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Why we ask you to submit something through CLARA…

Researchers are encouraged to get in touch with the IRB office whenever they have a question. We’re happy to take queries by phone or email, and to provide guidance regarding IRB submissions when appropriate.

Some queries are best handled through a submission process in CLARA, however. The big one is, “Does my project need IRB review?” (Use the Human Subject Research Determination form in CLARA to find out.) Or sometimes people will ask us whether the convened IRB would approve a change the study team is thinking about making. (You’d have to submit a modification form to find out what the convened IRB would do.)

The reason we ask you submit things like this through CLARA is that these kinds of “official” determinations can only come through our official submission system, CLARA. While we can offer opinions outside of CLARA, sometimes the information conveyed in a phone call or email is ¬†incomplete. CLARA forms are designed to capture the specific information the IRB needs to make decisions about submitted materials. The response letter you get from CLARA also serves as documentation of what the IRB decided on your submission, whether it was an approval of a modification, or a determination that the project did not require IRB review.