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 University of Maryland, Baltimore (UMB) adopts the University System of Maryland (USM) POLICY ON INTELLECTUAL PROPERTY (IV - 3.20) approved by the Board of Regents February 8, 2002.  In addition, the UMB Policy Regarding Ownership, Management, and Sharing of Research Data (UM IV-99.01(A) applies to Research Data that result from research activity performed at or under the auspices of UMB, regardless of funding source. These two policies shall be referred to as the IP Policy hereafter.

Occasionally, in the course of sponsored projects, sponsors, particularly Foundations or other non-Federal sponsors, include terms or conditions in their award notices that do not conform to UMB’s IP Policy. In these cases, Sponsored Programs Administration (SPA) works with the sponsor to negotiate mutually agreeable language that is in accordance with the preferred ownership and licensing terms in the UMB IP Policy. However, in some cases, this is not possible, and UMB may agree to waive certain requirements as allowed per the IP Policy. In these cases, the Principle Investigator (PI) and the project team will need to decide whether to request a waiver of the IP Policy in order to permit UMB to accept the award.

When negotiations on IP language come to an impasse, but the PI and project team still wish to pursue the award, SPA will initiate an IP Policy Waiver request ("IP Waiver") via UMB-SPA Negotiated Agreement IP Waiver form which then must be reviewed and approved by the PI, Chair, and Dean before proceeding for review by OTT and the Senior Vice President and Chief Enterprise and Economic Development Officer. IP Waivers should be carefully considered before acceptance and signing, particularly when there are graduate students working on the research project. Any person(s) joining a project after the project starts, where an IP Waiver has been approved, is subject to the terms of the waiver. PIs and Departments are responsible for obtaining signatures for anyone who joins the project after the initial IP Waiver is processed/approved and keeping the documentation on file.

Other situations may require a waiver of the IP Policy, including agreements signed by OTT or CCT.   OTT or CCT would be responsible for the IP Waiver process for their agreements.

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.