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Questions and Answers Table of Contents

Where do I find information on writing an application using research animals?
Where can I find the main PHS policy for using live vertebrate animals in research?
What are my alternatives to animal research?
What does an IACUC do?
Must an IACUC be from an institution accredited by AAALAC, or is an IACUC from a non-AAALAC-accredited institution acceptable?
How soon should I start developing the animal research component of my application?
What elements should I include in an animal protocol?
Does the PI on a grant have to be listed as PI on an animal protocol?
What assurances and certifications must be in place before I can use research animals?
What does the Office of Laboratory Animal Welfare look for when issuing an assurance?
Can OLAW withdraw an animal welfare assurance?
When do I need to send IACUC approval?
Does my subaward organization need an assurance and IACUC approval?
If my institution doesn't have an assurance, can I have animal work performed by a collaborating institution?
If I let IACUC approval lapse, will NIAID place a restriction on my research until it is recertified?
If my application does not follow NIH Animal Welfare regulations, will my priority score be affected?
What do codes mean on my summary statement?
Can I get an award if I have a bar?
Does work with nonhuman primates have special animal welfare requirements?
Where do I find NIH conferences on animal use?
What if my question wasn't answered here, or I'd like to suggest a question?

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

See How to Write an Application Involving Research Animals tutorial and Will Your Research Have Special Requirements? in the NIH Grant Cycle: Application to Renewal.

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.

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 on the matter.

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 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 a description of these protocol elements.

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

If the IACUC approval document submitted to the grants management specialist does not reflect the PI's name, we will request written confirmation that the IACUC approval is for the application to be funded. (This also applies to IRB approvals.) So the PIs can be different, and we will verify at the time of award that the approval covers the application being funded.

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

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

To receive an award, you need IACUC certification, and your institution 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 NIH Grant Cycle: Application to Renewal.

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, see the What OLAW Looks For: Veterinary Care through What OLAW Looks For: Animal Facilities and Species Inventory sections 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 NIH Grant Cycle: Application to Renewal.

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 NIH Grant Cycle: Application to Renewal.

If I let IACUC approval lapse, will NIAID place a restriction on my research until it is recertified?

Yes. We will place a temporary restriction on your award until you send us documentation that your research has been recertified. See Avoid Suspension of Animal Activities for more information.

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

Yes. Study section group 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 priority 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 also signify missing information, insufficient procedures, peer review concerns, or the fact that all issues have been resolved and an award can be processed. Read Know What a Summary Statement Means in the NIH Grant Cycle: Application to Renewal.

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 NIH Grant Cycle: Application to Renewal. Also read 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 Enrichment for Nonhuman Primates and the National Research Council's Psychological Well-Being of Nonhuman Primates.

Where do I find NIH conferences on animal use?

Go to IACUC 101 Series and Workshops and Conferences for a schedule of OLAW's upcoming workshops and conferences.

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.

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