As a public non-profit educational institution, the university is subject to certain policies and rules on what it can and cannot accept in a clinical trail contract. These actions are aimed at protecting the well-being of those involved in research activities, promoting the university`s fundamental mission in teaching, research and public service, and minimizing the various forms of responsibility associated with human research. In the case of higher education policy, the university will provide appropriate medical treatment in the event of injuries sustained by persons directly related to the administration of medicines or study procedures, in accordance with the protocol established by the sponsors. Academic policy expressly prohibits the counting of the subject or a third party for the costs of treating these injuries. Therefore, the university requires the promoter to reimburse the costs of such treatment. The well-being of professionals is a major concern of the university and exceptions to these concepts cannot be taken into account. Sponsors of university research generally benefit from patent rights in accordance with university guidelines. However, the university may grant greater rights to study sponsors who meet all the following criteria: the standard agreement on the university`s clinical studies and the clauses proposed by the university during the contract negotiations are based on the following assumptions: the university follows the promoter`s instructions for the implementation of a clinical study protocol developed by sponsors. As a public non-profit educational institution, the UCI cannot assume financial responsibility for injuries or damages resulting from the completion of the clinical trial. Therefore, the UCI asks the sponsor to maintain an insurance policy or insurance program sufficient to support this obligation.
The obligation for the promoter to assume all financial responsibilities does not apply to injuries or damages caused by: 1) non-compliance with the protocol by the UCI; 2) Non-compliance with the FDA or other UCI regulatory requirements; or 3) the negligence of a faculty or university member. Investigators should provide MS with a copy of the draft clinical trial agreement (ATC), the protocol and a company contact person as soon as possible. If a master`s contract already exists between the sponsor and the University of California, the negotiation process is usually expedited.