When a study proposes to include people who can communicate but cannot provide their own consent, the IRB will typically require some sort of assent process or document be used to explain the proposed research to the subject. This requirement is most often seen in studies involving minor children age 7 and up. Please keep […]

The 4th quarter IRB Research News and Tips blog quiz is now available at learnondemand.org! Get the most convenient 0.5 hours of Certified Research Specialist elective credit around. To access the quiz, go to the learnondemand.org link and type “IRB” in the search box at upper right. Please note you have to complete the entire […]

In research, the regulatory definition of a “human subject” encompasses more than just living, breathing, actual humans. In fact, a research study that involves accessing identifiable medical records involves human subjects, even if the investigators will have no direct contact with the study participants. Federal regulations governing research define human subjects as living individuals about whom an […]

When putting together a submission for study involving an investigational drug, please make sure the submission includes the related investigator’s brochure (the IB). The IB contains important safety information about the drug the IRB will need to see before it can review the study. All investigational drugs will have an IB provided by the study […]

Remember – when you need to change something in an approved study, please review the entire submission to make sure you catch and amend everything that needs changing. For example, even a minor protocol amendment, such as changing a study’s end date, or a staffer’s phone number, might require changing the new submission form, the […]

Well, we must admit we’ve been a little spooked lately by some of the document stacking issues we’ve seen in CLARA. Nothing chills our bones quite as much as seeing tracked-changes and clean copies of revised documents in a single stack. We shiver in horror whenever we have to send something back to have you […]

The Food and Drug Administration (FDA) has strict requirements regarding the emergency use of test articles to treat patients. Failure to follow those requirements can create big headaches for investigators and institutions. Here’s a refresher on some of the key elements of emergency use of test articles. First, emergency use, per the FDA regulation at […]

We love hearing from our researchers; we really do. But here’s a tip that may save you a bit of extra work when submitting modifications, and contingency responses. We often notice investigators send in separate letters to the IRB explaining something in their CLARA submission. Unless that letter includes information that’s not addressed elsewhere in […]

Some research projects anticipate the use of tissue that has been removed surgically. If you plan to use fresh tissue in a research project, please remember that UAMS Policy requires most tissue to be cleared through the Hospital Pathology Department before it can be used for research. There are a few exceptions – they’re listed […]

Just a friendly note from your local IRB reminding research team to try to make informed consent materials read at somewhere in the grades 4 through 8 range. We know that sounds like a low reading level, but in most cases, it’s doable. It’s also appropriate for most studies. Health literacy can be low in […]