Out with the old IRB process, in with the new

Children’s hospital adopts flexible model

For many years, the IRB office at Children’s Hospital Los Angeles (CHLA) followed a process that was standard at most institutions: long, regularly scheduled meetings organized to review an ever-increasing number of protocols. "The approach of the human subjects protections program and the IRB had been the same for many years," says Michele Kipke, PhD, vice chair of research in the Department of Pediatrics at CHLA.

Feedback from the investigator community was mixed; researchers wanted a more streamlined process to accommodate the varied and expanding research program at CHLA, Kipke says.

"Knowing that we could improve this process, we defined some metrics that the staff tracked for several months," she says. The metrics included volume of administrative protocols, volume of full committee proposals, turnaround time, how quickly staff were moving a protocol along, how it was submitted, and how quickly division chiefs signed off. "We collected the data, and it was really informative," she says.

Kipke and colleagues learned that 75% of protocols received are expedited or administrative, yet turnaround time was on par with full committee reviews. The full reviews were much longer than the average turnaround time of other children’s hospitals. "It told us that there was some work that we needed to do," Kipke says.

"In the early phase when we were monitoring turnaround time, we were seeing a lot of variability," she continues. "Measuring and looking at the data became an intervention in and of itself and helped to reduce turnaround times, but we hadn’t put any specific interventions in place."

Flexible IRB

To cut down turnaround times and streamline the approval process, the office developed a flexible IRB model consisting of seven or eight core IRB committee members and a pool of 35 alternates. Meetings are now held once a week, and members from the pool of alternates can be called in as needed, usually when protocols call for a particular alternate’s expertise. "This way, we have the right mix of expertise and knowledge base," Kipke says. "They are all scheduled, so there’s no randomness to it and no one gets a call the day before, asking them to attend. We easily have a quorum and, by bringing in alternates, the right expertise is there to review." Members only have to attend one meeting per month.

The IRB has one chair and three vice chairs, with at least one present to facilitate each meeting. Meetings are typically limited to 90 minutes and have no more than six or seven protocols. "Another difference is that when you have a meeting with 35 committee members and 30 protocols, they’re not looking at all 30 of them," she says. "They’re only looking at the ones that interest them, or what they’re assigned. Now with committee members assigned a smaller number of protocols, we believe the protocols are getting a more thorough review."

Pre-submission improvements

The team also clarified the expectations for staff members and narrowed the pre-submission review process to make sure staff were not overreaching their responsibilities. "We created a checklist that they use for pre-submission review so they know they looked at everything they had to look at and that’s all," Kipke says. "When they have a fully developed protocol, they can move that on and get the proposal seen within seven days of submission."

They also created a staff position dedicated to assisting investigators in developing and submitting protocols to ensure timely processing. The regulatory support specialist acts as a liaison between the study team and the IRB, educates and trains members of the study team on regulatory issues, assists with IRB application and submission, and assists with regulatory and compliance documentation and submission to study sponsors. "We’ve had fellows submitting protocols that weren’t completed appropriately and were taking up a lot of time," Kipke says. "This new service helps investigators to submit a well-developed protocol."

They are also training certain IRB staff to handle administrative expedited reviews, protocol amendments, and other tasks that don’t need to go to the chair or the full committee. "If you have an amendment to add staff to a protocol, there’s no reason for that to go to the committee or chair," Kipke says. "That’s something a well-trained staff member can review and sign off on."

"We did uncheck the Federal-wide Assurance box and we’re now implementing changes associated with that," she continues. "For some of these reviews, like chart reviews, that are no-risk or studies with minimal to no risk, we’re re-evaluating how often they need to come back for review. They had all been on annual review, which is not necessary for minimal-risk studies."

Tracking results

Since implementing the flexible IRB on January 1, Kipke says the improvements have been significant, and they are moving closer to the IRB’s goal of 45 days average turnaround time. "I think we can do better than that, but that’s been the goal from the start," she says.

"We’re giving a short survey to every person who submits a protocol and gets it approved," she says. "We’re six months into this now and everyone is feeling very positive about it." The survey data show an increasing number of investigators reporting a more positive experience with the flexible IRB, and overall they are very satisfied with the rationale given for protocol changes needed, guidance provided by the IRB, and support from the HSPP office.

They also plan to survey IRB members after six months to see if they have any recommendations. "The groups are running really well," Kipke says. "Each group has a rhythm and is getting protocols through really quickly and not sacrificing the integrity of the review. We report these numbers to the division chiefs and department chairs to show how we’re doing and make this as open a process as possible."

Buy-in and training for staff was a little slow, Kipke says, but the goals are being accomplished. "There was a lot of training to be done for staff," she says. "The approach in the HSPP office and IRB had been the same way for many years, and there was work that needed to be done to help folks know what we’re trying to achieve, and to lay out expectations. Change is hard, but we have a group that’s still with us and working hard and committed, so we can declare success in that area as well."

"We’re definitely at this point hitting goals we’ve set and achieving what we hoped to achieve," Kipke adds.