See the Glossary for more terms.
Table of Contents
See our How to Write an Application Involving Research Animals tutorial.
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 for the Euthanasia of Animals, and all institutions must abide by the Animal Welfare Act and Regulations.
See Consider Alternatives to Using Animals for advice and resources.
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.
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.
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.
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.
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.
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.
You should start early and consult experts as you plan your application. See Research Planning Is a Team Effort for more information.
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.
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.
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.
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.
Yes, though this is extremely rare. See Avoid Suspension of Animal Activities for more information.
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.
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.
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.
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.
Yes. Study section members consider how well an investigator responds to the four points in the Vertebrate Animals Section* of the Research Plan. Failure to comply affects your overall impact score.
Read Answer the Four Points in the Vertebrate Animals Section in the How to Write an Application Involving Research Animals.
*NIH is updating the Vertebrate Animals Section requirements. All applications due on or after January 25, 2016, except those for fellowship (F) and training (T) grants, should follow the new policies. Applications for F and T grants due on or after May 25, 2016, should also follow the new policies. Under the changes, you are no longer required to:
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.
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.
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.
Go to OLAW's IACUC 101 Series and Workshops and Conferences for schedules.
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.
You can also find instructions at NIH's What Investigators Need to Know About the Use of Animals.
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Last Updated June 24, 2014
Last Reviewed November 21, 2014