How long have you worked at UAMS?
18 years
How long have you worked in your current position?
1.5 years. I worked in the Office of Research Compliance for 9 years before moving to the IRB in 2012.
Summarize your current job responsibilities.
Our office oversees human subject research to ensure, to the extent possible, that human research subjects’ rights, safety, and welfare are protected, and that our research studies are conducted in accordance with federal and state requirements, and industry best practices. A goal I have for myself in this position is to create an IRB office that investigators are comfortable contacting with questions or concerns, and to be responsive and engaged in the entire UAMS human subject research enterprise.
What aspect of your job do you find the most engaging?
Our Principal Investigators (PIs) come up with some really innovative research proposals. I often think, “Wow! What a great idea. I really hope it works!”
What is your favorite part of the job?
The diversity of protocols and working with PIs with various levels of experience (e.g. students to long-time faculty members) keeps each day interesting.
Are there any challenges?
One of the main challenges of my work is keeping up with the federal regulations and guidances. They are always changing and their applications evolving. Different funding agencies also have different requirements at times. Part of our job is to make sure the research community knows about the regulations and guidances that apply to them.
Can you give us some examples?
There’s an increasing push toward single IRB review of multisite studies, so we’ve had to educate researchers about the need to make sure UAMS institutional reviews get done while the IRB reviews are done outside the institution.
What else keeps you busy in the IRB office?
I write two IRB blogs dedicated toward research-related education. One is directed to IRB members and the other that includes research news and tips is for PIs and staff. Check out the blogs here.
Who is involved in the IRB?
Our office has 8 full-time employees, with a total of more than 140 years of research experience between us. That experience includes both doing our own studies and our research administration work. We also have more than 30 volunteer IRB reviewers, who represent at least a dozen different fields of expertise. Our IRB chairman, Allen Sherman, estimates he spends at least 20 hours a week on IRB responsibilities, in addition to his day job.
Give us an idea of the number of studies the IRB has under its purview.
Right now we have about 1,000 open, non-exempt studies. Not all of those go to full board – some can be reviewed in the office by our expedited reviewer.
When does the IRB meet?
The four separate IRB committees meet the first four Tuesdays of every month.
Is the IRB subject to site visits from any outside reviewers?
Yes. The UAMS IRB has been accredited since 2005 by the Association for the Accreditation of Human Research Protection Program (AAHRPP). We are in the middle of a reaccreditation application and expect another site visit this spring. These required visits are scheduled once every five years.
What do these site visits entail?
The AAHRPP site visitors want to know pretty much everything about our Human Research Protection Program. They interview representatives from the IRB and many other offices on campus involved in research (conflict of interest, Research Regulatory Affairs, Biosafety, etc.) and review IRB documentation in detail.
In your off hours, what do you do for fun and/or to recharge?
I relax by playing piano and occasionally play the Steinway in the Cancer Institute lobby. I started playing as an adult; what I lack in skill I make up for in enthusiasm.
I am also trying to relearn the Hungarian I spoke as a child and the Spanish I studied for 5 years in high school but never actually used. I’ve managed to hang on to the French I learned in college. I’m hoping they’ll all help with the traveling I hope to be able to do more of in the future.
Any last thoughts on your position as an IRB Research Program Manager?
I enjoy communicating with the UAMS research community and working with PIs to get protocols in good shape for review.
Edith Paal, MS Journ, MPH, CIP, CHRC
UAMS Institutional Review Board
PaalEdithS@uams.edu
501-686-5544