The fee will be a direct charge of $1,000 for all new industry sponsored clinical trial agreements (fixed price agreements either directly from industry or from a non-industry sponsor provided the pass through or prime funding is from industry). Indirect costs at the rate of 25% will apply to the fee (the same rate charged to all other direct costs on industry sponsored clinical trials). The implementation date will be July 1, 1999.

When new clinical trial agreements are being negotiated with industry, the $1,000 fee should be included as a separate line item "IRB Review Fee $1,000." The fee ($1,000) and the indirect costs on the fee ($250) will be nonrefundable and included as part of the first payment from the sponsor. When the budget number is established, a direct charge of $1,000 will be made by the Grant and Contract Accounting Office resulting in a corresponding indirect charge of $250 per instructions to be provided on the Notice to Establish Account (NEA) by Office of Sponsored Programs. Please note that this IRB Review Fee as a separate line item is different from the "IRB Preparation Fee" which is sometimes included in clinical trial budgets and used for direct costs incurred in academic departments.

The "IRB Review Fee" will be charged once on all new clinical trials sponsored by industry regardless of the total amount of the clinical trial agreement. There will not be an additional fee for amendments or supplements to the initial agreement.