The use of a placebo in a study assessing whether vitamin D supplements reduced the number of asthma attacks in kids with asthma raised some eyebrows in research ethics circles, according to a recent online publication in Science. Per the article, children with asthma and known to have low vitamin D levels were to receive either […]
A new, and vastly improved, HIPAA research authorization template is now available
Simplifying the language in our HIPAA research authorization template has been on the IRB’s to-do list for, oh, about 15 or so years now. We’re happy to report that, thanks to both a nudge from and the assistance of the UAMS Center for Health Literacy, we have a brand new, much more reader-friendly HIPAA authorization […]
A revised Human Research Protection Program Plan is now available
UAMS has updated its Human Research Protection Program (HRPP) Plan, and the revised version is now posted on the IRB’s website. The HRPP plan describes the various institutional components that play a role in the ethical conduct of human subject research at UAMS. The most notable change to this iteration of the plan is the […]
Ethics in Research Involving Prisoners to be Discussed
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 […]
A new IRB staffer, focusing on xIRB 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 […]
A new-ish book about human research protections
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. […]
Updated protocol template posted June 18, 2021
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 […]
A reminder about chart reviews and CLARA’s “vulnerable populations” questions
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 […]
Please tell the IRB what has changed when submitting modifications to xIRB studies
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 […]
Restricting the use of genetic data
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 […]