When University of Illinois at Chicago graduate student Jacklynn Fitzgerald first began working with her school's Institutional Review Board (IRB) back in 2009, she — like many other students — found the process frustrating. Fitzgerald, who uses fMRI, EEG and other brain-imaging techniques to study patients with mood disorders, discovered that her classes hadn't prepared her for the rigors of IRB review.
"There was very little formal training and you just learn as you go," she says. Her research proposal came back with what seemed like endless corrections from reviewers, and the process seemed cumbersome and slow.
But two years ago, Fitzgerald had a change of heart about the role of the IRB. It was prompted by every researcher's worst fear — the IRB ordered the lab that she was working in to suspend its research after realizing that its patient-record documentation was not up to par.
"Any time you have to stop research because of something administrative like this it is scary and embarrassing. But it changed how I felt about the IRB," she says. That's because the IRB gave Fitzgerald and her colleagues support, resources and training to overhaul their documentation system. The experience "helped me see that they were there as a resource and not a bureaucratic hassle," Fitzgerald says.
That's a perspective that more students should embrace, according to Virginia Commonwealth University psychology professor Thomas Eissenberg, PhD. He served on an IRB for 10 years and chaired APA's 2007 Presidential Task Force on IRBs and Psychological Science. Too often, he says, students — and even more experienced researchers — see IRB approval as an impediment or a hurdle to clear.
"But the IRB, just like you, is concerned with safe and ethical research," he says. "No one wants to harm participants or do something that's unethical. … So you should go into it thinking that ‘these people have the same interests as me, and we need to work together.'"
IRBs are volunteer boards that the federal government requires to review all behavioral and biomedical research projects, to help protect the welfare of human research participants. The boards are locally administered by universities and other institutions, and are regulated by the Department of Health and Human Services' Office for Human Research Protections. IRBs usually include researchers from various fields of study at an institution, as well as nonscientist faculty and community representatives.
It's important to keep that composition in mind during the review process, Eissenberg says.
"One major thing is to remember to be respectful of the reviewers," he says. "You may get questions that appear to come out of left field because the reviewers are not experts in your field — and there's nothing wrong with that. Something that might seem obvious to you may not be obvious to them."
Below, Eissenberg and others offer more advice on how to successfully navigate the IRB process.
IRB process advice
Prepare carefully and thoroughly. "Treat the [IRB] document as carefully as you would a manuscript or grant application because it's every bit as important," Eissenberg says. "Be very detailed. It's better to be more detailed than less detailed in a proposal."
That IRB proposal may include a comprehensive description of your research idea and methods, as well as consent forms, survey instruments and other pertinent documents. The description may include details that students might not realize are within the scope of IRB review, Eissenberg says — for example, justifying the number of participants in your study. Reviewers might want to know, if your study puts participants at any risk, even a minor one, then why include 100 people? Why not 50? Why put 50 more people at risk?
"All it takes to explain that is a power calculation," Eissenberg says. "So put that in. And that goes for pretty much any part of the research protocol. You should explain why you are doing it that way."
Citing examples of previous research that has used similar protocols can help. "If you present something that's new, the reviewers will be particularly attuned to any risks," he says. "If you show them it's been done before safely and ethically, they'll know it's likely to be safe and ethical at their university."
For example, a common way to induce stress in a study is to ask participants to deliver a short speech. So if you're using that technique, explain that it is a common research tool and reference some of the many studies that have used it in the past.
Rachel Becker Herbst, PhD, a pediatric psychologist at Children's Hospital Colorado, discovered the utility of citing past research when her research was up for IRB review a few years ago. As a graduate student at the University of Miami, Herbst was conducting a mixed-methods, community-based study of migrant farm workers. The protocol involved flexible, open-ended interviews of the workers and others in the community. The IRB initially had trouble with the proposal, she says, because the methodology didn't allow her to submit in advance all of the questions that she would ask participants.
"There was a lot of back and forth with the IRB," she says, "because this understandably didn't align easily with their review. I had to present the literature to explain that this was a respected, validated methodology."
Know your resources
In addition to the volunteer review board, many IRBs also have an administrative staff that coordinates the review process and interacts with researchers and the review board.
"Our university has a point coordinator for the IRB," Fitzgerald says. "She is an indispensable resource, and she's there for minor questions about formatting and major questions, too. She's been a lifesaver for me."
Many students may not realize that their first point of contact with the IRB doesn't have to come after they submit a proposal for the first time. Instead, Fitzgerald says, "start early in your communication, and don't be afraid to tap into those people who are there for your support."
Plan ahead
Speaking of starting early, make sure that you leave yourself plenty of time to complete IRB review, says Eissenberg. "I tend to work backwards with students," he says. "You know you want to defend here, and it's going to take X number of months to collect data, so you need to get the IRB approval by X. If you wait, thinking that you're going to get approval as soon as you submit, you may be disappointed because there will be legitimate questions about any protocol."
Of course, he adds, if you submit an IRB application before your research plan is entirely thought out, you might find yourself submitting a lot of amendments later. In general, he says, the time to get the proposal in is as soon as you have a clear idea of what your research will entail.
Be willing to think flexibly
Sometimes, despite your best efforts, your original research plan does not pan out. Herbst discovered that when, as a graduate student, she submitted a research plan for IRB review. The study was to involve participants in a support program that she and her colleagues ran for undocumented immigrant youth who had been detained by U.S. immigration authorities and were living in a temporary detention shelter.
She soon found out that conducting research with this group involved a lot of complications. In addition to getting personal permission from the participants, she and her colleagues also needed to get official consent from the Office of Refugee Resettlement — which proved impossible.
"It was really a curveball for the IRB," she says. "They had not dealt with this issue before."
In the end, Herbst had to modify her plan to study only program development and outcomes, rather than individual factors that contributed to resilience among the youth, as she had originally intended.
If you hit such hurdles, she says, it's important to keep your ultimate research goals in mind and think flexibly about what is within the scope of possibility, rather than being married to one research methodology.
"It wasn't, in an ideal world, what we wanted to focus on, but at least in the end we were able to generate new knowledge about this population, which, at base, was what we wanted to do," she says.