It’s that time of year again – winter (which is kinda of feeling like potentially a real thing so far this year) and the holidays both loom. Keep that in mind in your end-of-year planning if you have approval deadlines you really, truly need to meet. Here’s a reminder that, for reasons that are a […]
Blog
Joint OHRP and FDA guidance on meeting minutes
The federal Office for Human Research Protections and the Food and Drug Administration have released a joint guidance addressing the requirements for IRB meeting minutes. We are excited about this for at least two reasons. First, we love it when OHRP and FDA work together on something. The two agencies have separate regulations, and while […]
Scary goings-on in the CLARA document files
Well, we must admit we’ve been a little spooked lately by some of the document stacking issues we’ve seen in CLARA. Nothing chills our bones quite as much as seeing tracked-changes and clean copies of revised documents in a single stack. We shiver in horror whenever we have to send something back to have you […]
Your weekly workload may vary, aka insight into how we assign agenda items and reviewers
First, we at the IRB office and throughout the UAMS/ACH research community want to thank all of our members for their IRB service. We know that you have a lot going on in your lives, and we are grateful for the not-inconsiderable time and effort you devote to your IRB obligations. Our longest-term members may […]
Important Reminders About Emergency Use of a Test Article
The Food and Drug Administration (FDA) has strict requirements regarding the emergency use of test articles to treat patients. Failure to follow those requirements can create big headaches for investigators and institutions. Here’s a refresher on some of the key elements of emergency use of test articles. First, emergency use, per the FDA regulation at […]
A glorious day in the world of Certificate of Confidentiality procurement
Oct. 1 is when the new policy pertaining to NIH’s issuance of certificates of confidentiality (CoC) takes effect, according to a recent NIH Blog post. Under the new policy, CoCs “will be issued automatically to NIH funded grants, cooperative agreements, contracts and intramural research projects research funded wholly or in part by the NIH that […]
Vulnerable subjects under the revised Common Rule
The revised Common Rule’s changing definition of vulnerable populations is the focus of Public Responsibility in Medicine and Research (PRIM&R) director Eliza Hurley’s most recent PRIM&R blog post. Dr. Hurley has some interesting comments about the removal of pregnant women as a vulnerable population, a change she describes as “welcome and long overdue.” She also […]
Those separate “letters to the IRB” we see in CLARA files
We love hearing from our researchers; we really do. But here’s a tip that may save you a bit of extra work when submitting modifications, and contingency responses. We often notice investigators send in separate letters to the IRB explaining something in their CLARA submission. Unless that letter includes information that’s not addressed elsewhere in […]
Say hello to the new IRB staffer, Ashley Block
The IRB has welcomed Ashley Block to its office staff. Ashley has worked in research and research administration for more than 15 years at UAMS. For the past 7 years, she was the Project Manager at the Research Division of the Section of Birth Defects in the College of Medicine, Department of Pediatrics at UAMS. She […]
Using surgically removed tissue specimens in research
Some research projects anticipate the use of tissue that has been removed surgically. If you plan to use fresh tissue in a research project, please remember that UAMS Policy requires most tissue to be cleared through the Hospital Pathology Department before it can be used for research. There are a few exceptions – they’re listed […]