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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 funding opportunity announcement. 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, 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.
Find more information on animal research requirements at Research Using Vertebrate Animals.
- As you plan your application, see Research Using Vertebrate Animals.
- Get institutional animal care and use committee (IACUC) approval of your research protocols.
- Make sure your institution and all performance sites have an approved animal welfare assurance on file with the Office of Laboratory Animal Welfare (OLAW).
- 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 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. See the Subawards (Consortium Agreements) for Grants SOP..
- 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.
- You may not conduct animal research without an approved assurance and IACUC approval on file, or when your IACUC approval has expired or been suspended. If you conduct research without IACUC approval, NIH may reduce the amount of your award or request return of funds, and you may not use any animal data obtained during this time for any activity related to the grant.
- For domestic awards, submit a certification of IACUC approval every three years. See Research Using Vertebrate Animals.
- Every year, your IACUC submits a report to OLAW through your business office that describes any changes in your program of animal use and care. For information on the content of this annual report, see Research Using Vertebrate Animals and 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.
- Get IACUC approval for significant changes to animal activities. For details, go to the Significant Changes section of the OLAW Topic Index—Protocol Review.
- Get NIAID approval before doing anything that would constitute a change in scope. Go to Changes to Project or Budget.
- For more about reporting requirements, read Reporting Requirements During Your Grant.
- Foreign organizations do not need to submit certification of IACUC approval if they receive a direct award. If they receive a subaward from a domestic institution, the domestic institution must provide a certification of IACUC approval for all domestic and foreign activities.
- Foreign institutions do need to negotiate an assurance with OLAW. Foreign assurances are approved for up to five years and may be renewed only for current or pending awards involving vertebrate animals.
- Foreign institutions must 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.
- For competing applications
- Work with applicant to lift any bars to award or restrictions to contract awards.
- Forward documentation to OLAW so that it may lift the bar.
- See Bars to Grant Awards—Research Animals SOP.
- 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.
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 the OLAW Contact for NIAID Staff 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
- Ensure that peer reviewers for applications evaluate a project's compliance with federal requirements for animal research, coding applications based on responses to the three points in the Vertebrate Animals Section of the Research Plan. See Answer the Three Points in the Vertebrate Animals Section on Research Using Vertebrate Animalsfor more information.
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.
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