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 […]

We were thrilled to stumble across this newly available, open-access, paper titled Promoting Ethical Payment in Human Infection Challenge Studies in The American Journal of Bioethics. The paper discusses the process to determine ethically defensible compensation levels for research subjects, with special emphasis on trials that involve intentionally exposing participants to infectious agents, such as the virus that […]

The Association for the Accreditation of Human Research Protection Programs, or AAHRPP, sets standards for human research protection programs (HRPPs). AAHRPP is our accrediting body, and its website has several resources that may help IRB reviewers in their review. Of particular note are AAHRPP’s tip sheets, which delve into detail about specific topics. We use […]

Since the IRB has started allowing the submission of only tracked-changes copies of revised documents, we’ve found that our reviews are a little easier, and CLARA document files are a little cleaner, for studies that only submit the tracked-changes copy. Therefore, the IRB now asks that you submit only a single copy of any revised documents, […]

Happy New Year to all! Here’s our best guess as to what our IRB reviewers can look forward to in 2021. We’ll cover this information in our in-person education in January. Some of you will be selected to meet with our AAHRPP accreditation site visitors. We’re not quite sure when the site visit will take […]