“The FDA works in mysterious ways,” or maybe, “The answer you get kinda depends on which staffer you talk to and what kind of mood they’re in that day,” is how we’ve heard research professionals describe the Food and Drug Administration. Among other responsibilities, the FDA manages the research processes that lead to the approval […]

Our collection of short form consent forms has grown by one new addition – Ukrainian translations of the adult and pediatric short forms consents. That brings us up to four foreign languages total – Spanish, Marshallese, French, and Ukrainian, plus the English short form if you need to create a quick translation into a language […]

An updated IRB Policy 17.9, Prisoners in Research, is now available on the IRB’s policies website. The policy changes include clarifying what kind of studies involving prisoners the IRB can approve. In looking closely at the OHRP regulations and the kinds of research we do here, and after consulting with OHRP,  we became aware of […]

Federal regulations and UAMS IRB practices require informed consent information to be in language understandable to the subject. While there has been much debate about what, exactly, “understandable to the subject” means, we generally assume it to mean that people who don’t speak English well should have consent information presented to them in a language […]

The IRB has updated its Policy 4.6, now titled “IRB Staff Responsibilities.” This policy describes the work of the IRB office staff and its role in promoting the rights, safety, and welfare of human research subjects. Give it a read to get a better idea of how the staff spends it workdays.  

All are invited to join us for UAMS’ first regulatory compliance conference for researchers and study teams, hosted by the Translational Research Institute.  “Connecting while Complying” is a virtual conference scheduled for the mornings of October 27 and 28. Quincy Byrdsong, Ed.D., executive director of Research Administration at Wellstar Research Institute, is scheduled to be […]

Uploading clean and tracked-changes documents in CLARA takes up a lot of time that’s better devoted to getting research reviewed, approved, and completed. So, here’s some news regarding IRB submissions: You can avoid having to upload both clean and tracked-changes copies of documents you submit if you use the track-changes function in Microsoft Word to […]

The IRB has added French translations of its short form consent forms to the IRB’s website. These templates can be used to create study-specific short form consents when non-English-speaking potential subjects are unexpectedly encountered. Spanish, Marshallese, and French short form templates for adult subjects and for parents of research subjects who are minors are now […]

We’ve made some important changes to our protocol and consent form templates, and the new versions are now available on the Templates, Training, Tools page on our website. The revised consent form template revises some language to improve readability, and to correct some inaccurate template language that we’re always sending contingencies about. The updated protocol […]

“When will the IRB run out of policies to update?” you may be asking yourself by now. Well, pretty much never – regulations, best practices, and accreditation standards keep changing, and we need to keep on keeping up. The latest revised and updated policies are: 2.3, Use of Single/Central IRBs. As we keep learning more […]