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 […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
Start the New Year off right with a NICE review!
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 […]
Scheduling reminder — no IRB meeting December 30
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 doing CITI training, be careful to pick the correct institution!
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 […]
A hint for the biological specimens questions on the new submission form
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 […]
A hint to get modifications approved faster
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 […]
Is your study subject to FDA review? Edit documents accordingly
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 […]
Minimizing the possibility of coercion or undue influence in the consent process
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 […]
Two hints for completing continuing review forms
Hint No. 1 – When completing your study’s continuing review form, please remember NOT to include with the form any document amendments you’re hoping to get approved. The IRB no longer reviews amended documents with continuing reviews, and hasn’t done so since we switched from ARIA to CLARA. In some cases, the IRB may have […]
Age ranges do matter!
When drafting your protocol, please pay close attention to how the subjects’ age range is described in the text. Different regulatory requirements apply to different ages, which is why the IRB may send contingencies asking you to be very, very specific when describing how old your participants are. For example, when we see an age […]