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Avoiding common pitfalls with new electronic system
Hiring IRB/IT specialist is key to success
For many IRBs, the hybrid electronic/paper systems they've used for a half decade or longer are ready to be replaced. Research and medical institutions are moving toward full electronic communication systems, and IRBs will need to make the leap too.
But how do you make the move efficiently and effectively?
A first step is to hire the right person to head up the electronic transformation, says Philip A. Cola, MA, vice president of research and technology at the University Hospitals Case Medical Center in Cleveland, OH.
"You definitely need to find someone who is familiar with IRBs, and not just information technology," Cola says.
"You need a person who is a research administrator and who understands IRBs to be dedicated to running the project," Cola advises. "But I don't mean an IRB coordinator who also will be reviewing protocols, running meetings, doing agendas, and writing meeting minutes."
An IRB's coordinators have other duties and should not be asked to shoulder the technology implementation in their scarce spare time.
"We hired a person who had been doing IRB work for another center," Cola says. "When we brought her here we said she wasn't going to do IRB work, but would be building the electronic system with our software vendor."
For a large IRB, like the one at University Hospitals, which has 2,000 active protocols, it also made financial sense to keep this dedicated IRB information systems expert on fulltime once the new electronic IRB system was implemented.
"Our IRB electronic system expert provides information technology (IT) training and education, maintains software with the vendor, and works with our IT people to make sure the technology is working well in our environment," Cola says. "And that's a regular, full-time job."
For smaller IRBs, they might consider hiring a fulltime electronics systems and IRB expert for the implementation period and then shifting the worker to other IRB tasks once the implementation is complete, Cola suggests.
Having a dedicated IT/IRB employee is perhaps the most important step IRBs could take to ensure the smooth implementation of an electronic IRB system. But there are other ways they can do this, as well, and Cola offers these suggestions:
Provide inexpensive laptops to IRB members for meetings: One of the advantages of an electronic IRB system is that IRB meetings can go paperless.
But Cola advises against relying entirely on a large screen with the electronic protocol displayed. Screen navigation at IRB meetings is not the most convenient method for individual IRB members during protocol discussions, Cola notes.
If each member has his or her own inexpensive laptop, just as each typically had their own paper copy of protocol applications, then members could refer to sections in the application more easily and conveniently.
"If an IRB member is talking about a certain part of the protocol, then I can say, 'That's not what I read,' and I could page forward to the section that I remember," Cola says.
"If you're projecting the protocol on a screen that someone in the room is navigating, then you can't double-check it as a member while the conversations are going on," he adds. "With laptops, any member can be anywhere in that agenda at any time, and that's the closest to being paper-based without the paper, so that's why it's important."
Phase in electronic implementation: It's far easier on staff and investigators to implement the electronic system over time.
"Back in November, we said all new protocols after this day must be in the electronic system," Cola says. "But we didn't just one day turn on the switch and say everything you do has to be electronic."
Investigators who had 10 studies and were submitting an 11th to the IRB were required to use the electronic format for their 11th protocol. Any continuing review submissions or amendments needed to be in electronic format. But they were not required to immediately type all existing studies into the electronic system. That process could take place over time, he explains.
"Slowly, but surely, we're converting those 2,000 active protocols to electronic format," Cola adds. "Every submission, no matter what it is in the future, becomes electronic."
This phase-in approach alleviated staff and investigators' fears about not having enough time to make the transition, he notes.
"It was very user friendly to the group, and it allowed us in the research office some time to get used to receiving electronic information and reviewing electronic submissions," Cola says.
Expect glitches in data conversion between systems: Most IRBs use some electronic formats, and the trick will be to convert data in existing systems to the new electronic format.
This is not as easy and straightforward as IRB directors might hope.
"We're a little bit behind in converting some of those pre-existing protocols because there was so much clean-up necessary for the old data," Cola says. "It's an unexpected delay."
The IRB office had been using an old Access database that lacks the formatting necessary for the new electronic system. The new system had field requirements to create a shell for a protocol, and these didn't exist in the old data system, he explains.
The unexpected glitch resulted in the IRB manager having to get involved and spend time and energy on helping to make the conversion.
The protocol information also was stored in paper format, so the office is both converting protocols from the old database to the new system and having staff input paper documents into the new electronic system.
"Some of it is converted if it's clean enough, and some is typed in by a research team," Cola says.
"Data conversion is something you must pay attention to in grand detail from day one," he adds. "I think we did that, and it still wasn't enough to make the transition as smooth as we had hoped."
Pilot the transition: One of the most helpful steps the IRB made was to pilot the new electronic system with five different research teams.
Each of these teams was eager to be involved, and they helped identify problems, questions, issues, and concerns that could be resolved before the system was rolled out to hundreds of people, Cola says.
The pilot testing teams submitted protocols into the system on an unofficial basis and worked their way through the process to IRB approval.
"If they got stuck, we learned together how to fix it so we could help others in the next phase of implementation," Cola says. "People were willing and eager and happy to do that; they were excited to get their hands on the system, so it was a good strategy."