Some of the biggest sessions at next week’s Advancing Ethical Research conference in San Antonio will be available remotely on the UAMS campus, thanks to the UAMS Office of Research Compliance. The conference, organized each year by Public Responsibility in Medicine and Research (PRIM&R), is the big human subject research conference each year, where thousands of […]
Even a minor protocol change can mean a lot of things need updates
Remember – when you need to change something in an approved study, please review the entire submission to make sure you catch and amend everything that needs changing. For example, even a minor protocol amendment, such as changing a study’s end date, or a staffer’s phone number, might require changing the new submission form, the […]
Holidays, inclement weather, can complicate IRB meeting scheduling
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 […]
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 […]