Supply and demand: IRB fees now are the norm
Covering expenses is the goal
Is your IRB charging for reviews yet? If not, you are probably in the minority. A quick Internet Google search is all one needs to see that most institutional review boards now charge for reviews of sponsored research and that they require payment prior to reviews.
Click on some of the links that pop up, and you can even get a sense of how much the IRBs typically charge. It doesn’t seem to matter where the IRB is located or how big the school is: Most seem to charge about $1,500 for an initial review and $500 for continuing review services.
"IRBs have become a resource intensive operation for nearly every institution," explains Steven M. Lascher, DVM, MPH, director of research and clinical trials at Saint Vincent Catholic Medical Centers in New York City. "They require a great commitment from staff and committee members, so it makes sense that we charge."
That wasn’t the case until the fall of 2001. "If we charged before then, we charged it through the principal investigators, and it was up to them to collect the money," he says. "That just didn’t happen, though." Now it is suggested that investigators include IRB fees in their proposed budgets.
Only the 100 or so sponsored protocols each year are responsible for the fees, however. "We are an academic medical institution and have a large number of residents and fellows," Lascher says. "For most of them, part of the requirement is that they do some scholarly research. Usually, that’s not funded, but it still has to be reviewed by our IRB. We don’t charge them."
To avoid the appearance that the investigators are paying the IRB, billing and payment are handled by the office of research, which sends bills directly to study sponsors. Payment is sent to the corporate finance office, he explains. "That makes it clear that no one is paying for a result."
Although Lascher thinks his institution’s fees — $1,500 for an initial review and $600 for continuing reviews — are about the norm, he isn’t sure that the fees charged actually cover the cost of a review. "I know we aren’t making money on this. The human subject protection program is still in-kind supported by the institution."
Fees started popping up at IRBs in the late 1990s. In many instances, they stayed static until very recently. At Southwestern Vermont Health Care in Bennington, the fee used to be $1,000 at the time of submission, explains Caryn L. Fleming, human protections administrator for the system. In 2000, it went up to $1,500, and now the fee is $2,000. The cost includes ongoing review, although an additional charge for that may be in the offing.
"If you want to have adequate human protections programs, you have to pay the staff to do it," she says. "We are providing a service to both the community and physicians in the community."
As with Saint Vincent’s, the fees aren’t intended to become a profit center. Fleming says the goal is to be budget-neutral for reviews. And not every research protocol has to pay. "We do waive fees on occasion," she says.
Fleming also is in the middle of discussions on whether grant-funded research should be exempt from fees in general, rather than each investigator having to apply for waivers. But that begs another issue, she says: If some of the grant-funded investigators are employees and you don’t charge them, does that leave the IRB open to criticism or some potential legal issue?
Currently, those requesting to have fees waived submit a memo in lieu of payment that explains why they can’t pay the IRB fees. "We consider each application on its merits, but we always accept them," she says.
Another topic of discussion is whether surplus fees should be refunded to investigators, says Fleming. "Let’s say there are 100 protocols opened in a year, and the Alzheimer’s researcher submits 20% of those. If our budget is $60,000, and our revenue is $200,000, should we give them back 20% of the surplus?
In the future, Fleming says she’ll review the fees every couple of years. If the IRB committee of the board of directors approves an increase, then it will be forwarded to the full board for approval. "In the informal surveys I’ve done on the IRB Forum, I think we’re the most expensive I’ve come across," she admits. "But we justify that because we have very little funding for our IRB."
Abandoning local IRBs
IRB fees never cover the cost of the IRB function, says Valerie Konopka, MA, the director of research quality assurance at the Albany (NY) Medical College. That’s why the college opted to shift IRBs from the institution to a central IRB. "We looked at the increase in the personnel we would need, the paperwork we would have to do, even just the copying we’d have to do since there is no way you cannot make a copy of something. This was something we had to consider," she says.
Task force checks audits, staff numbers, etc.
Konopka says the college looked at both moving the IRB function to an on-line service — "but that was really expensive" — and shifting it to a central IRB. A task force was created that looked at about a half a dozen different central IRBs before choosing Western IRB (WIRB).
Among the things it checked: whether there had been any FDA audits of WIRB, how many people were on staff, who those people are, and their areas of expertise. It also looked at who the IRBs’ current clients were and made sure to check references.
At the time of the change, Albany Medical College was charging $2,200 per review. The first annual review didn’t have additional cost, but after the first continuing review, the cost was $500. No charge was imposed for amendments and revisions. "Usually for cancer centers, you can have amendments and revisions almost weekly," she explains.
Over time, Konopka says she has come to the conclusion that "there is no way you can charge fees that will cover the costs of the IRB. You have to make a decision about whether the institution will support the board and pay for it another way, or outsource it."
By outsourcing, the number staff in her office was cut from six to three. They need three because grant-funded research still goes through the college IRB, unless the grant comes from another institution and they already are using a central IRB. If all research went through WIRB, then the IRB at Albany could function with a single person, Konopka says.
A seamless process
Under the current system, investigators submit their protocol to the Albany College IRB with a cover sheet and submission form that WIRB requires. Once that is checked off by internal staff, it’s sent on to WIRB. The total time of that simple function is less than an hour per day. Konopka is kept apprised of all communication between investigators and WIRB.
For investigators, it’s a good deal, too: The cost is $600-$1,300, and the turnaround time is just seven to 10 days.
It seems like an obvious solution to a problem that is often discussed on IRB listservs and forums, but Konopka says one reason many don’t choose to go the central IRB route is prestige.
"There is an innate bureaucracy around IRBs," she explains. "People don’t like to give up their turf or admit they are anything other than absolutely necessary. So they don’t look at the practicality of outsourcing."
The idea may be catching on, though. The National Institutes of Health and the Food and Drug Administration (FDA) don’t oppose it, Konopka notes. "They even came out and said recently that it isn’t a bad idea." Not that one could really criticize the outsourcing process when it occurs regularly if an institution has a problem or is the subject of an FDA audit.
There are dozens of central IRBs to choose from, although she says reputation is important. "You don’t want to just have a cursory review and have someone not paying attention to those things that might potentially be problematic in research."
Along with reviews, central IRBs also can help investigators develop consent forms, do consent reviews, and provide regulatory advice. They can even help principal investigators develop protocols.
"An institutional IRB would love to have the ability to help investigators with all that stuff, but we don’t have usually have the time, the staff, or the resources."