IACUC Protocol Requirement Policy
Approved February 17, 2005 (Download)
Background: The Animal Welfare Act (AWA) and the Health Research Extension Act of 1985 require IACUC review and approval for use of live vertebrate animals in research, teaching and testing. Federal regulations do not require Institutional Animal Care and Use Committee (IACUC) approval for use of dead animals per se, or for use of tissues from dead animals. There is sometimes confusion over this issue, however, because in the Animal Welfare Act the definition of animal includes the statement “live or dead.” However, the definition for “research facility” in the AWA specifies that a research facility is one that “uses or intends to use live animals.” Therefore, the AWA does not require IACUC approval for use of dead animals per se. The Public Health Service (PHS) Policy, which is the policy for implementation of the Health Research extension Act of 1985, also specifies that it is applicable to activities involving live vertebrate animals.
Tissue sharing and the use of tissues from slaughterhouses is perfectly in keeping with the “3 Rs” (i.e., reduction, refinement, replacement) of Russell and Burch. 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.” In addition, OLAW points out that grant applications proposing use of shared animal tissues or tissues from slaughterhouses must be written so that the origin of the tissues is clear. Otherwise, questions regarding IACUC approval are likely to be raised by reviewers.
Policy: Use of Live Vertebrate Animals: Approval in writing from the IACUC 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 on campus. This includes, for example, field studies and any activities for which University credits are awarded (e.g., 499 credits, etc.). Application for approval is made by submission of a completed Project Review Form (PRF) to the IACUC by a University faculty member or research scientist.
Project approval must be renewed annually and any “Significant Changes” to the protocol must be approved by the IACUC prior to implementation. Refer to the IACUC policy on Significant Changes.
Note that per OLAW, any time that an animal is euthanized “for the purpose of using their tissues”, or any time that “project-specific antemortem manipulation” is involved, IACUC review and approval is required. These activities do not constitute use of tissue per se and they are not exempt from federal requirements for use of live vertebrate animals.
Use of Shared Tissues and Slaughterhouse Materials: The University IACUC encourages the use of shared tissues and slaughterhouse materials when it is scientifically appropriate. An individual may obtain tissues from a slaughterhouse or from an animal that has been euthanized for the purposes specified in an approved IACUC protocol. In the latter case, the individual may obtain parts or the whole animal and there is no requirement for them to have IACUC approval for the use of the dead animal or to be listed on the approved IACUC protocol for which the animal was euthanized. However, the individual should enroll in the Occupational Health program for animal users so that the Environmental Health and Safety Occupational Health Nurse (EHS OHN) can determine whether the individual needs to take any special precautions when handling the tissue. There are some health issues that can be impacted by working with certain tissues. Users should contact the EHS OHN (221-3025 or email@example.com) for advice.
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 in 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. That is, unapproved procedures cannot be performed in order to make the tissues suitable for another researcher.
- Live animals cannot be transferred to another researcher who has no IACUC approval for their use. This applies even when the only procedures planned are euthanasia and tissue harvest. In other words, euthanasia and tissue harvest require IACUC approval.
- Euthanasia of an animal whose tissues are to be shared must be performed for the IACUC approved purposes in the protocol to which it is assigned. That is, a researcher with an approved IACUC protocol cannot euthanize animals for the sole purpose of providing tissues to another researcher.
Avian Embryos: Federal policy guidance has been written specifically to address 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 so IACUC approval for their use is not required. As such, researchers may order eggs directly from vendors for use of embryonic tissue. Researchers who do wish to order eggs via the Department of Comparative Medicine animal purchasing will need to list them on an IACUC protocol so that they can be entered into the protocol/purchasing database. If a protocol does not already exist, please contact the IACUC for advice. Eggs can be added to an existing IACUC protocol administratively, by contacting the IACUC in writing (e.g., memo or e-mail) and indicating the IACUC protocol number, the type of eggs needed (e.g., chicken, quail), the number needed and a brief explanation of the planned use (i.e., assuring that they are to be used prior to hatching).
Users of eggs should also contact the EHS OHN (221-3025 or firstname.lastname@example.org) for advice.
Code of Federal Regulations, Title 9 (Animals and Animal Products), Subchapter A (Animal Welfare), Parts 1-3.
Guide for the Care and Use of Laboratory Animals, Institute of Laboratory Animal Resources, Commission of Life Sciences, National Research Council. Washington, D.C., National Academy Press, 1996.
Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, National Institutes of Health, U.S. Department of Health and Human Services. Washington, D.C, 2000.
Russell WMS and Burch RL. The Principles of Humane Experimental Technique, London, UK, Methuen and Co. Ltd., 1959.
Jerry Silverman, Protocol Review, Lab Animal 26(3):21, 1997.