Adult subjects are routinely assumed to be able to weigh the potential risks and benefits of joining a research study. However, functional abilities can vary depending upon the population, and can even fluctuate in a particular individual, due to mental or physical health changes. So what kind of things does the IRB look for when reviewing […]
Blog
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 […]
We’re cracking down on form completion
We’ve been getting a close look lately from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), a.k.a. our accrediting agency, as part of a reaccreditation application. One bit of feedback AAHRPP has provided is that we need to pay closer attention to the way our CLARA forms are filled out to ensure the forms are accurate and complete. […]
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 […]
Enrollment v. accrual — how many subjects will I have?
We’ve had some questions about how to answer a couple of questions related to a study’s planned number of subjects, and how to address enrollment in the consent form. See the questions below: The first question, “What is your enrollment goal?” is asking “How many subjects do you need to have in your study to […]
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 […]