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(From left) Research compliance officers Barbara Wilborn and Susan Forbes, and IRB staffer Misty Braggs, are among the users of the IRBNet software package at the Central Arkansas VA Healthcare System. (Photo by Jeff Bowen)
October 31, 2019
By Mitch Mirkin
VA Research Communications
"This enterprise solution will harmonize and standardize processes across VA research."
Amy Lallier, the IRB administrator at the Central Arkansas VA Healthcare System in Little Rock, remembers the old days when reviewing research studies at her site involved a paper trail—literally.
It wasn’t that long ago—2010—when Lallier joined the Little Rock VA, but the work of the site’s IRB, or institutional review board, still relied on reams of paper and an overworked, temperamental copy machine. The “beloved behemoth,” as Lallier refers to the copier, “was well-known for revolting and shutting down for every time-sensitive assignment.”
That same year, the site switched to an electronic system known as IRBNet. Lallier recalls the transition fondly.
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“We went from a paper to an electronic submission and review system,” she says. “One of the earliest and most obvious changes related to meeting preparation and record storage. The IRB office went from preparing 19 copies of huge stacks of paper for review to assigning reviews electronically. This system allowed committee members to see the particular submission application along with the entire submission history of a given project to support their reviews with a click of the mouse.”
Fast-forward nearly a decade, and now VA’s Office of Research and Development (ORD) is instituting the same software system nationwide, across all 108 VA sites that conduct research.
To do so, the agency has contracted with a small tech business owned by a service-disabled Veteran. The product is expected to streamline workflows and improve management of research at VA medical centers nationwide.
“This enterprise solution will harmonize and standardize processes across VA research,” says Dr. Molly Klote, director of the Office of Research Protections, Policy, and Education within ORD.
The software is called IRBNet. Among other tasks, it covers all the functions handled by IRBs. These bodies oversee research involving people to ensure it is ethical and safe.
A dozen VA sites, including Little Rock, have been successfully using the software for years, through separate contracts. The product has also been used by researchers at the Department of Defense and Kaiser Permanente.
VA’s new enterprise deal is with Virginia-based Minburn Technology Group. Within VA, the software package will be known as the VA Innovation and Research Review System.
While the technology upgrade will be largely invisible to Veterans who take part in VA research, it will affect them nonetheless. Dr. Rachel Ramoni, VA’s chief research and development officer, says the step “is critical to delivering on our promise to Veterans and our researchers to make our processes more efficient and effective. When, for example, we can open up a potentially life-saving cancer clinical trial months faster, it means that more Veterans will be able to benefit.”
Klote says IRBNet will ease the administrative load on VA research staff and other stakeholders, including the many oversight and regulatory committees that help oversee VA studies. “The decrease in administrative burden will allow these staff to focus on education, training, and protocol development.”
Lallier’s colleague Barbara Wilborn, the research compliance officer at Little Rock, spends most of her time auditing studies, making sure they conform to all the VA and federal rules that apply. She says IRBNet “allows me to locate critical and required documentation with accuracy and ease in a much shorter period of time,” compared with the old paper system. “I also enjoy the ability to have access to agendas, minutes, research forms, SOPs , and the statuses of my studies I am auditing at my fingertips. This reduces time spent on the telephone and the need for routine paper and computer searches.”
Researchers, likewise, will have real-time access to the status of their studies as those projects wind their way through the review and approval process. This will boost transparency, notes Klote.
Another benefit of the new software, she says, is that it will spur more collaboration across VA sites and with outside partners, given that they can now share a common platform for documentation and tracking, and can more easily share single IRBs for multisite studies.
It is also expected to help with data analysis and decision-making, both at local sites and nationally within ORD.
“Data-driven decisions require that we first collect data on a standardized, central platform,” Klote says. “We’ve been overdue for an enterprise solution that will give us access to these research data.”
Not all sites, however, are ecstatic about the move. In recent years, nearly 20 local VA research offices invested on their own in IRB software packages other than IRBNet. They wanted out of the antiquated paper-based system and got tired of waiting for a national electronic system to take hold. A couple of approaches were tried at the nationwide level, but the products didn’t stand up well to the complex and fast-changing demands of the research environment. Also, many sites have relied for years on the IRB software of their university affiliates. They will be able to continue using those systems, but will also have to get on board with IRBNet.
Klote has worked to reassure these sites about the potential gains of switching to IRBNet. She’s emphasized that the decision to go with IRBNet was thoroughly researched, and that the software has unique advantages when it comes to serving a nationwide network of sites, and not just a single VA medical center.
For those sites, adds Lallier, “moving to the new platform will mean compromise, consensus-building, and commitment to change.” She admits it will take some adjusting.
Wilborn also understands their frustration. “For research compliance officers, it will involve learning to maneuver in the new system. For those sites that have [other] databases and programs already in place, it most likely means a redo. This is a challenge that will require extra time”—a commodity, she concedes, that is probably in short supply.
But Klote’s office is committed to as smooth a transition as possible. She told stakeholders in an email in late September: “As discussed in numerous meetings and cyberseminars, there will be a tiered, phased-in rollout of the product over the next two to three years. …We will work with each research site to plan and support a seamless transition to IRBNet.”
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