Guidelines for Grant and Contract Management
312. Sample Language – Intellectual Property and Research Tools
The following sample texts are provided to assist you with the preparation of grant applications. Should the sponsor require a Data Sharing/Intellectual Property Plan or a Plan for Sharing of Model Organisms/Animal Models, you may adapt this language to suit the specific needs and circumstance of your proposal.
Background regarding Intellectual Property/Data Sharing Plans
Increasingly, NIH RFAs and RFPs either require or encourage a statement pertaining to the sharing of research resources or to intellectual property. The following sample language may be useful to Principal Investigators to consider as they prepare proposals.
Objectives:
NIH wants to ensure that research tools, resources developed with NIH funds are readily available to the research community. NIH looks for specific plans for sharing data, materials and software generated with NIH funds. Such resources should be freely available by entire research community, consistent with the terms of Bayh-Dole (PDF). The NIH Policy statement on this subject is titled "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources."
A statement on data sharing is required by NIH of applicants seeking $500,000 or more in direct costs in any year of the project period ("Final NIH Statement On Sharing Research Data"). Data sharing is particularly important in those NIH-funded programs where databases are being developed, or libraries of methodologies, sequences, SNPs, etc. are a funding objective. Investigators should describe clearly and directly how data will be shared: e.g. open source code, posting of data to an open web site, publications/presentations to the research community. Reasonable time delays for protection of rights are permissible under Bayh-Dole and should be mentioned, if appropriate.
Your proposal may be adversely affected if you do not document that you understand and agree to abide by applicable NIH and University of Chicago policies and procedures. To assist you in fulfilling your obligations as a recipient of federal funding and as a member of the faculty, we have prepared some sample language that you should adapt to reflect the types of research tools involved or that you expect to be created if your application is funded. Your signature on the proposal confirms to NIH that you understand and accept these important responsibilities.
Sample language:
The University of Chicago is committed to the open and timely dissemination of research outcomes. Investigators in the proposed activity recognize that promising new methods, technologies, strategies and computer software [revise as applicable to the nature of the research program] may arise during the course of the research. The Investigators are aware of and agreed to abide by the principles for sharing research resources as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources."
While the investigators expect that research tools will be freely shared with the research community, opportunities for technology transfer through commercialization will be explored as appropriate. Working with the University community, the University of Chicago's Office of Technology and Intellectual Property (UChicagoTech), manages intellectual property at the University of Chicago. UChicagoTech serves faculty, staff and students by commercializing inventions, ideas and software developed at the University to ensure that new knowledge benefits society.
UChicagoTech works with researchers to assess the commercial potential of new ideas. UChicagoTech's goals are to disseminate new ideas so the public can benefit from discoveries, and to generate revenues for research and education. When the best means of disseminating discoveries and new intellectual property is collaboration between the University and commercial entities, UChicagoTech has a special role to play. It protects the rights of the inventors and the University—and then typically works with industry, granting licenses so that a company will develop the discovery and bring it to the market. Revenues from licenses secured by UChicagoTech are shared with the inventor, the inventor's laboratory, and the inventor's academic division. Where opportunities arise for corporate sponsored research related to the NIH-funded research programs, the University expects any agreements to conform to the principles described by NIH in the 1994 policy "Developing Sponsored Research Agreements: Consideration for Recipients of NIH Research Grants and Contracts."
Background regarding Sharing of Model Organisms/Animal Models
Under the NIH Policy on Sharing of Model Organisms for Biomedical Research, published May 7, 2004 (NOT-OD-04-042), investigators who develop such model organisms (animal or biologics) must include a model organism sharing plan or explain why the research tools cannot be shared. A sample Model Organism Sharing Plan follows that can be used in applications to demonstrate the University's commitment to the open dissemination of research tools. We also recommend you look at the FAQs and examples of plans NIH has developed to assist investigators at http://grants.nih.gov/grants/policy/model_organism/index.htm. Note that grant applicants responding to a Request for Applications (RFA) or a Request for Proposals (RFP) may find additional requirements to those listed below, related to resource or data sharing for the specific announcement or solicitation. It is the responsibility of the investigator to address any such additional requirements in the Sharing Plan.
Sample Model Organism Sharing Plan
- University Statement
The University of Chicago is committed to the open dissemination of research results, information and research tools that facilitate research and further scientific progress. It is the expectation and goal of the University that all "model organisms" (as defined by the NIH at www.nih.gov/science/models/) that are created during the course of NIH funded research grant projects, are shared with the research community. In accordance with these efforts the University of Chicago will use as guidance the NIH Policy on Sharing of Model Organisms for Biomedical Research, published May 7, 2004. - Guiding Principles
The guiding principles that the University will follow to achieve the above stated goal are outlined below:
- The University will work with and encourage its faculty to disclose newly created model organisms on a timely basis.
- The University will facilitate the transfer of model organisms to researchers requesting access through its material transfer agreements or the UBMTA Implementing Letter. Alternatively, the University may, when appropriate, make the material available through the use of a repository or a commercial distributor. In all cases, arrangements will be made to ensure that the materials are made widely available to the non-profit research community.
- If the University decides to patent the model organism, it will take steps to ensure that the protection of rights shall not interfere with the distribution of the organism to the scientific community.
- If the University decides to patent and license the model organism, it will negotiate terms with licensees that promote widespread distribution of the organism. With respect to exclusive licenses, the agreements will include provisions for the return of rights to the University should the licensor fail to commercialize the technology and offer it for public sale in a timely manner. The University will also make every effort to reserve rights to the licensed material to the University and other non-profit institutions.
- The University will draw upon the expertise within University Research Administration, UChicagoTech, the office of General Counsel and other appropriate offices within the institution when developing individual model organism sharing plans with its principal investigators.
- If third party patents or contract obligations exist the University will seek to minimize any possible restrictions affecting the availability of model organisms.
- Model Organism Sharing Plan Specifications
(to be completed prior to submission)
- HOW THE NOVEL STRAINS WILL BE MADE AVAILABLE TO THE SCIENTIFIC COMMUNITY
- Describe the organism(s) to be made available:
- Indicate the form in which the organism will be provided (e.g., adults, embryos, sperm):
- List any related research resources or data that you plan to provide:
- Include a time frame for the periodic disposition of material and associated data:
(materials should be made available at least upon publication of the primary results announcing the development of any genetically modified organisms) - Will a repository be used? ___ yes ____ no
(Note: examples of available resources are posted on the NIH Model Organism for Biomedical Research Web site and are updated periodically) - If relevant, describe how risks of infection or contamination will be minimized:
- How technology transfer issues will be handled
The University will facilitate the transfer of model organisms to researchers requesting access through its material transfer agreements or the UBMTA Implementing Letter. Alternatively, the University may, when appropriate, make the material available through the use of a repository or a commercial distributor. In all cases, arrangements will be made to ensure that the materials are made widely available to the non-profit research community.
If the University decides to patent the model organism, it will take steps to ensure that the protection of rights shall not interfere with the distribution of the organism to the scientific community.
If third party patents or contract obligations exist the University will seek to minimize any possible restrictions affecting the availability of model organisms.
- HOW THE NOVEL STRAINS WILL BE MADE AVAILABLE TO THE SCIENTIFIC COMMUNITY
| Principal Investigator | Date | Institutional Officer | Date |
