How to Write an Application Involving Research Animals
Explains procedures for writing an application and then applying for and maintaining an NIH
(“the Agency”) grant application for research that uses animals. You can also visit our other All
About Grants Tutorials.
Table of Contents
• Requirements for Grantees Using Research Animals
• Research Planning Is a Team Effort
• Consider Alternatives to Using Animals
• Check for Limits on Your Planned Animal Species or Source
• Is Your Institution Assured by OLAW?
• How to Get an Assurance
• What OLAW Looks For
o Veterinary Care
o Personnel Qualifications and Training
o Occupational Health and Safety
o Animal Facilities and Species Inventory
• Working With Your IACUC
• How Your IACUC Is Structured
• Write Your Protocol
• Write the Application: Indicate Use of Animals
• Answer the Five Points in the Vertebrate Animals Section
• How the Agency Reviews Applications Using Research Animals
• Understand Codes on Your Summary Statement
• The Agency Will Send a Just-in-Time Request
• Reporting Requirements During Your Award
• IACUCs Monitor Your Progress
• You'll Have Semiannual Reviews and Inspections
• Avoid Suspension of Animal Activities
• Know Your IACUC's Reporting Requirements
• Keep Your Records Accessible
• In Conclusion
Other Resources
• See our other All About Grants tutorials
Requirements for Grantees Using Research Animals
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 funding, you need to answer all five points in the Vertebrate Animals
Section (VAS) of your grant application package. 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 .
• AAALAC is a private, nonprofit organization; participation in its accreditation program
sends the message that your institution is committed to high-quality animal care and
use.
• OLAW accepts AAALAC accreditation in lieu of some required documentation. Non-
accredited institutions are required to provide a copy of their most recent semi-annual
report of program review and facility inspection with their assurance.
Resources
• Animals in Research portal
o Animals in Research SOPs
• The Agency's Application portal
o Grant Application, Electronic SOP
Research Planning Is a Team Effort
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 institutional animal care and use committee (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 submits 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 for Ebola research, you might not receive funding you otherwise could have received.
See the Agency's Strategy for NIH Funding for more tips and advice on organizing and conveying
your ideas.
Resources
• Animals in Research portal
• Sample Applications and Summary Statements
Consider Alternatives to Using Animals
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.
Limit Animal Use and Discomfort
• Limit animal involvement by using the minimum number required to obtain valid
results.
• Use non-animal methods, such as mathematical models, computer simulation, or in
vitro biological systems.
• Avoid or minimize animal discomfort, distress, and pain as is consistent with sound
scientific practices.
• Use appropriate sedation, analgesia, or anesthesia when your procedures will cause
more than momentary pain or distress. Do not perform surgical or other painful
procedures on non-anesthetized animals.
• If animals are necessary, select the lowest phylogenetic species appropriate for the
experiment.
Resources
• Animals in Research portal
• National Library of Medicine
o Bibliography: Alternatives to the Use of Live Vertebrates in Biomedical Research
and Testing
o Index Medicus
o Medline Plus
o PubMed
• OLAW Useful Links—Alternatives to Animal Testing
Check for Limits on Your Planned Animal Species or Source
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 Funding News.
Here's a summary of the latest policies on chimpanzees, dogs, and cats:
Chimpanzees
See the November 18, 2015 NIH Director Statement, "NIH Will No Longer Support
Biomedical Research on Chimpanzees." For background and information on the
Chimpanzee Research Use Panel, see NIH's Use of Chimpanzees in NIH-Supported
Research.
Dogs
Your ongoing NIH-supported research 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:
• USDA Class A dealers
• Privately-owned colonies (e.g., colonies established by donations from breeders or
owners)
• Client-owned animals (e.g., animals participating in veterinary clinical trials)
For details, see the December 17, 2013, Guide notice.
Cats
Awardees must not use NIH funds to get cats from Class B dealers. See the February 8,
2012,Guide notice.
