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Explains procedures for writing an application and then applying for and maintaining an NIH grant application for research that uses animals.

This is the print-friendly version. We update it monthly. For the most current information, read the page-by-page tutorial. 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
  • Is Your Institution Assured by OLAW?
  • How to Get an Assurance
  • What OLAW Looks For
    • Veterinary Care
    • Personnel Qualifications and Training
    • Occupational Health and Safety
    • 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 NIAID Reviews Applications Using Research Animals
  • Understand Codes on Your Summary Statement
  • NIAID 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

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 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.

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 answer all five points in the Vertebrate Animals Section 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, but training (T), career (K), and fellowship (F) grants still use paper forms.

Go to our NIH Grant Cycle: Application to Renewal for beginning-to-end, step-by-step information about applying for the most common grant types.

If your application receives a fundable 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. If you have domestic subaward agreements, those organizations also need IACUC approval and an animal welfare assurance.

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 Domestic Institutions with a PHS Approved Animal Welfare Assurance or Foreign Institutions with a PHS Approved Animal Welfare Assurance on the OLAW Web site. Assurances must be renewed every four years.

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. AAALAC is a non-regulatory organization; participation in its accreditation program sends the message that your institution is committed to high-quality animal care and use.

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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 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 four facilities to inject mice with Ebola virus, you might not receive funding you otherwise could have received.

See NIAID's NIH Grant Cycle: Application to Renewal for more tips and advice on organizing and conveying your ideas.

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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, or even better, not using them at all.

USDA regulations require that investigators search the scientific literature for alternatives, but if this isn't done until the IACUC approval stage, most researchers will have already determined what animals they are going to use and how.

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.

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Is Your Institution Assured by OLAW?

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.

There are three types of assurances: full, inter-institutional, and foreign.

  • Full assurances are for domestic institutions that control their own facilities and have a complete animal care and use program in place, including a veterinarian and IACUC. Full assurances remain in effect for four years and can be resubmitted for an additional four years.
  • Inter-institutional assurances are for organizations that contract animal work to an assured institution or use its facilities. The organizations agree to conduct the project according to the assurance of the covered organization. Timeframes for these agreements are project specific. For example, a small business subcontracting animal work to a performance site must reapply for an inter-institutional assurance each time it 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 either animal welfare requirements for domestic institutions or the laws and regulations of the country in which it resides. For example, a German institution or performance site could adhere to German laws for animal care and use. Foreign assurances are in effect for five years.

Institutions that collaborate with grantees through a subaward also require assurances. Alternatively, a grantee may amend its assurance to cover a collaborating institution.

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How to Get an Assurance

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 priority score is within NIAID's payline.

For that process, OLAW will send your institution a 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.

Your institution will designate an institutional official for animal welfare, who signs the assurance and sends it to OLAW using either of these methods:

  • Email. Send the signed assurance to olawdoa@mail.nih.gov as a PDF attachment.
  • Postal mail. Send the signed assurance to the following address:
    Office of Laboratory Animal Welfare
    RKL1, Suite 360, MSC 7982
    6705 Rockledge Drive
    Bethesda, MD 20892-7982 (Use this ZIP code for the U.S. Postal Service, including express mail.)
    Bethesda, MD 20817 (Use this ZIP code for commercial carriers such as FedEx and UPS.)

Do not include attachments for the following documents: resumes of the veterinarian or IACUC members, description of the institutional occupational health and safety program, or description of the animal care and use training program. 

OLAW will review your institution's 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 satisfied with the response. Your application is barred from an award until an 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, and animal facilities and husbandry.

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What OLAW Looks For: Veterinary Care

All veterinary programs must 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 on Euthanasia.
  • Drug storage and control.

The attending veterinarian must 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 form. Follow the format shown on OLAW's Sample Animal Welfare Assurance.

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Personnel Qualifications and Training

Your institution must ensure that staff working with animals are qualified and train investigators on policies and means to minimize animal pain and distress.

Do not include an assurance attachment to describe the animal care and use training program. Instead, describe the program in the assurance form. Follow the format shown on OLAW's Sample Animal Welfare Assurance.

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.

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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.

  • Pre-placement medical evaluation.
  • Identification of hazards and safeguards against risks.
  • Appropriate testing and vaccinations.
  • Staff training on hazards, safeguards, and roles and responsibilities.
  • Policies and facilities that promote cleanliness and safety.
  • Provisions for documenting and treating job-related injuries and illnesses.

Do not include an assurance attachment to describe the occupational health and safety program. Instead, describe the program in the assurance form. Follow the format shown on OLAW's Sample Animal Welfare Assurance.

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.

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Animal Facilities and Species Inventory

Institutions provide a facility and species inventory as part of their assurance. Follow the format shown on OLAW's Sample Animal Welfare Assurance.

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, occupational health, and safety.

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Working With Your IACUC

Your IACUC is an oversight body appointed by an official at your domestic institution, such as the chief executive officer. The Office of Laboratory Animal Welfare relies on the IACUC to enforce PHS policy and your institution's animal policies.

