November 2, 2015

How do I submit something to the IRB? FAQs

We get a lot of queries from people who are new to research asking about how to submit something to the IRB. Here is a rundown of the most frequently asked questions related to IRB submissions, and their responses.

Does my project need IRB review?

Submit a human subject research determination form through CLARA to find out. This form can be accessed by clicking the green “create a new submission” link after logging into CLARA.

When completing the determination form, please provide as much information as you can. While you will not be required to upload a protocol as part of this form, if you already have a protocol or other similar scope-of-work document available, we encourage you to attach it. The same is true for any other project-related materials, such as questionnaires. The more information you can include, the better idea we’ll have of your project’s scope, making it easier for us to evaluate it.

Am I required to submit a determination form?

No. If you already know that your project is research requiring review, you can go straight to the new submission step described below. If you are uncertain, or are pretty sure your project is not human subject research, then please go ahead and submit the determination form. Don’t rely solely on the opinion of your friends, or faculty advisors, or even on years-ago experience with the IRB (we have gotten much better at discerning what needs review and what doesn’t.) If someone asks you later whether your project got IRB review, you want to have documentation that the IRB looked at the submission and found it didn’t need review.

How do I log in to CLARA?

There is a link to CLARA on the IRB’s homepage. Try to log in using your UAMS username and password. If your CLARA account is not already activated (i.e., you can’t log in using your UAMS username and password), click on the “Don’t have an account?” link to access the CLARA account request form. Complete this form and submit it. You should get an email either from the IRB office or directly from CLARA saying your account has been activated. If two business days have elapsed since you requested an account, and you are still not able to log in, please call the IRB office directly at 501-686-5667.

I’ve submitted my human subject research determination form in CLARA, and gotten a response that my project does not meet the definition of research involving human subjects. Now what?

If the IRB tells you, through CLARA, that your project is not research involving human subjects, you are done with the IRB. You will want to hang on to that correspondence, though, to document that you have had the IRB look at your project and that it doesn’t need IRB review.

I’ve submitted my determination form, and been told that my project does require IRB review. Now what?

If you haven’t already, go ahead and complete the required online human subject protection training at Affiliate with UAMS to access the required training.

Draft a protocol. If you have never written a protocol before (or even if you have), the IRB has a protocol template available on its website. Please use it, or at least refer to it, as you are putting together your protocol, because it is a guide to the minimum information the IRB needs to review study. And please note that your protocol should be very detailed — things that may seem obvious to you still need to be written down, so the IRB can make the determinations it is required to make.

Start a new submission form in CLARA. This, again, can be accessed via the green “create a new submission form” link after logging in. Note that this is a separate form from the human subject research determination form you submitted. You will be starting from scratch with the new submission.

Who can help me put my submission together?

Faculty advisors and mentors can provide excellent guidance regarding working with the IRB. Other resources include the protocol development services available through the Translational Research Institute. TRI staff can help you draft protocols, informed consent forms, and HIPAA authorizations, when needed.

How can I track my protocol’s progress through CLARA?

Check the protocol’s “History” tab to see where your study is in the review process. Please note — if your submission shows that it is in “draft” status, that means it has not been electronically signed or submitted into CLARA. Please make sure, when submitting anything through CLARA, that you have reached the end screen where you will be asked to enter your username and password again to submit something.

How long does it take to get IRB approval?

A CLARA submission does not go directly to the IRB. Depending on the nature of your project, several other committees may need to look at before it even makes it to the IRB office for review. These other committee reviews can take several weeks. For example, studies involving active interventions with UAMS patients typically take much longer to reach the IRB than simple retrospective chart reviews or interview/survey studies. Once a study reaches the IRB, approval can take anywhere from a few days to 6 weeks or more. Chart reviews and interview studies are on the lower end of that range, as they can often be reviewed in the office. Full-board review studies will usually take longer.

How can I speed up the IRB’s review of my study?

The better the quality of your initial submission, the faster you will get it approved. If you are new to the IRB submission process, please don’t try to go it alone. Seek help from faculty advisors, TRI, and/or others who have experience dealing with the IRB.

Also — please make sure to upload your CV to your CLARA profile, accessible via the “your account” link at upper right after logging in to CLARA. We need to have the PI’s CV on file before we can approve a study, and “please upload your CV” just might be the most common contingency we send to research teams.

Last but not least, stay up to date with the IRB Research News blog. That’s where we publish lots of tips for preparing IRB submissions.