TEXAS TECH U NIVERSITY
Office of the Vice President for Research
Institutional Animal Care and Use Committee™
IACUC Policy: Animal Product Use Protocol
Policy Purpose: The purpose of this policy is to describe the use of outside source, vertebrate animal
tissues, cells, fluids and biologically-related materials at TTU.
Table of Contents
1.
2.
3.
4.
5.
6.
Introduction
Background
Definition
Policy
Procedures
References
Revision No:
01
Authors:
Paul Stonum
Replaces: Date in effect:
0
07/16/2014
Responsible faculty:
(Signature/Date)
Phil Smith
1. Introduction
a. It is important to recognize that tissue sharing and the use of tissues from slaughterhouses is an effective
implementation of Russell and Burch’s “3Rs” (reduction, refinement, replacement). The use of tissue sharing
by multiple PI’s or obtainment of tissue from animals euthanized for human consumption helps to reduce and
replace the overall number of animals used in the course of research. This approach is encouraged where it is
scientifically and practically appropriate.
b. This policy shall apply to all animals and animal tissues used, housed, or maintained for teaching or research
purposes. It is the purpose of this policy to provide ethical, practical, humane, and reasonable methods for the
sharing or use of animal tissues/carcasses prior to their disposal.
2. Background
a. While both the Animal Welfare Act (AWA) and PHS Policy require IACUC review and approval for the use
of live vertebrate animals in teaching, research and testing, federal regulations do not apply to dead animals in
the research facility setting. Confusion has arisen as the AWA defines an ‘animal’ as any live or dead warmblooded animal intended for use in research, teaching, testing, or experimentation. However, the definition of
a ‘research facility’ is one that ‘uses or intends to use live animals.’ In addition, PHS policy would not
normally extend to anything other than a live animal with the exception of the intent for ultimate use of any
live animal.
b. It should be noted that both OLAW and USDA/Animal Care have gone on record that a proposal involving
animals to be killed for the purposes of using their tissues, or one that involves project-specific manipulation
prior to euthanasia is not exempt from protocol review. Therefore, if an animal is acquired and euthanized
specifically for tissue collection, a full animal use protocol must be submitted and approved by the TTU
IACUC.
3. Definition
a. For the purposes of this policy “tissue” will pertain to any part of a vertebrate animal, including tissue, blood
or other bodily fluids, organ and carcass, that contributes to the individual’s or species’ homeostasis when the
animal is alive. This policy is NOT intended for COMMERCIALLY available or purchased materials.
4. Policy
a. Although not required by federal regulations to review and approve the use of animal tissues, Texas Tech
University’s IACUC has determined that it is in the best interest of the University to require review and
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TEXAS TECH U NIVERSITY
Office of the Vice President for Research
Institutional Animal Care and Use Committee™
approval for all activities involving both live and dead vertebrate animals. This is done not only for the
purposes of compliance with guidelines and regulations, but also for the reasons of personnel safety, liability
and public relations.
b. The 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 to determine whether the
individual needs to take any special precautions when handling the tissue.
c. In brief, in order to be exempt from IACUC Animal Use Protocol review and approval:
i.
The tissue use must not result in a need for an increase in the number of animals to be used in an
approved IACUC protocol.
ii.
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.
iii.
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.
iv.
A researcher with an approved IACUC protocol cannot euthanize animals for the sole purpose of
providing tissues to another researcher.
v.
Tissues that are donated to, or maintained in University repositories, and shared with other
researchers for scientific purposes would be exempt from this policy.
5. Procedures
a. To provide/receive any animal tissue:
i.
The recipient must complete an Animal Product Protocol Form.
ii.
The Form must be submitted to and approved by the IACUC prior to tissue purchase or receipt.
iii.
If the tissue to be purchased/received will contain radioactive, hazardous, infectious, or recombinant
DNA material, the Animal Product Protocol Form must also receive approval from the Institutional
Bio-Safety Committee prior to tissue purchase or receipt.
iv.
Any Animal Use Protocol from which any tissue is to be provided must be approved by the IACUC
for tissue sharing. The Principal Investigator for the Approved Protocol may request such approval
by filing with the IACUC an Animal Protocol Amendment Form. If any aspect of animal treatment
(care, use, euthanasia, disposal, etc.) is to be modified to meet the requirements of tissue harvesting,
the details and purpose of the modification(s) must be described on the Animal Protocol Amendment
Form. If an Animal Protocol Amendment Form is submitted, it must be approved by the IACUC
before any tissue may be provided.
6. References
• Federal Register, Department of Agriculture, Animal and Plant Inspection Service, 9 CFR Parts 1, 2, and 3.
Animal Welfare; Proposed Rules. pp. 10821-10954. Government Printing Office, Washington DC, March 15,
1989. Retrieved from: http://awic.nal.usda.gov/final-rules-animal-welfare-9-cfr-parts-1-and-2
•
Public Health Service Policy on Humane Care and Use of Laboratory Animals: National Institutes of Health,
Office of Laboratory Animal Welfare. Public Health Service: Policy on Humane Care and Use of Laboratory
Animals (8/7/02). Retrieved from: http://grants.nih.gov/grants/olaw/references/phspol.htm
Effective_Date:_______________________IACUC_Chair:
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TEXAS TECH U NIVERSITY
Office of the Vice President for Research
Institutional Animal Care and Use Committee™
Animal Product Use Protocol Form
Approval Date:
Protocol Number:
The completion and submission of this form is required if you’re funded research involves the use of tissues,
cells, fluids, or other biologically-related material that is taken from a vertebrate animal, BUT:
• Does not involve Texas Tech University owned, purchased or housed animals.
• No Texas Tech University faculty, staff or students are involved in collecting the samples.
• The original intended use/procedure of the animals was NOT for the collection of the samples being used
in this research project.
Project title:
Principal Investigator:
Department:
Funding Source:
ORS Routing Number:
Expected Project start date:
Expected date of completion:
Who will be performing the sample collection procedures described in this project?
Collecting entity:
Contact Person:
Contact Phone#:
Contact Email:
Does the collecting entity operate in accordance with AWA policy, IACUC oversight, USDA license or
AAALAC certification?
Yes
No
Indicate the type of samples to be used/stored and any identifying features (serum, tissue, ID number, label, etc.):
Briefly describe in layman’s terms your involvement with the study objectives and procedures.
All parties involved in the study should be aware of the potential biological and zoonotic risks involved.
Therefore, all individuals in this project must be appropriately qualified and trained, and are responsible for
contacting the appropriate safety committees when approval is necessary.
Signature:
Date: