WHY IS A WRITTEN AGREEMENT NECESSARY FOR A CLINICAL TRIAL?
When a pharmaceutical company or any other Sponsor funds research at MUOT, the parties must sign a written agreement (contract) that defines the scope of work, establishes acceptable payment arrangements, and addresses important issues such as the right to publish research results, protection of confidential information, assignment of patent rights (in the event a patentable discovery is made), and indemnification in case of injury. MUOT, as a state institution, also has certain statutory restrictions under the Ohio Revised Code which must be adhered to in these contracts. MUOT has developed a standard research agreement that can be used for investigator-initiated research sponsored by a company or for company-initiated research in which an investigator participates, if the Sponsor will accept the terms of this agreement. The terms of this agreement have received prior approval of the MUOT legal counsel, thus minimizing approval delays.
