Contracts

A clinical trial agreement (CTA) is an agreement between OUHSC and an industry sponsor (typically a pharmaceutical or device company) for the study, in human subjects, of particular biomedical or behavioral interventions including devices, drugs, treatments, or therapies for a particular disease or medical condition. Usually, the protocol is written and provided by the industry sponsor. However, the scope of work and study procedures in the study protocol must be approved by OUHSC IRB prior to the study.

In some cases, the sponsor requires that a Confidential Disclosure Agreement (CDA) be in place before it will send the materials/protocols to the PI. The CDA assures the sponsor that the institution will protect the confidential information against unauthorized disclosure for a period of time.

A Sponsored Research Agreement (SRA) is a contract between OUHSC and a sponsor for the purposes of funding and conducting research at the University. An SRA may be supported by funding from for-profit (e.g. private industry) or non-profit (state or federal government, foundations, etc.) sponsors.

Research materials are often exchanged between PIs at OUHSC and other academic institutions and commercial organizations. To exchange these materials between OUHSC and another organization, a Material Transfer Agreement (MTA) must be completed. The types of materials transferred under MTAs include, but not limited to, biological materials, such as reagents, cultures, cell lines, vectors, plasmids, nucleotides, bacteria, proteins, transgenic animals, pharmaceuticals, chemicals, and other proprietary physical materials. MTAs define the legal rights of each party with regard to publication, freedom of research, confidentiality, and intellectual property.

A data use agreement (DUA) is a formal contract that documents what data are being shared and how the data can be used.  DUAs serve to outline the terms and conditions of the transfer that may include limitations on the use of data, obligations to safeguard the data, and privacy rights that are associated with transfers of confidential or protected data.

A data sharing agreement is a formal contract that clearly documents what data are being shared and how the data can be used Such an agreement serves two purposes. First, it protects the agency providing the data, ensuring that the data will not be misused. Second, it prevents miscommunication on the part of the provider of the data and the agency receiving the data by making certain any questions about data use are discussed. 

Professional service represents a scenario where an OUHSC Faculty or Staff Member will perform a professional service for an outside entity. Examples of professional service may include participation on a Board of Directors, or consulting. The fees charged for these types of services typically represent Professional Practice Plan (PPP) monies. 

A speaking agreement is a legal document between OUHSC on behalf of its personnel and an outside party to define the terms and conditions associated with the OUHSC personnel’s presentation and/or speaking engagement.