IRB Project Cuts Protocol Modification Time in Half
An IRB process improvement project reduced the protocol modification time by half.
Before the process improvement, all modifications — including the simple ones — were assigned to the IRB chairs, and it would be several days before they were completed, says Katie Sellers, CIP, IRB director of the human research protection program at East Tennessee State University (ETSU).
“Now, modifications are mostly approved the same day they come in,” she says. “It really has helped our researchers because it allows fast changes for studies.”
At a different IRB, Sellers saw how IRB coordinators could play a larger administrative role and that it helped with streamlining and eliminating redundancies.
“Once I arrived at ETSU, we talked about ways we could do something like that,” Seller says. “We got input from chairs and members, and buy-in from leadership. [We] ultimately decided to change the program to empower IRB coordinators to perform more professional functions on behalf of the IRB.” These included delegations of administrative review.
This is how the streamlining process worked:
• Obtain buy-in. The ETSU IRB structure includes two chairs and one vice chair for each IRB. Each IRB includes a full-time IRB coordinator as support. Previously, the IRB chairs performed all the reviews. Every new study or modification submission would be assigned to the chair for review, Sellers says.
The change required the IRB chairs to give up some of their responsibilities and put these new responsibilities on the IRB coordinators. Sellers first met with the IRB coordinators to gauge their feelings about taking on these added responsibilities.
“The coordinators were the first ones I talked about it with, and they seemed confident in taking on more responsibility,” she says. “Both had been here for over five years. They also supported reducing some of the redundancies.”
Previously, coordinators pre-reviewed submissions to ensure everything was included. The coordinators sent the submissions to the chair for review. Then, the chair would send it back to the coordinator to finish processing.
It took a little longer to obtain buy-in from the chairs. “I started the conversation and they were a little hesitant at first,” Sellers says. “One of our chairs had been here for 13 years and had never done anything like this.”
They discussed how the changes would work and how it would give the chairs more time to focus on bigger issues with protocols, Sellers notes.
“With all of the Common Rule changes that have happened over the last couple of years, there are more new policies and requirements overall for IRB review,” she explains. “After the chairs had time to think about it, they were more comfortable with the change because they realized how much their workload had increased over the last several years.”
• Make the change. Logistics were the next step. The IRB had to revise its policies, giving more delegation to IRB coordinators. The electronic submission system also was adjusted, routing forms to IRB staff instead of to chairs.
“Then, we did some education before we launched it, publishing newsletters so it wasn’t a big change for our researchers,” Sellers says. “We wanted them to know to call the staff first and not the chairs.”
The IRB coordinators could jump into the review of modifications, but it was six months before they were fully comfortable with making human subject research determinations.
“We had a formal education session with chairs and coordinators,” Sellers says. “We had case studies that we worked on together to make sure we all did things consistently in the same manner.”
Sellers asked the staff to re-review previous determination forms to see if they would make the same determination as the chair.
For the first months of the change, Sellers and the chairs would check the determination forms for consistency and to ensure everything was handled correctly. The process has become more efficient because changes are made almost immediately.
“We saw that it cut our overall modification time in half, from six days to three days,” she says. “Having the chairs not be in charge of so many administrative changes means they can focus on the larger changes and initial reviews, enabling them to complete the reviews more quickly.”
• Reinforce the process improvement. Sellers and the IRB coordinators submitted a poster about the project to the Public Responsibility in Medicine and Research (PRIM&R) 2020 annual conference. This helped augment the changes.
“[Creating] this poster was really meaningful to reinforce how important making constant improvements to the IRB processes and procedures are,” she says. “It drove home some additional buy-in post-improvement so we have more leverage to make better changes to our program in the future.”
Other IRBs struggling with the same issue contacted Sellers after the conference, saying they wanted to make this change in their own programs.
“Being able to share the poster and show people that we made a successful change really hit it home that we should be committed to making these process improvements,” Sellers says.
- Sellers K, Zerby L, Cannon T. Streamlining IRB review process through staff empowerment. Presented at the PRIM&R Advancing Ethical Research Virtual Conference, Dec. 1-2, 8-9, 15-16, 2020. Poster/Abstract: 50.
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