An informed consent process note is distinct from the informed consent process form. While the form documents the information that is to be exchanged during the consent discussion (and is typically required by federal regulations), the process note documents that an actual consent process occurred. While the regulations don’t require separate process notes, UAMS IRB […]

We’ve overhead members say in the IRB meetings that they’re not able to see the tracked changes in a document that’s labeled as the tracked-changes version, or that a particular change the PI says has been made in a document hasn’t been made. Here are some tips when you’re not able to see the changes in […]

AAHRPP is coming! AAHRPP is coming! Eventually, anyway – we’re expecting an AAHRPP site visit in the months ahead as part of our reaccreditation process, and some IRB members will likely be asked to meet with the AAHRPP site visitors. To help you prepare, our IRB Members Blog will review some elements that AAHRPP will […]

The proposed revisions to the Common Rule (known as the Notice of Proposed Rulemaking, or NPRM) is still working its way through the public comment process.  You may recall that it took about 4 years for the NPRM to be released after the Office for Human Research Protections (OHRP) announced its intent to revise it […]

Dr. Thomas Kieber-Emmons’ investigational breast cancer vaccine is working its way through the clinical trial process (it’s now in a phase II trial), and this research is a prime example of how all of UAMS research resources work together to make this kind of activity possible. A recent article on the TRI website describes how the […]

As mentioned in a previous Research News post, the federal Office for Human Research Protections has released a Noticed of Proposed Rulemaking, describing possible changes to the Common Rule (45 CFR 46), the regulation that governs all human subject research done at UAMS. Some of the proposed changes could lead to significant adjustments in how […]

On some of the studies you’re assigned, you’ll see something in the notes/comments/contingencies section labeled as a “studywide note.” As you probably know, most notes you see in CLARA are associated with only a single CLARA form, e.g. you’ll see notes associated with a particular continuing review form only when you’re reviewing that continuing review. […]

UAMS’ reach extends across the state and beyond – and that reach includes our research endeavors as well. The Association for the Accreditation of Human Research Protection Programs (AAHRPP), as it reviews our application for reaccreditation, will look at (among many other items) how UAMS engages with our research participants (current or prospective) and our […]

It’s tempting to review written consent forms closely and note all the little typos and grammar errors that could use correction. However, keep in mind that, when reviewing informed consent in research, the IRB’s role is to assure that informed consent will be appropriately sought and, if written consent is required, documented using an approved consent […]

The first big hurdle on the road to reaccreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) is behind us – our application has been submitted. There will be several other steps in the months ahead, one of which will be an AAHRPP visit to our site. During that visit, we […]