We’ve gotten a query or two in recent weeks asking if we can waive the requirement for continuing review (CR), since, say, the IRB just approved a modification so it must have just reviewed the study anyway, or there hasn’t been anything new on the study in the past year.
Our short answer to requests asking us to waive continuing review is, “Nope. Sorry. Can’t do it.”
The longer answer goes something like this — an IRB is required by federal regulation to perform a continuing review on each study at least one a year, and more often if the IRB determines the research merits more frequent review. This requirement is spelled out at 45 CFR 46.109. When considering continuing review, the IRB is looking at information that isn’t routinely included in modification forms. The CLARA CR form intentionally collects specific information that allows the IRB to get an idea of how the study has been proceeding, and if anything has changed in terms of possible risks or benefits, or in the ability to actually carry out the research.
Note that while the IRB can allow certain study procedures to continue while a study CR is expired, the PI must get approval for this continuation before allowing the study to continue. This permission will usually only be granted in exceptional circumstances, and with an assurance that the continuing review form has been submitted. If you continue study activities after CR expiration without prior IRB permission, you run a very high risk of the IRB determining that those data were collected without IRB approval.