Note or contingency?

Here’s a recap of the difference between a note and a contingency in CLARA:

A contingency is an item that must be responded to before a submission can be approved. A note, on the other hand, is appropriate for anything you’d like to relay to the study team but  does not require a response before the IRB can grant approval. In fact, PIs can’t respond directly to notes in CLARA.

An example:  You’re looking at a continuing review submission and you notice a problem in the consent form.

If the problem is significant enough that you think it creates a flaw in the overall consent process or consent documentation, then a contingency would be merited. Examples would be an incorrect description of study procedures, or a failure to list all the risks associated with a study. You’d want the PI to make a correction before approving the study for another review period.

A minor item with little or no impact on the overall consent process, however, would be more appropriately addressed in a note. The note would remind the study team to correct things like a minor typographical error or an incorrect footer on one page of the consent form  the next time the form is revised.

Issues that relate to the criteria for approval as listed in 45 CFR 46.111 and IRB Policy 7.1 merit contingencies. Things that don’t directly relate to the criteria for approval merit notes. In the example above, the IRB is required to determine that informed consent will be sought and appropriately documented as required. If the current consent form represents appropriate documentation, even if it includes some minor typos, then we shouldn’t draft a contingency before approving it. We can, however, make a note suggesting future changes the next time the form is revised to make the form look or read better.

One possible exception — if you have a few minor items that ordinarily are worth only a comment, but you’ve got a separate contingency that will require a consent form revision, you can go ahead and write a contingency saying that since other revisions are required, you might as well go ahead and fix this minor stuff while you’re at it.

And remember, nothing in IRB-land is ever a “required change.” While that option does appear in CLARA, it is used by other, non-IRB offices, and we can safely disregard it.