Editor’s note: this article was originally published in July 2019; at that time, Jake Rome, JD, was a staff reviewer for the Health Sciences Institutional Review Board. Rome currently serves as ICTR Administrative Director, FDA-Regulated Research Oversight Program.
Tell me about your current position.
My role is to review research studies involving human participants and work with study teams to address any issues before a study goes to the IRB for review. Half of my job is to help study teams make sure that everything they plan to do is consistent with federal requirements—Common Rule, HIPAA, FDA, if applicable—and make sure everything is sorted out before we send to the IRB so that they can take a look and approve it. The other half of my job is to prepare all material for the board, essentially drafting a long document that says what is happening in the study, what the regulations are, and why the IRB should approve the study—or what things need to be tweaked in order to meet the requirements so that the study can be approved. I also communicate the determinations the board makes back to the study team so that they can address anything the IRB notices during their review.
What is your educational background?
I was a political science major and then went to law school. I always had an interest in medicine and medical ethics. I looked into health care law, but I didn’t really want to do medical malpractice. As a student I participated in the Center for Patient Partnerships clinical program here on campus, working as a patient advocate and helping people navigate the health care system. When I graduated law school I spent time as an advisor at the Center, where I met someone who worked for the IRB and directed me to an open staff reviewer position that I might be interested in.
Walk me through a typical workweek.
A lot of what we do is based on our deadlines. The Health Sciences IRB usually meets once a week; Minimal Risk IRB every other week. My deadline is a week before a meeting so that the IRB members have time to review everything. Mondays and Tuesdays are prep days: meeting with IRB chairs to discuss studies so that they’re well-versed in what might come up in meetings, getting prepped for meetings, taking notes, etc.
Tuesdays, Wednesdays, and Thursdays involve diving in to studies and doing in-depth reviews: trying to understand what a study team is doing, why they’re doing it, how that makes sense and works under the Common Rule, and how it might need to be tweaked so that they can get it approved in a substantially similar way to what they’re hoping to do—and then communicating back-and-forth with them through the ARROW application system. I then prepare materials for the board, saying “this is why we want to approve their study, or this is why you should approve their study.”
Fridays are meeting days. We have staff meetings to discuss issues to be consistent in our reviews, or ask about issues that others may have collective knowledge of. Friday afternoons involve other projects, including education and outreach, and planning for the upcoming week. A lot of what we do involves dense reading, so I try to clear my slate on Fridays so that I can hit the ground running on Monday. Outside of that, I serve on different committees, including a committee that looks at FDA regulations and when they apply. I also spend a lot of time answering questions that come into our office – through email or as a daily point of contact – or meeting with researchers who request a consultation through our website.
How many IRB applications do you work on at any given time?
It ebbs and flows. At any given time I have a portfolio of 12-13 studies, with 4-5 ready for my review while others are with the study team, with the IRB, etc.
What is your favorite part of the job?
There’s a lot of interesting research that happens on campus. A lot of our researchers are at the forefront of their respective fields and doing novel and interesting work. It’s fun to peek behind the curtain and see what they’re doing. And beyond that, in a small way, to help them ensure they’re conducting research in a way that protects human subjects and considers the individual’s autonomy, and that they’re considering all the other fun regulations that apply.
What is the most challenging part of your job?
Trying to convince researchers that we’re really here to help. Everyone thinks that the IRB just doesn’t want you to do stuff. The reality is that we want you to do stuff, but we want to make sure that it’s done in a way that’s protecting human subjects, and also in a way that is consistent across research groups. Our goal is to get research studies approved, and I think we’re pretty successful at that.
Where are you from originally?
I’m from the suburbs of the Twin Cities. I went to La Crosse for undergrad and moved farther east to Madison for law school.
What do you enjoy doing when you’re not at work?
My spouse and I have an 18-month-old, so making sure he’s happy is what I spend the majority of my time doing. A lot of reading children’s books—or memorizing children’s books—visiting family, going to Badger games, the zoo, etc.
Share one fact about yourself that your coworkers might not know about you.
When I was at UW-Lacrosse, I rewrote the student association constitution as part of my work with the student association. That was my apex of political nerdiness.
— Interview conducted, condensed, and edited by Laurie Silverberg, PhD