By Melinda Young
It is possible to shorten IRB review time dramatically, but it requires some resources and time.
The IRB of Northcentral University in La Jolla, CA, a large, online academic research institution, serves a nontraditional population of students, some of whom want to complete a research study as part of their academic plan.
The IRB’s streamlining process reduced the submission-to-approval time to eight days, down from an average of 65 days before the new process, according to new, unpublished data, says Heather Miller, PhD, IRB director at Northcentral University. The new process offers several one-hour educational classes on improving the IRB submission. Student researchers and other researchers can take these classes if they like.
“We created a structure where the information coming in — if they go to our educational classes — looks good,” Miller says. I wanted to reduce conflict and anxiety. Our students have full-time jobs and lives, and online institutions are catering to them.” The newest course is about setting up consent letters through the institution’s online app that collects survey data, she adds.
Virtual students may not have access to as much hands-on research support as students attending a research institution in person, but it is important from an IRB’s perspective to not cut regulatory corners in their studies. Most of the institution’s more than 800 submissions are from students, although faculty also submit studies to the IRB.
“I’m really concerned about students doing things properly, even if their studies are minimal risk,” Miller says. “They need to understand how to protect human participants regardless of risk level of their study so they’re prepared for the future.”
Finding the Right Process
While some research programs may say a student researcher does not need a consent letter because the study is exempt, Miller sees asking them to write a consent letter as an opportunity to help students with their research training.
Before focusing on streamlining the IRB experience for student researchers, the IRB’s average submission-to-approval time for students’ studies was 65 days. After streamlining the process, the average time plummeted to eight days, she says.
Finding the right way to change the process was challenging. The IRB had to try several changes. “My first goal was to be open, accessible, and have a transparent process,” Miller says.
The program grew from a partnership between the university’s academic success center and the IRB. It includes collaboration with the academic success center’s writing experts, facilitates IRB webinars, and provides IRB application coaching. Researchers who take the writing and IRB submission classes can show the instructor their actual study and receive some help with it.1
IRB members and staff teaching the classes can identify red flags before the studies are submitted to the IRB. “It’s a really supportive environment,” she says. “The instructors tell students to attend the office hour [open-door information meeting] for help, and then the IRB director or chair and I can mitigate problems that would have been passive issues if they were not identified early.”
Shifting to a more transparent IRB process proved daunting. It took hours of staff time, helping researchers, explaining regulatory issues, and meeting with each student investigator at one-on-one appointments. “IRBs have to be well-resourced, and it takes hours of time,” Miller says. “It was not sustainable.”
Miller held a virtual meeting with Northcentral IRB analyst Jenelle Dembsey. She discovered Dembsey aspired to become a writing instructor for professionals. This led to the idea that if the IRB could teach student researchers how to write informed consent documents, their IRB submissions would greatly improve.
“The IRB application is a genre of writing,” Miller says. “We formed a partnership where I trained IRB members working with the university’s academic writing center.”
Students could access the IRB submission writing classes through the academic writing center’s scheduling system to make an appointment. “What we did was capitalize on this existing structure and started group writing sessions for the genre of writing the IRB application,” Miller says. “I trained half my team and allocated my resources, even on a tight budget, to the education arm, using these existing structures.”
Miller trained one academic writing center staff member to think like an IRB member and to understand what IRBs look for in study submissions. The writing center staff member could help for six hours a week.
“I wanted to teach her one thing: how to write a consent letter,” Miller says. “Everyone in the IRB world obsesses over consent. If you have a well-written consent letter, you have 90% of the battle done.”
The 60-minute classes for student researchers began with six people per virtual class. The classes started with how to write the informed consent document, but soon expanded. Now, there are 26 classes per week, divided into these four categories:
- How to choose eligibility criteria for participants;
- How to recruit participants and create flyers that are accessible for people with disabilities;
- How to write a consent letter;
- How to fill out the IRB application and understand terms, such as dual conflict.
“A lot of times, researchers struggle with eligibility,” Miller notes. “They say, ‘I’ll include school teachers or nurses,’ but [they struggle] when you get down into the nuts and bolts and who they want to talk to and who is eligible for their study.”
After working with the writing instructor for six months, the IRB developed its own sessions for researchers, using IRB staff and board members to teach the classes. They are paid an hourly rate per class.
“All of our board members are trained about the regulations. Four board members help to facilitate the classes, and six or seven do the reviews,” Miller explains. “Janelle and I worked on a job description for teaching the sessions. We were looking for board members who could facilitate a Zoom session, show their face, and provide written feedback to students.”
Every IRB member is expected to have regulatory knowledge, for which Miller provides weekly training sessions. “It took two months before we let them facilitate classes on their own,” she says.
The educational sessions are not mandatory for students. But if any researcher, including students, encounters a problematic study submission, they are directed to the classes for help in improving their submission.
“Professors love the program,” Miller says. “It alleviates all the anxiety they have [about mentoring students in research]. It gives them a place to send their students, researchers, and junior faculty for support.”
IRB reviewers also like the program because they are reviewing study submissions written more clearly and completely. “They’re not bogged down in a lack of clarity of who is going to be in the study, and there are no informed consent letters with typos and [lousy] margins,” Miller says. “They can focus on what we are looking for, and what’s really important.”
Now, when a research submission is poorly written, the researcher is told their paper is not yet ready for review. The electronic system suggests they attend an educational session. “We give them webinars and resources to review prior to the session,” Miller says.
Also, student researchers who engage in the program and its courses report a higher satisfaction of the overall IRB submission process, and they express feeling empowered, she says.
- Miller H, Dembsey J, Northern S, et al. Using existing university resources to streamline the IRB experience for student researchers with SBER studies. Poster presented at PRIM&R Advancing Ethical Research Virtual Conference, Dec. 1-2, 8-9, and 15-16, 2020. Poster/Abstract: 53.