How can I find out if my project needs review?
The decision of whether a project needs IRB review can be trickier than it seems. Federal regulations and UAMS policy have specific definitions of “research” and “human subject,” and they’re not entirely intuitive.
You can use the Human Subject Research Determination form in CLARA to find out whether your project needs IRB review. It is accessible via the “Create a new submission” link you’ll see when you log into CLARA.
Why does this form ask so many questions?
This form has been designed to elicit the information the IRB office needs to determine whether your project meets the definition of human subject research. Please read the questions carefully and provide a complete response to each.
The IRB has reviewed my form submission, and says my project is NOT human subject research. Now what?
Unless the scope of your project changes such that it might become human subject research, you are done with the IRB. There is no need to submit anything to us or to try to amend the human subject research determination form we’ve already reviewed.
The IRB says my project IS human subject research. Now what?
You can go ahead and begin the complete new submission process in CLARA.
Am I required to submit a human subject research determination form?
No. Experienced researchers and others may already know that their project requires IRB review. They can skip the determination form process and go straight to creating a new submission.
Others may be confident their project is NOT human subject research. In these cases, we strongly recommend, but do not require, that the investigator submit a human subject research determination form, for at least two reasons.
- Many journals or other dissemination venues will want documentation that an IRB at least looked at your project. The response letter you get to a human subject research determination form will serve as that documentation.
- It’s better to be safe than sorry. Inadvertently doing human subject research without prior IRB approval causes problems large and small. It’s a scenario that can be avoided if you routinely submit a human subject research determination form through CLARA for projects that you don’t think need IRB review.