If you’re an investigator who writes your own IND or IDE protocols – or you work with an investigator who does – here’s a new resource you’ll want to note. The NIH and FDA have jointly released a protocol template for phase 2 and 3 IND/IDE clinical trials. The link above takes you to a news […]

When we think “informed consent process,” we very often think of an interaction that involves a written consent form. However, there are other ways of exchanging and documenting information, and some of those alternatives may be appropriate for certain low-risk studies. The New England Journal of Medicine recently published “an overview of innovative approaches to […]

One issue the IRB pays close attention to is the proposed compensation for study subjects. When submitting studies, please make sure your materials clearly and thoroughly describe the compensation. The total amount it’s possible to earn for completing the study must be mentioned, as does how compensation will be prorated if subjects don’t complete all […]

Word has reached us, through the grapevine, of investigators being told things like, “You’ll have to rerecord that recruitment video” and “Unless you get a reconsent, you won’t be able to use that subject’s data because you didn’t follow your approved consent process” by people who are NOT the IRB. We’ve also heard that some […]

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 […]

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. […]

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 […]

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 […]

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 […]

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 […]