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May 2008 -- Effective July 1, 2008 the University of Minnesota Institutional Review Board (UMN IRB) will assess a $2500 initial review fee for business and industry sponsored clinical trials involving human research subjects. This practice is consistent with the policies and fees incurred at peer institutions, and will be used to support the administrative costs associated with reviewing research.
The volume of industry sponsored research has grown at the University and while this increase is desired and a sign of the University’s growth as a premier research institution, the UMN IRB has experienced a concurrent increase in submissions requiring review. This increase has forced the expansion of the University Of Minnesota’s Human Research Protection Program (UMN HRPP).
Business and Industry supported clinical trial submissions represent some of the most complex and resource demanding research reviewed by the UMN IRB and the funds will be used for UMN HRPP to continue staffing improvements, quality assurance efforts, and implementation of more robust electronic management systems.
IRB applications for research studies that are funded by non-business and industry sponsors (e.g., Federal, State, non-profit foundations, or internal funds) are not subject to the clinical trial review fee.
When an IRB submission is received and is not designated as industry-supported, but is later determined by the IRB to be industry-supported, appropriate IRB fees will be assessed.
It is expected that Investigators or their staff incorporate and negotiate applicable IRB fees into the research contract.
Departments should incorporate the clinical trial review fee in the budget of all industry-sponsored clinical trials research. To make the new fee clear to research sponsors, departments should refrain from referring to any other review fees they charge to sponsors as “IRB Review Fees
Q. Why are only business and industry clinical trials being charged a fee?
A. The costs incurred for reviewing IRB applications for non-industry supported studies are included in the Facilities and Administrative (F&A) rate, which is applied to those research projects. Business and industry studies reimburse the University for indirect costs at a rate that is lower than the Federally negotiated rate. These business and industry studies, typically clinical trials, are some of the more complex applications received and tend to be very demanding of IRB resources. The goal is to enhance the recovery for work expended on these studies and maintain a level of service that is acceptable to the research community.
Q. How was the amount of the fee determined?
A. The fee was determined by assessing the administrative costs of managing study review processes in HRPP. The fee is consistent with the policies and fees at Big Ten and other peer research institutions, and is an ISO-approved rate.
Q. Are there other fees I should be aware of related to this change?
A. The initial review fee is a one time fee. Changes in protocol, continuing review, and other submission reviews are encompassed by the initial review fee.
Q. Will potential contracts be affected by this new fee?
A. An IRB Review Fee is standard practice for the University of Minnesota's peer institutions and business and industry sponsors are accustomed to paying a fee for review services. Research areas affected by this change should not see a difference in the attractiveness of the University of Minnesota as a study site.
Q. Why do some schools have such a fee and not others?
A. Most of the University of Minnesota's peers have seen an increase in business and industry sponsored research, and have started assessing a similar fee to cover the increasing costs of providing this service to business and industry. The new fee helps the institution bridge that gap in funding to keep pace with the studies received.
Q. What is to prevent the University from requiring researchers to pay this fee for reviewing IRB applications for research that is supported by non-sponsored funding?
A. The review of these projects is already supported by institutional funds. This fee will not be assessed on research that is funded from non-sponsored sources.
Q. Is it ethical for an IRB to charge a potential sponsor a fee for the review of a research proposal?
A. The fee covers the cost of providing a specific service to the sponsor. IRB members do not consider any potential financial benefit of the study to the University when reviewing the application. Payment of the fee does not guarantee approval of the study protocol. The fee covers the cost of the service – which is why the fee must be paid even if the industry funding does not ultimately materialize.
Q. For some industry funded studies the IRB application is submitted before an agreement is reached on the final budget. Must the fee be paid at the time of the IRB submission?
A. No, however the PI must provide an appropriate, non-sponsored chart string as a guarantee account. After the protocol is reviewed, the IRB will begin tracking the study to see when the industry-funded contract arrives. This is done by working closely with SPA. If the contract does not materialize within 6 months, the Principal Investigator will receive a notice from the IRB office indicating that the non-sponsored chart string will be used to pay the fee. If SPA verifies that negotiations are still ongoing and a clinical trial agreement can still be expected, this six month period can be extended.
Q. Are IRB Fees only for industry sponsors?
A. The fee will be assessed on all clinical trials with business or industry funding.
Q. Is the IDC charged in addition to the IRB fee?
A. Yes, F&A costs are added to the overall total. Therefore, if the sponsor is reimbursing indirect costs at a rate of 26% the full budget impact to the project will be $2500 direct cost + $650 for indirect costs
Q. How should we justify charging indirect costs of an additional $650 to industry sponsors who are balking at $2500?
A. The indirect cost funds are never directly earmarked for the UMN IRB, and the indirect cost rate approved by the federal government only allows for certain pre-established exclusions such as rent, subawards over $25,000, and capital outlays. Yet, business and industry sponsored clinical trials are some of the most complex and resource demanding research reviewed by the UMN IRB. The practice of an IRB fee is consistent with the policies of peer institutions and the funds will allow the University to continue providing through, timely reviews.
Q. What happens when a study closes or never opens and no funds are received for IRB fees?
A. Departments will need to establish a guarantee account with the IRB for the review of business and industry sponsored clinical trials. If after six months funding has not yet been established, departments will be responsible for the initial review fee. Each department can determine whether or not these assessments will be shared by their department’s investigators. Investigators often establish with prospective sponsors, an agreement that the sponsor will be responsible for any fees incurred in the pursuit of approval, even if full funding is not granted.
Q. What is the process for invoicing industry sponsors for IRB fees? Who does the billing? Will sponsors be invoiced directly? How will we deal with contract language which requires an invoice directly from the IRB, specifically denying additional overheard charges?
A. The sponsored project account associated with the study will be charged the fee, and the project code associated with the fee is 730212. The IRB review fee is an item in the sponsor budget included in agreements, and is therefore an obligation of the external business and industry sponsor. The Principal Investigator will be responsible for covering costs not allowed by the sponsor. The PI may arrange with the IRB to pay these costs from another allowable University source if their sponsor will not pay for the fee.
If you have any questions, please contact HRPP Assistant Director Patrice Webster, 612-626-5654, firstname.lastname@example.org.