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With state university budget cuts it might be time to cut IRB costs
Experts discuss future of IRB in troubling times
IRBs across the nation are bracing for budget cuts as states slice funding to higher education and the recession's impact is felt by IRBs and research institutions.
"Everybody at public universities I've talked to is either experiencing a hiring freeze, or they're trying to figure out ways to stop spending," says Todd Wagner, PhD, a health economist in the U.S. Department of Veterans Affairs in Menlo Park, CA. Wagner also is a consulting associate professor at Stanford University in Stanford, CA.
IRBs may have travel budgets reduced and limits on staff hiring and replacements, he adds.
"All states are experiencing a budget crunch," says Norma B. Epley, MS, CIP, an administrative director and department chairperson at the University & Medical Center Institutional Review Board at East Carolina University in Greenville, NC.
When Epley became the administrative director last fall, she walked in as the state's budget crunch began.
"I felt like the most important thing we can do, if at all possible, is to not reduce services," Epley says. "But to do that you have to have money as research grows, so I started looking at ways we can save money."
One way to save money, particularly over the long run, is to move the IRB from a paper process to an electronic process, Epley notes. "East Carolina University is currently not electronic," she says. "So we're going to start initiating electronic submissions and electronic agendas."
IRBs have always had to deal with limited resources even as their work grows, notes Roberto A. Dominguez, MD, CIP, a professor at the University of Miami, Miller School of Medicine in Miami, FL.
"There's not enough money to do the work that is required at the level that is required," Dominguez says. "One has to cut corners."
Dominguez and co-investigators have researched ways for an IRB to run more efficiently in light of budget shortfalls.1
"Here you have a research administration office and its many components, and often when you're looking to save money, one of the first targets is the IRB function," Dominguez says.
Tapping into economies of scale
However, as IRBs grow they can take advantage of economies of scale.
"One thing we do know quite well from previous literature is that high volume institutions have a much lower cost than low volume institutions — both in total costs and cost per protocol," says Margaret Byrne, PhD, a research associate professor and health economist at the University of Miami, Miller School of Medicine.
Research institutions should avoid the danger of cutting back too sharply on IRB staff and resources, Byrne notes "The economy will change, and things will get better eventually," he says.
"Who knows when or how long it will take to do that," she adds. "But in all cases if you cut down too far and cut down on IRB staff and board time in the short term, then you'll get worse reviews."
This type of short-term blindness can have dire consequences.
"Some institutions have gone through very hard times and cut staff, and the result is that a bunch of protocols had to be shut down," Byrne says. "The research programs weren't shut down by federal regulators, but individual research projects couldn't get reviewed on time, and they had to shut down."
When this happens, research institutions will lose grant funding, she adds.
Human subjects research organizations might consider a variety of options during difficult budget times.
One possibility is to take a hard, honest look at the IRB budget and its efficiency and then decide whether it continues to make sense to handle all IRB functions in-house. The alternative might be to hire an independent IRB to handle at least some of the research protocol reviews, Wagner suggests.
"It doesn't mean the research institution has to outsource everything," Wagner says. "Say an independent IRB would cost $1,500 for a protocol, and you can say you're doing very well on oncology protocols, costing less than that amount, but you're doing poorly on health sciences protocols and costing more."
In that example, it makes sense to outsource the health science protocol reviews, but to keep the oncology reviews in house, he adds.
"Or maybe in a metropolitan area where there are a number of research facilities, you could pool resources and take advantage of economies of scale," Wagner says.
A third way might be for research institutions to make IRBs independent financially, he suggests.
"What I'd like to see is more separation, and that could mean there is a system set up where the IRB's revenues were based on a fixed fee for reviewing and handling the protocol," Wagner says. "There should be some sort of prospective payment system where you pay per protocol, and, ideally, you'd pay more for protocols that take more effort."
This type of model would provide strong incentives for efficiency, he adds. And it would enable IRB administrators to calculate budgets, which are difficult to do at present, Wagner says.
One size does not fit all
Also, studies suggest that IRBs operate so differently that what works for one IRB might not work for another. Byrne's research into the cost of IRB oversight has shown great variability in how IRBs are run.2,3
A study on that variability was conducted through a survey of academic medical centers. Respondents were asked about their resource utilization, including both paid IRB staff and unpaid IRB members' time. Using national cost weights, the study assigned a cost to each type of resource used and generated descriptive statistics for overall costs.
"If you go by only financial costs and what was spent on the IRB then you miss out on board member time that's not compensated, but is a cost to the university because the member could be doing something else that is revenue enhancing," Byrne explains.
The study showed a wide range of costs and time spent by IRB staff and boards.
"We looked at the variability of the ratio of staff to board costs and found that at some IRBs the board costs were three times higher than staff costs," Byrne says. "At the other end of the range, the IRB staff costs were 11 times higher than the board costs."
Those outliers suggest that IRBs are being run and managed very differently, Byrne says.
The research raises many more questions, she notes.
"People are doing things very differently, and we don't know if places where board members are putting in less time are IRBs that are more efficient or it's because they are doing cursory reviews," Byrne says. "What's behind this variability? Who's doing the right job? You need to do a study that measures quality and efficiency of IRB reviews, which would be very difficult to do."
What the research did find was that institutions that do not have very many protocols have very high costs for those protocols, Byrne says.
"So they might benefit going to an outside IRB for reviews," she adds. "They may not be considering volunteer time, but these are opportunity costs where board members might be doing something that brings in more grants or teaching more if they weren't spending so many hours on the IRB."
In the broader economic sense, it appears to make better economic sense to hire IRB staff to run human research review programs, Byrne says.
"IRB staff can focus on operations and become experts at it, whereas a professor is teaching and running research, so it's less efficient to have volunteer professors running an IRB," she explains.
But from a chief financial officer's point of view, the short-term savings might win.
"If the board member/faculty member is doing the work voluntarily, then it will cost the CFO more to hire someone," Byrne says. "In the long run it's better for an institution if the board member uses his or her time productively, but up front there might be a higher cost."