Resources
• NIH's Model Organisms for Biomedical Research
• National Research Council's Scientific and Humane Issues in the Use of Random Source
Dogs and Cats in Research (2009)
Is Your Institution Assured by OLAW
Before the Agency 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.
There are three types of Animal Welfare Assurances: domestic, interinstitutional, and foreign.
• Domestic assurances are for U.S. institutions that control their own facilities, conduct
animal research, and have a complete animal care and use program in place, including a
veterinarian and IACUC.
o Domestic assurances typically remain in effect for up to four years and can be
renewed.
• Interinstitutional assurances are for organizations that do not have their own animal
facilities and will conduct animal activity at an assured institution, named as a
performance site on the grant or contract.
o The organizations agree to conduct the project according to the assurance of the
covered organization.
o Timeframes for these assurances are project specific and approved for the life of
the project, up to five years. For example, a small business subcontracting animal
work to a performance site must apply for a new interinstitutional assurance
each time it successfully competes for a grant.
• Foreign assurances are for foreign institutions that are grantees or subaward partners
to a domestic grantee.
A foreign entity must state that it will comply with the International Guiding Principles for
Biomedical Research Involving Animals and the applicable laws, regulations, and policies of the
country in which the research will be conducted. For example, a German institution or
performance site should adhere to German laws governing the care and use of laboratory
animals.
o Foreign assurances are approved for up to five years.
Foreign assurances may be renewed if there is a current or pending
award that involves vertebrate animals.
Even without an assurance, an institution may apply for funding or be
named as a performance site.
If we plan to fund a new award, we will ask OLAW to negotiate a new
assurance with your institution. For a direct award, foreign institutions do
not need to submit certification of IACUC approval.
o For an indirect or subaward from a domestic institution, the domestic institution
must provide the verification of IACUC approval for all activities conducted at the
foreign institution (i.e., certification that the activities conducted at the foreign
performance site are acceptable to the grantee.)
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 the institution doesn't have an assurance, OLAW will negotiate one with the grantee.
• The grantee may amend its assurance to include a collaborating institution; in this case,
the grantee takes full responsibility for the animal care and use program of the
collaborating institution.
• Read more in the Subawards (Consortium Agreements) for Grants SOP.
Resources
• Animals in Research portal
• Animals in Research SOPs
• OLAW—Obtaining an Assurance
• OLAW Topic Index—Animal Welfare Assurances
How to Get an Assurance
If your institution has never had an assurance, don't worry about it when you apply. The Agency
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 the Agency'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 approves 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.
Resources
• Animals in Research portal
• OLAW—Obtaining an Assurance
• OLAW Topic Index—Animal Welfare Assurances
What OLAW Looks For
Veterinary Care
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:
• Access to animals and periodic assessment of their well-being.
• Appropriate facilities, personnel, equipment, and services.
• Treatment of diseases and injuries and the availability of emergency, weekend, and
holiday care.
• Guidelines for animal procurement and transportation.
• Preventive medicine.
• Pre-surgical planning, training, monitoring, and post-surgical care.
• Pain relief, including analgesics, anesthetics, and tranquilizers.
• Euthanasia. Follow the American Veterinary Medical Association Guidelines for the
Euthanasia of Animals .
• Drug storage and control.
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 sample Animal Welfare Assurance for Domestic Institutions.
Resources
• Animals in Research portal
• OLAW Topic Index—Veterinary Care
Personnel Qualifications and Training
Your institution must ensure that staff working with animals are appropriately trained. This
includes 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 .
Resources
• Animals in Research portal
• IACUC 101 Series
• OLAW Topic Index—Training of Staff
• OLAW Useful Links—Training and Education
Occupational Health and Safety
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:
• Control and prevention strategies
• Hazard identification and risk assessment
• Facilities, equipment, and monitoring
• Personnel training
• Personal hygiene
• Animal experimentation involving hazards
• Personal protection
• Medical evaluation and preventive medicine for personnel
• Where appropriate, special precautions for personnel working with nonhuman primates
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 .
