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Electronic IRB submission integrated for easier use
Paper mountains no more
Electronic IRB submission technology can be of great use to even small research institutions, once it's integrated with existing technology.
"We live in a world of a lot of paper and iron mountains of filing cabinets because protocols can be anywhere from 100 to 500 pages," says Kimberly Clinton, CIP, CIM, IRB analyst at Fox Chase Cancer Center in Philadelphia, PA. Fox Chase is a national comprehensive cancer center, and its IRB reviews about 250 protocols per year.
"Every time investigators change a protocol — even one word — they submit a new copy," Clinton adds. "And before long the paper really adds up."
Relying on paper documentation also poses obstacles whenever an institution is audited by sponsors and the federal government, she says.
"It's just overwhelming," Clinton says. "So a lot of institutions, universities are looking to go electronic to manage this whole situation better."
Fox Chase is in an early stage of implementing an electronic system purchased from Click Commerce of Chicago, IL, she notes.
The cancer center is expected to have an increased research workload, so a well-established eIRB program was selected, Clinton says.
"Some products were started in the grant world or in clinical trials management or some other phase of research, and then they're backed into an IRB component," she explains. "But we were not going to purchase a grants or clinical trials module because we have different systems for both of those."
The cancer center's leadership didn't push the IRB to stick with its existing software vendors, so the IRB was free to find a vendor and eIRB system that would best suit the IRB's needs, Clinton says.
Plus, the IRB itself had no home-grown electronic system, which made it simpler to switch from paper to an electronic format.
"Unfortunately, some institutions get stuck because they've already purchased a grants module from a company, and it's kind of decided for them that they'll get the IRB module that matches that system," she says. "And sometimes that's not the best system for it."
The IRB selected Click Commerce as the eIRB vendor because of the company's proven track record and because the IRB has a very active user group with yearly meetings. At these meetings the users can meet with sales people and technical support staff to discuss the problems they're having and to find out when there will be changes to resolve the situation, Clinton says.
"Then once we decided on the product and started the initial phase, we had to create an implementation team," she says. "The team consisted of principal investigators, the information technology department, and IRB staff."
The team's goal was to determine how the switch to eIRB would be implemented and to develop a timeline.
"Right now, we're reviewing all of our forms and procedures and making sure they are following the regulations and are as good as they can be and can translate into the electronic system," Clinton says. "We are doing an internal need analysis of all of our policies and procedures forms."
The institution's information technologies department is handling integrating the eIRB software with existing research software, she notes.
"Another reason we selected Click Commerce is because they have the capability of being integrated with a lot of different things out there," Clinton says. "They're very respectful of our having other systems and say they can feed into whatever we have."
The IRB is helping to design the system by deciding how much or little they want the eIRB system to do.
"We identify the problems we have in the system now and see if the electronic system will meet those needs," Clinton says. "The answer is not always 'Yes.'"
Once an IRB has the dates for when the eIRB will be up and running, it's time to schedule training meetings and input the skeletal legacy data, Clinton says.
"We'll put some skeletal information in it, and then it will be up to the study team and principal investigator to submit continuing information," Clinton explains. "We'll have a requirement that says that anything new will have to be submitted electronically."
This process will be time-consuming because the information cannot be scanned in.
"Click has smart forms, and the information has to be migrated into the forms for it to collect data," Clinton says.
"The questions we'll need answered are not questions the IRB can go in and answer about our protocols," she adds. "We want them to build this the way the protocol should look in the electronic system, and right now, we're in the early stages."
The cancer center and IRB leadership decided to put in only the principal investigator's name, title, IRB number, the approval date, and the coordinator in the system for legacy data, Clinton says.
"This is enough information for someone to access the protocol," Clinton explains. "And then the PI would be responsible for finishing the submission."
This means some ongoing studies would have many screens that need to be completed, while others would not need that much information, Clinton says.
"It would depend on whether it was a continuing review or an amendment they were putting in," she adds.
Switch is labor intensive
IRBs that intend to make a switch to eIRB should keep in mind that this is a labor intensive project that's piled on top of their regular, labor-intensive work.
"It's a great project to be involved in, but it's really time-consuming when you still have to run the IRB and do your every day work and keeping up with the meeting schedule," Clinton says.
The training sessions will vary from one-on-one sessions to descriptive manuals.
"In the beginning, it will be a challenge for people to learn the new system," Clinton says. "It will be a change for them, and not everybody is embracing that change."
But it's important for IRB directors to maintain a positive outlook and reassure staff and investigators that once they learn the system they can view it at any time and see the status of protocols, she adds.
"It will be very helpful for them," Clinton says. "In the beginning, you usually have a little feedback whenever you're doing something new."
Another consideration is the discomfort of living with both paper and the eIRB data for a number of years.
For instance, the IRB will need to continue to store its existing paper documentation and store closed study information in an offsite location for three years, Clinton says.
"We'll have to fight for space," she adds. "These files take up so much physical space, and our institution wants that space for research, labs, and clinics."
So the transition will be somewhat inconvenient and expensive.
"For a while, we'll have to live in two worlds: the electronic world and the paper world," Clinton says. "We couldn't figure a way around that, so people have to think about it and make arrangements because that's the way it's going to be."