Office of Laboratory Animal Welfare - Vertebrate Animals Section

The following guidance is provided to assist applicants and offerors in preparing the Vertebrate Animals Section (VAS) for submission to the NIH, and to assist reviewers in evaluating the VAS of applications and proposals. Here you will find an overview of the requirements, submitter and reviewer responsibilities, a checklist, and detailed instructions.

Applicability

A VAS is required if the work proposed in a grant application, contract proposal, or cooperative agreement involves live vertebrate animals, including:

  • Animals obtained or euthanized for tissue harvest
  • Generation of custom antibodies

The criteria in the VAS must be addressed for work proposed at every performance site – this is the site (institution) where procedures with animals will be performed. If the applicant institution is not the site where animal work will be performed or if the work will be performed at several sites, these performance sites must be identified.

Requirements

If live vertebrate animals are to be used, federal policy requires applicants to address the following criteria:

1. Description of Procedures

Provide a concise description of the proposed procedures to be used that involve vertebrate animals. Identify the species, strains, ages, sex, and total number of animals by species to be used. 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 to minimize discomfort, distress, pain, and injury. These include analgesia, anesthesia, sedation, palliative care, and humane endpoints. 

Note, for applications with due dates on or after May 25, 2016: (1) the method of euthanasia is eliminated from the VAS and is addressed in the FORMS-D Cover Page Supplement or PHS Fellowship Supplemental forms; (2) a description of veterinary care is no longer required; and (3) the justification for the number of animals has been eliminated from the VAS and should now be addressed in the Research Strategy as part of experimental design.

Applicant Responsibilities

Each of the criteria must be addressed in the VAS of NIH applications or proposals. All of the items must be evaluated by reviewers as appropriate for an application to be rated as ACCEPTABLE. Failure to address the criteria will result in the application being designated as incomplete and it will not be reviewed. The VAS must not be used to circumvent page limits.

Reviewer Responsibilities

Members of scientific review groups (SRGs) must evaluate the VAS to determine if plans for the use of vertebrate animals are appropriate relative to the scientific work proposed. An application will be rated UNACCEPTABLE if all required items are not addressed adequately or found inappropriate. Reviewers will assess the VAS for applications proposing the use of chimpanzees as they would any other application.

NIH Staff Responsibilities

Grants Review Staff

  • Performs an administrative review of each VAS, checking that all criteria are addressed, if applicable.
  • Provides reviewers with instructions for reviewing the VAS (e.g., worksheet), noting that all criteria must be evaluated as appropriate for the VAS to be ACCEPTABLE.
  • Subsequent to SRG review, codes the application and includes reviewers’ comments in the summary statement. 

Grants Program Staff

  • Obtains additional information or clarification to resolve concerns for any application found to be UNACCEPTABLE if it is to be recommended for funding.
  • Works with the applicant to provide information to the Office of Laboratory Animal Welfare (OLAW) allowing resolution of the animal welfare concerns.  

Grants Management Staff

  • Verifies that the institutional Animal Welfare Assurance number is provided.
  • Obtains verification of IACUC approval.

Contracting Officer

  • Provides reviewers with instructions for reviewing the VAS (e.g., worksheet), noting that all criteria must be evaluated as appropriate for the VAS to be ACCEPTABLE.
  • Subsequent to SRG review, determines the competitive range, as applicable, and if discussions are held, provides the offeror with the opportunity to address the concerns raised by the reviewers.
  • With the advice of the project officer and OLAW, as necessary, determines if the concerns have been resolved and the VAS can be considered ACCEPTABLE
  • Confirms whether the offeror has an Animal Welfare Assurance and IACUC approval.
  • Makes contract awards.

Project Officer

  • Assists the contracting officer in determining the acceptability of the revised VAS. 

VAS Checklist

Performance Sites

The required criteria must be addressed for all performance sites.

__ If the applicant’s institution is not where animal work will be performed, are all collaborative performance sites identified?
__ If more than one performance site is planned, are descriptions of animal use addressing the required criteria provided for each site?

1. Description of Procedures

Describe the animals and their proposed use. Address the following for all species to be used:

__ Species
__ Strains
__ Ages
__ Sex
__ Total number of animals by species to be used 
__ Concise, complete description of proposed procedures (i.e., sufficient information for evaluation)
__ Source, only if dogs or cats are proposed

2. Justifications

Provide justifications for:

__ Choice of species
__ Why research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro)

3. Minimization of Pain and Distress

Describe interventions to minimize discomfort, distress, pain, and injury. Examples of the kinds of items that may be appropriate to include are:

__ Circumstances relevant to the proposed work, when animals may experience discomfort, distress, pain, or injury. 
__ Procedures to alleviate discomfort, distress, pain, or injury.
__ Identify (by name or class) any tranquilizers, analgesics, anesthetics, and other treatments (e.g., antibiotics) and describe their use.
__ Provisions for palliative care or housing that may be necessary after experimental procedures.
__ Plans for post-surgical care, if survival surgeries are proposed.
__ Indicators for humane experimental endpoints.

Instructions

Typically, all of the required elements for the VAS can be addressed within 1-2 pages. The VAS must not be used to circumvent page limits. Applicants should be aware that NIH may release information contained in funded applications pursuant to a Freedom of Information Act request.

Note, for applications with due dates on or after May 25, 2016: (1) the method of euthanasia is eliminated from the VAS and is addressed in the FORMS-D Cover Page Supplement or PHS Fellowship Supplemental forms; (2) a description of veterinary care is no longer required; and (3) the justification for the number of animals has been eliminated from the VAS and should now be addressed in the Research Strategy as part of experimental design.

1.    Description of Procedures

Investigators must include a concise, complete description of the proposed procedures. While additional details may be included in the Research Strategy, a coherent, albeit brief, description of the proposed use of the animals must be provided in the VAS. The description must include sufficient detail to allow evaluation of the procedures.

Examples of the types of procedures that may be described include:

  • Blood collection
  • Surgical procedures
  • Administration of substances
  • Tumor induction
  • Post-irradiation procedures

In describing the animals, investigators must provide the following information:

  • Species
  • Strain
  • Ages
  • Sex
  • Total number of animals to be used by species
  • Source of the animals, if dogs or cats are proposed

2.    Justifications

Investigators must justify the use of animals in the proposed research. U.S. Government Principles require grantees to consider mathematical models, computer simulation, and in vitro biological systems. The justification should:

  • Indicate why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).
  • Provide rationale for the choice of species (e.g., advantages of the species chosen and why alternative species are not appropriate).
  • Discuss why less highly evolved or simpler animal models are not appropriate. For example, the use of non-human primates, dogs, or cats should be thoroughly justified.

3.    Minimization of Pain and Distress

Investigators should identify procedures or circumstances that may result in more than momentary discomfort, distress, pain, or injury and describe:

  • Interventions to alleviate discomfort, distress, or pain.
  • Name or class of pharmacological agents, if used.
  • Additional (e.g., non-pharmaceutical) means to avoid discomfort, distress, pain, or injury, including palliative care.
  • Manner, circumstances, and duration of all post-surgical provisions and care.
  • Special housing following surgery or manipulations, if necessary.
  • Procedures (e.g., pharmacological, surgical) that might lead to severe discomfort, distress, pain, or injury.
  • Indicators for humane endpoints and euthanasia (e.g., severe infection, respiratory distress, failure to eat, tumor size).

All of these issues are particularly important for survival surgeries. If multiple surgeries are proposed, these should be well justified and provisions to avoid any potential complications may be described.

Resources

References

This guidance 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 (PDF) and the U.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 (PDF). Additional background information and references are available on the OLAW website.