- Key Issues for a Research Agreement
- Corporate Identity
- Scope of Work
- Proprietary/Confidential Information
- Rights in Data and Reports
- Publication Policy
- Facilities and Administrative Cost Policy
- Research Involving Human Subjects
- Research Involving Vertebrate Animals
- UC Patent Policy
- Inventions and Patents
- Applicable Law
Office of Research (OR) officials have authority to solicit, negotiate, and execute awards for research on behalf of the Regents. The OR staff handles research agreements, material transfer agreements, confidentiality and non-disclosure agreements, as well as licensing agreements. The OR staff can help identify the appropriate contacts and facilitate these agreements. The Sponsored Programs unit of the OR is responsible for the development of appropriate and effective research agreements with industry and other potential collaborators.
If there are multiple sponsors for one laboratory, it is important that the scope of work of each research contract be clearly defined and that expenses under each contract not be co-mingled (separate accounts must be established). That way, any inventions arising from activities in any laboratory can be clearly attributed to the correct sponsor. Detailed laboratory notebooks must be kept up to date and should be associated with the appropriate contract exclusively.
The University of California has identified eight core principles to be addressed in University agreements with external parties. Rights and obligations associated with future research results must be based on these principles.
The University of California is a public trust, administered by the Regents of the University of California, a California constitutional nonprofit corporation. All research agreements must be issued in the University’s legal, corporate name: “The Regents of the University of California”.
The scope of work is a detailed written description of the work the principal investigator will undertake during the period of performance of the contract. It must be as explicit as possible. This scope of work will generally be included as an attachment to the research agreement.
UC Davis agrees to protect sponsor-provided proprietary information or materials from disclosure to third parties, and regularly enters into secrecy or confidentiality agreements for the protection of its own unpublished proprietary information, materials and technology. However, UC Davis has no “secure” or restricted areas, nor does the campus conduct government-classified research. The university does not keep trade secrets.
All rights in data arising from university employment or the use of university resources belong to the university. Title to the copyrightable materials and data that are developed under a contract or grant from a commercial sponsor normally belong to the university. As an academic institution, the university must ensure that the data, information and materials generated during the course of research remain widely available for academic dissemination and scientific validation. Retaining rights to such research products allows the university to ensure that its faculty can pursue their research without undue impediments.
The university regularly affords its research sponsors the right to use the data, information and reports, but the use of such data, information and reports is limited to research and evaluation purposes. Because the university owns such data, information and reports, any commercial use by a sponsor would require special licensing terms.
California Education Code section 92000 provides that the name “University of California” is the property of the State and that no person shall use that name without permission of The Regents of the University of California. University policy prohibits any statement or implication in any publication or other published announcement that the university has approved any product that is or might be manufactured, sold, or otherwise distributed. The university also requires that its name not be used in connection with any advertisement, press release, or other form of business promotion or publicity, or refer to a research agreement, without its prior written approval.
The freedom to publish and disseminate the results of its research is integral to all university work. Consequently, the university will undertake research or studies only if the scientific results can be published or otherwise promptly disseminated. A provision may be made for a short delay (30 to 60 days) so that a sponsor may review publications to remove sponsor-provided confidential information or establish patent protection before the results are released to the public. Copyrights and publication rights belong to the university and/or the author(s). The university reserves the right to announce to the public the existence of each of its awards and the subject of its research, typically without elaborating on the details of each specific project. University policy precludes assigning ownership of results and data to extramural sponsors.
Research at the university is performed on a “no-profit/no-loss” basis. Research project budgets must provide both the direct and the Facilities and Administrative Costs (formerly “indirect costs”) associated with the research. The rate and the method of facilities and administrative cost application conform to the institution’s federally negotiated Facilities and Administrative Cost Rates. The applicable rates are applied to all direct costs except graduate student fee remission, lease costs, that portion of subcontracts in excess of $25,000, patient care costs, purchase cost of permanent, non-expendable equipment, and construction and renovation costs.
UC Davis requires a minimum of quarterly payments in advance during the research project. The first quarterly payment is requested at the time the agreement is signed and needs to be received before the project begins so that the university can be assured of adequate project funding to cover project expenses as they are incurred. Other payment provisions (monthly, etc.) can also be discussed and negotiated by the Sponsored Programs office as appropriate.
