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 […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
Investigational drug studies need investigators’ brochures to be reviewed
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 […]
Even a minor protocol change can mean a lot of things need updates
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 […]
Scary goings-on in the CLARA document files
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 […]
Important Reminders About Emergency Use of a Test Article
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 […]
Those separate “letters to the IRB” we see in CLARA files
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 […]
Using surgically removed tissue specimens in research
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 […]
A reminder about consent form reading levels
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 […]
Minimal risk research, the FDA, and consent waivers and alterations
Well, while we freely admit to muttering under our breath about some FDA research requirements, we want to take this opportunity to shout from the rooftops about a new FDA guidance indicating the agency will not object to the IRB waiving or altering informed consent requirements in some minimal risk research. This guidance – which […]
NIH policy changes related to human subject studies
We recently received word from NIH about policy changes that people who conducted NIH-funded human subject research, or who seek to apply for NIH support for such research, need to know about it. The correspondence is below. Please contact the Office of Research and Sponsored Programs for more information about these changes. If you are […]