See the Glossary for more terms.
Explains procedures for writing an application and then applying for and maintaining an NIH grant application for research that uses animals. You can also visit our other All About Grants Tutorials.
If you are a principal investigator planning to use live vertebrate animals for research, research training, or biological testing, you must adhere to requirements in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (referred to as PHS policy in this tutorial) and the Animal Welfare Act and Regulations.
The PHS policy is summarized in the brochure What Investigators Need to Know About the Use of Animals.
PHS's definition of research animal use includes production of custom antibodies and animals obtained for their tissues. Read more at Applicability of the PHS Policy.
Read about NIH animal research, policies, and crisis management at OER Animals in Research.
Peer reviewers will evaluate your application based on your compliance, so it's important to know what's expected of you and your institution.
When you apply for NIAID funding, you need to answer all five points in the Vertebrate Animals Section (VAS) of your grant application package (for electronic applications) or your PHS 398 (for paper applications). Most grant types, including research grants such as the R01 and Exploratory/Developmental Grant (R21) use electronic application. Find guidance on completing the VAS in the Worksheet for Review of the Vertebrate Animal Section (PDF).
Go to our Strategy for NIH Funding for beginning-to-end, step-by-step information about applying for the most common grant types.
If your application receives a fundable overall impact/priority score, have your animal use protocol reviewed and approved by an institutional animal care and use committee (IACUC), which evaluates your institution's animal research program.
To receive an award, you must have IACUC approval, and your institution must have an Animal Welfare Assurance approved by the NIH Office of Laboratory Animal Welfare (OLAW).
If you have domestic subaward agreements, those organizations also need IACUC approval and an assurance. Read more in the Subawards (Consortium Agreements) for Grants SOP.
For foreign awards and subawards, learn more at IACUC Requirements Vary for Domestic and Foreign Institutions.
To find out if your institution is assured, see OLAW's Domestic Institutions with a PHS Approved Animal Welfare Assurance or Foreign Institutions with a PHS Approved Animal Welfare Assurance. Domestic assurances are valid up to four years, then they must be renewed. Foreign assurances last up to five years and may be renewed only for current or pending awards involving vertebrate animals. Learn more at Is Your Institution Assured by OLAW?
It's also a good idea to find out if your institution has animal facilities accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International.
Planning and teamwork are key to preparing a successful application. An animal research application requires a lot of work, so start early, leave time for unanticipated issues, and involve experts in your project from the beginning.
Ask senior IACUC members to validate your ideas and methods. Consult with the attending veterinarian about available facilities, equipment, personnel, and products.
For example, the veterinarian may know of a new analgesic that introduces fewer variables into the research. The institutional business official who signs your grant application should also be comfortable with your proposal.
These early consultations protect you and your institution. Since NIH allows just-in-time IACUC approval of animal use protocols, a PI can move a research project all the way through NIH initial peer review before an IACUC has a chance to see it.
If your IACUC has last-minute problems with your protocol, e.g., you have no biosafety level 4 facilities to inject mice with Ebola virus, you might not receive funding you otherwise could have received.
See NIAID's Strategy for NIH Funding for more tips and advice on organizing and conveying your ideas.
When planning your research, consider whether you can achieve your scientific objectives while reducing the number of animals, refining the use of animals by minimizing their pain or distress, using a lower order species, or designing your experiments to avoid using animals at all.
USDA regulations require that investigators search the scientific literature for alternatives. Conduct this search while you plan your experiments. Include the search results in the animal study protocol for your IACUC's approval.
Considering alternatives during the planning stage gives you enough time to incorporate methods that benefit the animals and the science. It also shows peer reviewers that you are thorough and reduces your chances of a bar to award because of animal welfare concerns.
As you plan, remember that NIH or HHS policies may affect your choice of species or source of animals. Review existing policy through the OLAW Web site, and for new policies, watch the NIH Guide and NIAID's Funding Newsletter.
Here's a summary of the latest policies on chimpanzees, dogs, and cats.
You may propose research using chimpanzees or biomaterials from chimpanzees. However, your research may require additional approval steps, so you should expect to wait at least a year for an award.
After you send your proposal, NIH will check whether you must also complete a Chimpanzee Research Use Form. If so, NIH will send you the form along with an official due date. Once you return the form, NIH compares your responses to a list of exceptions to determine whether your research plans must also be approved by a Chimpanzee Research Use Panel (CRUP).
