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 that the following criteria are addressed in all applications:

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.

4. Euthanasia

State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification. Note, for applications with due dates on or after May 25, 2016, the method of euthanasia is eliminated from the VAS and is addressed in the FORMS-D Cover Page Supplement or PHS Fellowship Supplemental forms.  

Applicant Responsibilities

Each of the first three criteria must be addressed, and the fourth if applicable. 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 OLAW-approved 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.

4. Euthanasia

State if the method of euthanasia is consistent with AVMA guidelines. If the method does not follow the AVMA guidelines:

__ Describe the method of euthanasia
__ Provide a scientific justification

Note, for applications with due dates on or after May 25, 2016, the method of euthanasia is eliminated from the VAS and is addressed in the FORMS-D Cover Page Supplement or PHS Fellowship Supplemental forms.

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.

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.

4.    Euthanasia

Investigators should state whether euthanasia will be performed and indicate if the method of euthanasia is consistent with AVMA guidelines. If consistent, no further information is needed. If it isn’t consistent, they must describe the method of euthanasia and provide scientific justification. Note, for applications with due dates on or after May 25, 2016, the method of euthanasia is eliminated from the VAS and is addressed in the FORMS-D Cover Page Supplement or PHS Fellowship Supplemental forms.

Coding of Applications

At the time of receipt, applications or proposals are assigned either:

  • Code 10: NO VERTEBRATE ANIMALS – If animal tissue used in the study is obtained from other sources (e.g., tissue repository, animals euthanized for an unrelated purpose), the application is coded as no vertebrate animals used. The source of the tissue should be described in the application to validate the coding as no vertebrate animals used.
  • Code 20: VERTEBRATE ANIMALS – If animals are obtained or euthanized for tissue harvest, the proposed research is coded as use of live vertebrate animals. The generation of custom antibodies must be coded as use of live vertebrate animals.

Following peer review, coding is based on review of the VAS and applications or proposals are assigned one of the following:

  • Code 10: NO VERTEBRATE ANIMALS
  • Code 30: NO CONCERNS/ACCEPTABLE – If there are no Scientific Review Group (SRG) or Technical Evaluation Panel (TEP) concerns 
  • Code 44: CONCERNS/UNACCEPTABLE – If the SRG or TEP has animal welfare concerns, these may be resolved prior to award and recoded through OLAW action.

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.