If you are leading a class in which all of the students will be required to make a submission in CLARA, we can help get your students’ accounts activated before they begin their new submissions. Please send Kate Henning an email at khenning2@uams.edu and cc irb@uams.edu with a list of all students whose CLARA accounts should […]

The “Subjects” section in the new submission form includes the following question – How will potential subjects be identified? When completing the form, keep in mind that this question is asking how you plan to find potential subjects in the first place. Every now and again we see people describe their plans for identifying the […]

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 […]

The PI is the one study staffer who cannot be changed using a “staff-only modification” form in CLARA. To change a PI in CLARA, please submit a regular modification form, and not a staff-only modification. Please ensure the new PI’s CV is uploaded to his or her profile in CLARA as well. Using a regular […]

When drafting responses to research compliance audits, please feel free to write long. Include as much information as you think the IRB might find helpful in your responses. Audits are sent to the full IRB for review, and the more information the IRB has at its disposal, the faster the IRB can process a response. […]

When creating a new submission that requires a HIPAA research authorization, it can be tempting to pick up the HIPAA form that was approved for a previous study and try to revise it for the new project. Here’s a bit of advice about that: Don’t do it. Really. Start fresh with the HIPAA authorization template […]

The IRB strongly discourages the attachment of study-related documents, such as consent forms, data collection tools, etc., directly to a protocol document as appendices. We prefer that these items be uploaded as separate documents with your CLARA submission. Separating them out makes them much less likely to be overlooked by a reviewer, and also simplifies […]

If you’re facing any looming approval deadlines, please remember that there will be no IRB meeting on Tuesday, June 30, which is a fifth Tuesday. The IRB meets only on the first four Tuesdays of each month. If you need something approved around that time, please be sure to get it submitted to the IRB […]

The CLARA Portal Facilitator (yes, that’s a real person; that position used to be known as the CLARA gatekeeper) no longer routinely performs in-depth content reviews of new submissions before sending them on to the IRB for review. However, that level of prereview is still available at no charge to research teams who request it, […]

Please keep a close eye on the calendar when planning ahead to submit continuing reviews or any other submissions that have an approval deadline. If items need to go to full board, they should come to the IRB no later than the listed submission deadline to ensure placement on the agenda you’d like them to […]