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Handbook of Operating Procedures
Chapter 10 - Research
Publication Date: July 18, 2012
Responsible Executive: VP for Research


10.11 Use of Animals in Research, Teaching, Testing, or Public Exhibitions


I. POLICY STATEMENT


All University of Texas at San Antonio (UTSA) employees engaged in funded or unfunded research, teaching, testing or public exhibitions that involves Animals will at all times handle and treat such Animals in an ethical, responsible and humane manner as set out in this policy. All UTSA employees who will have direct contact with such live Animals will abide by all Federal, State, and UTSA regulations, policies, and laws that pertain to the care and use of Animals and will ensure that their activities involving such Animals conform to UTSA’s Animal Welfare Assurance.

Animals will NOT be used in research, teaching, testing or public exhibitions at UTSA without prior written approval of the Institutional Animal Care and Use Committee (IACUC). Approval for such research projects or other activities is requested by the submission of a written Animal use protocol, which contains a detailed description of how animals are cared for and used in the project or activity and which must be in a format approved by the IACUC.


II. RATIONALE


UTSA promotes the ethical, responsible, and humane care and use of Animals in research, teaching, testing, or public exhibitions. 

UTSA will comply with applicable federal law, regulations and policies relating to the care and the use of Animals involved in UTSA research, teaching, testing or public exhibitions. The Animal Welfare Act (Title 7, United States Code Sections 2131-2159) sets the minimum standards of care and treatment for certain Animals. The U.S. Department of Agriculture (USDA), working through its Animal and Plant Health Inspection Service (APHIS), enforces the Animal Welfare Act and its implementing regulations, which are located in Title 9, Code of Federal Regulations Chapter 1, Subchapter A, Parts 1, 2 and 3 (collectively referred to as the “Animal Welfare Laws”). UTSA, a public research institution, is registered with APHIS and is subject to periodic inspections by APHIS staff.

Additionally, because UTSA receives grant or contract money from the National Institutes of Health (NIH) to conduct research involving Animals, UTSA is also required to file an approved Animal Welfare Assurance with the appropriate federal office. This Assurance outlines UTSA’s program for the care and use of Animals, which program must, at a minimum, (a) comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, (b) be based on the Guide for the Care and Use of Laboratory Animals and, (c) ensure compliance with any applicable Animal Welfare Laws.

Finally, the Assurance process set out by the federal government creates two categories of institutions. UTSA is a Category 1 institution because its Animal care and use program (IACP) and facilities have been evaluated and accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). Achieving and maintaining AAALAC accreditation is an integral part of UTSA’s commitment to the ethical, responsible, and humane care and use of Animals.    

* When the IACUC approves a protocol, it is also approving the project or activity set out in that protocol; therefore, the terms activiti(ies), project(s) and protocol(s) are used interchangeably throughout this policy.


III. SCOPE


This policy applies to all activities involving living vertebrate Animals used in research, testing, teaching, and public exhibitions at UTSA or at any location if such activities are conducted under the auspices of UTSA. It also applies to anyone engaging in such activities, whether or not they are UTSA employees.


IV. WEBSITE ADDRESS FOR THIS POLICY


http://www.utsa.edu/hop/chapter10/10-11.html


V. RELATED STATUTES, POLICIES, REQUIREMENTS OR STANDARDS


Animal Care and Use Program Policies

  1. The Animal Welfare Act [Title 7, United States Code (USC) Sections 2131-2159)]
  2. Animal Welfare Act Regulations  [Title 9 of the Code of Federal Regulations (CFR), Chapter 1, Subchapter A, Parts 1, 2, and 3] implementing The Animal Welfare Act and administered by the U.S. Department of Agriculture: Animal and Plant Health Inspection Service (APHIS)
  3. Public Health Service Policy on Humane Care and Use of Laboratory Animals
    (PHS Policy) (based on Public Law 99-158, November 20, 1985, "Animals in Research") administered by the U.S. Department of Health and Human Services, National Institutes of Health
  4. Guide for the Care and Use of Laboratory Animals (Guide) (National Academy Press, 2011, Washington, D.C.)

VI. CONTACTS


If you have any questions about HOP policy 10.11, Use of Animals in Research, Teaching, Testing or Public Exhibitions, contact the following office:

Office of Research Integrity
210-458-6587


VII. DEFINITIONS


Animal - Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing, teaching, public exhibition or for related purposes.

Animal Welfare Laws – The Animal Welfare Act  (Title 7, United States Code (USC) Sections 2131-2159) (Act) and its implementing regulations, which are published in Title 9 of the Code of Federal Regulations (CFR), Chapter 1, Subchapter A, Parts 1, 2, and 3, and are administered by the USDA.

