On the Road to Grant Success – Addressing the Use of Vertebrate Animals Effectively
January 2. 2021
If the Research Strategy for an NIH SBIR grant application employs live vertebrate animals, completion of a Vertebrate Animal Section (VAS) is required, but careful attention is needed for other sections of the application to address aspects of animal research as a supplement to information provided in the VAS.
Facilities & Other Resources Section
An “Animal Facilities” subheading of this section supplies information to demonstrate that the site(s) for the animal work are adequately equipped and staffed to handle any animal care needed for the proposed experiments. Provide a description of all animal laboratory facilities to be used, including those of contractors and collaborators, along with any accreditations. Describe the supervisory and technical personnel arrangements, and availability of veterinary expertise. Show that there is suitable access to any equipment/devices that may be required for specialized surgical procedures or immediate sample processing.
Research Strategy Section
This is the place to describe how the animal experiments will contribute to the Specific Aims of the grant and advance the project towards a marketable outcome. Describe the animal experiments in detail, along with a rationale for the choice of specific animal model (species, age, gender). Cite the method used to determine the number of animals required to support a desired level of statistical significance. For complicated experiments (more than a few test groups), a summary flowchart of activities would be helpful for reviewers.
Importantly, this part of the Research Strategy section needs to address sex as a biological variable (SABV), a scorable criteria for reviewers. Use of a single gender for animal experiments must be scientifically justified (see SABV primer at website below).
Vertebrate Animal Section (VAS)
If live vertebrate animals are used (including custom antibody generation and acquisition of tissue samples), federal policy requires specific criteria that must be addressed in the Vertebrate Animal Section (VAS). It is important to note that a VAS is required for each research site that will use live vertebrate animals for experiments proposed in the application. Although this section does not contribute to the overall grant score, reviewers’ concerns with this section must be addressed prior to funding.
The format for this section has the following parts:
1.) Description of Procedures: Provide a brief summary of the planned work involving animals, including the species, strains, ages, sex, and total number of animals. List any procedures, treatments, and sample collections. If dogs or cats will be used, provide the source.
2.) Justification: Provide an explanation for why the animal species is appropriate to meet the Specific Aims and why alternatives such as in vitro methods are not suitable.
3.) Minimization of Pain and Distress: Describe interventions and humane endpoints to minimize discomfort, distress, pain and injury.
4.) Euthanasia: Provide a statement that the method of euthanasia is consistent with the recommendations of the AVMA Guidelines for the Euthanasia of Animals. If not consistent, a scientific justification is required.
Additional details for the VAS are provided at the NIH Office of Laboratory Animal Welfare (including a 30 minute training video) and the Worksheet for Applications Involving Animals at the websites below.
Unlike other sections of an SBIR grant application, the VAS has no page limits. Don’t be tempted to supply research data or extensive methodology descriptions in this section to overcome page limits in the Research Strategy section.
Check and Re-check
Since similar information regarding animal studies appears in various places in the application, it is critical for all of these sections to be consistent and describe or refer to the same experiments. If a contractor’s quote for animal work is provided, make sure the experiments (number, species, gender etc.) and group labels are the same as those described in the Research Strategy and VAS sections. Discrepancies will only cause confusion and frustration in the review process, and may contribute to a less than optimal score.
NIH Office of Laboratory Animal Welfare
Worksheet for Applications Involving Animals
Sex as a Biological Variable: A Primer