As of March 1, 2001, the indirect cost rate for human clinical trials will be increased from 15 percent to 25 percent. This modification comes at the request of the Medical School, which undertook a review of the rates charged at peer institutions. The review revealed that the U-M rate has been well below the national average for several years. Following review of the request by DRDA and other affected units, it was agreed that the new rate would apply to clinical trials in all academic units.
The new rate, 25 percent on total direct costs, will be applied to project grant accounts for new industry-sponsored human clinical trials of investigational new drugs or investigational devices established March 1, 2001, or later. Project grant accounts established before March 1 will not be affected by the increase and will be permitted to continue at their current rate. Projects under negotiation during the period of rate change may be awarded at the rate agreed on in negotiation, subject to approval by the relevant school or college.
Indirect cost rates for other kinds of activity and for clinical research that do not meet the definition of human clinical trials are not affected by the change.