Ever wondered how to make a grown IRB office staffer cry? Easy — send them a protocol submission that almost but not quite meets the criteria for expedited review. An example — protocols that involve multiple teeny tiny blood draws done over a short period of time. Expedited category 2a allows a reasonable amount of blood to be drawn — but the draws can occur no more than twice a week. A protocol that just misses eligibility for expedited status review has to go to the full board for review. Ditto for studies that just barely miss qualifying for exempt status review — a study interviewing teenagers just barely misses qualifying for exempt category 2, so it has to be reviewed using expedited procedures.
So, to streamline reviews of this study that feel “exempty” or “expeditey” (sorry for the technical language there) but don’t qualify because of a minor difference between the study and the exempt/expedited categories, we’ve created a new flexible review process. This process will allow these studies to be reviewed under procedures better suited to their level of risk, IF certain conditions are met.
And that is intentionally a big “IF.” The most important condition is that the study in question cannot be federally funded, supported, or regulated. The full policy describing all the conditions is available on the IRB’s website.
What will change from the study teams’ perspective? Not much, really. You’ll complete and submit the regular new submission form. When we review it in the IRB office, you may get some emails (or prereview contingencies, if we’re sending back other contingencies as well) from us to confirm that the study meets the criteria for flexible review. Then your approval letter will indicate that the study qualified for review using flexible exempt or flexible expedited procedures.