Learn more about the panel's role and when they review the Chimpanzee Research Use Forms at NIH's Chimpanzees Research Use Panel.
Your ongoing NIH-supported research may use dogs from any legal source until October 1, 2014.
After that date, you may not use or procure dogs from Class B (“random source”) dealers using NIH funds. Instead, use only approved legal sources such as the following:
For details, see the December 17, 2013, Guide notice.
Awardees must not use NIH funds to get cats from Class B dealers. See the February 8, 2012, Guide notice.
Before NIAID can award your grant, your institution and all performance sites involved in animal work must have an Animal Welfare Assurance on file with OLAW and provide certification of IACUC approval.
Learn about IACUC requirements for foreign and domestic awards and subawards at IACUC Requirements Vary for Domestic and Foreign Institutions.
Institutions that collaborate with grantees through a subaward are required to have an assurance, whether domestic or foreign.
If your institution has never had an assurance, don't worry about it when you apply. NIAID grants management or program staff will contact OLAW to negotiate an assurance with your institution if you're likely to be funded based on peer review results, e.g., your percentile or overall impact/priority score is within NIAID's payline.
For that process, OLAW will send your institution an electronic packet that includes a sample assurance and PHS policy information. IACUC members and other experts at your institution should collaborate to draft the assurance, inserting your institution's animal policies and procedures where appropriate. Follow the format shown at OLAW's sample Animal Welfare Assurance for Domestic Institutions, Interinstitutional Assurance, or Animal Welfare Assurance for Foreign Institutions.
OLAW will review your institution's domestic assurance for compliance with federal policies. If acceptable, OLAW signs it and your institution is assured. If not, OLAW will prompt your institution for more information until the responses describe your animal care and use program in compliance with the PHS Policy and the Guide for the Care and Use of Laboratory Animals. Your application is barred from an award until an approved assurance is in place.
When reviewing your institution's animal welfare assurance, OLAW will evaluate several items, including veterinary care, personnel qualifications and training, occupational health and safety, IACUC procedures, and animal facilities and husbandry.
When reviewing your institution's domestic assurance, OLAW will evaluate several items, including applicability, lines of authority, veterinary care, IACUC procedures, personnel qualifications and training, occupational health and safety, and animal facilities and husbandry.
All veterinary programs should provide for the following:
The veterinarian must have program authority and responsibility for the institution’s animal care and use program, including access to all animals. He or she must also have the authority to implement the veterinary care program and oversee the adequacy of other aspects of animal care and use, e.g., animal husbandry, nutrition, sanitation practices, and hazard containment.
The size of the veterinary staff depends on the institution and the size and nature of its animal program. Consultant or part-time veterinary services may be appropriate for small programs with limited numbers of animals.
Do not include the veterinarian's resume as an assurance attachment. Instead, describe the veterinarian's qualifications in the assurance documentation. Follow the format shown at OLAW's sampleAnimal Welfare Assurance for Domestic Institutions.
Your institution must ensure that staff working with animals are qualified and train investigators, animal technicians, and other personnel involved in animal care, treatment, or use on research or testing methods that minimize the number of animals used as well as animal pain and distress.
For more information, read Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs, developed by the Institute for Laboratory Animal Research.
OLAW makes sure your institution has an occupational health and safety program for all personnel who work with animals. The program will depend on the facility, research activities, hazards, and animal species involved. Minimally, the program should include the following:
For guidelines on establishing and maintaining an effective safety program, check out Occupational Health and Safety in the Care and Use of Research Animals, published by the National Research Council.
Institutions provide a facility and species inventory as part of their domestic assurance. Follow the format shown at OLAW's sample Animal Welfare Assurance for Domestic Institutions.
OLAW uses this information to assess the nature and size of the animal care and use program and evaluate the adequacy of other program components, e.g., veterinary care and occupational health and safety.
Your IACUC is an oversight body appointed by an official at your institution, such as the chief executive officer. OLAW relies on the IACUC to enforce PHS policy and your institution's animal policies.
As outlined in PHS Policy IV.B 1 through 8, IACUCs do the following:
Find out your institution's policies before you plan your research. In most institutions, policies for research animals are a combination of institutional and USDA and PHS requirements. Some are more stringent than others, so a procedure you performed at another institution may not be acceptable at your current workplace.
