As you draft the projects you’re planning to submit to the IRB this semester, here are a few things to keep in mind that may help speed approval of your submission: Please pay special attention to your description of how the study data will be stored and who will have access to it. Make sure your description is […]

We’ve noticed that a lot of student research projects involve surveys, interviews, and/or focus groups. (Actually, a lot of faculty projects involve the same activities, but a wave of these kinds of student projects has arrived at the IRB in recent weeks.) Many of these proposals include full-blown draft consent forms that subjects are expected […]

‘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 […]

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 […]

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 […]

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 what it is today, on multiple levels. Now, four years after the Office for Human Research Protections (OHRP) indicated that it […]

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 […]

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 […]

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 […]

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 […]