The research community is invited to hear a guest lecture by Elizabeth Victor, PhD, titled The Ethics of Risk Assessment in Prison Research. The talk is scheduled for August 5 at 10 am, in the Jo Ellen Ford Auditorium (1st Floor, Institute on Aging). Dr. Victor is Associate Professor of Philosophy and Director of Liberal Studies […]

Join us in welcoming Neitrisha Harris to the IRB staff. Neitrisha came to the IRB from the Winthrop P. Rockefeller Cancer Institute, where she was a clinical research associate/study coordinator. Prior to coming to UAMS, she spent 8 years in quality assurance for the American Red Cross. While she’ll have varied responsibilities in the IRB […]

We didn’t hear about this title when it was first released in early 2020 (we, and the entire rest of the planet, had some other stuff going on around that time), but then the folks at PRIM&R posted a review of Regulating Human Research by Sarah Babb, PhD, on their blog, and we got intrigued. […]

We’ve made a small-but-significant update to the IRB’s protocol template. A sharp-eyed reader noticed an important word (“waiver”) was missing in the language requesting a HIPAA authorization waiver. It’s not missing anymore. And we’ll take this opportunity to remind everyone to always start with a fresh protocol template when creating a new study. Trying to update […]

When completing the new submission form for a chart review study you expect to qualify for exempt status review, a careful response to one particular question will save you some unnecessary hassle. In the form’s “Subjects” section, you’ll get a question asking you to “Select all of the vulnerable populations that will be, or potentially […]

When an external IRB is responsible for the oversight of a UAMS study, the UAMS IRB’s role in reviewing the study is very limited. However, we are required to do something called a “local context review,” which ensures the material seen by UAMS subjects is appropriate. Local context issues can be influenced by state law […]

On the one hand, human genetic data has great promise for use in research. The human genome, and small portions thereof, show great potential in helping us answer questions related to human health, including developing treatments for genetic conditions. On the other hand, the ethics of using genetic data keeps researchers, IRBs, ethicists, and others […]

The Food and Drug Administration is expected to soon decide whether to approved a new drug, aducanumab, intended to slow the progression of Alzheimer’s-related symptoms. The need for better treatments for Alzheimer’s is not in question. However, debate is ongoing regarding whether this particular drug merits FDA approval. A recent New York Times opinion piece […]

Despite a requirement to report clinical trial results, the number of studies actually reporting results on time remains painfully low, according to this recent New York Times article. Trial sponsor are to report findings within a year of collecting the most critical data, the author writes, a deadline that many miss. Read the entire article […]

So, you’ve got a great multisite study started, for which the UAMS Institutional Review Board will be the institutional review board of record. You’re ready to take the step of submitting site addition modification forms in Clinical Research Administration (CLARA) to add additional sites. We’ve recently updated our method for entering sites into CLARA. Rather […]