Should an institution consider a proposal’s scientific or scholarly validity when reviewing research? Yes, according to the Association for the Accreditation of Human Research Protection Programs (AAHRPP). You may recall a) AAHRPP is the organization that accredits us and b) we are in the throes of a reaccreditation process right now. Specifically, AAHRPP expects us to […]
Continuing Review comes once a year, at least
We’ve gotten a query or two in recent weeks asking if we can waive the requirement for continuing review (CR), since, say, the IRB just approved a modification so it must have just reviewed the study anyway, or there hasn’t been anything new on the study in the past year. Our short answer to requests asking […]
Remember — No IRB Meeting Dec. 29, or on three 5th Tuesdays in 2016
Because the UAMS IRB meets only on the first four Tuesdays of every month, there will be no meeting on Dec. 29th, which is a fifth Tuesday. If you have something awaiting review, the next available agenda is for Tuesday, Jan. 5. Looking ahead to 2016, we notice that March, May, and August all have […]
IRBs and their oversight of researchers getting a closer look, article says
Workloads, member qualifications, and potential conflicts of interest are concerns when assessing the performance of institutional review boards, according to a recent article in Modern Healthcare. This scrutiny of IRB operations coincides with the announced proposal to revise the Common Rule, which is the federal regulation that outlines the requirements for research involving human subjects. […]
Remember — Only one form at a time can be open in CLARA
CLARA generally allows only one form at a time to be under IRB review. This restriction means, for example, you can’t submit a modification on a study until your new submission is approved, or, importantly, you can’t submit a continuing review (CR) form while a modification is outstanding. The only exceptions are that CLARA will […]
A new way to check your study submission’s progress in CLARA
CLARA has always given you an overview of your whole study’s progress through the submission and review process via the “History” tab. The new “Timeline” option can quickly update you on a particular form’s progress. To access the timeline, log into your study in CLARA, click on the form you’re interested in, and then look […]
What’s an informed consent process note? And what should a good process note contain?
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 […]
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 […]