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Vertebrate Animals in Research Questions and Answers

Table of Contents

Where do I find information on writing an application using research animals?

See our How to Write an Application Involving Research Animals tutorial.

Where can I find the main PHS policy for using live vertebrate animals in research?

Go to the Public Health Service Policy on Humane Care and Use of Laboratory Animals for the main PHS policy for research involving vertebrate animals. This document is summarized in the brochure What Investigators Need to Know About the Use of Animals.

You can also consult Publications and Resources Available from OLAW for videos and brochures explaining policies and guidelines.

Remember that PHS expects assured institutions to follow the American Veterinary Medical Association Guidelines on Euthanasia, and all institutions must abide by the Animal Welfare Act and Regulations.

What are my alternatives to animal research?

See Consider Alternatives to Using Animals for advice and resources.

Are there limits on which animal species or sources I may use?

Yes. See our summary at Check for Limits on Your Planned Animal Species or Source. Watch the NIH Guide and NIAID's Funding Newsletter for news.

If I will use animal tissue from a company and not the animals, do I need to include a vertebrate animal section in the application and a protocol number?

Yes, you must include a vertebrate animal section and include your collaborator's protocol number. For general information about vertebrate animals, visit our Animals in Research portal.

Do the title and PI of an animal protocol have to match the title and PI name on the grant?

No. Neither the title nor the PI name on the animal protocol needs to match those of the grant.

For more on the standard information to include, see Write Your Protocol in our tutorial How to Write an Application Involving Research Animals. The most important aspect is that IACUC-approved activities and animal details match what you proposed in your application.

If we are preparing a multiproject application where one core is using animals to generate cell lines that will be used by the five projects, which sections on the face page should be Yes for Vertebrate Animals?

The overall program and each project using vertebrate animals need a Vertebrate Animals section, unless any project is using the cell lines only. On the face page, indicate Yes for vertebrate animals.

The administrative core does not need a Vertebrate Animals section. Basically, any part of the application that uses animals must have a Vertebrate Animals section, otherwise the application will receive a bar to award.

What does an IACUC do?

An institutional animal care and use committee ensures that work with animals in research is appropriate and humane. Read Working With Your IACUC for a list of IACUC activities.

Must an IACUC be from an institution accredited by AAALAC, or is an IACUC from a non-AAALAC-accredited institution acceptable?

An IACUC does not need to come from an institution accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).

According to the Public Health Service Policy on Humane Care and Use of Laboratory Animals, your program and facilities must be either accredited by the AAALAC or evaluated by the institution.

Keep in mind that you must have an OLAW assurance to conduct animal work under an NIH grant.

How soon should I start developing the animal research component of my application?

You should start early and consult experts as you plan your application. See Research Planning Is a Team Effort for more information.

What elements should I include in an animal protocol?

A standard animal protocol includes a project description, justification for the use of animals, a consideration of alternatives to animal use, animal procedures, staff qualifications, and endpoint criteria. See Write Your Protocol for descriptions.

Does the PI on a grant have to be listed as PI on an animal protocol?

The PIs can be different, and we will verify at the time of award that the approval covers the application being funded.

For fellowship and career awards, we often get the sponsor's IACUC approval, which covers what the fellow or K awardee is working on. This also is acceptable.

What assurances and certifications must be in place before I can use research animals?

You submit a certification of IACUC approval every three years, and your institution and performance sites must have an animal welfare assurance approved by the Office of Laboratory Animal Welfare, the NIH office that oversees institutional compliance with PHS guidelines.

For more information, read Requirements for Grantees Using Research Animals, and go to If You Have Animal Research Documentation in the Strategy for NIH Funding.

What does the Office of Laboratory Animal Welfare look for when issuing an assurance?

OLAW examines an institution's veterinary program, personnel qualifications, occupational health and safety program, animal facilities, and species inventory.

For more information, read What OLAW Looks For: Veterinary Care through What OLAW Looks For: Animal Facilities and Species Inventory in the How to Write an Application Involving Research Animals tutorial.

Can OLAW withdraw an animal welfare assurance?

Yes, though this is extremely rare. See Avoid Suspension of Animal Activities for more information.

When do I need to send IACUC approval?

If you didn't send this with your application, wait until you get a just-in-time request after your initial peer review. Read If You Have Animal Research Documentation in the Strategy for NIH Funding.

Does my subaward organization need an assurance and IACUC approval?

Yes, subaward organizations must adhere to the same animal welfare requirements that apply to your organization. If the subaward organization has an assurance but your institution doesn't, get an inter-institutional assurance. See Is Your Institution Assured by OLAW? for more information.

If my institution doesn't have an assurance, can I have animal work performed by a collaborating institution?

The collaborating institution may perform animal work as long as it has its own assurance. Read If You Have Animal Research Documentation in the Strategy for NIH Funding.

If I let IACUC approval lapse, will NIAID place a restriction on my research until I send a new certification of IACUC approval?

Yes. We will place a temporary restriction on your award until you submit a new certification of IACUC approval. See Avoid Suspension of Animal Activities for more information.

If my application does not follow NIH animal welfare regulations, will my overall impact score be affected?

Yes. Study section members consider how well an investigator responds to the five points in the Vertebrate Animals Section of the Research Plan. Failure to comply affects your overall impact score.

Read Answer the Five Points in the Vertebrate Animals Section in the How to Write an Application Involving Research Animals.

What do codes mean on my summary statement?

Research Animals Involvement Codes indicate the extent of research animal involvement and may signify missing information, insufficient procedures, peer review concerns, or the fact that all issues have been resolved and an award can be processed.

Read the Bars to Grant Awards—Research Animals SOP and Know What a Summary Statement Means in the Strategy for NIH Funding.

Can I get an award if I have a bar?

Check your Notice of Award to find out. A bar to award does not necessarily prevent you from receiving an award, but it does prevent you from spending funds on the parts of your project that are barred.

Go to Read Your Notice of Award, Know Your Terms in the Strategy for NIH Funding and the Bars to Grant Awards—Research Animals SOP.

Does work with nonhuman primates have special animal welfare requirements?

Yes. The Animal Welfare Act and Regulations states that researchers should provide nonhuman primates a physical environment that promotes their psychological well-being.

For more information, see OLAW's Nonhuman Primate Enrichment and Social Housing Resources and the National Research Council's Psychological Well-Being of Nonhuman Primates.

Where do I find NIH conferences on animal use?

Go to OLAW's IACUC 101 Series and Workshops and Conferences for schedules.

When filling out an electronic application, what should I do if I don't have an Animal Welfare Assurance number?

You can fill in the word "none" if you don't have an Animal Welfare Assurance number at the time of application.

Remember that before we can issue you an award, you need to submit a certification of IACUC approval of the research, and your institution must have an Animal Welfare Assurance approved by the Office of Laboratory Animal Welfare.

For more information, read Requirements for Grantees Using Research Animals, and go to If You Have Animal Research Documentation in the Strategy for NIH Funding.

You can also find instructions at NIH's What Investigators Need to Know About the Use of Animals.

What if my question wasn't answered here, or I'd like to suggest a question?

Email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base.​​​

Last Updated June 24, 2014

Last Reviewed September 08, 2011