Financial Obligations in Research Sponsored by Private Sponsors

This is the UC policy for financial obligations in research with private sponsors (e.g. pharmaceutical companies).

Policy #32 - Date of last revision: July 6, 2006

A. The cost of clinical trials of drugs or devices conducted according to the sponsor's protocols should always be fully funded by the sponsor and not supported in whole or in part with other funds, including gift or foundation funds.

B. All costs associated with the conduct of the clinical trial must be charged to the clinical trial fund and should not be charged to other University funds or be billed to third party medical insurance, unless FDA approval for such charge is documented.

C. The Chancellor may approve exceptions to the above requirements in individual cases in areas within his/her jurisdiction when it is in the best interest of the University.

D. Approval by the Regents is required in all cases where the University assumes liability for a third party's actions.

E. The sponsor must assume responsibility for reimbursing the University for reasonable cost of medical treatment for injuries directly resulting from participation in the study.

F. It is not acceptable for such agreements to require billing of third party insurance companies in lieu of recovery of such costs from the sponsor, nor is it appropriate to accept provisions restricting participation of human subjects on the basis of medical insurance coverage status or on the subject's ability to pay.

G. Applicable University of California policies are appended to this policy.