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Frequently Asked Questions
FAQs on Forms Updates 2016 - Vertebrate Animals Section
Last Revised: June 21, 2017

  1. How has the Vertebrate Animals Section (VAS) of the application changed?
    As announced in NOT-OD-16-006, the VAS is simplified by the following changes: 1) description of veterinary care is no longer required; 2) justification for the number of animals has been eliminated from the VAS; and 3) method of euthanasia is eliminated from the VAS and is addressed in the Cover Page Supplement or PHS Fellowship Supplemental form, as applicable. The justification for the number of animals, sex, ages and other biological variables should be described in the Research Strategy.
  2. When will the simplified VAS be implemented?
    The new instructions and review criteria for the VAS are effective for applications submitted for due dates of January 25, 2016 and beyond.
  3. Why was the VAS changed?
    The changes were made to remove redundancy with Institutional Animal Care and Use Committee (IACUC) review while still meeting the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The changes simplify the VAS criteria and reduce burden on applicants and reviewers.
  4. What are the VAS criteria that must be addressed?

    If live vertebrate animals are involved in the project, applicants must address each of the following criteria in the VAS:

    1. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the application or proposal. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.

    2. Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

    3. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

    In addition to the criteria above, applicants should also:

    • Identify all project performance (or collaborating) sites and describe the proposed research activities with vertebrate animals that will be conducted at those sites.
    • Explain when and how animals are expected to be used if plans for the use of animals have not been finalized.
    Note, method of euthanasia is addressed in the Cover Page Supplement or PHS Fellowship Supplemental form, depending on the application.
  5. If an applicant provides responses to the old VAS criteria in their applications submitted for due dates in 2016 and beyond, will it impact the review?
    No, as long as the simplified criteria are addressed, the application will be reviewed. However, the VAS must not be used to circumvent page limits.
  6. Are there any new requirements in the VAS?
    No, the criteria have been reduced and simplified.
  7. Do applicants describe and justify the sex of the animals proposed in the VAS?
    No, how sex is factored into the research design should be described in the Research Strategy. Applicants must state only the sex of the animals in the VAS.
  8. Do applicants justify the number of animals in the VAS?
    No, the justification for the number of animals is an element of rigor in the experimental design and should be described in the Research Strategy.  Applicants must state only the total number of animals proposed in the VAS.
  9. Where can I find more information about the changes in the VAS?

    The Vertebrate Animal Section webpage has more details about the VAS and includes links to the Grant Application VAS Worksheet and the Contract Proposal VAS Worksheet.

  10. Do applicants describe and justify the method of euthanasia in the VAS?
    Beginning May 2016, applicants address the methods of euthanasia in the FORMS D Cover Page Supplement or PHS Fellowship Supplemental form depending on the application. If the applicant answers “No” to the question “Is method consistent with AVMA Guidelines?”, they need to describe the method and provide scientific justification.
  11. Do applicants describe all proposed procedures on animals in the VAS?

    Yes, applicants must include a concise description of all proposed procedures on live animals in the VAS. While additional details of the experimental design may be included in the Research Strategy, a brief description of each procedure must be provided in the VAS and include sufficient detail to allow evaluation by reviewers. Examples of types of procedures include:

    • Behavioral tests
    • Blood collection
    • Surgical procedures
    • Administration of substances
    • Tumor induction
    • Post-irradiation procedures
  12. If an applicant fails to address one of the criteria in the VAS, will the application score be affected?
    Each of the criteria must be addressed in the VAS. Failure to adequately address the criteria may negatively affect the application’s impact score. The VAS must not be used to circumvent page limits. The applicant should only address the required criteria and include descriptions of the proposed use of live animals.

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This page last updated on June 21, 2017 
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