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 […]
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Are your students/residents/fellows flummoxed by the IRB process?
Many UAMS students, residents, and/or fellows must complete a research project as part of their education. The research project part, they can cope with. The IRB submission process that precedes the research project, on the other hand, seems weird and mysterious and maybe a little unnerving to them. IRB staffers are happy to provide information about […]
Why we ask you to submit something through CLARA…
Researchers are encouraged to get in touch with the IRB office whenever they have a question. We’re happy to take queries by phone or email, and to provide guidance regarding IRB submissions when appropriate. Some queries are best handled through a submission process in CLARA, however. The big one is, “Does my project need IRB […]
What’s a “studywide note” in CLARA?
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 and the community — things AAHRPP will want to know
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 […]
Reporting Events and Deviations at Continuing Review
We know that, per IRB Policy 10.2, certain events need to be reported to the IRB right away. But how about all those other little incidents that don’t require immediate reporting, but instead are sent in with the study’s continuing review form? What does the IRB need to know about those? We have a handy-dandy […]
Upcoming Research Education Opportunities Galore
It’s fall, and the schedule of research education classes is filling up faster than the leaves are falling off the trees! Join the following classes to network with your research colleagues, become better informed in your field, and earn CRS credit: Upcoming Live Classes Research Education – Developing a Research Protocol. Wednesday, Oct. 21, 12 […]
Typos in consent forms — do they need fixing?
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 […]
AAHRPP reaccreditation — an update, and where to find the HRPP plan (please read it!)
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 […]
New blog quiz for CRS credit now available
The next blog quiz that will allow you to earn 0.5 CRS elective credit hours is now available! To access it, please go to learnondemand.org and click “login” at upper right to get started. Once you get to the page where various activities are listed, put “IRB” in the search box to find the newest quiz. […]