Identify your situation below for a summary of IACUC requirements.
Your IACUC will have at least five members, including people with the following backgrounds.
Other IACUC members are usually faculty members and fellow researchers who are familiar with the issues you are facing and can serve as resources to help you prepare the best possible application.
Coordinate writing your application and protocol. Be sure to write and submit your protocol early enough for the IACUC review. It is extremely important that the information in the protocol you submit to the IACUC is consistent with the information in your grant application.
Most IACUCs require investigators to submit information about proposed animal use on an institutional protocol review form. Before writing your protocol, consult with the attending veterinarian on the latest technologies and procedures that could improve your approach. Also send the veterinarian a draft of your protocol to resolve any issues before it goes to the IACUC. A standard animal protocol includes the following information.
Your rationale for using a species may be size or availability; the existence of previous work or laboratory data that validates the use of a certain animal model; or the availability of reagents.
Also see Working with the IACUC: Writing an Animal Protocol, a booklet published by the American Association for Laboratory Animal Science, for help preparing your animal protocol as well as interacting with an IACUC.
If you're using live vertebrate animals (including production of custom antibodies and animals obtained for their tissues), you'll need to answer "Yes" to the question "Vertebrate animals, yes or no" in Item 5 on the face page of the PHS 398 (for paper applications) or in Item 2 of the Other Project Information component in your grant application package (for electronic applications).
Remember that your application covers all performance sites, including subaward partners, collaborators, and others involved in the research. Even if the animal work will be done somewhere other than your institution, mark "yes."
For electronic applications, follow the instructions for Vertebrate Animals in the SF 424 Application Guide. For paper applications, follow the instructions for Vertebrate Animals in the PHS 398.
Go to Show Resources, Institutional Support in the Strategy for NIH Funding for a brief description of what you need to put in the application.
To see if your institution or performance site is assured, refer to OLAW's Domestic Institutions with a PHS Approved Animal Welfare Assurance or Foreign Institutions with a PHS Approved Animal Welfare Assurance.
Peer reviewers can adjust your overall impact/priority score based on your responses to the five points below. An incomplete or missing response could exclude your application from review or lead to a bar to award.
Address these five points in the Vertebrate Animal Section (VAS) of the Research Plan:
NIH's Worksheet for Review of the Vertebrate Animal Section (PDF) describes requirements and provides an example of a complete VAS.
Since there is no page limit for this section, use as much space as you need to convince reviewers that you'll do everything right. Don't assume reviewers will automatically know what you're talking about. Help them understand why your approach will yield the best results and how you will limit animal pain and distress to that which is scientifically necessary.
See Strategy to Write the Research Plan and Strategy to Prepare the Forms and Just-In-Time in the Strategy for NIH Funding for more advice on drafting your application.
When assessing the scientific merit of an application, all NIH initial peer review committees use the same review criteria. For information on NIH review criteria, read How NIH Review Criteria Affect Your Score in the Strategy for NIH Funding.
Peer reviewers also evaluate your project's compliance with federal requirements for animal research, rating your application based on your responses to the five points in the Vertebrate Animals Section. Any problems may negatively affect your overall impact/priority score.
SROs will code your summary statement to reflect your use of research animals. Such codes can also indicate assurance status, need for IACUC review, missing information, reviewer concerns, or the fact that there are no problems and NIAID can issue your award. See Research Animals Involvement Codes for a complete list.
Codes that result in a bar to award must be resolved before NIAID can release your award. If your summary statement lists such a code, contact the program officer listed on your summary statement right away.
After you've cleared initial peer review, we'll send you a request for just-in-time information if your application is in the fundable range.
For animal research, you will need to send in your certification of IACUC approval and resolve any reviewer concerns before NIAID can issue your award. See If You Have Animal Research Documentation and Prepare Your Just-In-Time Information in the Strategy for NIH Funding.
During the life of your grant, there are several reporting requirements NIAID requires. For example, you'll need to get your certification of IACUC approval at least every three years.
For general reporting requirements, start reading at Your Reporting Requirements in the Strategy for NIH Funding.
By signing your application, your institutional official promises the federal government that your institution will comply with all terms and conditions of award, including those covering animal care and use. Monitor your work closely. As PI, you are accountable for all activities involving animals during the project.
