May 2008 -- Starting July 1, 2008 it will be the University of Minnesota Institutional Review Board (UMN IRB) policy to assess a $2500 initial review fee for all medical business and industry sponsored applications involving human research subjects submitted to the UMN IRB. 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.
Business and Industry sponsored submissions represent some of the most complex and resource demanding research reviewed by the UMN IRB and the funds will be used for UMN RSPP to continue staffing improvements, quality assurance efforts, and implementation of more robust electronic management systems like eResearch Central.
Q. Why are only business and industry studies being charged a fee?
A. Federal research studies are already covered by government Facilities and Administrative Rates (F&A), which cover the administrative costs of IRB review. Business and industry studies have been covered by a lower F&A rate in the past, which did not cover review costs. 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 querying the number of research proposals received by RSPP and the direct costs associated with reviewing each type of submission (IACUC, IBC, Exempt, and Full IRB). The fee is consistent with the policies and fees at Big Ten peer institutions.
Q. Are there other fees I should be aware of related to this change?
A. The initial review fess 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 is attractiveness of UMN 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 are administering a fee because of the rising number of studies requiring review and the increasing costs of supporting the research infrastructure. 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 for review from non-sponsored projects?
A. The review of these projects is already supported by institutional funds. Non-sponsored projects will not be charged.
Q. Is it ethical for an IRB to charge a potential sponsor a fee for the review of a research proposal?
A. The review board does not take into consideration a projects' sponsor, the size of the study budget, the number of subjects enrolled, or whether the project is initiated. The board's purpose is to ensure that two broad standards are upheld: first, that research subjects are not placed at undue risk; second, that they give un-coerced, informed consent to their participation. There are no financial considerations involved with their judgments. The fee covers specific costs and is not adding profit to the RSPP.
Q. The indirect rate for industry funded, non-clinical studies is 51% which is the same as for all federally funded research including clinical trial studies. Isn’t the federal rate included toward the operation of the IRB?
A. Most industry studies pay only 26% indirect, not the federal rate.
Q. For many investigator initiated 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. The fee will be collected post-review in those cases.
Q. Will indirect costs be added to this, which for small grants adds up to a considerable amount of money?
A. No, only direct costs are accounted for by the fee.
Q. We work with several small businesses on federal grants on which we are a subcontract (SBIR/small business grants), would we pay the IRB fee if we area a subcontract on a grant that is given to one of these businesses?
A. Only commercial business and industry grants will be charged, not projects associated with federal grants.
RSPP Business and Industry Fee Policy
If you have any questions, please contact RSPP Director Moira Keane at (612) 626-4851, or keane002@umn.edu.
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 Research Subjects’ Protection Program (UMN RSPP).