The work pace is speeding up, and it’s not just IRBs — although IRB directors are noticing the effect of having more demands on existing staff. This is a challenge IRB managers can meet by improving their office workflow and operational efficiency.
“One of our challenges involves the increase of volume of work with everyone wanting output quicker and quicker,” says Rebecca Banchik, CIP, manager of the IRB at Icahn School of Medicine at Mount Sinai in New York City.
Banchik’s office handled the workflow pressure through operational changes, some of which worked and others that needed to be tweaked.
“Our office tried to distribute incoming work to staff without losing quality,” Banchik says. “We tried, and it failed, becoming an administrative nightmare to assign all incoming work on a daily, rolling basis.”
Each day, the IRB office assigned work to employees, asking them to complete those tasks by the end of the day. It didn’t work and only added administrative stress and burden to the team, Banchik says.
The chief problem was that there was no way for staff to predict which days would have heavy loads and which would have light loads, and this made it difficult for them to prioritize their efforts. So the IRB kept the same intent of scheduling work for office staff, but distributed work on a weekly basis instead of daily basis, Banchik says.
“We found it worked much better when it was implemented as a weekly deadline schedule,” she says. “Every Friday, our office has a deadline that tells the research community when their project should be expected to go to the board, and they’re on a routine schedule.”
IRB staff can plan their submissions and help their team plan and prioritize their work. “On Mondays, we reassign the work to the analyst, depending on what teams they’re on,” Banchik says. “They get their work for the week, rather than on a daily basis, and they can plan it out rather than have every morning be a complete surprise.”
Having a weekly schedule improved staff satisfaction and productivity, she adds.
To make the weekly schedule efficient without workflow bottlenecks, the IRB advised study teams and investigators of the change and suggested that rather than rushing to submit less well-prepared applications by Monday, they should take a few extra days to make them better and submit on Thursdays, Banchik says.
“We think it’s much better communication, and everyone is clear on what our schedule is,” she explains. “There are flexibilities and ways to put people at the front of the line if a high-priority item is happening.”
Another IRB office efficiency change involved the office’s central review process, which has been underway for the past year and a half.
“Our team structure includes IRB associates, who do first-line administrative support to the team,” Banchik says. “There are IRB analysts who do regulatory pre-reviews and manage projects with board members.”
Banchik views the IRB associates as the review process bouncers. They have the authority to reject incomplete submissions, send a letter to the study team outlining which information is missing, and explain how they can resubmit once the application is complete.
Once all basic information is in place, it proceeds to the IRB analyst who conducts a complete review of the study.
“This process increases the IRB’s overall [efficiency] metrics and turnaround time because no submissions are accepted unless certain administrative processes or criteria have been completed,” she says.
Once an analyst has reviewed the project, it can be seen by official IRB reviewers, who determine whether the study needs a full board or expedited review. Expedited reviews are seen by a designated member of the IRB, including Banchik and other staff members who are appointed to the board.
“Because we have an organized structure and schedule, the IRB associates know where to go to get their projects for the day,” Banchik says. “They know where the projects end up going once they’re either accepted or rejected, and the analysts know what is expected of them.”
The IRB’s workflow also is enhanced by the IRB’s policy to rely only on general boards, rather than specific department IRBs, she notes.
“We have a general board that can see a project from any department,” she says. “The reason I think that’s a good thing is because it doesn’t cause a time delay when you have to send it to a specific board that has a specialty focus.”
Review time bottlenecks occur when projects are delayed while waiting for a specific board to have room on the agenda, Banchik adds.
The IRB learned this the hard way when trying out a specialized oncology board and finding that projects had increasingly long waits. The specialized board model also led to more chaotic scheduling for IRB analysts, she says.
The general boards have specialists who are members, and if they are missing a particular specialist or expertise, they can call for someone from the outside to help with the review, Banchik says.
Another workflow best practice is the IRB’s deferrable issues process.
“We meet with our chair before every board meeting to review issues raised by the board reviewers, and we provide the opportunity to the study team to address those issues prior to the actual meeting,” Banchik says. “This helps reduce our deferral rate, so more studies are approved than deferred to another meeting.”
The process works by giving researchers the opportunity to address issues raised by board members prior to the review meeting.
When board members raise a question about a study, the IRB lets the study team know that a particular issue was raised and tells them they can answer those questions prior to the full board review, Banchik explains.
This helps investigators get their study submissions into better shape and improves the chances of a project being approved. “We’ve gotten great feedback on this,” Banchik says.