Making the case for a new electronic system
IRB director outlines process initiation
Academic research institutions continue to cope with challenging economic times, looking for ways to cut costs and improve efficiencies. IRB directors can make a good case that one of the best ways to do both is to move to an electronic data and IRB review system.
A switch to an electronic data entry and review system will have a large price tag upfront, but the savings in paper, copies, and staff time could provide a full return on the investment in a year or slightly longer, an IRB director says.
"By going electronic we're going to eliminate $50,000 in paper and copying costs for each of the five colleges we provide services to," says Norma B. Epley, MS, CIP, an administrative director and department chairperson at the University & Medical Center Institutional Review Board of East Carolina University in Greenville, NC.
The estimated $250,000 annual savings will recoup the electronic system investment after one year, she adds.
"That is a large annual savings for the institution," Epley says. "What the electronic system also does is free up research coordinators and investigators from spending all their time on making copies."
As the economy flounders and research professionals are asked to do more work, any change that relieves some of that stress is very important, she adds.
But the key is convincing institutional leadership to invest in the electronic conversion and successfully initiating the change.
Here's how East Carolina University made the change:
Convince top administrators to make the investment: Epley brought the idea of switching to an electronic IRB system to key people at the institution.
"I convinced our information officer (IO) to attend a PRIM&R meeting with me," Epley says. "I had been talking about electronic systems with her ever since I was hired, so this wasn't a new topic."
The IO officer was impressed with what she saw at PRIM&R, and she accompanied Epley to see all of the electronic system demonstrations of currently available systems.
Then Epley wrote a justification proposal and presented it to the IO and to the institution's executive council.
"They liked it and felt like I did that an electronic IRB system would be the best thing for the university," she says.
Some of the key points in favor of the switch are as follows:
Researchers at the institution had been asking for an electronic submission process for some time;
The IRB required 20 copies of every protocol submission, and an affiliate hospital site required an additional 25 copies of every submission. Together these amounted to a massive amount of paper copies, costing the institution a large amount of money each year.
The electronic system would be web-based, allowing affiliate staff and researchers access.
Find the most suitable vendor: "We talked to several vendors, and it was a process of elimination," Epley says.
"Since we have affiliates who are spread out all over Eastern North Carolina, and we have agreements with nine hospitals, we needed a system that would allow them access," Epley explains. "It had to be something that was Internet and not Intranet, and that narrowed it down to one vendor."
Epley had some previous experience with an Intranet-based system, and she believed the firewalls and access would be a problem.
"So we took care of this problem with just one program," she adds.
Present the change to staff and researchers: "We held a kick-off meeting where the vendor showed us the process, and we began to compare our current system to the system we hope to have," Epley says.
The IRB office also made announcements about the change at IRB meetings, put a notice in the institution's newsletters, and held lunch and learn sessions on the switch.
"So many of our investigators had already requested it that it wasn't a hard sell by any means," Epley says.
Change processes and policies to prepare for transition: "We are re-examining our business practices, standard operating procedures (SOPs), and everything we follow right now to ensure we minimize the staff burdens as much as possible," Epley says. "If something is not absolutely necessary then we're trying to eliminate it."
IRB staff's time will be strained during the transition process, so the goal is to reduce its current burden through process changes that increase efficiency.
One process improvement that has saved a considerable amount of staff and IRB chair time involves a change in how unanticipated events and adverse events are reported.
Another change involved how submissions are handled when they arrive.
The old process resulted in duplicate actions that added more time than value, Epley says.
"We logged in new submissions both on paper and electronically, and we stamped each page with the submission date," she says.
The IRB office switched to requiring a date stamp on only one page of the submission form.
"That's the sort of thing you don't think about taking up resources," Epley says.
But an IRB office's staff is a primary resource, and when employees spend time stamping hundreds of pages, then it quickly adds up to a considerable drain on resources.
"We modified those procedures so we still have a log, but it's not as detailed, and we can trace back each protocol very easily without having to record every action," Epley explains. "It was a simple thing to change but when we looked at time management, it made a huge difference."
Academic research institutions continue to cope with challenging economic times, looking for ways to cut costs and improve efficiencies. IRB directors can make a good case that one of the best ways to do both is to move to an electronic data and IRB review system.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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