This conflict-of-interest form must be completed for every industry-sponsored project. Also called a Statement of Economic Interests, it is mandated by the State of California Fair Political Practices Commission and requires that principal investigators disclose certain financial interests related to the pending study. The 700U form is found on http://www.research.ucsf.edu/coiac/fppc700u.pdf.
This document includes basic information about the study, including the direct and indirect costs breakdown. The Accounting Department will set-up an account for the study upon receipt of the completed Award Synopsis.
To qualify for a clinical trial facilities and administrative rates at UCSF, a Clinical Trial must either:
- Involve the controlled, clinical testing of Investigational New Drugs (INDs) or Investigational Devices (IDEs) using either a sponsor or investigator developed protocol under FDA Phase I, II, III, or IV drug study or a FDA-regulated medical device study; or
- Involve the controlled, clinical testing of a protocol performed under the sponsorship of an approved national cooperative consortium for clinical trial services (please contact Contracts & Grants Office); or
- An ancillary study at UCSF that supports an FDA-approved clinical trial performed at an outside agency, or under a clinical trial sponsored under the direction of an approved national cooperative consortium also qualifies for the CTA rate (please contact Contracts & Grants Office); and
- May not include projects involving animal subjects. These should not be classified as clinical trials.
Conflict of Interest
A conflict between the private interests and the official responsibilities of a person in a position of trust. If a university investigator has an outside interest in an entity, such as a corporation, it may potentially conflict with his/her research in the University. A common conflict of interest is an investigator who wants to conduct a clinical trial while at the same time is a stockholder in the company sponsoring the trial. In this case, there may be a real or perceived concern of scientific objectivity. Universities often have policies that can assist faculty and staff with conflict-of-interest questions.
Conflict of Time
A conflict between the time a person spends on private interests and the time required by the person's employer. If an investigator has an outside relationship with an organization, it may call into question the proper amount of time spent with his/her primary employer. Universities often have policies that can assist faculty and staff with conflict-of-time questions.
Fee-for-service arrangements paid by corporations for the use of faculty time. Most, but not all consulting agreements are structured outside the University environment, where faculty are signatories to the agreement, not the University. Consulting arrangements are disclosed during conflict-of-interest reviews.
A Collaboration Agreement is used when UCSF and an industry partner determine to work together on a particular research project, and both parties agree to contribute resources. Under a typical Collaboration Agreement, the industry partner and UCSF may each contribute substantial materials, equipment, personnel, or specialized expertise to the project.
Protects the form of an "original work of authorship" from unauthorized copying, reproduction, distribution, public performance or display. Copyright covers literary, artistic, and musical works as well as computer code.
A Fellowship is a source of funding for either a graduate student, post-doctoral fellow, or fellow ("UCSF Recipient").
Fixed-cost vs. Cost Reimbursement Contracts
Fixed-Cost Contracts provide a fixed funding commitment from the Sponsor. Payment may be made in advance of work done. Cost-Reimbursement Contracts require UC to return unused funds to the Sponsor. Payments are usually made after expenses are incurred, usually upon invoice to Sponsor.
A gift is any item of value given to a University by a donor where there is no expectation of value in return. The donor must not impose contractual requirements and the funds are awarded irrevocably. The donor may receive recognition for the gift (e.g., being listed on an honor roll or naming a building, fund, professorship, etc. in the donor's honor).
One party to an agreement agrees to compensate another contracted party for incurred hurt, loss or damages. The agreement defines the scope of the liability/risk that each party will cover. University policies require that a sponsor indemnify the University for all claims resulting from the actions of all persons not affiliated with the University, including the perofrmance of the sponsor-written protocol of a clinical trial.
An inventor is a person who contributes significant creative input into the design of an original useful material or process, through the use of the imagination, or of ingenious thinking and experiment. An application for a patent on an invention must be made in the name of the inventor (or names of all inventors if more than one) even if a commercial or nonprofit organization actually owns the invention.
A new or improved idea, method or material/device, including (1) development of new technologies, (2) refinement of existing technologies, or (3) development of new applications for existing technologies. An innovation may or may not be an invention.
Property as an idea, invention or process that derives from the work of the mind. Intellectual property must be "reduced" to tangible form. There are four major types of intellectual property: Patents, Trade Secrets, Copyrights and Trademarks. The University owns all intellectual property resulting from the work of its employees, and can license such property to sponsors and private companies.
Invention disclosures are made to licensing offices when something new and useful has been conceived and developed, or when unusual, unexpected or unobvious research results have been achieved that may have commercial value. The disclosure enables the University to determine whether to file a patent and seek licenses for the invention.
A faculty member who conducts a research project. A team of faculty usually has a lead investigator, the Principal Investigator, appointed to the study. The term "Subinvestigator" includes any other individual member of that team.
A legally-binding written agreement in which the owner of definable rights in property grants permission to someone else to use (and possibility commercialize) that property (prace the invention) in exchange for consideration.
An agreement between the University and a sponsor that states all the terms and conditions for sponsored activities that will be conducted in the future between that sponsor and the University. A Master Agreement decreases the negotiation time because a substantial portion of the terms and conditions have already been negotiated. With a Master Agreement in place, only study specific terms (e.g., budget, scope of work) need to be negotiated in the Letter Agreement. See Letter Agreement.
Material Transfer Agreement (MTA)
A Material Transfer Agreement (MTA) is a contract between a provider and a recipient for the transfer of tangible research materials, including, but not limited to: chemicals, proteins, nucleic acids, biological samples, and organisms (including laboratory animals). An MTA defines the terms and conditions under which a provider is willing to transfer materials to a recipient and substantially reduces the possibility of future misunderstandings between the provider and recipient of materials.
Memorandum of Understanding (MOU)
A written statement used as a reference to construct contracts or future agreements.
Payments made to the owner of patents in recognition of significant points in development in bringing a product to market. Milestones ensure that the invention is developed diligently and marketed successfully.
Publication – Freedom to Publish/Delay of Publication
University policies require the freedom for faculty and students to publish or present the results of their research/projects. Companies who fund research at universities may request to delay publication until they can make a decision whether or not to file for patents on inventions revealed by the publication and/or delete confidential information. University policies do not allow companies to have editorial rights and do not allow for lengthy periods of delay.
Scope of Work
The brief but detailed description of the research program to be performed under a sponsored research agreement with enough information to clearly distinguish it from other research carried out in the Investigator's laboratory.
A sponsor is the agency or company who funds the performance of a research project.
Sponsored Research Agreement
UCSF uses Sponsored Research Agreements (SRAs) for research funded by industry partners. Under these agreements, the industry sponsor funds a specific project for a definite time period and in return receives certain deliverables such as research data, reports and certain rights to intellectual and tangible property. An industry sponsor may fund an SRA as either a fixed-price agreement or cost-reimbursement agreement, where any monies not used can be returned to the sponsor.
Cost considerations and/or expenditures (i.e. staff time) needed before a study can begin.
Terms and Conditions
Contract language that defines the terms (what you agree to do) and the conditions (the requirements associated with receiving certain funds). Often found in government grants and contracts.