Preparing the Vertebrate Animal Section

Preparing the Vertebrate Animals Section (VAS) Heading link

The VAS is the section of grant applications, contract proposals, and cooperative agreements where you must describe the use of animals in your work. See additional information on the NIH website.

You must provide a VAS if your work involves the use of live vertebrate animals, including generating custom antibodies and obtaining tissues from live vertebrate animals.

You will need to address all the criteria of the VAS for each performance site.

1. Description of Procedures

  1. Describe the proposed use of animals for the study and identify the species, strains, ages, sex, and total number of animals
  2. Describe the proposed work using animals, including procedures (e.g., injections, blood collection) and surgical procedures, including anesthetic regimes, monitoring, and recovery
  3. Provide source, if dogs or cats will be used
  4. Describe circumstances when animals may experience discomfort, distress, pain or injury
  5. Describe the interventions including analgesia, anesthesia, sedation, and palliative care to minimize discomfort, distress, pain and injury, identifying drugs by name/class
  6. Outline plans for post-surgical care, if applicable
  7. Describe humane experimental endpoints

2. Justifications

  1. Provide an explanation of the appropriateness of the species for the proposed research
  2. Explain why goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vivo)

3. Minimization of Pain and Distress

The National Institutes of Health (NIH) released an announcement regarding changes to the requirements of the Vertebrate Animals Section (VAS) of grant applications, cooperative agreements, and contract proposals. In an effort to reduce redundancy, the VAS no longer requires:

  1. A description of veterinary care
  2. Justification of animal numbers
  3. A description of euthanasia methods (please note: if the euthanasia method is not consistent with AVMA guidelines, a description is required)

4. Euthanasia

  1. State whether the method of euthanasia is consistent with the recommendations of the AVMA Guidelines for the Euthanasia of Animals
  2. If not consistent, describe the method and provide a scientific justification

Resources

References

  • The guidance in this worksheet is based on Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and federal requirements. The PHS Policy incorporates the standards in the Guide for the Care and Use of Laboratory Animals and the S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, and requires that euthanasia be conducted according to the AVMA Guidelines for the Euthanasia of Animals. Additional background information and references are available on the OLAW website.

Vertebrate Animals:

Aims 1-3 will be addressed in vitro; Aim 4 will be addressed using a mouse model of ocular infection.

  1. Description of Procedures: Male and female Balb/c mice will be used to determine if virions treated with enzyme can cause viral keratitis, and to test the in vivo efficacy of the test The studies will require 700 mice, 4 to 6 weeks old. Ocular infection is accomplished by scratching the cornea of anesthetized mice with a sterile needle and exposing the scarred portion of the cornea to inoculum. Test articles are applied directly to the scarified cornea as liquid or cream. Following inoculation and recovery, mice are monitored for 30 days. With the mice under anesthesia, the eyes will be examined at intervals, microscopically, and are flushed with medium with 2% serum to determine viral titers. Thirty days post-infection, with the mice under deep anesthesia, the trigeminal ganglia are removed aseptically for viral assay, followed immediately by euthanasia.
  2. Justifications: The proposal is to study mechanisms for the prevention of ocular disease caused by viral infections, a leading cause of blindness in the mice are needed for these experiments because no alternative in vitro model incorporates all elements of the mammalian ocular immune system; too little is known about this system for the development of computer simulations or for clinical studies to be considered. Mice are a well- accepted model for studying viral keratitis, assessing the virulence of viral strains, and testing the efficacy of antivirals. Mice provide several advantages over other models for these studies: a) The murine ocular immune system is similar enough to that of humans to allow extrapolation of the results; b) Their small size allows the use of smaller amounts of drugs for testing; and c) The entire mouse genome is known and easily manipulated genetically, allowing extension of the work in future genetic studies. Balb/c mice will be used because they have intermediate resistance to infection.
  3. Minimization of Pain and Distress: Mice will be anesthetized with isoflurane (3-5%) during the infection process, when treatments are administered. This eliminates the need for restraint devices and topical anesthetics that would interfere with the infection and disease process. For post-procedural pain relief, we will administer buprenorphine twice daily for the duration of the experiments (i.e., approximately two weeks post-inoculation). [NOTE: Per The Guide, pg. 112 animals must be monitored at least daily by Death is not an endpoint for the studies; the Balb/c strain was chosen because of its resiliency and resistance to this particular virus. Our goal is to avoid severe infections leading to death. Though unlikely, if an animal reacts severely, it will be euthanized, based on humane indicators (e.g., failure to groom or feed). These experiments involve no post-surgical survival animals.
  1. Per the Guide, p. 112 “All animals should be observed for signs of illness, injury, or abnormal behavior by a person trained to recognize such signs. As a rule, such observation should occur at least daily, but more frequently if required, such as during post-operative recovery, when animals are ill, or have a physical deficit, or when animals are approaching a study endpoint.”. Therefore, PIs will need to confirm that animals will be monitored at least daily and more frequently if needed to ensure that the animals do not go past the predetermined humane endpoints.
  2. For animals who show clinical signs of illness due to experimental procedures, but have not yet reached humane endpoint criteria, are there other interventions in place to alleviate any more than momentary (less than severe) discomfort, pain, or stress? These interventions need to be described; including pharmacological agents and non-pharmaceutical means, such as palliative care.