Small IRBs weigh benefits, buy-in when going green
Small IRBs weigh benefits, buy-in when going green
Electronic reviews save more than paper
Some larger research institutions in recent years have taken incremental steps to having an electronic IRB submission, review, and documentation process. But transitioning to a paperless process has been more of a challenge for smaller IRBs and institutions.
However, this go-green transition can be done in a way that saves money, time, and satisfies board members, some IRB managers say.
"You need to have patience during the transition period," advises Lisa A. Bonneau, MSED, institutional review board administrator and human protections administrator at Southern New Hampshire Medical Center in Nashua, NH. Bonneau works part-time in the IRB office, which has no other staff. The IRB handles about 26 open protocols, a number that has been on the rise.
"You should have both paper and electronic submissions at the first couple of meetings, and then at the third meeting you could offer the option of printing something specific upon request," Bonneau says.
Before the office switched to an electronic review process, Bonneau spent an estimated 70% of her IRB office time copying paper and filling binders.
"Now I'm using my time so much more effectively and efficiently, and I'm able to be more thorough," Bonneau says.
For instance, Bonneau now has time prior to IRB reviews to research information regarding new and continuing protocols.
"If I have a protocol coming up for renewal, I might Google information on it and find out there were some concerns," she says. "So I'll make sure I share that with the principal investigator and the board."
Since she's spending less time on handling paper, Bonneau has more time for flagging potential issues regarding protocols.
"I teach 25 hours a week and then work here in the IRB office after that," she notes. "So you never finish everything you want to do."
But the new electronic review process has helped Bonneau derive more satisfaction from her IRB work.
"It definitely has made things much more efficient, and I feel like we have saved on our budget," Bonneau adds.
A paperless IRB review process is much less work for IRB staff, and it's easier to organize, says Denyse Pettersson, CIM, CIP, IRB manager at Children's Hospital and Research Center Oakland in Oakland, CA. Each month, the IRB reviews five to six new studies and about five to 10 continuing reviews that require full board approval.
An IRB office, especially, saves time in clerical work, such as having to assemble hard copies, Pettersson says.
"With a paper system, we'd spread the submissions on a large table and assemble a huge package — 30 stacks of paper — for everybody, and that's an incredible amount of work," she explains. "A lot of IRBs still are doing that."
At Southern New Hampshire Medical Center, the old paper process meant that Bonneau made 10-12 copies of everything and put them in binders. After the protocol had been reviewed, she then shredded the extra copies and had a master copy sent to a company that would put it on a disk.
"I don't have to do any of that now, and it saves us time and expenses," she says.
Bonneau and Pettersson offer these tips on how to make a smooth transition to an electronic IRB review process:
1. Survey IRB members prior to any change.
The Children's Hospital and Research Center Oakland conducted a survey in the spring of 2008, asking IRB members about whether they would prefer paper or an electronic version of protocols for review.
"We acknowledged that it might not be convenient to review the details of each study electronically, but that it would reduce the amount of paperwork," Pettersson says.
"It was a simple little survey with a checkbox," she explains. "They could check, 'I prefer to receive only email copies of all meeting material to be reviewed, and I can bring my laptop for use at the meeting," yes or no."
Alternatively, they could check that they would prefer to receive both emails and hard copies to see which would work best for them, she adds.
"Most people checked that they wanted email only," Pettersson says.
About half of the IRB members bring their laptops to the meetings; some print out the submission material on their own, and Pettersson prints out the pages for which she has specific questions.
For those members who still wanted hard copies, the IRB office then asked whether they would be willing to review large documents, full protocols, and investigator brochures in electronic form.
"We said we'd send them hard copies of the consent forms, and they agreed to that," she says.
The only exception was the IRB's community member who doesn't use a computer very often, so this member still receives paper submissions for review.
2. Ease board members into electronic reviews.
Bonneau gave IRB members a combination of electronic and paper materials for the first couple of months of the transition period.
"I put it on Sharepoint, so it was electronic, and I also gave them paper," she says. "Then I gave them a heads up that by the third month we'd just do electronic submissions."
At first, about half of the IRB members were disgruntled with the change, saying they liked the flexibility of having paper submissions that they could take home with them to review outside of their work time, Bonneau notes.
"They're all volunteers on the IRB board, and they're so busy during the day that they feel they can focus and concentrate more after hours," she explains. "So that's why they like the hard copy."
Bonneau discussed their concerns with her supervisor, who supported her in making the transition despite the objections.
"It helped to have the support of the person I report to — that was huge," she says. "He said, 'This whole hospital is going green,' and he supported our not jumping back to using paper."
After further discussing the transition with the IRB chair, Bonneau settled on a compromise: "We said, 'We'll print anything anyone needs.'"
The board members also have the option of printing out their own copies. However, if there's a protocol with many details, the IRB office would print it out for them upon request.
"If it was a modification or continued review, and there weren't any changes, then I didn't need to print it," Bonneau says. "But when we have a new protocol and they want a hard copy, then we'll do it."
Just having the paper option available helped with the board's buy-in, she adds.
3. Move toward more electronic processes.
When an IRB switches to an electronic process, it doesn't have to be a very expensive switch.
For instance, the Children's Hospital and Research Center Oakland uses Microsoft Word and email transmission for its electronic documents, Pettersson says.
"Investigators email us everything," Pettersson says. "We have a joint email box for my assistant and I, and they send everything to us electronically."
Research coordinators download the submission forms, fill them out, click and paste answers, and then send them back electronically, she explains.
"We would like to have on-line submissions, but we can't afford it right now," she adds.
Still, having electronic forms themselves is a big improvement and a great way to save paper, Pettersson says.
The IRB previously required investigators to send 25 hard copies of each lengthy document. Now they need only to send two copies and an email, she says.
"One hard copy is for our file, and the other one is for when we need a copy that we're sending to a community member or to someone else," Pettersson says.
The IRB's electronic process required some training and buy-in.
"There were some problems where people were not that comfortable with Word, so they'd call us and say, 'I can't get the information into this form,'" Pettersson recalls. "Some people's formatting would look different, and we'd tell them to not worry about formatting because we could fix it."
The Children's Hospital and Research Center Oakland also uses Pro IRB to access a database and make it easier to send research sites letters from the IRB.
When the IRB approves a study and that information is entered in Pro IRB, the program will prompt the IRB office to send a study approval letter, automatically preparing it with the principal investigator's name and address, Pettersson explains.
Some larger research institutions in recent years have taken incremental steps to having an electronic IRB submission, review, and documentation process. But transitioning to a paperless process has been more of a challenge for smaller IRBs and institutions.Subscribe Now for Access
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