Model Organism Sharing Policy

Policy Overview

The NIH Policy on Sharing of Model Organisms for Biomedical Research sets the expectation that all NIH applications and proposals that will produce unique model organism research resources include a sharing plan for distributing these research resources in the application or proposal, or provide a justification for why such sharing is restricted or not possible.

Why Share Model Organisms?

Advances in science depend on the timely sharing and distribution of biomedical research resources, including model organisms. The timely sharing of materials, reagents, and data, which has been essential to the rapid progress in research on many model organisms, avoids duplication of very expensive efforts and permits NIH to support more investigators and a greater variety of model organisms. To further ensure that NIH-funded research resources are available to the research community for future research efforts and to accelerate the development of products and knowledge to benefit the public, NIH maintains a policy on the sharing of model organisms for biomedical research.

Applicability

This policy statement applies to those submitting a funding application or contract proposal beginning with the October 1, 2004, receipt date.

This policy statement applies to extramural investigators funded by NIH grants, cooperative agreements, and contracts, including Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms. All investigators are expected to develop a model organism sharing plan. There is no cost threshold for this policy.

Definitions of Model Organisms and Related Resources

Model organisms include but are not limited to:

• Non-human mammalian model organisms, such as:
  • Mouse
  • Rat
• Non-mammalian model organisms, such as:
  • Budding yeast
  • Social amoebae
  • Roundworm
  • Arabidopsis
  • Fruit fly
  • Zebrafish
  • Frog

Resources include materials and data necessary for the production and understanding of model organisms. Examples include but are not limited to:

• Genetically modified organisms
• Mutant organisms
• Sperm
• Embryos
• Vectors
• Non-human embryonic stem cells
• Established cell lines
• Protocols for genetic and phenotypic screens
• Mutagenesis protocols
• Genetic and phenotypic data for all mutant strains

Genetically modified organisms are those in which mutations have been induced by chemicals, irradiation, transposons, or transgenesis (e.g., knockouts and injection of DNA into blastocysts), those in which spontaneously occurring mutations have occurred, and congenic or consomic strains.

Interaction with other NIH Data Sharing Policies

The model organism sharing policy covers all projects that produce or may produce model organisms, regardless of the amount of the budget. Other NIH sharing policies such as the Genomic Data Sharing policy, 2003 Data Sharing Policy, and the Data Management and Sharing Policy pertain to data. To find out which policies apply to a research project, see Which Policies Apply to My Research? 

Compliance

When evaluating non-competing continuation applications, NIH program staff may consider, as part of the criteria for continued funding, adequate progress in model organism sharing as well as a demonstrated willingness to make research resources developed during the project widely available to the research community. NIH program staff may consider failure to comply with NIH research resource sharing policies and the accepted plan in future funding decisions for the investigator and the investigator’s institution.

Specific funding announcements or solicitations may have additional requirements related to resource or data sharing. 

As ways for sharing model organisms evolve, the NIH Institute or Center as well as the funded institution may revise the sharing plan during the project period in response to unforeseen developments. 

Sharing Plans

The sharing plan should be included in the Resource Sharing section of the application.

Details within sharing plans may vary, depending on the organism, the nature of the resources that will be shared, the extent to which intellectual property issues may be considered in sharing, and plans for distributing the resources.

In general, a sharing plan should specify:

• How the novel strains will be made available to the scientific community, including:
  • The form in which the organisms will be provided. Forms in which new genetically modified model organisms developed with NIH funding may be shared include but are not limited to:
    • Mature adult organisms
    • Sperm
    • Eggs
    • Embryos
    • Vectors used to generate transgenic or knockout organisms
  • A reasonable time frame for periodic deposition of material and associated data;
  • Whether a repository will be used; and
  • If relevant, how risks of infection or contamination will be minimized.
• How technology transfer and intellectual property issues will be handled, including:
  • How the institution plans to make organisms and resources widely available to the research community;
  • How the institution plans to make certain any rights or obligations to third parties are consistent with the terms and conditions of the NIH award to ensure appropriate dissemination of model organisms under the NIH award;
  • A description of the mechanisms that will be used to distribute organisms and related research resources, e.g., material transfer agreements (MTAs).

Applicants are encouraged to contact their institution’s offices of technology transfer and other relevant institutional offices for help with addressing these issues.

Sample Sharing Plans

The precise content and level of detail to be included in a sharing plan depends on several factors, such as the status of the development of a model organism, the method of sharing and the potential impact of intellectual property (IP) rights on the available of the animal model. NIH has provided three sample plans to assist the applicant community in responding to this policy:

• A simple plan that may be appropriate for a project with the goal of producing a model organism but has not produced one
• An example of a complex plan for sharing mice with IP held by various parties

Costs of Sharing

NIH program staff will consider the sharing plan at the start of each competitive funding cycle for new and renewal applications.

Specific funding announcements or solicitations may have additional requirements related to resource or data sharing.  Research may also be subject to NIH data sharing policies.

As ways for sharing model organisms evolve, the NIH Institute or Center as well as the funded institution may revise the sharing plan during the project period in response to unforeseen developments. 

Intellectual Property

NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with federal funding pursuant to the Bayh-Dole Act. The investigator and their institution may choose to retain title to subject inventions such as a mutant mouse developed with federal funding, under the provision of the Bayh-Dole Act. However, a patented resource must still be made reasonably available and accessible to the research community in accordance with the NIH Grants Policy Statement, including the NIH Research Tools Policy.