The learnondemand.org website now has not one, but TWO IRB Blog quizzes available. Each is worth 0.5 hours of elective education credit toward the earning or renewal of your Certified Research Specialist credential. To access the quizzes, go to learnondemand.org and type “IRB” into the search box at upper right.

Well, we can’t promise to make contingencies go away altogether, but you know what they say – Happy IRB office staffers/reviewers write fewer contingencies. Here are a few tips to keep the IRB happier and contingencies at bay: –When you’re notifying the IRB of a temporary study closure of any kind, e.g. closure to enrollment […]

Investigators studying non-English speaking populations usually plan ahead and get any documents subjects will see translated before the study begins. The IRB sometimes receive new submissions with study documents already submitted in both English and the language of interest. While the IRB will eventually need to see both versions, it may save you some time/hassle […]

When you revise an informed consent form, the IRB will consider whether you need, or plan, to addressing the following items in your modification form will allow the IRB to review and approve your revised form more quickly: –Does the change affect any subjects currently on study? The IRB needs to know whether current subjects might […]

We’ve noticed some issues that are almost guaranteed to get you a minor prereview contingency from the IRB office these days. We thought we’d address them on our blog so you can minimize approval delays: –In new submissions: Failing to request the correct kind of waiver relating to the consent process and documentation. Consent process […]

We’ve found some more reports about the new NIH rules pertaining to clinical trials that we thought we’d share with the UAMS research community. One of the biggest changes is the expansion of NIH’s definition of “clinical trial,” which will apply to some UAMS and ACH researchers who are now conducting NIH-funded “clinical trials,” which […]

We review a whole lot of CLARA new submission forms in the IRB office, meaning we tend to notice patterns in the forms. Here are a few questions that tend to trip up study teams, and reminders for how to complete them. Subjects section: –How many subjects do you anticipate consenting to meet this goal? […]

When approving research, the IRB is required to make certain determinations, as spelled out in UAMS IRB Policy 7.1. The IRB therefore needs complete information about projects before it can review and approve a new submission. While we can very occasionally make exceptions, by doing things like issuing an approval letter saying we approve what […]

That “document type” drop-down box in CLARA is important – it helps classify study documents correctly, and allows CLARA users to sort documents by type. We’ve noticed a fair number of documents uploaded as document type “other,” which has struck us as odd, since these documents often fit into one of the other document type […]

In an attempt to ensure that all populations that may benefit from research findings are included in clinical research, the NIH will soon require more discussions about including all age groups in NIH proposals. Specifically, says NIH’s Dr. Michael Lauer on his blog, “For application due dates on or after January 25, 2019 (yes, one year from […]