Was there a research-related class offered onsite that you wanted to attend, but you couldn’t fit it into your schedule? Check the UAMS Translational Research Institute’s (TRI’s) website to see if it was added to the TRI video library. Topics include Biomedical Informatics, Research How-To’s, Grants and Programs, Research Ethics (click on the “Luminaries Lecture […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
Feel like you’re being watched? Well, there’s a reason for that.
That’s because not only might someone be watching you, but readily available facial recognition software might be able to figure out who you are pretty quickly. In yet another installment in our fixation on privacy and what changing notions of privacy may mean for research (both conducting and reviewing it), we draw you attention to […]
Is the world turning into one big dataset?
Every time we use a fitness tracker, or swipe a loyalty card, or check in at the gym, or search Google, we create data. That data doesn’t just disappear – entities can access it for reasons we may never learn about. Here’s a news report about insurers and employers using data from an app designed […]
Does your research involve the MMAS medication adherence instrument?
If you have used, are considering using, or have published about, the Morisky Medication Adherence Scale in a research study, UAMS Attorney Nathan Chaney, J.D., asks that you get in touch with him to let him know (if you haven’t already talked with him about it). There have been some questions raised about the MMAS’ […]
“Research Gone Awry”, per a published report
One of the many things keeping study teams, research administrators up at night is the fear of phrases like “Research Gone Awry” next to their names. The Chronicle of Higher Education, in conjunction with ProPublica Illinois, has published a piece about goings-on at the University of Illinois at Chicago. The story helps illuminate how complex […]
April 30th — Reviewers, save the date!
We plan to hold a training session for new IRB reviewers and current reviewers seeking a refresher the afternoon of Tuesday, April 30. That’s a fifth Tuesday, so there’s no regular IRB meeting that day. We will cover the basics of IRB reviewing and walk through the use of CLARA from the reviewer’s perspective. This […]
A “key information” mention suffices for informed consent contents
Remember that new Revised Common Rule requirement to start informed consent with a “concise and focused” summary of “key information” to help subjects decide whether or not to participate in a study? We all know we haven’t gotten too much direct guidance about what that “key information” should address. For some studies, that “key information” […]
Corrective action plan guidance
Corrective action plans are often called for when you, or an auditor or monitor, notice a problem with a research study. The IRB may also request such a plan in response to an audit report or reportable new information submission. Corrective actions may also be appropriate for protocol deviations reported at continuing review. When drafting […]
NIH cracking down on bad behavior
Getting NIH funding is cool. Losing that funding due to bad behavior, not so much. NIH reports it looked at more than two dozen allegations of sexual harassment last year involving scientists whose work it supports, with 14 investigators who had received NIH grants being replaced, according to an article in Nature. Another 21 PIs […]
Will the FDA look more closely at some devices?
The Food and Drug Administration (FDA) may be on a trend to look more closely at some medical devices, according to a recent NPR report. Problems related to what FDA calls 510(k) devices are prompting this change, per the article. 510(k) devices are those the manufacturer has shown are “substantially equivalent” to a legally marketed […]