Sponsored Programs Administration (SPA) or the Center for Clinical Trials and Corporate Contracts (CCT) will draw up an appropriate agreement or will review the other party’s offered award notice, letter, or agreement. When necessary, SPA or CCT will negotiate award terms and conditions to ensure that they do not conflict with applicable regulations, state law or university (UMB or University System of Maryland) policy. An authorized institutional official in SPA or CCT will sign the agreement.

The principal investigator may sign an agreement to indicate commitment to a project and acknowledgment of agreement terms and conditions, but the PI is not authorized to commit the institution by signing the agreement as the authorized institutional signatory.

Scope of Work: The PI is responsible for defining and agreeing to the scope of work, which should clearly describe the specific project that the sponsor is funding. As a rule, project work should not be initiated until after the agreement is signed for UMB.

Budget: The PI and department administrator are together responsible for ensuring that the agreed-upon budget covers the cost of the project and includes the appropriate F&A rate.

Routing and Approvals: The PI and department administrator are responsible for routing the project in Kuali Research before award acceptance or agreement signature.

Review and negotiation of terms can take time. The negotiator needs to understand the project and how the agreement terms apply to the project and, more broadly, to the University. The negotiator may need to consult with colleagues or with University counsel on the nuances of certain legal terms. Other reviews may be required (e.g., export compliance or technology transfer). The sponsor may or may not respond promptly to UMB's concerns.

The bottom line is that there are certain “must haves” in our agreements. Compliance with policy as to the terms for clinical study agreements is essential to maintaining the accreditation of the IRB. University System of Maryland policy requires the ability to publish research results openly. State law prohibits agreeing to indemnification.

If you have questions regarding the negotiation of a government contract (federal, state, or local) or an agreement with a nonprofit organization (foundations, other universities), please contact your SPA team, following SPA Business Practices.

If you have questions regarding the negotiation of a corporate research agreement or corporate clinical study agreement, please contact CCT.

The following terms are among those that require careful review and negotiation.

Publication rights: PIs must be able to publish the results of their sponsored project work. The University will allow the sponsor an opportunity to review the manuscript before submission but cannot agree to long delays.

USM Policy on Classified and Proprietary Work (see Paragraph 3)

Indemnification: The University is prohibited by state law from agreeing to indemnify or hold harmless any entity or individual.

Arbitration: The University’s status as an agency of the State of Maryland prohibits it from agreeing to binding arbitration.