In a change from the IRB’s previous online submission system, ARIA, our current system, CLARA, accepts study documents created using Microsoft Word. In the ARIA days, all study documents had to be converted to PDF. The new system will accept documents in Word format, so that conversion is no longer required. Keeping everything in Word […]

Here’s another reason to get your continuing review forms in early: The IRB now routinely closes studies once a continuing review (CR) has been expired for 30 days. Even studies that have a CR form pending, or that have contingencies outstanding from a pending CR form, are subject to closure if the approval has been […]

We’ve noticed that some investigators routinely use underscores between words when typing in document titles in CLARA. We ask that you don’t use any underscores that aren’t strictly necessary, i.e. that aren’t an essential part of a document name. The underscores prevent the titles from wrapping across lines in CLARA, making it difficult for IRB […]

New to research? Or has it been a while since you’ve gotten some feedback on your research processes? If so, and if you have a study that’s about to be approved or that hasn’t enrolled any subjects yet, consider getting in touch with the Office of Research Compliance (ORC) to request a New Investigation Consult […]

There will be no IRB meeting on Tuesday, Dec. 30,  a fifth Tuesday. The IRB only meets on the first four Tuesdays of the month. Please keep that “missing” week in mind if you are facing deadlines for approvals and continuing review renewals. Also, remember that the campus will be closed for much of the […]

When you log into the human subject protection training program at citiprogram.org, you’ll be asked to affiliate with a particular institution. Please be careful to select UAMS to ensure that you are directed to the correct training! We’ve noticed that some people have accidentally affiliated with UALR, which, while also part of the University of […]

When completing a new submission form in CLARA, you may encounter a question asking whether you will obtain biological specimens as part of the research. This question should be answered “yes” only if you will be obtaining the actual specimens, either directly from subjects, or from a secondary source, such as a pathology lab or […]

When submitting study modifications, please clarify in your submission whether any subjects are currently on study and, if so, if they will be affected by the change. For example, will anybody need to be reconsented, or will any study activities that directly involve the subjects change? If this information is included up front, the IRB […]

The Food and Drug Administration (FDA) has oversight over some, but by no means all, of the research that comes through the UAMS IRB. When submitting studies, please confirm that your consent and HIPAA authorization forms correctly reflect whether the FDA will have access to study records. Projects that involve FDA-regulated products such as investigational […]

For studies that involve an informed consent process, the new submission form requires a response to the query, “Explain how the possibility of coercion or undue influence will be minimized in the consent process.” We see a lot of variety in the responses to this query. However, what we don’t see a lot of are […]