A speaker at April’s annual AAHRPP conference (yes, the same AAHRPP that accredits us) mentioned that, whether we know it or not, we are all research subjects. Every time we swipe a store’s loyalty card to get a discount, we create analyzable data. Ditto for using electronic activity and health trackers like FitBits, MapMyWalk, or […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
The rewards of research
Sometimes you read a media report about study results, and all you can do is think, “Wow, that sounds so cool!” Unless, of course, you work at an IRB. Then you also can’t help but think about the risks and benefits, and how a study like this would be handled at your institution. How do […]
More background on why, exactly, we have IRBs and why they matter
Anyone who has done their basic human subject protection training is aware of some of the research-related abuses that led to the creation of ethics oversight boards. We recently came across a couple of publications about one fairly well-known study that involved feeding radioactive cereal to institutionalized children. While these publications aren’t new, they do […]
AAHRPP Site Visit Recap
Well, we made it through another site visit from our accrediting agency, the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Our two site visitors spent 2.5 days at UAMS reviewing records and policies and interviewing people from several components of our human research protection program. We are to receive a draft report […]
Simplifying consent forms, part 5 (and the Plain Language Consent Templates)
Consent form formatting and word choice can go a long way in making written consent forms easy to understand. While it may be tempting to cram as many words as possible onto a single page, in an effort to reduce the overall page count, having a bunch of gray text on a page will likely […]
If you see something, say something. Like when the minutes you’re to approve are for the wrong date.
We’ve noticed that if we’re not very, very careful, CLARA has the tendency to pull minutes from the wrong meeting to add to the agenda. The reason for this relates to a CLARA quirk involving the timing of agenda creation and meeting finalization in the CLARA system. CLARA is supposed to pull the minutes from […]
AAHRPP site visit scheduled for May 23 – 25, includes interviews
Back in 2005, UAMS was one of the first 25 organizations in the world to become accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and is in the middle of its third reaccreditation process. Part of each accreditation involves a site visit by AAHRPP staff. This year’s site visit is […]
Reviewing the entire renewal period when looking at Continuing Reviews
Ongoing studies are required to undergo continuing review by the IRB at least once per year. Please keep the entire timeframe in mind when looking at a continuing review submission. In addition to reviewing the CR form and any documents submitted with the form, take a look at everything that has been submitted on the study […]
Sorting comments on agenda items
So, you’ve gotten your assignments for the week, you’re logged into CLARA, you open the first study you’ve been assigned, and what do you find? Sometimes what greets you is a jumbled mess of comments and suggested contingencies from the IRB consent reviewer, IRB prereview, and maybe the other IRB reviewer as well. Use the […]
Formatting, word choice, white space — they all matter in consent forms
Think back to your high school days, when you’d try to tackle a reading assignment from, say, your history textbook. Did you look forward to the prospect of reading page after page of small text, arranged in long paragraphs? Or were you hoping for some illustrations, bulleted lists, and white space to break up all […]