PIs have an opportunity to appeal IRB decisions, such as not approving a proposed modification, or a finding of serious or continuing noncompliance. To do so, they draft a written appeal request and send it, along with any supporting documentation, to the IRB office, where staff then assign it to an agenda using the “office […]

Investigators will sometimes submit items to the IRB on an Excel Spreadsheet. This is most common at Continuing Review for PIs who use the Events and Deviations Table template that is available on the IRB’s website. This table is in the form of a spreadsheet with two worksheets on it. When looking at these tables, […]

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 […]

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 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 […]

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 […]

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 […]

When reviewing new submissions for an agenda, please keep in mind that you can discuss any questions or issues with the other assigned reviewer or the IRB chair before the meeting. You also have the option of getting in touch with the study staff directly. However, in case you want to maintain the anonymity of […]

Occasionally you’ll notice an item on a meeting agenda that includes a “budget modification” tag. These items should be reviewed in the normal way. The “budget modification” language indicates that the item in question has resulted in a change in the study’s budget, which is handled in another office and not by the IRB. So […]

The American Association of Public Opinion Research (AAPOR) has some publications and resources available online that will be of interest to IRB members. AAPOR recently announced the release of what it calls “updated and expanded resources for researchers who conduct surveys subject to institutional review board (IRB) review.” Although the announcement focused on researchers, the […]