CLARA allows reviewers and IRB office staff to make two different types of notations on studies they’re reviewing – “Notes” and “Contingencies.” There are important differences between the two, and using them correctly will improve workflows and speed up submission processing (and that can mean shorter meetings!). Here is a refresher on how to use […]
Full schedule of CRS classes planned for fall
The Office of Research Compliance has a full schedule of Certified Research Specialist classes planned for fall. Make plans to attend classes to earn or renew your CRS credential, or just to stay current on research best practices. All classes are to be held on the UAMS campus unless otherwise specified. Live class schedule: Essentials […]
Tips about Human Subject Protection training through CITI
The IRB requires current human subject protection training through CITI (citiprogram.org) for everyone listed as staff on research studies. CITI training is now valid for 3 years (up from the previous 2 years). CLARA automatically tracks CITI training status, and it’s accurate – most of the time. Here are some pointers to increase the likelihood that […]
New checklists to document IRB discussions and reviews
“If it’s not written down, it didn’t happen.” That saying has been used in reference to documenting medical procedures (you can’t bill for it if you don’t document it) and also to conducting research (you can’t prove that you did it unless there’s a documentation trail showing you did it). It also applies to IRB discussions, […]
The different kinds of prereview
I’ve gone into CLARA, I’ve checked the “history” tab for my new submission that I completed a couple of days ago, and the tab shows the study is in prereview. So the IRB already has my study and I should be hearing from the IRB in a few days, correct? Well, not exactly. CLARA is the […]
IRBs and Big-Data Research — A few commentaries
The use of big datasets that are just kind of Out There – and that may have been created without the intent of using them for research – continues to be discussion topic. Below are links to a few articles we’ve noticed on this issue. Wired published a piece about some of the confusion on […]
Remember — please don’t delete previous versions of documents
Responding to IRB contingencies often involved making changes to previously submitted documents. When uploading revised documents, please remember to not delete previous versions of the documents you’ve changing. The IRB will need to keep those on hand to be able to compare changes and to document all the iterations of a particular item. If the […]
Privacy, data confidentiality, and community engagement in an online, genome-sequencing age
Move over, Framingham Heart Study and Nurses Health Initiative studies – there’s a new kid on the block. A new federal project, initiated as part of the Precision Medicine Initiative , aims to enroll a million volunteers willing to provide genetic and lifestyle information in an attempt to better understand what causes disease, and how to […]
Does clinicaltrials.gov have a dark side?
Clinicaltrials.gov, a database maintained by the National Library of Medicine at the National Institutes of Health, lists research studies involving human subjects. Certain types of studies are required to be listed at clinicaltrials.gov, and, per the clinicaltrials.gov website, study registrations have increased as more sponsors and investigators voluntarily register their studies. But as interesting as […]
Certificates of Confidentiality, and what they can, and can’t, do
Some research may touch on sensitive or potential illegal behaviors, such as drug addiction. Or a subject’s research participation may be of interest in a legal matter; for example, a parent in a custody battle may seek access to the other parent’s medical information. In cases like these, a Certificate of Confidentiality can be a […]