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 NUMS Letter on IRB Fees

The following is a letter dated 09.11.03 from Robert Rosa, MD, Professor of Medicine and Executive Associate Dean for Clinical Affairs.

To all investigators and administrative staff:

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 /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.

If there are any questions in regard to these matters, please contact me.




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