Expedited Process

What is expedited review?

"Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The Agency's IRB regulations [21 CFR 56.110] permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk." (FDA Responses to General IRB Questions_May2019)

What is Minimal Risk?

Minimal risk means that the probability of the research subject incurring any bodily or psychological harm and/or damage to their reputation is extremely unlikely.