IRB Fees

Introduction

With the continued growth of industry-sponsored clinical trials at Northwestern, it has become apparent that there are a number of areas in which substantial administrative efforts are being expended by medical school faculty, their staff and, often, supporting offices without appropriate reimbursement from sponsors. The increasing burden of regulatory materials has required the university to collectively allocate significantly greater resources to this function. A survey of other research-intensive academic medical centers indicates that many institutions recover these expenses by direct charges to sponsors. At Northwestern, this issue has been in part addressed by the introduction of the IRB fee, as well as a separate fee implemented by the Clinical Research Office of the Robert H. Lurie Comprehensive Cancer Center for the administrative work required to initiate a study.

Effective September 15, 2003, the Feinberg School of Medicine will require that all industry-sponsored trials include a line item in the budget that reflects additional costs related to the preparatory work required prior to submission of a protocol to the IRB. A total combined regulatory fee of $4,500 (representing the $2,000 IRB fee plus $2,500 for regulatory preparation) must be included with all industry-sponsored clinical trial budgets submitted to the Office of Sponsored Research after September 15, 2003, except for trials performed through the Robert H. Lurie Comprehensive Cancer Center. Trials performed through the Robert H. Lurie Comprehensive Cancer Center will continue to be subject to the Clinical Research Office's standard regulatory preparation fee.

The combined $4,500 fee will need to 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 September 15, 2003, 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 was performed by the investigator and/or department staff, appropriate salary should be charged to the study accounts. If the preparatory work was performed by the Northwestern Center for Clinical Research (NCCR), NCCR will charge the study accounts by IV (intra institutional voucher) 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.

The goal of this initiative is to enhance recovery for work expended on clinical trials. A common approach across all units of the medical school will assure uniformity among investigators and sponsors, enhancing our ability to collect these funds. The "bundling" of the preparatory fee with the IRB fee is aimed at assuring a greater likelihood of successful capture of such revenues. Under the approach outlined above, all additional funds received will support those units responsible for having actually done the work, allowing investigators to provide direct support for activities that previously have been subsidized.

Budget Preparation

All investigators submitting industry sponsored clinical trial materials to OPRS and to the Office of 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. The Office of Clinical Research and Training (OCRT) will review all budgets for industry sponsored trials and is available to assist investigators in budget preparation.

Fee Charging Process

Investigators submit IRB materials to OPRS. OSR establishes a trial account (a sponsored account) when the OSR-CT packet - which includes a completed OSR-CT 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 amount of the 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 OCRT at 312/503-1500
• Check receipt, account close-out, overdraft resolution - contact ASRSP at 847/491-3385