A December 4, 2020, update to the FDA’s policy on conducting clinical trials during the current public health emergency is now available. While we haven’t read all 38 single-spaced pages of it, we notice it contains information useful to our research community, such as guidance about informed consent options, and adapting study procedures to minimize […]

In a randomized, blinded trial, when one group gets the test article and the other a placebo, what happens when the intervention turns out to be wildly effective? From an ethical standpoint, it would make sense to halt the study and offer the placebo group the intervention. But from a scientific perspective, that greatly complicates […]

We’re still cranking out the revised policies here at IRB Policy central. Newly posted are: IRB Policy 1.1, which describes the IRB’s principles and authority. We’ve added language about International Conference on Harmonization (ICH) guidelines. ICH guidelines are a standards many clinical trials involving investigational products follow. At UAMS, studies for which the institution holds […]

Under the Revised Common Rule (RCR), expedited status studies initially approved after January 19, 2019, (and older expedited studies that switched to the RCR), are no longer required to undergo a complete continuing review. Those studies instead will get the two-question annual check-in form, which basically tells the IRB that the study is still a […]

We continue to expand our collection of translated short form consent templates, with the addition of Tagalog (Filipino) adult and pediatric versions. A short form consent process can be used when you unexpectedly encounter a potential subject who doesn’t speak English well, and you don’t have your full consent form already translated into a language […]

You know how we’re always harping on about always starting with fresh protocol and consent templates, and don’t try to adapt old documents to new studies, because we’re constantly updating template language to reflect new regulations, guidances, or best practices? Well, the updated protocol template we just now posted on the IRB’s website is an […]

“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 […]