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​IACUC Protocol Requirements

Purpose

To define which activities involving animals require an IACUC protocol, and which activities are exempt from IACUC review and approval.

Background

The Animal Welfare Act (AWA)1 and the Health Research Extension Act of 19852 require Institutional Animal Care and Use Committee (IACUC) review and approval for use of live vertebrate animals in research, teaching, and testing. AAALAC Rules of Accreditation require that “all animals used or to be used in research, teaching or testing at accreditable units are to be included and evaluated, and that nontraditional animals, inclusive of invertebrate species, are also included where they are relevant to the unit’s mission.”3  IACUC approval is typically obtained by means of an animal use protocol, which provides a detailed description of the proposed use of laboratory animals.4 Federal regulations do not require IACUC approval for use of dead animals or their tissues.5

Tissue sharing and the use of tissues from slaughterhouses is in keeping with the “3 Rs” (i.e., reduction, refinement, replacement) of Russell and Burch.6 Use of tissues from animals that are being euthanized for other purposes reduces the overall number of animals used in research, teaching, and testing. However, as noted by the Office of Laboratory Animal Welfare (OLAW) in Lab Animal (Lab Animal 26(3):21, 1997), “a proposal involving animals to be killed for the purpose of using their tissues, or one that involves project-specific antemortem manipulation, is not exempt from protocol review.”7 In addition, OLAW points out that grant applications proposing use of shared animal tissues or tissues from slaughterhouses must be written such that the origin of the tissues is clear.​

Policy

Use of Live Vertebrate Animals: IACUC approval is required for any use of live vertebrate animals in research, teaching, or testing by University faculty, staff, students, volunteers, or visiting scientists. Projects conducted at field sites and in non-University facilities are subject to the same review process required for projects conducted at University research sites. This includes, for example, field studies and any activities for which University credits are awarded (e.g., 499 credits, etc.). Approval is obtained by submission of a completed protocol to the IACUC by a University faculty member or research scientist. All protocols must be created and submitted within HoverBoard, the University’s electronic protocol management system.

HoverBoard: https://hoverboard.washington.edu

All protocols, regardless of species or funding source, must be reviewed in their entirety and approved by the IACUC every three years (“de novo” review). All amendments to the protocol must be approved prior to implementation (see IACUC Policy “Review and Approval of Protocol Amendments”).

Any time an animal is euthanized for the purpose of using their tissues, or any time project-specific antemortem manipulation is involved, IACUC review and approval is required.

Use of Invertebrate Animals: IACUC approval is required for any research and teaching involving cephalopods, whether in the field or on campus. This applies to cephalopods of any life stage after hatching. The IACUC recognizes that its oversight of other invertebrates will evolve over time and it will continue to work with the faculty and research community to assure animal welfare.

Use of Shared Tissues and Slaughterhouse Materials: The University IACUC encourages the use of shared tissues and slaughterhouse materials when scientifically appropriate. An individual may obtain tissues from a slaughterhouse or from an animal that has been euthanized, given that the animal was euthanized for the purposes specified in the approved IACUC protocol to which that animal was assigned. In the latter case, the individual may obtain all or part of the animal, and there is no requirement for that individual to be approved as personnel on the IACUC protocol for which the animal was euthanized. However, the individual should enroll in the Occupational Health Program for animal users by submitting an Animal Use Medical Screening (AUMS) Form so that the Environmental Health and Safety Occupational Health Nurse (EH&S OHN) can determine whether the individual needs to take any special precautions when handling the tissue.

In brief, in order to be exempt from IACUC review and approval:

  • The tissue use must not result in a need for an increase in the number of animals to be used on the approved IACUC protocol.
  • Live animals must not be subjected to any changes in procedures, or additional procedures, beyond those approved in the IACUC protocol to which they are assigned.
  • Live animals cannot be transferred to another researcher who does not have IACUC approval for their use. This applies even when the only procedures planned are euthanasia and tissue harvest.
  • Euthanasia of an animal whose tissues are to be shared must be performed for the IACUC-approved purposes on the protocol to which it is assigned. A researcher with an approved IACUC protocol cannot euthanize animals for the sole purpose of providing tissues to another researcher, unless that is specifically described and approved in the IACUC protocol to which the animals are assigned.​

Larval Amphibians and Fish: Federal guidance has specifically addressed the use of larval amphibians and fish8. Per federal policy, larval amphibians and fish are classified as “live vertebrate animals” immediately after hatching. Zebrafish larvae, for example, typically hatch 3 days post-fertilization. IACUC approval is therefore required for use of amphibians and fish at all post-hatch life stages.

Avian Embryos: Federal guidance has specifically addressed the use of avian embryos. Per federal policy, avians are classified as “live vertebrate animals” only after hatching. Avian embryos are therefore defined as “tissue” prior to hatching, and therefore IACUC approval for their use is not required. As such, researchers may order eggs directly from vendors for use of embryonic tissue. For further information, refer to the IACUC Guideline “Purchasing and Use of Eggs Pre-hatching”.

References

  1. Animal Welfare Act and Animal Welfare Regulations, Animal and Plant Health Inspection Service, United States Department of Agriculture, 2017.
  2. Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, National Institutes of Health, United States. Department of Health and Human Services. Washington, D.C, 2015.
  3. AAALAC Rules of Accreditation
  4. Guide for the Care and Use of Laboratory Animals: Eighth Edition, National Research Council. Washington, D.C., The National Academies Press, 2011.
  5. Code of Federal Regulations, Title 9 (Animals and Animal Products), Subchapter A (Animal Welfare), Parts 1-3.
  6. Russell WMS and Burch RL. The Principles of Humane Experimental Technique, London, UK, Methuen and Co. Ltd., 1959.
  7. Jerald Silverman, Protocol Review: Optimal Animal Use, Lab Animal 26(3):21, 1997.
  8. Bartlett DH and Silk SB. Office of Laboratory Animal Welfare Comments: Hatching Fish – When Should Animal Tracking Begin?, Zebrafish 13(6):1-2, 2016.

Approval/Review Dates

Originally A​​​pproved: 02/17/2005
Last Reviewed/Revised by the IACUC: 06/23/2022

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