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. […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
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 […]
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 […]
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 […]
Do you need Good Clinical Practice training? You might, and here’s where to find it
If you work on NIH-funded research, take note. The NIH policy on Good Clinical Practice training that took effect Jan. 1 applies to you. Investigators and site staff responsible for the management, conduct and oversight of NIH-funded clinical trials will need to complete Good Clinical Practice training. Per information available on the Office of Research […]
The contingencies about “fasting” — and how to avoid them
It’s not unusual for a study to require subjects to be fasting before a certain study procedure, such as a blood draw. What is unusual, we’ve noticed here at the IRB, is a new submission that adequately describes what is meant by “fasting” on the first go-around. Addressing the following items in the consent form and […]
A request for assistance for students, residents, and the like
Many UAMS programs require students, residents, or fellows to complete a research or quality improvement project. For many of these people, this will be the first time they’ve had to interact with an IRB. If you’ve been working in research for a while, you probably already know the ins and outs of submitting a project […]
Publications and the IRB
The IRB occasionally fields queries about writing up research results for publication. Please note that the IRB has no input or oversight of the content of manuscripts or other publications. It is the researcher’s ethical responsibility to accurately reflect their research in any publications. The one thing the IRB asks related to publications is that if […]
What needs to be in the information sheet for an interview or survey study?
Many interview and survey studies can be reviewed as exempt status research. Even though no formal written consent is required for such projects, the IRB will typically require that some kind of informed consent process will occur. That process would typically involve a short information sheet, for a focus group or interview study, or asking […]