- For purposes of NIH policy, which organisms are considered “model organisms,” and which are related research “resources” that must be added?
- How will the adequacy of my sharing and distribution plan be evaluated?
- What is expected of Scientific Review Officers (SROs) and reviewers?
The term “model organism” includes mammalian models, such as the mouse and rat, and non-mammalian models, such as budding yeast, social amoebae, roundworm, Arabidopsis, fruit fly, zebrafish, and frog. Examples of model organisms for which a sharing plan is expected when new, genetically modified organisms are developed is posted on the NIH Model Organism for Biomedical Research Web site as a brochure. This list is updated periodically. Although genetic variants of viruses, bacteria, and other prokaryotic organisms should be made widely available pursuant to the NIH policy, at this time NIH is not expecting the submission of a sharing plan from investigators who intend to develop non-eukaryotic organisms unless specified otherwise in the funding opportunity announcement. 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 spontaneous mutations have occurred, and congenic or consomic strains. Depending on accepted practice, new, genetically modified model organisms developed with NIH funding may be shared as mature organisms, sperm, eggs, embryos, or even the vectors used to generate transgenic or knockout organisms. The term “resources” includes materials and data necessary for the production and understanding of model organisms, such as vectors, non-human embryonic stem cells, established cell lines, protocols for genetic and phenotypic screens, mutagenesis protocols, and genetic and phenotypic data for all mutant strains.
The Scientific Review Group, or study section, will comment on the adequacy of the sharing plan. Reviewers will be asked to describe their assessment of the sharing plan in an administrative note and, except in defined circumstances, will not include their assessment in the overall impact score. For some special initiatives, such as Request for Applications and Request for Proposals specifically directed to the development of model organisms, reviewers may be asked to integrate their evaluation of the plan for sharing with other review criteria and factor their assessment into the overall evaluation of scientific merit. Any concerns must be resolved before an award can be made. Program staff, who will review your sharing plan before making funding recommendations, should be your first point of contact for resolving sharing plan deficiencies.
Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For mechanisms other than special RFAs or special RFPs, the presence or adequacy of a plan should not enter into the scoring of the application. The sharing plan itself should be discussed after the application is scored and reviewer comments recorded in an administrative note.
For special initiatives and research mechanisms, where the text of the announcement specifically includes the adequacy of a sharing plan as a review criterion, the adequacy of the plan will be discussed by the reviewers and will figure into the score.