Human volunteers are involved in clinical trials. The consequences, if things go wrong, can be catastrophic (many readers will remember the TGN1412 process, also known in 2006 as the Northwick Park “Elephant Man process”). It is therefore essential that any agreement relates to debts and determines who is liable in the event of default and that appropriate insurance rules are made. Sponsored Projects (SP) is responsible for the audit, negotiation and legal implementation of external funding agreements. The resolution of many contractual issues requires coordination between the external funding source, the investigator and the SP; the involvement of each of the parties is essential for the contractual agreement to be successfully concluded under mutually acceptable conditions. Private for-profit sponsors, such as.B. Pharmaceutical companies are driven by forces other than academia. As a result, sometimes they do not understand the ideals and principles behind our policy. Therefore, additional time may be required to negotiate contracts, while SP cooperates with the sponsor to reach a mutually acceptable agreement.
Auditors should provide PS with a copy of the draft Clinical Trials Agreement (ATA), protocol and a company contact person as soon as possible. If there is already a framework contract between the sponsor and the University of California, the negotiation process is usually accelerated. The IRB`s agreement is not required to submit the proposal to PS and enter into contractual negotiations. The university cannot cover the costs of sponsorship; Therefore, the university requires a minimum deposit of 10-20% of the total cost provided for at the conclusion of the contract. If a project involves significant start-up costs, the university may require a higher upfront payment. The standard agreement for the university`s clinical trials and the clauses proposed by the university during contract negotiations are based on the following assumptions: the faculty and staff of the UCI participate in many clinical trial projects to study drugs or trial equipment. These studies are typically funded by pharmaceutical companies and are an important part of the process of ensuring the safety and efficacy of the drug or device, obtaining food and drug administration (FDA) approval, and bringing a product to market. When implementing a clinical study protocol designed by the sponsor, the university follows the sponsor`s instructions. As a non-profit public educational institution, the UCI cannot assume financial responsibility for injuries or damage resulting from the conduct of the clinical trial. Therefore, the UCI requires the promoter to have a sufficient policy or insurance program to support this obligation.
The obligation for the Promoter to assume full financial liability does not apply to injury or damage caused by: 1) uCI`s failure to comply with the Protocol; 2) the UCI`s failure to comply with the FDA or other administrative requirements; or (3) the negligence of a faculty or university member. The results of clinical studies are often not directly obtained by research companies (e.g.B. The characteristics of computer use and human resource use. Depending on the jurisdiction, creators may hold IP rights to all results obtained. In order to use and market the results of clinical trials, a research company must acquire ownership of the results or, at the very least, a right of use and/or IP rights to the results. When negotiating the respective terms under a CTA, it is necessary to take into account specific IP rules. . . .