Policy Name: Agreements and Contracts Policy
Policy Number: F/UNTHSC/RES/OGCM-002
Scope: All Researchers
Created/Revised: Created 7/13/01, Revised July 11, 2003
Effective: 8/17/01

I. POLICY

All agreements and contracts related to or arising from research efforts, including but not limited to industry contracts for research studies, licensing agreements and material transfer agreements shall be administered through the Office of Research & Biotechnology.

II. PURPOSE

To safeguard the interests of the University of North Texas Health Science Center and any entity thereof; and to comply with institutional policies, and federal and state regulations.

III. DEFINITIONS

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge.

Human Subjects: Living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

IV. PROCEDURE

1. All research and research related agreements and contracts shall be submitted to the Office of Grant & Contract Management (OGCM) for review, negotiation and to obtain required institutional signatures.
2. An institutional contract template, approved by the Office of Legal Affairs, should be used for all contracts.
3. When submitting the contract of agreement for review, bring it to OGCM. The OGCM secretary will log the document and establish the tracking process. The document will be reviewed by OGCM for both content and budget and appropriate comments indicated to the Attorney.
4. A Request for Legal Review will be appended to the document and it will be hand carried to Legal Affairs. It will be tracked as to finalization.
5. When it is approved by Legal Affairs, a copy will be sent to the PI and to the sponsor. If both PI and sponsor agree to content, two copies will be prepared and they will be routed through normal UNTHSC signature process.
6. One original document is maintained in the Office of Legal Affairs and a copy of the finalized contract is used to establish the institutional file in the OGCM. A copy of the signed contract will be forwarded to the PI and the departmental coordinator.
7. No research involving human subjects may occur until the research protocol is reviewed and approved by the UNTHSC IRB and a final document has been signed by all parties and is on file in the appropriate institutional offices.