Animal Welfare Assurance or Assurance - The documentation from UTSA assuring the National Institutes of Health (NIH) that UTSA complies with the Public Health Service policy.

Guide - Guide for the Care and Use of Laboratory Animals, National Academy Press, 2011, Washington, D.C., or succeeding revised editions.

IACP – UTSA’s Institutional Animal Care Program for humane care and use of Animals that includes the IACUC and UTSA’s Laboratory Animal Research Center.

IACUC - Institutional Animal Care and Use Committee (IACUC) is the regulatory committee required by and established under federal law for the purposes of evaluating UTSA’s care, treatment, housing, and use of Animals and certifying UTSA’s compliance with the Animal Welfare Laws, and which is qualified through the experience and expertise of its members to oversee UTSA's Animal program, facilities, and procedures.

Institutional Official (IO) - The individual who signs, and has the authority to sign, UTSA’s Assurance, making a commitment on behalf of UTSA that the requirements of the Assurance and this policy will be met. The Institutional Official for Animal Care and Use Issues at UTSA is designated by the UTSA president in writing.

PHS Policy - Public Health Service Policy on Humane Care and Use of Laboratory Animals. The NIH’s Office of Laboratory Animal Welfare administers this policy, which includes cross-references to the Guide and the Animal Welfare Laws. 

Principal Investigator (PI) –The UTSA employee with the primary responsibility for designing, managing, and overseeing research, teaching, or testing activities that involve Animals or public exhibitions that involve Animals. The PI should have a UTSA faculty appointment or be employed as a UTSA veterinarian; however, with the appointment of a UTSA veterinarian or faculty member as a Co-PI, visiting scholars, post-doctoral students, or graduate students may be allowed by the IACUC to serve as a PI. 

USDA APHIS – The United States Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) is responsible for enforcing and administering the Animal Welfare Laws.


VIII. RESPONSIBILITIES


    1. Institutional Official (IO)
      1. Appoints the members of the IACUC;
      2. Ensures that UTSA complies with all applicable Animal Welfare Laws, regulations, and policies;
      3. Submits forms, reports, and letters to the federal government on behalf of UTSA;
      4. Interacts with IACUC in overseeing IACP; and
      5. Oversees the Laboratory Animal Research Center.
    2. Institutional Animal Care and Use Committee (IACUC)
      1. Reviews at least once every six months UTSA's IACP, using the Guide and the Animal Welfare Laws as a basis for evaluation.
      2. Inspects at least once every six months all of UTSA’s Animal facilities (including satellite facilities) using the Guide and the Animal Welfare Laws as a basis for evaluation;
      3. Prepares reports of the IACUC evaluations conducted as required by Sections IV.B.1 and 2 of the PHS policy, and submits the reports to the IO;
      4. Reviews concerns involving the care and use of Animals at UTSA;
      5. Makes recommendations to the IO regarding any aspect of UTSA's Animal program, facilities, or personal training;
      6. Reviews and approves, requiring modifications in (to secure approval) or withholding approval of, activities related to the care and use of Animals as specified in Section IV.C. of the PHS policy and the Animal Welfar Laws;
      7. Reviews and approves, requiring modifications in (to secure approval), or withholding approval of, proposed significant changes regarding the use of Animals in ongoing activities; and
      8. Suspends anactivity involving Animals in accordance with the specifications set forth in Section IV.C.6 of the PHS policy and the Animal Welfare Laws.
    3. Principal Investigator (PI)
      1. Prepares a detailed, written protocol that is in a format approved by the IACUC and that outlines his/her Animal related project and all aspects of Animal care and use associated with such project;
      2. Obtains IACUC approval of such protocol;
      3. Ensures that such approved protocol is strictly followed;
      4. Ensures that all Animal users identified in the protocol have completed the required training prior to use of Animals;
      5. Consults with the Director of UTSA's IACP or the University veterinarian every time changes to the approved protocol are being considered; and
      6. Obtains any required IACUC approval of changes to an approved protocol PRIOR to implementing them.

