Rate changes and policy updates for non-federal clinical trials

Effectively immediately, the university is implementing a new indirect cost rate for non-federal clinical trials of 26% on Total Direct Costs (TDC). 

• No budgeted items are excluded from the application of the indirect cost rate.
• This change does not affect federally funded clinical trials, including those trials which are “federal flow-through” which will continue to be charged at our full federal rate. 

For all non-federal clinical trials that have a fully executed agreement in place that budgeted with a different rate, that rate will be honored (i.e., grandfathered).

For all new non-federal clinical trials agreements, the rate of 26% TDC must be used.

The university recently updated the Residual Balance on Fixed Price Contracts for Sponsored Projects policy. While this updated policy applies to all fixed-price contracts, it provides specific guidance related to industry sponsored clinical trials, which should support a timely close-out of studies and a more timely transfer of residual funds to investigators and/or their departments/schools.

These changes will bring UB’s treatment of clinical trials in line with national best practices in the management of non-federal clinical trials. This clarification should also result in less confusion among various business offices which in turn should expedite the administration of these trials.