Good news! Our most recent application to the Association for the Accreditation of Human Research Protection Programs (AAHRPP) was approved last week, so we are now fully reaccredited for another five years! According to the organization, “AAHRPP accreditation indicates that your organization follows rigorous standards for ethics, quality, and protections for human research.” UAMS was initially accredited […]

Making informed consent information understandable to participants has long been a challenge, as we at the IRB well know. Reading levels of many consent forms often exceed the recommended no-great-than-8th-grade guideline. The UAMS Center for Health Literacy has been working on coming up with ways to make working with some IRB staff, TRI, and others on […]

If you’ve ever been assigned an audit, you may have seen a form in CLARA called the assessment of noncompliance. IRB office staffers have been routinely completing that form as they prepare audits and audit responses for board review. Well, like so many other things, that form dates from the “BC” (Before CLARA) era, and we […]

Study staffers’ CITI training status is something that comes up a lot during IRB meetings. All study staffers listed in CLARA who interact with subjects or with identifiable data must be current on CITI training. A couple of things to keep in mind when evaluating whether someone’s CITI training is up to date:

Recent posts on this blog have highlighted the fact that, in the final analysis, we are all basically research subjects creating research data, whether we know it or not. Sometimes our environments also get manipulated without our being aware  – does anybody remember the Facebook study that caused much wringing of hands? And here’s a […]

The issue of whether, and how much, to compensate subjects for research participation is something IRBs and researchers struggle with. Is a particular compensation scheme affordable given available funding? Will the proposed compensation be so high as to unduly influence the target population’s decision to join a study? Or is it so low that it […]

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 […]

“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 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 […]

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 […]