Animals in Research for Grants SOP

This standard operating procedure (SOP) includes the following sections: PurposeProcedureContacts, and Links.

Some links will work for NIAID staff only.


To require institutions applying for animal research awards to comply with NIH policies for the care of research animals.


To receive U.S. Public Health Service (PHS) awards, applicants working with research animals must abide by the PHS Policy on Humane Care and Use of Laboratory Animals and follow the American Veterinary Medical Association Guidelines for the Euthanasia of Animals.

They must also base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals. To clarify how to use this guide, the NIH Office of Laboratory Animal Welfare (OLAW) issued Position Statements, including an Adoption and Implementation Plan.

PHS policy is summarized in the brochure What Investigators Need to Know About the Use of Animals.

The PHS definition of research animal use includes production of custom antibodies and animals obtained for their tissues. Read more at Applicability of the PHS Policy.

Applicants must follow instructions in the notice of funding opportunity. Contract offerors must follow instructions in the solicitation.

An application involving research animals must address the three points listed in the Vertebrate Animals Section of the Research Plan. If it does not, the Center for Scientific Review or NIAID (depending on where it is reviewed) will designate it incomplete and code it accordingly. See Answer the Three Points in the Vertebrate Animals Section for more information.

For grants, certain animal research codes in IMPAC and on an application's summary statement indicate a bar to award that must be resolved before funding. For a list of codes, go to Research Animals Involvement Codes.

Principal investigators (PIs) may not conduct animal research without an approved assurance and Institutional Animal Care and Use Committee (IACUC) approval on file or when IACUC approval has expired or been suspended. If PIs conduct research without IACUC approval, NIH may reduce the amount of their awards or request return of funds, and PIs may not use any animal data obtained during this time for any activity related to the grant. 

See what happens During and After Award

Find more information on animal research requirements at Research Using Vertebrate Animals.


  • As you plan your application, see Research Using Vertebrate Animals. OLAW also offers a training module on how to Complete the Vertebrate Animals Section (VAS).
  • Get IACUC approval of your research protocols.
  • Make sure your institution and all performance sites have an approved animal welfare assurance on file with OLAW.
    • If your organization does not have an approved assurance, OLAW will negotiate one before NIAID issues an award. For more information, refer to Domestic Assurance
    • If you are contracting out animal work through a subaward or using the facilities of another institution, make sure that the other organization has an assurance and IACUC approval. See the Subawards (Consortium Agreements) for Grants SOP.
    • If the other organization has an assurance but your institution doesn't, get an interinstitutional assurance. For more information, refer to Interinstitutional Assurance.
  • If you did not submit animal documentation with your application, send it to NIAID when you receive a just-in-time request. See Respond to Pre-Award Requests (“Just-in-Time”).
    • Include your assurance number, certification of IACUC approval, and any consortium or contractual agreements. 
    • Include the title and number of your grant application to avoid a delay in making your award. 
  • For domestic institutions, submit a certification of IACUC approval every 3 years. See Research Using Vertebrate Animals
  • For foreign institutions: 
    • Do not submit certification of IACUC approval. For direct awards, none is needed. For subawards from U.S. institutions, the U.S. institution will provide this certification. 
    • Apply for a Foreign Assurance if either of the following conditions exist: 
      • Your institution has submitted a grant application and received notification from the funding component that the grant or contract will be awarded. 
      • Your institution is listed as a performance site on a grant and award of the grant or contract is imminent. 
    • Comply with the International Guiding Principles for Biomedical Research Involving Animals and the laws, regulations, and policies governing the care and use of laboratory animals of the country in which the research will be conducted. 
  • For a step-by-step explanation on how to apply for and maintain funding for research that uses animals, go to Research Using Vertebrate Animals.

Program Officers

  • For competing applications
  • For noncompeting applications
    • Review annual progress reports.
    • Use the Program Officer Checklist in eRA’s Program Management Module to indicate concerns or changes in animal care and use.
  • If a grant is transferring to a new grantee
    • Review and approve the new grantee's response to the three points in the Vertebrate Animals Section of the Research Plan.
    • Check that the new grantee has an assurance on file with OLAW and a certification of IACUC approval. If not, inform the institution that they must get these. 

Grants Management Specialists

  • Ensure that animal welfare assurances and IACUC certifications are in place before issuing competing and noncompeting awards. If documentation is not in place, contact OLAW and request that it negotiate the documentation with the applicant.
  • If animal welfare assurances or IACUC approvals are still pending at the end of the fiscal year, contact OLAW to change the code and allow a restricted award.
  • If a grant is transferring to a new grantee, confirm that the new grantee has submitted the three points in the Vertebrate Animals Section of the Research Plan. Also ensure that its animal welfare assurance and IACUC certification are in place.

Scientific Review Officers


Applicants and grantees should go to Contacting Program Officers and Grants Management Specialists to determine who to contact.

Offerors, see the contact listed in the solicitation or see the Office of Acquisitions Staff Listing.

Contacts for NIAID Staff

Grants Management Program—Contact for NIAID Staff 

Office of Acquisitions—Contact for NIAID Staff 

Scientific Review Program—Contact for NIAID Staff 

Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at


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