Protocol Activation Model Leads to Reduction in Time-to-IRB Approval
One tool is a consent language library
A large cancer research institution in New York City overhauled its protocol review process, devised a library of scientific terms commonly used in consent forms, and invested in more staff. Within a couple of years, the updated process resulted in a striking reduction in the median time for protocol and consent review by the IRB. Time-to-IRB approval decreased from 135 days in 2017 to 80 days in 2018. The time has continued to decrease.1
“Many institutions are concerned with trying to activate trials faster,” says Collette Houston, vice president of clinical research compliance at Memorial Sloan Kettering Cancer Center (MSKCC).
MSKCC approached this goal with a complete overhaul. “It was like cleaning a blackboard and starting over,” Houston says. “We started the process in 2017, and went live in January 2018.”
Each fresh protocol in 2018 began with the updated centralized protocol activation core (PAC) process. “Two years in, we found out what really works, and what needs additional support and Lean processing,” Houston says. “We built Lean processing into the workload so we could reach a goal of having the IRB approval and trial activation at less than 90 days. Now, we can get IRB approval accomplished in less than 75 days. We’re enhancing our processes a little bit to make it leaner on that end stage of activation.”
They accomplished this by building a team of experts on how the process works, she explains. “We work with investigation teams and with the committees required for protocol activation, including the budget and contracts team and the study team.”
The idea behind the protocol activation core is to make the process leaner, says Sam Briggs, protocol activation manager at MSKCC. The team of experts includes eight protocol activation managers and two dedicated editors who have developed a library of informed consent language. (See story on consent language improvements in this issue.)
“The great thing about the protocol activation core is that a number of the people came from different disease management teams,” Briggs says. “I came from neurology, and we have GI [gastrointestinal] specialties and blood cancer specialties. We came together to share our expertise, and with the help of the editors, we came up with some well-crafted consents.”
Centralize Processes, Responsibilities
The process improvement project started with centralization of the responsibilities, Houston notes. “It was reasonably quick, and we made some drastic improvements to the IRB approval process,” she adds.
The PAC team collaborates with Memorial Sloan Kettering’s clinical research informatics and technology team, and the strategy and innovation team. The goal is to leverage the consent library as a primary resource for everyone involved in human research protection and informed consent.1
Another change was the development of a protocol review core, also under the umbrella of the human research protection program. Protocol review managers pair with a committee, such as the scientific committee, which is called the research council, Briggs says.
Protocol review managers go over submissions with the research council, checking for essential documents and ensuring there are no preliminary questions from the committee. “It is a polished and complete submission. This has been important in reducing delays and letters from the committee, and miscellaneous holdups,” Briggs explains. “We’ve become experts at what it takes to get any type of protocol through our review process.”
For example, Briggs spends 30 to 60 minutes meeting with investigators to discuss the parts of the protocol that are most concerning.
“Those kinds of things help to cut down on time the protocol is reviewed by the research council,” Briggs adds. “The great thing about the protocol activation core is that we’re always meeting and brainstorming. It has a start-up feel with all of these experts.”
- Rolla K, Briggs S, Houston C, et al. Developing a standardized library of informed consent language to ensure consistency and quality across clinical studies at a large academic medical center. Presented at the 2019 PRIM&R Advancing Ethical Research Conference, Nov. 17-20, 2019, Boston. Poster: 25.
A large cancer research institution in New York City overhauled its protocol review process, devised a library of scientific terms commonly used in consent forms, and invested in more staff. Within a couple of years, the updated process resulted in a striking reduction in the median time for protocol and consent review by the IRB. Time-to-IRB approval decreased from 135 days in 2017 to 80 days in 2018.
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