Sharing scientific research and resources accelerates scientific progress, avoids duplication of efforts, and enhances collaboration. To that end, NIH’s Model Organism Sharing Policy requires investigators to include plans for sharing unique model organisms and related resources in their grant applications or contract proposals. Investigators unable to share model organisms or resources are required to state why sharing is not feasible.
The Policy covers mammalian models, such as mice and rats, and non-mammalian models, such as budding yeast, social amoebae, roundworms, Arabidopsis, fruit flies, zebrafish, and frogs. Related resources include the materials and data necessary for producing and understanding the organisms, such as vectors, nonhuman embryonic stem cells, established cell lines, protocols for genetic and phenotypic screens, mutagenesis protocols, and genetic and phenotypic data for all mutant strains.
When Does This Policy Apply?
The Model Organism Sharing Policy applies to all projects that produce or may produce model organisms, regardless of the budget amount.
The plan applies to research project grants, cooperative agreements, and research and development contracts, including Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms. It extends to international collaborations and foreign recipients. It doesn’t, however, apply to individual fellowship (F) and institutional training (T) awards.
Where to Include the Sharing Plan
Investigators submitting an NIH application—including competing renewals—are expected to include a concise plan addressing the timely distribution of organisms and resources unless the proposed research will not generate new model organisms and related resources. The plan should be described in the Resource Sharing Plan(s) section of the application. Additional information on sharing might be included in other sections of the application, as appropriate—for example, if you are producing an important resource for the scientific community, you probably want to mention this in the Significance section; or, you might address Institutional Animal Care and Use Committee and Animal Biosafety Level concerns in the Vertebrate Animals section.
In general, sharing plans can vary based on the organism, the nature of the resources to be shared, consideration of intellectual property issues, and distribution plans for the resources. However, applicants must clearly specify how they will make novel strains available to the scientific community and how they intend to manage technology transfer and intellectual property issues.
The sharing plan is effective for the duration of the grant. Consequently, applicants must also address how they or their institution will make the model organism available after the grant has expired. This could be through cost-reimbursable charges or by donating the organism to a repository. Using a repository is encouraged to ensure easy long-term access.
Program officers can share advice and resources with principal investigators to inform their development of sharing plans, and, after peer review, are responsible for assessing the appropriateness and adequacy of investigators’ proposed sharing plans based on comments from the review panel.
When reviewing the application, the study section will evaluate the adequacy of the sharing plan. Reviewers provide their assessment of the sharing plan in administrative notes and, except in specific circumstances, this assessment does not affect the overall impact score. As per usual NIH practice, the budget review will be included as part of the overall review.
Grants management specialists must verify with program staff that the sharing plan is acceptable before issuing an award. Though NIAID may issue a restricted award to afford an award recipient time to submit an acceptable sharing plan, we do so only in rare and exceptional circumstances.
Funding Considerations
Investigators may request funding from NIH to cover reasonable costs associated with sharing model organisms and related research resources. This funding can be used to support sharing efforts managed by the investigator or to cover costs related to transferring model organisms and resources to repositories that aim to distribute them widely to the research community.
Recipients of NIH funding can also recover costs associated with sharing, including shipping expenses, as a reasonable charge for the transfer. However, any charges that exceed the associated costs incurred on NIH grants must be reported as program income (refer to Section 8.3.2 Program Income of the NIH Grants Policy Statement).
When reviewing annual progress reports, program staff evaluate whether recipients are sharing resources as specified in the accepted plan, to make them widely available to the research community. In instances of noncompliance, NIAID may take measures to remediate the situation.
Also, as ways for sharing model organisms evolve, NIAID as well as the funded institution may revise the sharing plan during the project period in response to unforeseen developments.
Additional Resources
Learn more about the Model Organism Sharing Policy. Also read Frequently Asked Questions (FAQs): Sharing of Model Organism and Related Resources. Check out NIAID’s Sharing Model Organisms SOP as well as a Sample Sharing Plan.