IRB's electronic system is office's 'saving grace'

System saves volumes of paper, time

When the IRB at the University of Utah in Salt Lake City, UT, spent two years seeking accreditation, the institution's electronic system was what helped most, the IRB director says.

"Our saving grace is the electronic system," says John Stillman, director of the institutional review board. The IRB received full accreditation in June, 2007, from the Association for the Accreditation of Human Research Protection Programs in Washington, DC.

Before switching to an electronic documentation system, the IRB review process was cumbersome and a paper burden to investigators and IRB members, Stillman says.

Investigators would have to give the IRB about two dozen color-coded copies of each protocol submission, Stillman says. "We didn't have the budget to make copies," he notes.

The workflow under the electronic system is faster and more efficient, Stillman says.

The electronic system has made it possible for the IRB office to keep staffing level even as the workflow has increased, and it's cut other costs, Stillman says.

"We used to buy 1,000 boxes of paper a year, and now we buy 50 boxes," Stillman says. "But where the savings really comes from is all across the campus, investigators can log-in and no longer have to submit paper protocols."

Investigators report that the protocol submission process is very easy and fast now, and if the investigator has all of the necessary information available, he or she could complete the electronic form within an hour to 90 minutes, Stillman says.

Here's how the institution implemented and uses its electronic system:

Select and modify software: The institution chose Click Commerce® software, which initially was purchased from Web Bridge in Beaverton, OR, Stillman says.

"We were early adopters of the product," he says. "We got our version of software, and it required a great deal of modification in house."

A team of three information technology professionals helped make the necessary modifications after the software was installed, Stillman says.

"In the university there's a health science center, including a university hospital, school of medicine, and associated groups, so we had a nice information technology infrastructure that already existed," Stillman says. "They help us manage our hardware."

Also, the institution bought three servers to run the system, relying on National Institutes of Health-funded grants totaling $500,000, he says.

Decide how to handle work flow issues: "We hammered out the workflow by identifying how we do it on paper and deciding which issues we needed to identify," Stillman says.

The first piece was to build work flows into the system, and these were dictated primarily by the IRB staff, he notes.

Stillman, the IRB staff, IRB members, key research professionals, and a computer programmer all attended meetings on the subject.

"We did a lot of user testing to see what they wanted to see and what would be most efficient," Stillman says. "There probably were 10 people at the meetings, and they were held multiple times a week at first and then once a week."

The meetings continued for about 18 months. Slowly the meetings were reduced, and now the process is dictated by the site manager and program manager, he adds.

Integrate other programs: The goal always was to integrate the electronic system as much as possible.

"We've evolved to a system where we've just integrated the conflict of interest [committee] on-line," Stillman says. "So you can put in the information once, and it populates various systems."

The conflicts of interest committee can review the protocol submission and provide feedback to the IRB—all electronically.

The next step would be to integrate clinical communication, he says.

For example, if an investigator is doing research with cancer patients at the university, then the institution's clinical cancer investigation committee (CCIC) also would need to give approval, Stillman explains.

Once the CCIC is integrated into the electronic system, the submission process would be seamless for both the IRB and CCIC. The same integration could be done with all committees reviewing research protocols, he says.

The IRB asks the various committees if they want to be integrated, and the hope is that they all will as soon as it's possible, Stillman says.

"If they say they'd love to be a part of it, we develop it and test it with that group and then move on to the next group," Stillman says.

Train staff, IRB members, and investigators to use electronic system: The institution provided departmental training and hired a fulltime trainer who worked with each individual, Stillman says.

However, since everyone in the IRB office had been involved with the electronic system since it first was implemented, there was not as much need for training once it was completed, he notes.

IRB members and investigators also were involved in building the software process and could submit comments about how to make it more user-friendly.

"It'd take their comments to the developer and sometimes implement the enhancements within a couple of weeks," Stillman says.

"It's an intuitive system," Stillman says. "So a researcher, who has never used it, can fill out the form electronically once he gets a log-in and password."

In fact, the electronic process is so easy that the IRB office gets more questions about regulatory issues than it does about how to use the electronic submission system, Stillman says.

Market electronic system institution-wide: "The key selling point was the idea that investigators didn't have to submit paper and copies and that they had their own web-based workspace to access all of their own projects," Stillman says.

Also, investigators could see where they were in the queue.

Besides saving paper, the electronic process is much more flexible for investigators. "Now if an investigator's study has an expedited review, it can be logged in and done very quickly," Stillman says. "Before, the investigator might receive a packet with questions, but now it's a nice application that's pre-vetted by the IRB staff, and it allows users to log in anytime day or night."

These features helped to sell the system to investigators. "We were surprised in how well it was received," he says. "We got a lot of support from day one."

IRB members also needed to buy-in to the process. The electronic forms clearly show questions related to the type of protocol that has been submitted, Stillman says. If the electronic process had been difficult to maneuver, the IRB would have protested, he says.

"Most found it easier to work with the protocols on-line," Stillman says. "Older IRB members might not have liked it and asked for paper, but now they're used to it."

In the future, the electronic system will permit the IRB office to run reports showing how long a study was in the pre-review process and how long the IRB considered it. All of this information could be useful for quality improvement projects, Stillman says.