Your approved animal use protocol is a contract between you and your IACUC, stipulating that your project will follow all institutional polices and procedures. You must obtain IACUC approval before you make any significant changes to the research, including the following.
The definition of a "significant change" varies from institution to institution, so consult your IACUC for guidance. In a recent policy shift, NIH allows IACUCs to classify personnel changes other than PI as minor, provided the IACUC ensures that staff are trained and qualified.
If you're planning to make a significant change to your project, also contact your program officer right away. The NIH Grants Policy Statement requires grantees to obtain prior approval from NIH for changes in scope. For a list, see Some Actions Require Our Approval in the Strategy for NIH Funding.
You will also need to get a new IACUC approval every three years; some IACUCs may require it sooner. Institutional officials and IACUCs do not have authority to extend an IACUC approval beyond its expiration date. Conducting research in the absence of a valid IACUC approval constitutes noncompliance with PHS policy and it is reportable to OLAW.
As part of its semiannual program review and facility inspection, your IACUC will conduct routine assessments of institutional animal activities.
This review covers institutional policies and responsibilities, IACUC membership and functions, and IACUC record keeping and reporting procedures. It also looks at the adequacy and appropriateness of animal environment, housing, and management; veterinary care; staff training; emergency preparedness; and occupational health and safety programs.
A facility review is a physical inspection of buildings, areas, and vehicles (including satellite facilities housing animals for more than 24 hours) used for confinement, transport, maintenance, breeding, or experiments, including surgery.
Your lab may be inspected as part of a facility review, or your IACUC may randomly visit to verify that you are following your protocol.
IACUCs report the results of their program evaluation and facility inspection to the institutional official for animal welfare. These reports describe any deficiencies found and include plans and schedules for correcting each one.
Institutional officials submit semiannual IACUC reports to OLAW only if requested or if the institution is submitting a new or renewal assurance and is not accredited by the Association for Assessment and Accreditation of Laboratory Animal Care.
Your IACUC can suspend your project if it finds serious or continuing noncompliance with PHS policy or your institution's assurance or deviations from the approved protocol or the Guide for the Care and Use of Laboratory Animals.
If you have a subaward agreement, noncompliance at the subaward organization can also provoke a suspension. See the Subawards (Consortium Agreements) for Grants SOP for more information.
Your IACUC will convey its reasons for a suspension to the institutional official for animal welfare, who will take corrective measures and report the situation to OLAW.
OLAW can withdraw approval of your institution's assurance though this is extremely rare. Should this happen, your institution would become ineligible for spending NIH funds on research activities involving animals, and NIAID may seek to recover its monies. NIH may allow expenditures for the maintenance and care of animals.
OLAW can also place restrictions on an institution's assurance until compliance problems are fully resolved. OLAW always emphasizes corrective rather than punitive actions and will only restrict or withdraw approval of an assurance if an institution's efforts to correct its problems are unsuccessful.
At least once every 12 months your institution is required to submit a report from your IACUC to OLAW, signed by the institutional official for animal welfare and IACUC chairperson. The report includes the following.
Annual reports are due by January 31 for the previous calendar year. Your institution sends the report as a PDF email attachment to email@example.com. If you have questions or need assistance, call OLAW at 301-496-7163.
In addition to the annual report, your institutional official for animal welfare must notify OLAW promptly of any of the following:
Send preliminary and final reports of noncompliance, deviations, and IACUC suspensions to firstname.lastname@example.org.
Learn more about the reporting process and see a sample final report at OLAW's Reporting Noncompliance.
You must keep your project records accessible for three years after the grant ends. If an issue arises, NIAID must be able to verify the records, which must include all data and fiscal information.
Under PHS policy your institution is required to maintain the following records for a minimum of three years:
Through the Freedom of Information Act, the public can access information about your grant. If someone formally requests non-proprietary information about your application, our FOIA office will provide it.
We hope these pages have helped you. If you're looking for more in-depth information, please refer to the Animals in Research portal. If you have questions that weren't answered here, please contact OLAW or Communicating With NIAID—How to Get Help.
This site is part of NIAID's outreach to its extramural research community. Let us know how you liked the site and what other information or resources you'd like to see online—email email@example.com.
Last Updated February 10, 2014
Last Reviewed December 26, 2013