If you’re trying to think of ways to find people who might be interested in your study, the UAMS Translational Research Institute (TRI) may be able to help. TRI’s ARresearch.org volunteer registry provides investigators with access to nearly 3,000 potential research participants located primarily in Arkansas. Like all recruitment mechanisms, ARresearch.org database access requires IRB […]
Remember, NICE reviews aren’t “audits”
The New Investigation Consult and Education (NICE) reviews provided by the ACH and UAMS research compliance staff are wonderful tools. They can help a newly approved study get off to a good start by identifying and fixing any problems before subject enrollment begins. Keep this important tip in mind when following up on NICE review findings. […]
Answering the CLARA New Submission Form’s accrual questions
Confusion reigns about how to complete the new submission forms asking what your study’s enrollment goal is, and how many people you’ll need to consent to reach that goal. Here is a guide for how to handle these queries for various study types: For studies with consented subjects: The first question the submission form asks what […]
Updating your study? You may need to revise some form responses as well
A reminder when submitting modified documents, or when responding to contingencies – if the changes you are proposing relate to something that was asked on the new submission form, please edit the corresponding modification form response to match your changes. Example: Say that when you first proposed the study, you were going to provide compensation […]
A couple of hints when reviewing new submissions
Hint No. 1 – We sometimes see mention of a missing NCT number when reviewing a new submission. Please note that sometimes PIs won’t have received an NCT number from clinicaltrials.gov before the study comes to the IRB for review and approval. Therefore, any IRB request to obtain and document the NCT number should be […]
IRB office short-staffed; please remember the irb@uams.edu option
Due to some staffing changes, the IRB is currently without the two people who fielded a lot of the questions phoned into the IRB office. So, while we shift some job assignments around, please remember that you can also get answers to your IRB-related questions by sending an email to irb@uams.edu. We have fewer people available […]
Trial (or maybe treatment) found on clinicaltrials.gov leads to vision problems for three women
A procedure that fell somewhere between “research” and “treatment,” depending on who you ask, involving the injection of stem cells into the eye led to severe vision problems in three women, one of whom went blind as a result, according to a recent report in the New York Times. The article raises some interesting points. […]
Oft-studied community sets its own research ethics standards
You may remember the San people from the 1980s movie titled “The Gods Must Be Crazy.” That effort wasn’t the first time this community was under scrutiny. As a recent article in the online publication Quartz notes, the group has been studied and photographed for a long time, and “The traditional knowledge and culture of the […]
One-size-fits-all statistical analysis? Hmmmm….
We see a great many protocols with statistical analysis sections that read as follows: Data will be analyzed using SPSS version 20 (SPSS Inc., Chicago, IL). Baseline characteristics will be described as means and standard deviations for continuous variables and percentages for discrete variables. Continuous variables will be compared using Student’s t test and categorical […]
Patients advise on a cancer study
Here at the IRB, we see a fair number of social/behavioral studies that are designed with the help of community advisory boards or other representatives of the intended study population. However, that kind of patient involvement seems to be more rare in clinical studies, at least the ones we see. The NCI-MATCH study, per one […]