Many (but by no means all) human subject research studies require using a written informed consent form to document the subjects’ agreement to participate. Federal regulations and IRB policies have specific requirements for the information that must be conveyed during the informed consent process, and when you’re using a written consent form, that form should […]
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AAHRPP Reminder — Evaluating Risks in Research
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 […]
Learn More About the Notice of Proposed Rulemaking at OHRP’s website
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 […]
Hints to Get Your Studies Approved Faster
Yes, the UAMS Institutional Review Board looks at the big things when it reviews studies — are risks to subjects minimized? Are there appropriate provisions for obtaining the informed consent of subjects? etc. etc. But the little things can also slow down your study’s trek towards Institutional Review Board approval. Have you tracked your changes in […]
How Do I Submit Something to the Institutional Review Board? FAQs
We get a lot of queries from people who are new to research asking about how to submit something to the UAMS Institutional Review Board. Here is a rundown of the most frequently asked questions related to Institutional Review Board submissions, and their responses. Does my project need Institutional Review Board review? Submit a human […]
Wow! Teamwork gets the research job done!
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 […]
Summary of proposed Common Rule changes
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 […]
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. […]