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 […]
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.
Quick CLARA reminders
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? […]
Submissions that are complete get reviewed faster
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 […]
“Other” document types, that message you get when you “upload new document”
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 […]
NIH will want more specifics about study subject populations
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 […]
A quick HIPAA recap
HIPAA has been confusing for all of us as it applies to research. Even though we’ve been dealing with it for years, we still see scenarios that make us wonder whether HIPAA applies to a particular study and, if so, how to best meet HIPAA requirements. One thing to keep in mind is that HIPAA […]
Another tool to help with the informed consent process
Some great ideas regarding language to use during the informed consent process has come to us via firstclinical.com. Basic Concepts for Informed Consent covers some of the foundational elements behind the concept of truly informed consent, and translates them into language subjects are likely to understand. It addresses some of the issues that can be […]
IRB Meeting Scheduling, Fifth Tuesdays, Bad Weather, Quorum, Etc.
As we turn the calendars to 2018, here’s a reminder to keep an eye on any deadlines that you must meet with IRB submissions. Remember the UAMS IRB Committee meets on the first four Tuesdays of every month, so there is an “off” week in any month during which there’s a fifth Tuesday. January, May, […]
A quick and simple word about creating assent materials
When a study proposes to include people who can communicate but cannot provide their own consent, the IRB will typically require some sort of assent process or document be used to explain the proposed research to the subject. This requirement is most often seen in studies involving minor children age 7 and up. Please keep […]
Holiday bonus for the learnondemand.org blog quiz
The 4th quarter IRB Research News and Tips blog quiz is now available at learnondemand.org! Get the most convenient 0.5 hours of Certified Research Specialist elective credit around. To access the quiz, go to the learnondemand.org link and type “IRB” in the search box at upper right. Please note you have to complete the entire […]