State furloughs roil IRBs, affecting productivity, morale, scheduling
State furloughs roil IRBs, affecting productivity, morale, scheduling
Smaller institutions affected more severely
As the lingering pain of the recession continues to hamper state budgets, the prospect of furloughs may easily be in many IRBs' futures.
Nearly all states must balance their budgets every year, so state governments are cutting back on services in order to avert red ink. One mechanism they're using to achieve this is furloughs of state employees a recent report by the National Governors Association and the National Association of State Budget Officers showed that 22 states used furloughs to reduce or eliminate budget gaps for the fiscal year ending in 2010. In many state universities and public health departments, these furloughs have affected IRBs. Perhaps one of the hardest hit states has been California, which has furloughed its state employees on three Fridays a month since July 2009.
Although his IRB office at the University of California San Diego has officially ended furloughs for now, Director Michael Caligiuri, PhD, says he's prepared for the possibility that they could return. He says there are three ways in which furloughs affect an office: Productivity, because of lost work time; economic hardship, as staffers cope with pay cuts; and morale, as they deal with the stress of workload backups and financial issues at home. Caligiuri notes that smaller institutions will be affected more severely by furloughs.
"If you're required to take a couple days a month and you have a staff of 10 people, you can absorb the reduction in productivity," he says. "But if you have a staff of three people and two of them are required to take two days a month off, that's a much larger percentage of workflow."
He and other California IRB directors affected by the recent furloughs suggest various strategies for coping:
Try to get exempted Eric Mah, MHS, IRB administrator at UC Davis, says a director should argue that the IRB office is a business necessity and should not be subject to furloughs, even if it's unlikely that the request will be fulfilled.
Caligiuri notes that the unique mission of the IRB to protect human subjects in research provides a compelling argument for treating it differently.
"We're in the business of protecting individuals," he says. "That's very different than a unit whose job it is to investigate conflicts of interest, for example, or intellectual property."
Communicate with investigators Let them know from the start that the IRB is working with reduced resources and that there may be delays.
"A particular investigator may not care why something is taking a long time, but at least you made a good faith effort to be transparent and honest about the situation," Mah says.
Increased communication with investigators also helps an IRB office determine which protocols need to be prioritized, says Roxana Killian, LCSW, administrator of the Committee for the Protection of Human Subjects, which serves as the IRB for the California Health and Human Services Agency.
"(Investigators) understand we're on furloughs, but we also have to understand their deadlines due to the grants they have," she says. "So we try to work with them if there's somebody who really needs to have something right away."
Take the opportunity to review operations This is a chance for IRB offices to look for ways to work more efficiently. Killian says her office is making changes that should improve efficiency even after the furloughs end for her staff. For example, she's begun scanning approval letters into the computer system and sending them to investigators via email, saving paper and postage costs.
The office also is moving to a Web-based application system, which Killian says will provide a number of benefits. Because the application will include required fields that must be filled out, applications will be more complete and won't have to be returned to investigators. And investigators will be able to check the status of applications online, rather than calling the office and tying up staff.
Use flexibility to enhance morale A manager in tight budget times has limited tools to reward good work and keep office spirits high. Mah and Caligiuri say managers should try to use what flexibility they're given to allow staff to schedule furlough days as conveniently as possible.
"Let them take a Friday add a Monday to it if they want," Caligiuri says. "It may be possible for people to bank these furlough days and then take a full week. If you're in a situation where you have that flexibility, that's not a bad thing to do."
Killian says that initially, the first three Fridays of the month were targeted for furloughs, necessitating a change in the committee's meeting schedule. Normally, it meets on the first Friday of every other month.
"We moved the meetings to the week before the usual one," she says. "Sometimes it's been difficult getting quorums, but we always have."
Recently, the furlough schedule was changed to the last three Fridays of the month, and Killian says the CPHS has been able to return to its regular meeting schedule.
Killian says that so far, her committee has been able to review projects that have deadlines and make deadlines for annual reviews.
"What we're seeing a slowdown in for us is getting their approval letters out to them," she says. "We're meeting the deadline for approving it, but it's just not as easy to get the letters out to the researchers."
She says her small staff has worked hard to prioritize the studies with looming deadlines, while letting less urgent reviews take a little longer. But as a result of the slowdowns, her office is fielding more calls from researchers checking on the status of their protocols.
Campuses cope
While the 10 campuses of the University of California were not included in the state employee furloughs, they had to implement spending cuts that have resulted in their own furlough schedules.
Under the plan approved by the state Board of Regents, fulltime employees were required to take anywhere from 11 to 26 furlough days a year, depending on pay scale.
However the timing of those furlough days and who they affected varied from campus to campus. For example, at the University of California Los Angeles, the Office of Human Research Protection Program was not adversely affected by the furloughs, says Director Sharon Friend.
"Our office was funded appropriately because of other initiatives that were going on relating to implementing a Web-based online submission system, obtaining AAHRPP accreditation and an overall project to improve research administration," Friend says.
At UC San Diego, the Human Research Protection Program recently finished one year of furloughs, Caligiuri says.
Individuals within his office face a variety of furlough requirements ranging from no furloughs at all (for three staffers represented by a union) to a few days a month. The good news, he says, is that management was free to schedule those days themselves.
"For us, it simply meant staggering the furlough schedule so that no more than one person would be gone on any given day," he says. "It was almost formulaic the way our program was run it actually fell into place very nicely."
He says UCSD's five committees continued to meet on schedule. Staffers assigned to a particular meeting could not take furlough days during a two-week window around that meeting.
"So there was no impact on IRB meetings zero," he says. "No impact on getting protocols reviewed or the committee determinations disseminated."
However, Caligiuri says there was an impact from the lost workdays in the responses and follow-ups with investigators after the meetings.
"That usually consumes the remaining two weeks," he says. "When you send out 150 letters, you're going to get 150 responses and those were all dealt with during the two week off-period. That's when furloughs were taken and that's where there was delay."
Caligiuri estimates that the furloughs have slowed down the process of reviewing responses and issuing approval letters by a few days. He says the HRPP's website warned investigators of the potential for delays and that most have understood their situation.
The meeting has been cancelled
At UC Davis, the IRB office followed the same furlough schedule as the rest of the campus, he says. Those days have been clustered around holidays, which Mah says had both advantages and disadvantages.
"Even though we tended to have lower volume during those times, we would ordinarily use that time to catch up, so we no longer had that opportunity," he says.
He says any meeting that fell on a furlough day was cancelled, a situation that occurred three or four times over the year. Because the various committees meet five times a month, protocols could usually be rescheduled to another meeting. But he notes that there are caps on the number of protocols that can be reviewed at a meeting.
"There were times, because of reduced resources, that we had to roll studies over they made it in terms of a deadline submission, but we would have to roll it to another meeting because that meeting was at capacity," Mah says.
He says investigators did notice that it was taking longer to get study approvals, "but that was inevitable. It was something we shared with the research community and it's one of those things people don't want to hear, necessarily, but they need to know about it."
UCSD and UC Davis' furloughs ended this fall, and Mah and Caligiuri say that for the most part, they expect their offices to get back to normal fairly quickly.
"I'm pretty sure folks are going to catch up within a month," Caligiuri says. "Everybody chipped in and everybody made up the difference along the way."
As the lingering pain of the recession continues to hamper state budgets, the prospect of furloughs may easily be in many IRBs' futures.Subscribe Now for Access
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