The IRB of the Medical College of Wisconsin in Milwaukee experienced a protocol review turnaround time of 70.6 days, despite using a robust pre-review system.
“We felt like we had done what we could prior to the regular submission process to improve turnaround time, so we were looking for something creative,” says Ryan Spellecy, PhD, director of the human research protections program and professor of bioethics at the Medical College of Wisconsin. “That’s when we came up with a real-time review process. Even if things were perfect and firing on all cylinders, we wanted to see what we could do to speed up the process.”
An investigator and one other key research team member attend the IRB meeting to answer any of the IRB members’ questions in real time. The IRB turnaround time has dropped to 20 days, a 71% reduction through 2018.1 Before the real-time IRB process, the median time for study approval was in the 60- to 80-day range, over a three-year period, Spellecy says.
“The reduction is pretty significant,” he adds. “In 2019, the average was 18 days.”
Occasionally, IRB members will catch a problem that will lead to tabling a study, but it is far more common to find things that would need to be improved with minor modifications. Those modifications can be made during the IRB meeting, Spellecy explains.
“Those minor modifications are discovered during the IRB meeting,” he says. “The study team comes into the room, and we say, ‘Thanks for coming in. We had these questions about your application.’”
For example, an application might say the study will enroll 30 people, but the informed consent form says that 40 people will be enrolled. It might turn out the consent form is an older version. Someone from the research team will need to log into the application and make the change during the meeting, Spellecy says.
“They can go across the room to the computer workstation, review it, and make the changes,” he says. “We get a text message that the changes are made, and we bring this back into the meeting and approve the study on the spot.”
Previously, this type of minor error would have garnered an approval with modifications. The study team would have up to a week to make the change. Then, it would go back to the IRB for processing. That one small mistake would take a week or two to resolve, Spellecy says.
Process Familiarizes Researchers, IRB
Another benefit of the real-time IRB process is that investigators and board members get to meet each other in person. “Anecdotally, they say, ‘It’s nice to put names with faces,’” Spellecy explains. “Researchers become more comfortable reaching out to the IRB with questions. It humanizes the IRB to an extent.”
The real-time IRB process works this way:
• Study teams indicate interest. When research teams submit their studies to the IRB, they indicate whether they would like to use the real-time process. Those that agree must meet criteria set by the IRB, and are placed in the queue, Spellecy says.
“We ask them to be facile enough with the online review system to be able to go across the room and make those changes quickly,” he adds. “We request they submit several proposals without hiccups, so we can see they’re an experienced study team.”
It is not practical to use this process with every study, Spellecy notes. “It has a cost; extra staff members have to be there to shuffle the study team around,” he explains. “Principal investigators have to take time out of their schedules to attend the IRB meeting.”
Occasionally, the IRB allowed new researchers to apply for the real-time process with the request that they have a mentor sponsor them and walk them through the process.
“We allow folks, who can benefit from it, to use the real-time process as long as there is someone who can help them,” Spellecy says.
• Coach investigators on the process. “We coach investigators who have not done this before,” Spellecy says.
Sometimes, researchers will introduce themselves with a long explanation of the importance of their research. But this wastes time, so they are asked to keep their introduction short and simply answer questions.
Study teams insert changes using Click Commerce. For example, the IRB might ask for a modification of a specific section, and the researcher must be familiar enough with the online IRB management system to know what this means and how to make the change quickly, Spellecy says.
• Researchers attend the IRB meeting. The study team is required to attend the meeting to answer questions from IRB members. The IRB also requires sponsors to attend the meeting via teleconference.
If the IRB asks that researchers change wording in the informed consent document or something else in the review application, they often need the sponsor’s permission before they can submit the change. For the real-time process to work, sponsors have to give an answer during the IRB meeting.
“Sponsors make their staff available with a phone call during the IRB meeting to answer questions and to give a quick approval of the change,” Spellecy says.
The process increases the meeting time by three to 10 minutes on average, he notes.
“We only do one real-time review per meeting,” Spellecy says. “That’s logistics because we have to have an extra IRB staffer available to usher the study team around, bring them to the meeting, take them to the work station, and let the IRB coordinator know when the changes have been made.”
• The IRB provides specific and timely suggestions. IRB members often will pick up on an issue that is different from what the IRB staff’s pre-review assesses.
The IRB member might know how a hospital process works, and IRB staff would not know that nurses handle this situation in a specific way. For example, a study drug was to be administered in a blinded study. A pharmacist on the IRB noted that researchers planned to blind the study by using commercially available bags, placed over the IV bag, Spellecy says.
“The pharmacist said, ‘This doesn’t come in a bag. It has to be administered from an investigational pharmacy, in a bottle, so this wouldn’t work,’” he explains. “We had a talk with the study team and came to a resolution at the meeting, in real time.”
While this process does not work for every IRB, it is a great tool for some IRBs and studies, he says.
“It’s not a magic bullet, and it won’t solve all issues or decrease turnaround time for every study. But we’re proud of it, and want to help others adopt it,” Spellecy says. “It’s important people know it’s not a cure-all.”