The Process
Typically, the investigator and the sponsor connect to discuss ideas for a collaboration or project, and agree on a scope of work and budget.
Requesting a Proposal
The proposal process can result from informal discussions between the investigator and the sponsor, or can be in response to a formal request for proposals. Sponsor guidelines, if they exist, should be provided to the investigator. For federal flow-through funding, this is the request for proposals or agency announcement. UCI will need to know if the sponsor or prime sponsor has a deadline for receipt of the proposal.
Proposal
A proposal generally consists of the sponsor’s guidelines, a scope of work, a budget, and any other documentation required by the sponsor (e.g., cover letter, biographical sketches, etc.). The proposal is submitted for internal approval at UCI by the investigator and may include additional documents required for UCI review, such as conflict of interest disclosure forms.
Research Agreement
A research agreement is negotiated once the sponsor has decided to fund the proposal. We have a variety of agreements we use to cover the various activities undertaken by our investigators.
Sponsored Research Agreement
A formal agreement between UCI and a company to cover the full costs (both direct and indirect) of a research project in accordance with a mutually agreed upon scope of work and corresponding budget.
Link to Sponsored Research Agreement
Flow-Through Subcontract (Including SBIR/STTR)
A formal agreement between UCI and a company for UCI to serve as a subcontractor to the company on an award it receives from another entity, including federal or state agencies. After a proposal is approved by the granting agency, a subcontract is executed between the company and UCI to address the relevant contractual terms and fund the direct and indirect costs of UCI’s portion of the research project in accordance with a mutually agreed upon scope of work and budget.
Link to Flow-Through Subcontract
Material Transfer Agreement
Before proprietary or valuable material changes hands, a transfer agreement should be in place. This protects the rights of both parties and ensures agreement on subsequent use, care and further distribution. ISR has the responsibility of negotiating and executing these agreements on behalf of UCI.
UCI research material, including biological materials, may be shared with outside entities for research purposes, subject to the faculty researchers’ approval and a written transfer agreement between UCI and the outside entity. A license for commercial use, including appropriate fees, may be obtained under certain circumstances.
Link to Material Transfer Agreement
Confidential Disclosure Agreement (CDA)
A formal agreement to protect an entity’s proprietary information when it is shared with another entity. Also known as a Non-Disclosure Agreement (NDA). A CDA can be a precursor to other research agreements when the purpose is to evaluate a future relationship. There are two types of CDAs: one-way CDAs (i.e., only one of the parties is disclosing its confidential information) and mutual CDAs.
Please contact ISR for CDA
An Agreement for Other Sponsored Activity
A formal agreement between UCI and a company for the performance of work other than organized research and instruction. Examples are health service projects and community service programs.
Please contact ISR for an agreement for this type of activity
Registry/Observational Study Agreement
A formal agreement between UCI and a company for UCI to participate in a patient registry or observational study where UCI’s portion of the research does not involve the controlled testing of a drug, device or diagnostic in human subjects under an approved protocol.
Please contact ISR for a registry or observational study agreement
Data Use Agreement
A formal agreement between UCI and a company for the exchange of personal identifiable or non-public data that may be covered by law for a specific use or project. The data transfers can be outgoing (UCI’s data being transferred to a company) or incoming (a company’s data being transferred to UCI).
Please contact ISR for a data use agreement
Sales and Services Agreement
A sales and services agreement is appropriate when UCI renders a standardized service or provision of goods to an outside entity based on an established standard pricing method. These agreements are processed by Purchasing and Risk Services.