Note: If a researcher wishes to begin or proceed with the project without receipt of advanced payments from the company, the researcher’s department must accept any risk associated with non-receipt of payment prior to Sponsored Programs acceptance of the award. Also, since a sponsor may often require receipt of the final technical report prior to sending the final financial payment, assumption of this risk by the department would be a minimal requirement.
“Research involving human subjects,” as defined by federal regulations, includes any systematic investigation that is designed to develop or contribute to general knowledge, and which uses living humans or identifiable private information about humans. Examples of “research involving human subjects” conducted at UC Davis are drug/device comparison trials, disease prevention studies, ethnographic interviews, psychology experiments, and curricular evaluation studies.
Depending on the research proposed, the study may require Institutional Review Board (IRB) approval. The role of the IRB is to review and make decisions on all research involving human subjects at the University of California, Davis, with the intent of ensuring compliance with the appropriate regulations and policies, which are designed to protect the safety and welfare of subjects.
The UC Davis Policy on the Care and Use of Animals in Research and Teaching provides that University practices for the procurement, housing, and care of animals must conform to the Guide for the Use and Care of laboratory Animals in Research (NIH Publication No. 85-23, revised 1985, and succeeding editions) and all requirements of the United States Department of Agriculture (USDA) issued by the USDA implementing the Animal Welfare Act of 1966 and Amendments to the Animal Welfare Act. In addition, university policy requires that all facilities in which animals are housed must be accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC).
The campus is also obligated to file an Animal Welfare Assurance with the Public Health Service and certain other public and private agencies in order to receive grants from these sources. These assurances require review of funding proposals by an institutional committee of specified composition.
The Chancellor has delegated the responsibilities and authority of the Institutional Official to the Vice Chancellor for Administration. The Institutional Official is charged with establishment of an Institutional Animal Care and Use Committee (IACUC), to assure complete and adequate review of animal facilities, laboratory/study areas, procedures, and animal care and use protocols.
Upon employment, all university employees must sign a patent acknowledgment, which requires that they disclose all inventions or discoveries conceived or developed while employed by the university. Additionally, non-UC employees permitted to use university research facilities are also required to sign the university’s patent acknowledgment agreement before using such facilities. This agreement requires assignment to The Regents of all inventions made in the course and scope of university employment, as well as all inventions made by non-UC employees using university facilities. The university retains title to inventions developed by university employees, as well as inventions by visitors using university facilities, whether the research is funded by the university or by extramural sponsors. The sponsor of the research project that generates an invention may have the right to negotiate a commercial license. License negotiation takes place after an invention has been disclosed by the university researcher. UC Davis InnovationAccess is responsible for protecting and licensing UC Davis technology.
To assist the university inventor in the use of the patent system in a manner that is equitable to all parties, the university adopted the University of California Patent Policy. The major objectives of the policy are to:
- disseminate new and useful knowledge resulting from university research through the use of the patent system
- license patents to industry in order to promote the development of inventions for practical use by the general public
- provide income to support further research and education, with a share of the income going to the inventor
- ensure that patent-related obligations to sponsors of research are met
Research, by its nature, is unpredictable and inherently involves some risk. University research is conducted on a “reasonable efforts” basis and without guarantee of successful results. The university will agree to indemnify the research sponsor for the intentional misconduct or negligent conduct of university officers, agents, employees, students, invitees, and guests under research contracts, but only in proportion to and to the extent of such liabilities or claims for injury or damages are caused by the negligent or intentional acts or omissions of the university. It is expected that the research sponsor will reciprocate.
Generally, either party may terminate the research agreement provided that either party determines that the research project is no longer academically, technically or commercially feasible. However, the university cannot incur financial losses resulting from termination. In the event an agreement is terminated, the sponsor will be expected to reimburse the university for all project costs incurred through the date of termination and for all uncancellable obligations incurred to support the project.
The university is a constitutional entity of the State of California and contracts accepted by the university are interpreted under California Law. The university will also consider contractual silence regarding this issue.