Before you enter into an agreement with industry, it is important to determine whether the contemplated activity is research or fee for service (FFS). SMPH typically defines FFS as
The execution of a predefined or repetitive process, or the production of a product that meets predefined specifications. The activity is not expected to add to the body of fundamental knowledge in a given field.
If the activity involves data generation, the data may be so specifically related to a company product or process as to have little value to anyone other than the sponsor or the sponsor’s competitors.
Conversely, research generally involves the creation and dissemination of new knowledge. Research outputs are generalizable, and involve intellectual input from the individuals involved.
Examples
FFS
Company A would like a UW lab to administer its compound to a mouse model and provide the lung tissue from these animals collected 30 days after exposure.
Research
Company A would like help determining the optimal dosing regimen of its proprietary compound to obtain a certain tumor response when applied to a UW-developed mouse model.
Why this Distinction Matters
Fee for Service contracts generally grant the sponsor ownership in all deliverables. This means that any intellectual property that may be created during the process will pass to the sponsor. Research contracts generally provide for ownership of intellectual property to follow inventorship under US Patent law. Thus, if there is anything nonstandard about the activity the sponsor has proposed, and there is the possibility that new ideas may be incorporated, the activity is likely research.
Budgeting Fee for Service
All fee for service budgets must account for the costs of doing business at the University. This means that the standard F&A rate must be applied to the project costs. This amount need not be on a separate line item in a FFS contract. However, you must be prepared to show internal approvers that the charge to industry includes these costs.