IRB Fees

Introduction

Effective February 1, 2010 there will be an increase in the IRB fees for industry-sponsored clinical trials from $2,000 to $2,500 for initial IRB submissions and from $500 to $750 for continuing review submissions. Investigators submitting applications for new industry-sponsored clinical trials need to include a line item in the budget that reflects 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 clinical trial budgets submitted to the Office for Sponsored Research after February 1, 2010. Trials performed through the Robert H. Lurie Comprehensive Cancer Center will continue to be subject to the Cancer Center's Clinical Research Office's standard regulatory preparation fee.

The combined $5,000 fee should be invoiced to the sponsor by the principal investigator. To simplify this process, a web-based invoice form referencing the combined regulatory fee will be made available for use by investigators by February 1, 2010, at http://www.research.northwestern.edu/oprs/irb/irbFees/.

Revenues generated by both components of the combined regulatory fee will be deposited in study accounts as the fee is 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, appropriate salary 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 continue to be charged to the individual study accounts by the Office for the Protection of Research Subjects.

Budget Preparation

All investigators submitting industry sponsored clinical trial materials to OPRS and to the Office for Sponsored Research (OSR) are required to include a line item in the study budget for the initial IRB review. A footnote regarding future charges for the annual fee associated with continuing review should also be included. 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 fee, investigators are expected to budget for and recover all costs associated with industry sponsored clinical trials. NUCATS staff review all budgets for industry sponsored trials and can assist investigators with budget preparation.

Fee Charging Process

Investigators submit IRB materials to OPRS. OSR establishes a trial account (a sponsored account) when the OSR packet - which includes a completed OSR-1 form, draft agreement, sponsor budget*, study protocol*, and consent form* - is received (*may be submitted in preliminary form). OPRS 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 trial account until the trial has closed.

Non-payment of IRB Fees by Sponsor:

The IRB fees are assessments of real costs 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.

Contacts

For questions regarding:

• IRB review, fee invoicing and assessment - contact OPRS at 312/503-9338
• Contract negotiation, account establishment, check appropriation - contact OSR at 312/503-7955
• Budget preparation, budget review - contact NUCATS at 312/503-2333
• Check receipt, account close-out, overdraft resolution - contact ASRSP at 847/491-3385