Our IRB comprises multiple people because we want to get a diversity of opinions represented on the board. So it’s not unexpected to find that not everybody agrees on a particular submission. Votes on motions do not need to be unanimous – motions need only a majority of the vote to pass. Everyone who has served […]
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.
Some common factors behind research misconduct
Getting additional training is one common requirement for investigators who are subjects of noncompliance determinations. While full-blown misconduct findings are rare, they do happen, and often have their roots in compliance-related problems. A recent article in the journal Nature found that investigators subject to action by their home institutions (e.g. having their research privileges suspended) aren’t necessarily […]
Children, assent, quality-of-life, and life and death decisions
This child was younger than the usual 7-year-old cutoff we typically use for obtaining assent, and this involves treatment, not research, but this is a powerful story about a child’s decisions for medical care, and the debate over the extent adults should be involved in those decisions. Trigger warning – this is potentially a multiple-tissue story.
We are all research subjects — even though we may not know it
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 […]
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 […]