Resources
• Animals in Research portal
• OLAW Topic Index—Occupational Health and Safety
Animal Facilities and Species Inventory
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.
Resources
• Animals in Research portal
Working With Your IACUC
Your IACUC is an oversight body appointed by an official at your institution, such as the chief
executive officer. See OLAW's Who Is 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:
• Review and approve animal use protocols, including significant changes to previously
approved protocols.
o Institutional definitions of a "significant change" vary. Be sure you know your
institution's policy. Implementing a significant change without IACUC prior
approval is a serious violation of PHS policy.
o For more information, see OLAW Topic Index—Protocol Review.
• Monitor the animal care and use program, including semiannual program review and
facility inspection and report of the IACUC evaluations to the institutional official.
• Review concerns involving the care and use of animals.
• Make recommendations to the institutional official on the institution’s animal program,
facilities, or personnel training.
• Be authorized to suspend a previously approved protocol in instances of
noncompliance.
• Evaluate compliance with institutional policies.
• Report annually and notify OLAW of suspensions and instances of serious
noncompliance with PHS policy. See OLAW'sReporting Noncompliance for guidance on
what an IACUC should report to OLAW.
• Ensure that personnel working with animals are appropriately trained and qualified.
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.
IACUC Requirements Vary for Domestic and Foreign Institutions
Identify your situation below for a summary of IACUC requirements.
• Domestic grantees with no foreign subawards
o Follow all the IACUC requirements outlined in this tutorial and by OLAW.
• Domestic grantees with a foreign subaward
o The domestic institution's IACUC reviews and approves the animal activity as
described in the application.
o Both institutions must have an OLAW assurance.
o The foreign subawardee should also follow the instructions in the next section.
• Foreign grantees and subawardees
o The foreign institution doesn't need its own IACUC unless required by local law.
o The foreign institution must have an assurance. Follow the format shown at
OLAW's sample Animal Welfare Assurance for Foreign Institutions. It states that
the institution will comply with your country's laws, regulations, and policies
governing the care and use of laboratory animals and follow the International
Guiding Principles for Biomedical Research Involving Animals.
Resources
• Subawards (Consortium Agreements) for Grants SOP
• Animals in Research portal
• PHS Policy on Humane Care and Use of Laboratory Animals Frequently Asked
Questions—IACUC Composition, Functions, and Authority
• OLAW Topic Index—IACUC Composition, Functions and Authority
How Your IACUC Is Structured
Your IACUC will have at least five members, including people with the following backgrounds.
• A veterinarian with experience in laboratory animal science and medicine, who has
direct or delegated authority and responsibility for activities involving animals at the
institution.
• A practicing scientist experienced in research with animals.
• A person whose primary concerns are in a nonscientific area, e.g., an ethicist, lawyer, or
member of the clergy.
• A person not affiliated with the institution who represents community interests and
who is not a laboratory animal user.
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.
Resources
• Animals in Research portal
• PHS Policy on Humane Care and Use of Laboratory Animals FAQs—IACUC Composition,
Functions and Authority
o What are the IACUC membership criteria?
• OLAW Topic Index—IACUC Composition, Functions and Authority
Write Your Protocol
Coordinate writing your application and protocol. Be sure to write and submit your protocol
early enough for the IACUC review. When you send your protocol to your IACUC, it is extremely
important that the substantive information is consistent with what you proposed in your grant
application. Depending on how your IACUC tracks protocols, administrative details like PI name
and application title may vary or be omitted.
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.
• Description of project. Help IACUC members understand your animal procedures by
avoiding technical language only people in your field will understand. Use visual aids,
such as flow charts and bullets, to illustrate your points or break up text.
• Justification for using animals. Describe why an animal model is necessary. If you're
studying a human health problem, state its cause, existing therapies, and the potential
contribution of your experiments to further its understanding. Use lay language,
explaining all medical terms and defining acronyms the first time you use them.
• Justification for species. Tell IACUC members why you chose one species over others.
You should generally use the most appropriate and least sentient species capable of
providing the data you need. The following is a typical hierarchy of sentient animal
species.
