your proposed project will then be reviewed under those Exempt category regulations. Usually this results in a faster turn-around time for approval.

Occasionally, a protocol that was first thought to be “expedited review category” may NOT meet the federal regulations for Expedited Review: the project might be determined to have more than minimal risk, specific vulnerable populations might be involved, or the protocol has elements that do not meet any of the designated categories for such approval. The regulations state that protocols cannot be disapproved by Expedited Category, but must be then referred to a convened (Full Board) meeting of the IRB for consideration. If that happens, you will be notified by OReC staff that the protocol has been re-classified and you will be advised of any additional materials or copies needed for Full Board review. Note that a convened IRB meets once per month on a specific schedule (see link for IRB meeting dates and document submission deadlines).