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Audit helps pinpoint problems with IRB's electronic system
System is fixed, audited, and tested
Electronic IRB systems can be an efficient way to improve human subjects research compliance, but as one institution has found, these also can be a source of compliance problems.
The Cincinnati Children's Hospital Medical Center recently conducted a compliance audit that identified a recurring electronic IRB system problem.
"We received a question from the IRB manager about documentation discrepancies, and she asked us to perform an audit to confirm the actual number of these discrepancies," says Dawn Lowe-Gooden, CQA, CTSB, MS, research compliance manager in the hospital's office of research compliance and regulatory affairs.
There were automatic activities conducted within the IRB office's electronic submission system that resulted in inaccurate approval and informed consent form documentation dates, says Benjamin R. Byington, BS, research compliance specialist.
The IRB manager wanted compliance specialists to verify the cause of the discrepancies and the extent of the problem.
"I was given a query of all studies that involved informed consent, and I went from study by study to verify actual consent approval dates versus actual IRB approval dates to make sure they coincided," Byington says. "I looked at the header, the study number assigned, and the date it was approved by the IRB to use that consent document."
The problem occurred when there were open amendments in protocols.
"When you have an approved and active study in the electronic system and you submit an amendment, the system makes a copy of your currently approved study and all documents and makes it available to the researcher for submitting changes to the IRB," explains Jeremy Corsmo, MPH, CIP, director of the office of research compliance and regulatory affairs.
The electronic system had a problem reconciling the approved version of the study and amendments with the continuing review process when done in parallel, he explains.
When the continuing review process was completed and the informed consent forms were updated, the electronic system plugged in the old consent dates on the revised forms, Corsmo says.
"What we were displaying to researchers and on the front page of the system were consent forms that were old, plus outdated approval dates," he says. "It was displaying the expiration date from the previous period and not the new dates issued through the continuing review process."
The IRB staff discovered this through the office's normal quality assurance process.
Byington audited the electronic system forms, looking at each study that had consent forms. Plus he looked at continuing review forms and standard communication between researchers and the IRB office.
After the compliance office identified the problematic dates and process and told the IRB office how to fix these, a manual fix was made. Byington's audits showed that the manual fix reduced the error rate from 15.8% at the time of the first audit to 4.6% at the second audit.
"Over time the 4.6% will be fixed," Byington says.
"Immediately following the 4.6% error rate, we put in internal quality steps on consent forms and an amendment of continuing reviews and work flows in our system," Corsmo says.
Along with these manual improvements, the IRB office also brought in information technology staff to fix the electronic glitch.
"We have a dedicated information systems team who supports our function," Corsmo says.
They expect the electronic fix will bring the error rate to zero, Lowe-Gooden notes.
Sometimes electronic compliance issues can be the most challenging to anticipate, identify, and fix. The compliance office tested the fix created for the electronic system to make certain it would hold up.
"It's really hard in an artificial testing environment to come up with every different scenario in the IRB world," Corsmo says. "We put our heads together to come up with whatever scenario we could think of to break the system, and our testing environment proved the fix was okay."
When a compliance office is implementing an electronic solution, it's important to be careful of unintended consequences and know that the electronic system is just following the steps, he notes.
When working in the electronic world, one has to think about the steps of convenience built into the electronic system and how these occur below the radar, Corsmo says.
"Whenever you put in place a new electronic system, you should have a test phase where you input test data and see what happens as you are validating the system," Lowe-Gooden suggests. "You need to see if it does what you intend it to do."
And the same is true when an electronic system is revised to fix a glitch.
"The way it's fixed now the system won't allow this error to occur," Corsmo says. "We haven't done another comprehensive audit yet, but I feel confident that this particular problem is solved."