The Northwestern University IRB Office established fees to help fund services provided by the IRB which include study review, education initiatives, and compliance monitoring activities. Currently, the IRB Office charges fees for industry-sponsored research and research where Northwestern is the Single IRB for external federally-funded sites conducting non-exempt human subjects research.
Industry-Sponsored Research Fees
IRB fees for industry-sponsored research cover the real cost associated with protocol review by the IRB. These fees are applicable when Northwestern is the IRB of Record and when Northwestern cedes review to an External IRB. If subjects are never enrolled, the study terminates before milestones are met, expenditures exceed revenue, or a contract is never finalized, the investigator and department are responsible for all expenditures not covered by the sponsor, including IRB fees. These fees are in addition to the Feinberg School of Medicine regulatory preparation fee that must be included with all industry sponsored research budgets submitted to the Office for Sponsored Research after February 1, 2010. Trials performed through the Robert H. Lurie Comprehensive Cancer Center remain subject to the Cancer Center’s Clinical Research Office’s standard regulatory preparation fee.
Initial Applications submitted in eIRB+ on or after 9/1/2021 are subject to the following fee schedule:
(Inclusive, and billed annually)
Initial Applications submitted in eIRB+ on or between 04/18/2011 and 8/31/2021 are subject to the following fee schedule:
If the continuing review includes the request to close the study, the continuing review fee will be charged if the submission is within 60 days of the study’s expiration date. Investigators submitting applications for new industry sponsored clinical trials should include a line item in the budget to reflect these charges.
Budget and Charging Procedure
All investigators submitting industry sponsored research materials to the IRB Office and to Sponsored Research (OSR) are required to include a line item in the study budget for the initial IRB review. They must also include a footnote regarding future charges for the annual fee associated with continuing review. Payment of the fee(s) is considered a contractual obligation of the sponsor. Facilities and administrative (F&A) costs should not be applied to these fees. In addition to the IRB fee, investigators are expected to budget for and recover all costs associated with industry sponsored research. The NUCATS staff will review all budgets for industry sponsored research and can assist investigators with budget preparation.
Revenues generated by both components of the combined regulatory fee will be deposited in study accounts as the fees are collected from sponsors. The expenses associated with the preparation of the regulatory documents should be charged to study accounts by the unit that has actually performed the preparatory work. If the preparatory work is performed by the investigator and/or department staff, the appropriate salary(ies) should be charged to the study accounts. If the preparatory work is performed by the Northwestern University Clinical and Translational Sciences Institute (NUCATS), NUCATS will charge the study accounts by electronic journal for the regulatory preparation component. The IRB fee component will be charged to the individual study accounts by the Institutional Review Board Office.
The typical order of events for industry-sponsored studies is as follows: Investigators submit IRB materials to the IRB Office. OSR establishes a trial account (a sponsored account) when the OSR packet — including a completed OSR-1 form, draft agreement, sponsor budget*, study protocol*, and consent form* — is received. IRB charges the trial account for the IRB fee. The trial account will not be available for use by the investigator until IRB approval has been received and a fully executed agreement is in place. Upon receipt of fee payment from the sponsor, the payment is deposited in the trial account by Accounting Services for Research and Sponsored Programs (ASRSP) and appropriated by OSR. Annual review fees will be charged to the research account until the trial has closed. (* May be submitted in preliminary form)
Industry-Sponsored Research Contacts
- IRB review, fee invoicing and assessment — IRB Office, (312) 503-9338
- Contract negotiation, account establishment, check appropriation — Sponsored Research, (312) 503-7955
- Budget preparation, budget review — NUCATS, (312) 503-2333
- Check receipt, account close-out, overdraft resolution — ASRSP, (847) 491-3385
Single IRB Fees
Effective September 1, 2019, if your proposed research involves federal funding, human subjects, and multiple research locations, Single IRB (sIRB) fees may be applicable. This applies to initial, resubmission, and renewal applications for federal funding opportunities.
If you submit a pre-consultation request for the Northwestern IRB to serve as the Single IRB, and your project is a fit with the institutional evaluation criteria, the IRB will issue you an invoice with the fees associated with your study. The IRB fees take into account the number of sites, number of IRB submissions, the complexity of the research (minimal risk vs. greater than minimal risk), and the number of years the study will require IRB review.
Please see our Single IRB Planning webpage for more information.