Everybody knows the IRB reviews research. However, that’s not the IRB’s only role in research oversight. The IRB at UAMS also acts as the UAMS Privacy Board for HIPAA-related research issues. A Privacy Board is a review body established to act upon requests for a waiver or an alteration of the HIPAA Authorization requirement under […]
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 […]
Did this study get a regulatory review? Check the “History” tab or the documents section
Investigator-initiated studies involving drugs or devices may cause you to wonder if the study needs review by the UAMS Office of Research Regulatory Affairs (formerly known as the Research Support Center). With luck, the various prereview processes each study undergoes should catch the need for a regulatory review before the new submission shows up on […]
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 […]
PI change? Maybe not…
When reviewing items in CLARA, particularly contingency responses, you’ll notice that the author’s name of a particular comment will be visible, and will sometimes have a “Principal Investigator” notation next to it. This notation only indicates that the person responding, who is often a study staffer and not the PI, is acting on the PI’s […]
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 […]
Review ALL documents linked to a form, not just the bolded ones
Sometimes when reviewing an agenda item, you’ll notice that some of the documents linked to the form you’re reviewing will have bolded titles in CLARA, while others won’t. Please don’t take the bolding as a sign that only those documents with a bolded title need reviewing. The bolding could result from several things, none of […]
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 […]
Those massive reports we sometimes see at continuing review? You don’t have read the whole thing.
It’s not unusual for sponsors of multisite studies to draft long, periodic reports summarizing overall study progress. We recently saw one in the IRB that was more than 160 pages long submitted with a continuing review (CR). Please note that if you see one of these in a CR you are reviewing, you are NOT […]