1. Non-human primates, such as monkeys, marmosets, and baboons.
2. Large animals, such as cats, dogs, and pigs.
3. Rabbits.
4. Rodents, such as hamsters, rats, and mice.
5. Non-mammalian vertebrates, such as poultry, reptiles, and fish.
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.
• Justification for number of animals. Request the amount of animals you need and
explain why. Use the minimum number needed to yield statistically significant results.
• Consideration of alternatives. Convince IACUC members that you have adequately
explored alternative methods. Use techniques to minimize pain and distress. These are
known as "refinements" to your protocol. List databases you searched and when,
citations derived, and the keywords or search strategy. List other sources, such as
journal articles, presentations, and colleagues.
• Description of animal procedures. Include non-surgical methods, such as injections and
sample collections; surgical methods, such as suturing and anesthesia; and other
measures, such as pre-anesthetic fasting, drugs, and care during recovery.
• Assurance that qualified staff will perform work. Name all personnel who will be
working on your study, along with their animal research experience and familiarity with
your proposed procedures. If you or someone on your staff does not have the necessary
experience, list experts at your institution who can provide training. Your IACUC will
have to verify that this training took place before animal work can begin.
• Endpoint criteria. Choose endpoints that achieve the aims of the study and avoid
unnecessary pain and distress. Include the criteria you will use to decide when to
intervene or end animal use in the study, e.g., pain that cannot be controlled with
analgesics, tumor size, and stage of disease. Interventions include euthanasia,
treatment, or discontinuance of procedure. Many institutions have default criteria, so
check with your IACUC for guidance.
Resources
• Animals in Research portal
• ClinicalTrials.gov
• Index Medicus
• Medline Plus
• PubMed
• Sample Animal Study Proposal, OLAW
• American Association for Laboratory Animal Science
Write the Application: Indicate Use of Animals
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 2 of the Other Project Information component in your grant application package.
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."
Follow the instructions for Vertebrate Animals in the SF 424 Application Guide.
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.
Resources
• Animals in Research portal
• Sample Applications and Summary Statements
Answer the Five Points in the Vertebrate Animals Section
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:
1. Provide a detailed description of the use of animals in the research. Identify species,
strains, ages, sex, and numbers of animals to be used.
2. Justify the use and number of animals and choice of species with additional justification
if animals are in short supply or are costly or if you plan to use large numbers.
3. Provide information on veterinary care for the animals.
4. Describe procedures for ensuring that discomfort, pain, and injury will be limited to
what is unavoidable. Describe the use of analgesic, anesthetic, tranquilizing drugs, and
restraining devices to minimize discomfort, distress, pain, and injury.
5. Describe any euthanasia method to be used and the reasons for its selection. State
whether this method is consistent with the recommendations of the American
Veterinary Medical Association Guidelines for the Euthanasia of Animals . If not, justify
not following the recommendations.
Note that NIH updated 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 guidelines. Applications for F and T grants due on or after May 25, 2016, should also
follow the new guidelines. Under the changes, you are no longer required to:
• Describe veterinary care.
• Justify the number of animals.
• Describe and justify the method of euthanasia unless the method is not consistent with
AVMA guidelines.
Follow the instructions for Vertebrate Animals in the SF 424 Application Guide.
NIH's Worksheet for Review of the Vertebrate Animal Section (VAS) (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.
Resources
• Animals in Research portal
• VAS Factsheet (PDF)
How the Agency Reviews Applications Using Research Animals
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.
Resources
• Review Criteria SOP
• Animals in Research portal
• Sample Applications and Summary Statements
• CSR
o Roster Index for Regular Standing Study Sections and Continuing SEPs
o Integrated Review Groups
Understand Codes on Your Summary Statement
Scientific review officers 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 the Agency 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 the Agency can release your award.
If your summary statement lists such a code, contact the program officer listed on your
summary statement right away.
