If you’re not 100 percent certain whether your project requires IRB review and approval, your first step should be to submit a human subject research determination form. This form is much shorter and simpler than new submission form, it’s processed much more quickly than the new submission form is, and it gives you a more accurate determination than other options we’ve seen tried, such as relying on the opinion of someone in your department who may not have a good grasp of the nuances of making such determinations, or making a best guess on your own.
In fact, the only official determinations the IRB issues are those that come in response to Human Subject Determination requests submitted through CLARA. Even if the new project is similar to something you’ve done in the past and you’re pretty sure you don’t need IRB review, we strongly recommend submitting a new form for each project you’re not 100 percent sure about. That way, you’ll have formal documentation that you ran the project by the IRB for an official determination.
So, where to find the form?
Unlike in the ARIA days, where the form was a separate Word document that you’d complete and then email to the IRB, the Human Subject Research determination form is now submitted directly through CLARA using the “Create a New Submission” option (see below). After clicking on that button, the option box shown below pops up. You’d click on “Human Subject Research Determination Request” to start the form.