Sponsored Projects Administration (SPA) is the only University-wide office authorized to enter into grants and contracts with industry sponsors to fund research at the University. SPA’s contracting authority extends to clinical trials agreements, research agreements, and master agreements with for-profit entities.
Getting Started
Clinical Trial Agreement
SPA requires a proposal package to initiate contract discussions with industry sponsors. The clinical proposal package must include a Proposal Routing Form (PRF), protocol, budget and a copy of the agreement (if available). This package provides valuable context for SPAs negotiations, so an accurate and complete proposal package is extremely important. Email the proposal package to proposal@umn.edu and the file will be logged in and assigned to a B&I Grant and Contract Officer (GCO) for negotiation. The subject line for your email to proposal@umn.edu must be in the format:
PRF# PILastName SponsoringAgency
Example: 876676 Wiffel Boston Scientific
SPA cannot review or negotiate an agreement without the programmatic context and departmental authorizations contained in a proposal package.
Departments have the option to utilize the expedited PRF procedure for clinical trial activity. This procedure allows SPA to negotiate the terms of the clinical trial agreement in parallel to departmental budget and programmatic negotiations.
Effective January 2, 2019, industry-sponsored clinical trials should use a rate of at least 30% TDC.
Research Agreement
SPA requires a proposal package to initiate contract discussions with industry sponsors. The research proposal packet must include a Proposal Routing Form (PRF), work scope, budget and agreement (if available). This package provides valuable context for SPAs negotiations, so an accurate and complete proposal package is extremely important. Email the proposal package to proposal@umn.edu and the file will be logged in and assigned to a Grant and Contract Officer (GCO) for negotiation. The subject line for your email to proposal@umn.edu must be in the format:
PRF# PILastName SponsoringAgency
Example: 876676 Wiffel Boston Scientific
SPA cannot review or negotiate an agreement without the programmatic context and departmental authorizations contained in a proposal package.
Budgets for industry research agreements should reflect the University’s full federally negotiated indirect cost rate. Industry sponsors are NOT automatically eligible for reduced rates based on published company policies or requests for proposals. A reduced rate can only be used on an industry project if an approved waiver is in place. See the University policy and procedures on this topic for more information. An indirect cost reduction will impact negotiation of the research agreement and the terms that the University will offer the sponsor.
Master Agreement
A master agreement (MA) defines the terms for a single industry sponsor to fund multiple research or clinical projects over a period of time. While MAs generally take longer to negotiate upfront, MAs help to facilitate collaborative sponsored research and eliminate protracted legal review and negotiation of each new project. In most instances, SPA will require a history of successful single study agreements before it will agree to pursue a MA with an industry sponsor.
Requests for a master research agreement or master clinical trial agreement should be forwarded to your B&I GCO. SPA will work with the sponsor and the Office of General Counsel to put a University-wide master in place. [Let SPA know immediately if a sponsor has mentioned using a master agreement - not doing so can cause delays for the project in question if all parties are not on the same page.]
See a list of master research agreements at the U of M.
What Happens at SPA After I Submit?
Once the proposal package has been submitted to SPA, the file is assigned to a Grant and Contract Officer (GCO). The agreement is put into the GCO queue for agreement review. Generally, GCOs try to meet a two-week turnaround for initial review. That review time can be impacted by complexity of the arrangement, the condition of the project package, and GCO workload. The GCO will work directly with the sponsor to negotiate terms acceptable to both parties. The GCO will contact the PI and/or administrative contact during negotiation with any project specific questions and will provide the agreement for PI review and signature prior to University endorsement.
Requesting an Agreement Template
UMN prefers to contract using its standard agreements.
- Investigator Initiated Clinical Trial Template (OGC-SC744)
- Accelerated Clinical Trial Agreement (OGC-SC740)
- MN-IP Domestic Research Agreement (OGC-SC750)
- Letter of Understanding (OGC-SC752)
If a sponsor requests that you provide an agreement for their consideration, please share the appropriate UMN template available through the UMN Contracts Library. Contact your B&I GCO if you have any questions about which agreement should be used for a particular project or if you would prefer SPA to send the agreement to the sponsor.