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 […]
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The treasure trove known as the IRB Forum
It’s free, it’s full of good information, and some of our IRB members have been asking about it – it’s the IRB Forum. The IRB Forum is an online resource allowing exchange of ideas regarding human subject research, regulations, and protection. As described on its website, the Forum “promotes the discussion of ethical, regulatory and […]
Students, advisors — Get familiar with the exempt categories of research
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 […]
Note to grad students and their advisors — the Human Subject Research Determination form can be your best friend this semester.
‘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 […]
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 […]
Big changes possible to the Common Rule — learn more at upcoming class
A lot has changed in human subject research since 1991. You know, things like the widespread use of electronic systems in research, genetic research and its associated risks, different ways of obtaining informed consent, the rise of central IRB reviews of research, etc. etc. One thing that hasn’t changed much in the last almost-quarter-century is […]
A Court Decision, and More Debate, About Research Risks, Informed Consent, and Neonates
A federal judge has thrown out a lawsuit filed by parents who claimed their infants were injured as a result of research participation, the New York Times reported this week. The study, known by its acronym SUPPORT, was in the news a few years ago, after the federal Office of Human Research Protections (OHRP) accused the […]
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 what it is today, on multiple levels. Now, four years after the Office for Human Research Protections (OHRP) indicated that it […]
Potential Red Flags When Reviewing Research
The Journal of Clinical Research Best Practices (“Happy Trials to You” is its motto) recently published a list of items to be aware of when reviewing research. The authors, Dennis J. Mazur and Norman M. Goldfarb, call them “red flags” that should be addressed before an IRB begins its in-depth review of the project. The […]