Once a human subject research determination form is submitted into CLARA, the IRB office will determine whether the project meets the definition of research involving human subjects.
If you get back the letter saying that the project is research involving human subjects, the next step is to start a new submission in CLARA. Please remember that you’ll start fresh with the new submission form — you won’t go back in and edit the original human subject research determination form.
If your letter says that your project is not human subject research, the IRB doesn’t need to review any aspect of it, and you don’t have to submit anything further to us in CLARA.
The Most Important Reminder — Please submit your human subject research determination form to us BEFORE you begin carrying out your project. If a project needs to be reviewed by the IRB, that review needs to be done before you start working on it. If you are unsure whether your project requires IRB review, go ahead and submit the determination request form in CLARA.
A corollary to the Most Important Reminder — an intent to publish is not what determines whether something requires IRB review. So when somebody tells you, “Wow, we found some really interesting stuff during this QI project! Let’s get IRB approval so we can publish it!”, they’re wrong. If it’s really a QI project, then it doesn’t need IRB approval to publish the results. If it wasn’t really a QI project and was instead research involving human subjects, then it needed IRB review before you started the project.