The IRB fees for industry sponsored (to include industry sponsored Central IRB reviewed) research are $2,500 for initial IRB submissions and $750 for continuing review submissions. 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. The IRB fee is in addition to the $2,500 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. The combined $5,500 fee should be invoiced to the sponsor by the principal investigator.
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.
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. 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.
Fee Charging Process
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)
The IRB fees are assessments of real cost associated with protocol review by the 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 the initial and any annual IRB fees.
- 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