Remember: A contingency isn’t real until it shows up in a letter to you

We at the IRB have taken steps to increase the transparency of the review process. This change is typically a good thing, but can also create opportunities for miscommunication.

IRB reviews of submissions can take hours or days to complete. The reviewer may start and stop working on it several times, drafting notes and contingencies throughout the entire process. Many of these draft notes/contingencies are not actionable, and/or may be revised or deleted before a final contingency letter is issued. A review may write a note as a reminder to herself, or to document the rationale behind a certain determination, or to bring something to the attention of the committee. Some draft contingencies are written solely for the point of having them discussed in committee, and then they’re revised or deleted later in the review process. Many draft notes or contingencies also wind up being deleted by the person who wrote them as the review process evolves.

We try to make sure that draft notes and contingencies aren’t visible until the review is completed, but sometimes we fall short of that goal. So, until you see a note or contingency on an official CLARA letter, please do not act on draft notes or contingencies you may see in CLARA. If you start responding to notes or contingencies that aren’t finalized in an attempt to get a jump on a contingency response, you may wind up making changes the IRB will wind up not asking you to make after all, which will only slow down and confuse the review and approval process once the official contingency letter is sent.