Voluntary vs. compensated: New trend making inroads at some IRBs
Voluntary vs. compensated: New trend making inroads at some IRBs
Virginia IRB at VA hospital serves as model
As the scrutiny and duties of IRBs steadily increase, demanding ever more time from IRB members, it has become clear to some research universities and hospitals that there should be a change in whether and how IRB members are compensated for their time.
"IRBs are growing, and with that growth, there is an increase in the amount of work the members are required to do in order to protect the research participants," says Laura Orem, CIP, program manager of the Florida Hospital IRB in Orlando.
"We’re fortunate to have the member commitment we do have; but as we add more to the members’ workload, we have to remember their time is valuable, and some of the physicians have been volunteering for many years," Orem says. "They are dedicated, but busy, people."
For universities, IRBs are crucial to protecting the institution’s research reputation, which makes it even more important that members are compensated in some way for their time, says Anthony M. Boccanfuso, PhD, managing director of the University of South Carolina Research Foundation of Columbia.
"The impact an IRB has on the university’s reputation and stature is significant," he says. "It can really have a negative effect if your IRB is not professionalized."
At the University of South Carolina, faculty who serve on the IRB are recognized as providing an important service to the university, and their time spent on the board is recognized in some manner, Boccanfuso says. "Service should not be another box that gets checked."
Traditionally, IRB members have received token or no compensation at many institutions; but times are changing slowly, and more hospitals and institutions are making changes to improve IRB member compensation or to at least consider making these changes, Boccanfuso notes.
"I’m hearing a lot more about the IRB chairs receiving compensation," Boccanfuso says.
Florida Hospital has been looking at the issue, but no decisions regarding changes have been made yet, Orem says.
"We are looking at other institutions who have already decided to compensate their members to see what programs they have in place and how those programs are working," she says.
One potential model for professional IRBs is the McGuire Research Institute, which is affiliated with the McGuire Veterans Affairs (VA) Medical Center in Richmond, VA.
The nine members of McGuire’s IRB meet weekly between 4:30 and 8 p.m. and review copies of agendas that often reach a foot in height, says Bob Dresch, MSW, executive director of the McGuire Research Institute.
"This is work, and we pay people," he says. "We peg their salary to their VA salary."
For example, the IRB chair is a physician and head of a lab, so his salary is higher than the salary for the IRB’s community member, Dresch adds.
Dresch says the pay is enough to make it worth the IRB members’ time and is not a token amount as some IRBs pay.
Although there are eight IRB alternates who are compensated on a per-meeting basis, the IRB members are expected to show up for meetings, he says. "That’s their job, and people have excellent attendance records."
As a result of having made the IRB professional, the IRB has had very little turnover, and members take the time to keep apprised of new regulations, Dresch says.
"This is serious work — there are thousands and thousands of pages of complex laws and ethics, such as dealing with prisoners, science, and the lists goes on," he says. "The IRB is the most important thing to our research operation."
Not encumbered by tradition
Founded in 1999, the McGuire IRB had the benefit of starting its work from scratch, taking no traditions for granted. It also had an advantage over most IRBs because the research institute had the financial resources necessary to make the IRB a professional one, Dresch explains.
Before the IRB was formed, the VA hospital shared an affiliated IRB with the Medical College of Virginia of the Virginia Commonwealth University (VCU), but this relationship came to an end when the U.S. Food and Drug Administration (FDA) sent a warning letter to VCU, Dresch says.
"That got our attention, and a month later, we started our own IRB," Dresch says. "It was very difficult at first, just getting established and getting investigators invested in doing something a little more rigorous."
However, the VA’s investigators soon were enthusiastic for the new IRB when the FDA and Office of Human Research Protection (OHRP) shut down the medical college’s IRB, suspending all research, Dresch says.
"We had a tremendous amount of resistance at first because people didn’t see what was coming," Dresch says. "But when the medical college’s research was suspended in December, we had a line at our door for a couple of days."
The instant converts jump-started the new IRB, creating immediate buy-in, he recalls.
"We had the opportunity to see firsthand the edge of the abyss," Dresch says. "We could observe the crippling financial repercussions when the place was shut down and there were articles in the newspaper every week."
This made it easy for the new IRB to establish stricter rules, more oversight, meticulous observations, and many safeguards, Dresch says.
There was no money for the new IRB until the VA decided to put to use the funds collected by the VA’s nonprofit corporation, established in 1989 to support VA hospital research, Dresch explains.
The nonprofit corporation, which is the McGuire Research Institute, had gradually grown through grants and involvement in multisite studies where the residual costs could be saved to build net assets. Over time, it had collected and managed a nest egg that could only be spent on peer-reviewed research activities, Dresch says.
"There had been pressures to do this or that with the money, but we always felt we wanted to save it for a rainy day," Dresch says. "That rainy day hit in 1999, and we could throw a half-million dollars at this IRB without batting an eyelash."
The money has been used to develop IRB software from scratch, as well as to build the IRB’s infrastructure and pay for making the IRB a professional board.
"So we had a big advantage in starting our IRB — plus we controlled the purse strings," Dresch says. "Without money, people can talk about ethics, but you can’t run an IRB without money; and we understood very quickly that good human subjects protection equals good business."
Unfortunately, most IRBs are not as well funded as the McGuire VA’s IRB, so the cost of compensating members is a major issue. The way some IRBs have handled this issue is through alternative forms of compensation, Boccanfuso says.
"I’d differentiate between additional compensation vs. credit for the effort the university’s faculty expend," he says. "For many faculty, they’d be just as happy not receiving additional compensation, but would like their department to receive credit for their time."
For example, the IRB member’s time would be paid by the IRB to the faculty member’s college department. In turn, this credit would help the department make more money available for the faculty member to do his or her own research, Boccanfuso says.
"Those individuals want to support their research endeavors, so having the IRB either offset compensation or having a research account set up for them is something they would value more than the extra dollars in their pockets," he explains.
Alternative forms of compensation can be distributed in a variety of ways. For instance, a faculty member could be released from the obligation to teach a course, so instead of teaching three courses, the person would teach two, Boccanfuso says.
In turn, the IRB and department would determine what the cost is to the department for that professor to drop a course, and that amount of money would be credited to the department, Boccanfuso says.
Another form of compensation might be to hire a graduate student to support the faculty member in his or her work, so there would be more time to spend on the IRB.
At the University of South Carolina, the IRB chair is paid a stipend, and departments are asked to provide some sort of quantified recognition for faculty members who serve on the committee, Boccanfuso says. "The chair’s stipend can be credited to a research account if he chooses, so there is some flexibility."
The important thing is that that the IRB members’ time for serving on the board is measured and compensated in some way, he says.
"The IRB committee is much more professional than it has been historically," Boccanfuso says.
"It’s really only been five to seven years where we’ve really looked hard at IRBs and how they’ve operated," he adds. "Before that, they were treated in a much more casual manner than was expected by the regulations."
As the scrutiny and duties of IRBs steadily increase, demanding ever more time from IRB members, it has become clear to some research universities and hospitals that there should be a change in whether and how IRB members are compensated for their time.Subscribe Now for Access
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