‘Tis the time of year when student research ramps back up again. Grad students gearing up to begin their final projects are stressed enough as it is, and we’ve noticed that the prospect of dealing with the IRB stresses them out even further. This blog entry is the first of a handful of hints we’ll […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
Why we need all the details in your protocol documents
When the IRB approves your study, it is required by regulation to make certain determinations. Two criteria the IRB must be able to be able to document as being met are that risks to subjects are minimized by using procedures consistent with sound research design, and that selection of subjects is equitable (45 CFR 46.111). To be […]
Reminder — No IRB meeting Sept. 29
September is a five-Tuesday month, and the UAMS IRB meets only the first four Tuesdays of every month. If you have anything needing full-board review in a hurry, it should probably already be in the CLARA system if it is to make it onto the agenda for our last September meeting on the 22nd. And […]
Upcoming Class on Proposed Common Rule changes — Potentially a “Big Deal”
The Common Rule (45 CFR 46) is the regulation that UAMS must follow as it oversees research involving human subjects. It was first published in 1991, when the research environment was much different than it is today, on multiple levels. Now, four years after the Office for Human Research Protections (OHRP) indicated that it was […]
First blog quiz for CRS credit hour expires soon
The first IRB Blog quiz you can take to earn 0.5 hours toward earning or retaining your Certified Research Specialist (CRS) certificate will be available for only about another month! So hurry and log on at learnondemand.org to earn your credit. We’re planning to post a second quiz around September 18, and the first quiz […]
Vulnerable populations in Chart Reviews
When completing a new submission form in CLARA, one question will ask you about the vulnerable populations that will be, or potentially could be, included in the study. This question is included because specific regulations come into play when vulnerable populations are included in research, and the IRB must make additional determinations when it approves […]
A reminder about stacking — stack clean and tracked-changes items separately
You’ve probably seen our previous blog items about “stacking” documents in CLARA. Briefly, all versions of a single document should be stacked atop one another in chronological order, with the most recent version on top. Please note that the clean and tracked-changes versions should be stacked separately, with all of the clean copies in one […]
Industry-sponsored studies and prereviews
In an attempt to reduce the number of times study teams have to get with sponsors regarding consent form changes, the IRB is changing its prereview of sponsored studies. When a new industry-sponsored study arrives at the IRB for review (remember that it may stop at several other offices before getting to the IRB), we […]
Risk to confidentiality is another risk of research
All studies involve some level of risk. Sometimes, those risks are clear, such as in the case of investigational drug and device studies where the test article may have side effects. Other potential risks are much more subtle, however. One risk we see often overlooked in draft consent forms is the risk to confidentiality. Confidentiality […]
Stack audit responses just like you stack any other document in CLARA
Sometimes, for whatever reason, a study you’re working on will be audited more than once by the Office of Research Compliance. That means that you’ll be submitting more than one audit response to the IRB during the study. When that happens, the IRB asks that you “stack” new audit responses atop any previous audit responses […]