IRB software wins best-practice award
Software created along with IRB
Four years ago, when the IRB at McGuire Veterans Affairs (VA) Medical Center in Richmond, VA, needed software to support the IRB’s work, there appeared to be very little commercial software available. So the IRB decided to create its own software.
Since the IRB itself was brand new, it only made sense to allow the IRB’s software and database to evolve and grow with the board, says Bob Dresch, MSW, executive director of the McGuire Research Institute, which is affiliated with McGuire VA.
The resulting software was MIRB2002, which is used by about 30 VA hospitals, and a non-VA version called MIRBu2003, which is used by Baylor Research Institute in Dallas. Because of MIRB, McGuire VA Medical Center received the 2002 Award for Excellence in Human Research Protection by the Health Improvement Institute of Bethesda, MD.
The research institute had the funds available to develop the software, so everything came together at the right time, Dresch says.
"Had we started the IRB six years earlier, maybe we wouldn’t have found the need to develop a database program," he says.
More government, public scrutiny
But as the 21st century dawned, the role of IRBs had changed to one that was more closely scrutinized by governmental agencies and the public, Dresch notes.
Now with IRB accreditation systems, there’s a lot of emphasis put on IRBs’ correspondence systems, documentation of data, and continuing reviews, he adds.
Plus, the new IRB decided to demand a great deal of documentation from investigators, including 10 page-long initial review submission forms, Dresch says.
"It became evident in the first four to five months that it was way more work than we anticipated," he reports.
"You’ve got to have a database to do all of that," Dresch says. "It was all a matter of timing, and it happened to hit at the same time the IRB world was changing."
The IRB meets weekly and sends out correspondence within one week, which at least has eliminated the need for expedited reviews, he notes.
"We aren’t under pressure from investigators," Dresch says. "With monthly meetings, the lag time is long, but with weekly meetings there’s no pressure there."
But the challenge was to develop a software system that could handle the IRB’s fast correspondence and turnaround time.
In January 2000, Dresch met with N-CORE Systems Inc., also in Richmond, a software company that was hired to help develop the IRB software. "We learned what was required by running an IRB, and that’s how we developed the program for the past three years — with constant improvements," Dresch says.
Old data were uploaded, and the IRB staff spent many hours reviewing 200 ongoing projects, Dresch says. "It was a very busy time, and a lot of people went to great lengths and worked many hours to pull this off."
But the effort paid off. The resulting software provides a user-friendly database that allows IRB staff and members to retrieve and constantly re-evaluate every continuous review report, every new serious adverse event report, new amendments, all correspondence, and changes in principal investigators, he says.
"I wanted the IRB to be able to see every previous action and the IRB’s history, and I didn’t want them to look at some item out of context," Dresch says. "For example, how can you evaluate the amendment without seeing everything about the protocol for the past 16 months?"
All of the IRB data are arranged by date, and the software tracks all voting IRB members and their potential conflicts of interest.
"We had to build in a fail-safe system to not let somebody vote on something they had a conflict of interest with, and that was one of the first key basic things," Dresch says.
"It’ll give you a prompt saying that the sub-investigator is on the IRB committee, and it won’t let him vote on that protocol," Dresch explains.
The software also tracks items and titles to be reviewed, including investigational drug forms and dates, initial review submissions, conflicts of financial interest disclosures, summaries on the agenda, Dresch says.
N-CORE and McGuire VA are moving into a new phase of the software development in which it will be available via the World Wide Web, says Jeff Hooper, MIRB senior developer.
"As the database exists, it is only accessible by research administrators, like Bob and his staff," Hooper says. "But the idea of web interface is that it allows administrators to give access to that data to all of the investigators and research coordinators inside the hospital, via the Internet."
Soon, the new software, called MIRB.net, will allow investigators and coordinators to submit all documents on-line. Then Dresch and his staff will be notified that a new submission is taking place, and they can push a button to grant the investigator access into the database, Hooper explains.
The result will be a reduction in paper flow and more efficiency for the IRB staff.
Investigators quickly will be able to obtain information that otherwise would have required them to call the IRB office and request that reports be sent to them, Hooper says.
MIRB.net will be secured through a process that requires users to log on with a password, and Dresch will have control over its access and the extent of a specific person’s access, he says.
"If you’re an investigator, you will be able to see your own studies, and a research coordinator might be able to see one or more studies," Hooper adds. "But they can’t make changes at all, and all they can do is make new submissions."
Before any new submissions enter the database, they must be viewed and approved by Dresch, Hooper says.
Four years ago, when the IRB at McGuire Veterans Affairs (VA) Medical Center in Richmond, VA, needed software to support the IRBs work, there appeared to be very little commercial software available. So the IRB decided to create its own software.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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