IACUCs do the following:

  • Review and approve animal use protocols, including significant changes to previously approved protocols.
  • Monitor your animal care and use program, including a semi-annual inspection of animal facilities.
  • Hold orientation programs on institutional animal policies and procedures, e.g., what is expected, which protocol forms to use, and where to get animals.
  • Evaluate compliance with institutional policies.
  • Report annually and notify OLAW of suspensions and instances of serious noncompliance with policy. See the February 24, 2005, Guide notice for guidance on what an IACUC should report to OLAW.

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
    • Follow all the IACUC requirements outlined in this tutorial and by OLAW.
  • Domestic grantees with a foreign subaward
    • The domestic institution's IACUC reviews and approves the animal protocol in the application.
    • Both institutions must have an OLAW assurance.
    • The foreign subawardee should also follow the instructions in the next section.
  • Foreign grantees and subawardees
    • Your institution doesn't need its own IACUC unless required by local law.
    • Your institution must have an OLAW assurance.
    • You must complete a “Statement of Compliance with Standards for Humane Care and Use of Laboratory Animals by Foreign Institutions.”

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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.

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Write Your Protocol

Coordinate writing your application and protocol. Be sure to write your protocol early enough for the IACUC. It is extremely important that the information in the protocol submitted 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.

  • 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, availability, or cost; 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.

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.

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Write the Application: Indicate Use of Animals

If you're using research animals, you'll need to answer 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 paper applications, follow the instructions for Vertebrate Animals in the PHS 398. For electronic applications, follow the instructions for Vertebrate Animals in the Grant Application Guide.

Go to Other Project Information Form: Facilities, Resources, and Equipment in the NIH Grant Cycle: Application to Renewal for a brief description of what you need to put in the application.

To see if your institution or performance site is assured, check Domestic Institutions with a PHS Approved Animal Welfare Assurance or Foreign Institutions with a PHS Approved Animal Welfare Assurance.

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Answer the Five Points in the Vertebrate Animals Section

Peer reviewers can adjust your priority score based on your responses to the five points in the Vertebrate Animals Section of the Research Plan.

  1. Provide a detailed description of the use of animals in the work previously outlined in the experimental design and methods section. Identify species, strains, ages, sex, and numbers of animals to be used.
  1. Justify the use of animals, choice of species, and numbers used. If animals are in short supply, costly, or to be used in large numbers, provide additional rationale for their selection and numbers.
  1. Provide information on veterinary care.
  1. Describe procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable to conduct scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.
  1. Describe any euthanasia method to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present a justification for not following the recommendations.

For electronic applications, follow the instructions for Vertebrate Animals in the Grant Application Guide. For paper applications, follow the instructions for Vertebrate Animals in the PHS 398.

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 Part 5. Research Plan and Part 6. Other Application Sections in the NIH Grant Cycle: Application to Renewal for more advice on drafting your application.

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How NIAID 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.

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 priority score.

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Understand Codes on Your Summary Statement

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.

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NIAID Will Send a Just-in-time Request

After you've cleared initial peer review and resolved any reviewer concerns, 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 before NIAID can issue your award. See If You Have Animal Research Documentation and Prepare Your Just-in-Time Information in the NIH Grant Cycle: Application to Renewal.

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Reporting Requirements During Your Award

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 NIH Grant Cycle: Application to Renewal.

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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.

  • Study objectives.
  • Non-survival to survival surgery.
  • Species or number of animals.
  • Invasiveness of a procedure.
  • Use of anesthetics or analgesics.
  • Methods of euthanasia.
  • Change in PI.

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 NIH Grant Cycle: Application to Renewal.

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.

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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 animal welfare assurance and is not accredited by the Association for Assessment and Accreditation of Laboratory Animal Care.

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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 the Subawards 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.

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Know Your IACUC's Reporting Requirements

At least once every 12 months your institution is required to submit a report to OLAW, signed by the institutional official for animal welfare and institutional animal care and use committee (IACUC) chairperson. The report includes the following.

OLAW now strongly encourages institutions to send in their annual reports by December 31.

Your institutional official for animal welfare must notify OLAW's Division of Compliance promptly at 301-496-7163 of any of the following.

Your institution sends annual reports as well as follow-up reports of noncompliance, deviations, and IACUC suspensions to:

Office of Laboratory Animal Welfare
RKL1, Suite 360, MSC 7982
6705 Rockledge Drive
Bethesda, MD 20892-7982 (Use this ZIP code for the U.S. Postal Service, including express mail.)
Bethesda, MD 20817 (Use this ZIP code for commercial carriers such as FedEx and UPS.)

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Keep Your Records Accessible

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:

  • Assurance approved by the Office of Laboratory Animal Welfare.
  • 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.

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In Conclusion

We hope these pages have helped you. If you're looking for more in-depth information, please refer to Basic resources for applications involving animals. If you have questions that weren't answered here, please contact OLAW or Contact Staff for 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 by emailing deaweb@niaid.nih.gov.

 

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