Follow the money: IRB office boosts collections
Taking ownership has dramatic impact
IRB fees that are not billed or collected may cost an IRB office the staffing and resources it needs to maintain efficiency and quality in reviewing human subjects research. So it's a good idea for research institutions to take a second look at the IRB fee collection process and improve the policies and procedures wherever necessary.
At least one institution has a process that's worth taking a look at: The IRB office at Saint Louis (MO) University developed a very successful IRB fee collection process, doubling its number of collected invoices and raising its collection rate from 83% to 96% from 2006 to 2007.
This improvement occurred during a period in which the IRB reviewed 11% fewer protocols that qualified for billing than it had previously, says Melissa G. Fink, MA, behavioral and social sciences IRB manager at Saint Louis University in the department of research compliance/IRB office.
"We were just better about getting invoices out," Fink adds.
The IRB office and research institution decided to review the IRB fee collection process after Fink and others noticed some problems with generating invoices and collecting payment.
"The old system had a business manager who was part of the grants and contracts staff send invoices to sponsors," Fink explains. "Because the IRB fee went into the contract, that business manager generated the invoices because the person had contact information for the sponsor."
However, the business manager didn't have the best data from the IRB side with regard to when IRB reviews were completed, so it was a challenge to have fees billed consistently, she adds.
So one of the first changes was to give the IRB staff the fee-billing task.
"The first step was for our staff to take control of the actual invoicing to make sure bills were going out the door," Fink says. "Along with that, we enhanced our home-grown database system to include an invoicing component so that when we're entering information about new protocols we can flag it as a protocol that can be billed."
The invoices then are sent from the same database.
As a result the IRB billed 281,500 IRB fee invoices in 2007, compared with 112,000 in 2006. And the number of billed invoices that were collected was 271,500 in 2007, compared with 92,500 in 2006, Fink says.
Here's how the process works:
1. Negotiate fees.
"The fees remained constant throughout that period," Fink notes. "The IRB charges $2,000 to the sponsor or clinical research organization (CRO) for any initial review, and then we charge $500 for any continuing annual review or substantial modification to the protocol that requires board review."
Most sponsors will incorporate IRB fees into their research contracts, or it's negotiated by the research institution, says Anne Imlay, a secretary in the Saint Louis University IRB office.
Imlay was assigned the IRB fee collection process because she is the person who does the data entry for any protocol or protocol action and can see in the database when something is billable, Fink explains.
2. Include new protocols in field for fee billing.
"We compile a list of billables to protocols or to changed annual reviews, and that list goes to me," Imlay says. "We generate invoices from that list, and our board meets twice a month so twice a month the bills are sent out."
The IRB bills only for protocols that go to the full board, a determination that is made by the IRB coordinator, Fink says.
3. Check invoicing status regularly.
"I make it a habit when I get a submission to automatically check the invoicing status," Imlay says. "If it's a fair amount of time since our last correspondence with the sponsor then I'll send another invoice to remind them that it's outstanding."
Imlay makes a point of doing this at the end of each month.
"Some sponsors will pay after one invoice, but most sponsors have a 45 day turnaround, so I try to make a point at the end of each month to look at a list of everything I've done and follow up one more time on anything that's outstanding," Imlay adds.
4. Address ongoing challenges.
"There still are challenges we have that are internal in nature," Fink says. "I think that some sponsors and CROs that prefer to send payment for things related to contracts to one site at an institution, and often that is the research department here at the institution."
So when Imlay calls the sponsor, the sponsor might indicate that a check has already been sent and that it went to the department that is doing the research, Fink explains.
"Then she has to track down the research office person and let them know about the check," she adds.
IRB fees that are not billed or collected may cost an IRB office the staffing and resources it needs to maintain efficiency and quality in reviewing human subjects research. So it's a good idea for research institutions to take a second look at the IRB fee collection process and improve the policies and procedures wherever necessary.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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