Resources
• Animals in Research portal
• Bars to Grant Awards SOP
• Know What a Summary Statement Means in the Strategy for NIH Funding
The Agency Will Send a Just-in-Time Request
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 the Agency can issue your award. See If You Have Animal
Research Documentation and Prepare Your Just-In-Time Information in the Strategy for NIH
Funding.
Resources
• Animals in Research portal
• Paylines and Funding
• Sample Request for Just-in-time Information
• When to Contact an Program Officer
Reporting Requirements During Your Award
During the life of your grant, there are several reporting requirements the Agency 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.
Resources
• Animals in Research portal
• Strategy for Your Grant in the Strategy for NIH Funding
• NIH Grants Policy Statement
• When to Contact an Program Officer
IACUCs Monitor Your Progress
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:
• Switching from nonsurvival to survival surgery.
• Introducing procedures that result in greater pain, distress, or degree of invasiveness.
• Using different anesthesia, analgesics, sedation, or experimental substances.
• Changing PI, species, study objectives, or methods of euthanasia.
Consult your IACUC for guidance. The definition of a "significant change" varies from institution
to institution, and your IACUC's actions depend on the nature of your signficant change.
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.
Resources
• Animals in Research portal
• NIH Grants Policy Statement
• OLAW—Reporting Noncompliance
• Significant Changes section of the OLAW Topic Index—Protocol Review
You'll Have Semiannual Reviews and Inspections
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 .
Resources
• Animals in Research portal
• Institutional Animal Care and Use Committee Guidebook
• NIH Grants Policy Statement
• Semiannual Program Review and Facility Inspection Checklist
• Semiannual Report to the Institutional Official
Avoid Suspension of Animal Activities
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 theSubawards (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 the Agency 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 restrict
or withdraw approval of an assurance only if an institution's efforts to correct its problems are
unsuccessful.
Resources
• Animals in Research portal
• NIH Grants Policy Statement
• OLAW—Reporting Noncompliance
• OLAW Topic Index—Suspensions
Know Your IACUC's Reporting Requirements
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.
• Changes in the institution's program of animal care and use.
• Change of institutional official or IACUC membership.
• Dates when the IACUC conducted its semiannual program evaluations and facility
inspections.
• Minority IACUC views, i.e., dissenting opinions attached to required reports.
Annual reports are due by January 31 for the previous calendar year. Your institution sends the
report as a PDF email attachment to ol[email protected]. 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:
• Serious or continuing noncompliance with PHS policy.
• Serious departures from the Guide for the Care and Use of Laboratory Animals . Note
that exceptions listed in the Guideare not departures.
• IACUC suspensions.
Send preliminary and final reports of noncompliance, deviations, and IACUC suspensions
to [email protected]v.
Learn more about the reporting process and see a sample final report at OLAW's Reporting
Noncompliance.
Resources
• Animals in Research portal
• OLAW
o Annual Report to OLAW
o Examples of Program Changes that Should be Included in an Annual Report .
Keep Your Records Accessible
You must keep your project records accessible for three years after the grant ends. If an issue
arises, the Agency 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:
• Assurance approved by OLAW.
• Minutes of IACUC meetings.
• Records of IACUC activities and deliberations.
• Minority IACUC views.
• Documentation of protocols reviewed by the IACUC, and proposed significant changes
to protocols (this documentation must be maintained for an additional three years after
completion of animal activities).
• IACUC semiannual program evaluations and facility inspections, including deficiencies
identified and plans for correction.
• Accrediting body determinations.
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.
Resources
• Animals in Research portal
• Institutional Reporting to OLAW on OLAW’s Frequently Asked Questions on the PHS
Policy on Humane Care and Use of Laboratory Animals
• PHS Policy on Humane Care and Use of Laboratory Animals—Recordkeeping
Requirements
• Retention and Access Requirements for Records, 45 CFR Part 74.53
In Conclusion
We hope these pages have helped you. If you're looking for more in-depth information, refer to
the Animals in Research portal. If you have questions that weren't answered here,
contact OLAW or Communicating With the Agency—How to Get Help.
This site is part of the Agency'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—
