Animals in Research for Grants

Purpose

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

Procedure

To receive PHS awards, applicants working with research animals must base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals, abide by the PHS Policy on Humane Care and Use of Laboratory Animals, and follow the American Veterinary Medical Association Guidelines on Euthanasia. PHS policy is summarized in the brochure What Investigators Need to Know About the Use of Animals.

Applicants must follow instructions in either the Grant Application Guide (for electronic application) or the PHS 398 (for paper application). Contract offerors must follow instructions in an RFP.

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

For grants, certain animals in 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.

Find more information on animal research requirements at Animals in Research.

Applicants and Awardees

• Get institutional animal care and use committee (IACUC) approval of your research protocols.
• Make sure your institution and all performance sites have an approved assurance on file with the Office of Laboratory Animal Welfare (OLAW). Read If You Have Animal Research Documentation in the NIH Grant Cycle: Application to Renewal.
  • If your organization does not have an approved assurance, OLAW will negotiate one before NIAID issues an award.
  • 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 animal welfare assurance and IACUC approval. If the other organization has an assurance but your institution doesn't, get an inter-institutional assurance. See the Subaward SOP.
  • Read Is Your Institution Assured by OLAW?, and go to Consider Special Requirements in the NIH Grant Cycle: Application to Renewal for more information.
• If you did not submit animal subjects documentation with your application, send it to NIAID when you receive a just-in-time request. See Prepare Your Just-in-Time Information in the NIH Grant Cycle: Application to Renewal.
  • Include your animal welfare 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.
• If you are conducting animal research without an approved assurance and IACUC approval on file, NIH will reduce the amount of your award, and you may not use any animal data obtained during this time for any activity related to the grant.
• For domestic awards, get your certification of IACUC approval re-approved every three years. See IACUCs Monitor Your Progress and You'll Have Semiannual Reviews and Inspections for more information.
• Every year, submit a report to OLAW that describes any changes in your program of animal use and care. For information on the content of this annual report, see What is the annual report to OLAW and when is it due? on OLAW's PHS Policy on Humane Care and Use of Laboratory Animals Frequently Asked Questions.
  • You must get approval before doing anything that would constitute a change in scope. Go to What Constitutes a Change in Scope? in the NIH Grant Cycle: Application to Renewal.
  • For more about reporting requirements, read Your Reporting Requirements in the NIH Grant Cycle: Application to Renewal.
• Foreign organizations do not need to submit certification of IACUC approval, but they do need to negotiate an animal assurance with OLAW. Also, they must comply with the animal research regulations of their own countries.
• For a step-by-step explanation on how to apply for and maintain funding for research that uses animals, go to our How to Write an Application Involving Research Animals tutorial.

Program Officers

• For competing applications, work with applicant to lift any bars to award or restrictions to contract awards. Then forward documentation to OLAW so that it may lift the bar. See Bars to Grant Awards -- Research Animals SOP and Contracts Involving Live Vertebrate Animals SOP.
• For noncompeting applications, review annual progress reports and use the program officer checklist in the IMPAC Program 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 five points in the Vertebrate Animals Section of the Research Plan. Also check that the new grantee has an animal assurance on file with OLAW and an approved IACUC certification.

Grants Management Specialists

• Ensure that animal 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 assurances or IACUC approvals are still pending at the end of the fiscal year, issue a restricted award.
• If a grant is transferring to a new grantee, confirm that the new grantee has submitted the five points in the Vertebrate Animals Section of the Research Plan. Also ensure that its animal assurance and IACUC certification are in place.

Scientific Review Officers

• Ensure that peer reviewers for applications evaluate a project's compliance with federal requirements for animal research, coding applications based on responses to the five points in the Vertebrate Animals Section of the Research Plan. See Answer the Five Points in the Vertebrate Animals Section for more information.

Contacts

Applicants and grantees should go to Contact Staff for Help in the NIH Grant Cycle: Application to Renewal to determine who to contact.

Offerors should ask the primary contact listed in the RFP. See the Extramural R&D Solicitations list, or, see the Office of Acquisitions staff listing.

Contact for NIAID Staff

Contact for NIAID Staff

Contact for NIAID Staff

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Vertebrate Animals in Research questions and answers

OLAW: Office of Laboratory Animal Welfare

Grant Application, Electronic SOP

Grant Application, Paper SOP

IMPAC and RePORTER SOP

OLAW site on NIH intranet

IACUC 101 Series