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 […]
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Time’s running out to get that second half-hour of CRS credit
The most recent online blog quiz that allows you to earn 0.5 hours of Certified Research Specialist education credits will only be available for a few more weeks. We’ll post a new quiz in January, but we don’t want you to miss this opportunity to a half-hour closer to meeting your CRS requirements. Remember, you […]
Seeing a document’s “Tracked Changes”
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 […]
“Exempt” may not mean what you think it means
Exempt – in the dictionary, it means “not subject to or bound by a rule.” That definition does not apply to IRB-land, however. Studies that qualify for exempt review status are still subject to IRB oversight and must be submitted through CLARA. “Exempt,” in this case, means that a study is not subject to the usual […]
Tips and tools for drafting a consent form that sails through the IRB
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 […]
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 […]