    IX. PROCEDURES


      1. Preparation and Submission of Proposed Animal Care and Use Protocols
        1. A PI who desires to use Animals in research or other activities must file with the IACUC a written, detailed protocol outlining the proposed use and care of such Animals in the research or other activities. No research or other activity involving Animals may commence without such protocol being approved by the IACUC.
        2. Before submitting a protocol for approval by the IACUC, the PI should:
          1. Plan/design all activities relating to Animals so that they conform to this policy and all guides, policies, laws and regulations referenced herein;
          2. Ensure that the protocol is prepared and submitted in a format that is acceptable to the IACUC (which currently consists of a protocol application form);
          3. Ensure that an acceptable co-PI has been appointed if the PI is a visiting scholar, or a post-doctoral or graduate student; and,
          4. If the protocol requires the PI to use laboratory facilities or equipment that is under the exclusive or primary control of someone other than the PI, ensure that the lab/equipment supervisor approves the protocol in writing.
      2. IACUC Review and Apporval of Proposed Animal Care and Use Protocols
        1. In order to approve new proposed research projects or other activities involving Animals or proposed significant changes to ongoing research projects or other activities involving Animals, the IACUC will conduct a review of Animal care & use protocols submitted for such new or changed projects/activities as prepared by the PIs requesting permission to use Animals. The IACUC will determine whether such protocols comply with PHS policy. In making this determination, the IACUC will confirm that the research project or other activity will be conducted in accordance with the Animal Welfare Laws insofar as they apply, and that the project/activity is consistent with the Guide unless acceptable justification for a departure is presented. Further, the IACUC will determine that the project/activity conforms to UTSA’s PHS Assurance.
        2. The current PHS policy requires that protocols conform to the following requirements:
          1. Procedures with Animals will avoid or minimize discomfort, distress, and pain to the Animals, consistent with sound research design or proposed activity.
          2. Procedures that may cause more than momentary or slight pain or distress to the Animals will be performed with appropriate sedation, analgesia, or anesthesia, unless withholding such treatments is adequately justified for scientific reasons in writing by the PI.
          3. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure.
          4. The living conditions of Animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and nonmedical care of the Animals will be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.
          5. Medical care for Animals will be available and provided as necessary by a qualified veterinarian.
          6. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
          7. Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines on Euthanasia (2007) (PDF) or succeeding revised editions, unless a deviation is justified for scientific reasons in writing by the PI.
        3. Prior to the review, each IACUC member will be provided with a list of proposed projects or activities  to be reviewed and with access to the proposed, written protocols associated with such projects/protocols. Any member of the IACUC may obtain, upon request, full committee review of any proposed protocol. 
          1. If full committee reivew is not requested, one or more members of the IACUC who are designated by the chairperson and qualified to conduct the review will review the proposed protocol and will have the authority to approve, to require modifications in (to secure approval) or to request full committee review of such protocol.
          2. If full committee review is requested, approval of the proposed protocol may be granted only after review at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present. No member may participate in the IACUC review or approval of a protocol in which the member has a conflicting interest (including, but not limited to, being personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.
        4. The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of a protocol or vote with the IACUC unless they are also members of the IACUC.
        5. The IACUC shall notify PIs and UTSA in writing of its decision to approve or to withhold approval of a proposed protocol, or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of a protocol, it will include in its written notification a statement of the reasons for its decision and will give the PI an opportunity to respond in person or in writing.
        6. An activity involving Animal(s) may not take place without the prior approval of the IACUC. Therefore, UTSA officials cannot (a) overrule an IACUC decision to withhold approval of an activity involving Animal(s) or (b) grant final approval of an activity involving Animal(s) unless it has first been approved by the IACUC. Appropriate UTSA officials can, however, decide against allowing an IACUC-approved activity to move forward.     
      3. Oversight and Monitoring of Activities involving Animals
        1. UTSA faculty and staff with the exclusive or ultimate responsibility (a) for laboratories where activities involving Animals take place or (b) for specialized equipment needed for such activities, should take one of the following actions whenever someone requests to use  his/her lab or equipment for an activity involving Animals:
          1. Request a copy of the IACUC-approved protocol covering such activity; or
          2. Email the IACUC office at iacuc@utsa.edu to confirm that an IACUC-approved protocol covers such activity.
        2. The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by the PHS policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with Section IV.C.1-4 of the PHS policy at least once every three (3) years. Annual reviews will be conducted in accordance with the Animal Welfare Laws.
        3. At any time and from time to time, the IACUC may suspend an activity that it previously approved in a protocol if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Laws, the Guide, UTSA’s Assurance, or Sections IV.C.1.a.-g.of the PHS policy.  On the publication date of this policy, such PHS Policy requirements are found in Section B.2 of the Procedures part of this policy.
        4. The IACUC or the University veterinarian may immediately suspend an activity on a temporary basis if the University veterinarian determines an Animal is in distress or that an activity is not in compliance with UTSA’s IACP or this policy. At a convened meeting of a quorum of the IACUC, the IACUC may then formally review the matter and vote to continue the suspension on either a temporary or permanent basis. 
        5. If the IACUC suspends an activity involving Animals or if situations involving serious or continuing non-compliance with the PHS policy or serious deviation from the provisions of the Guide should occur, then:
          1. the IO in consultation with the IACUC will review the circumstances surrounding such suspension or situation and take appropriate corrective action; and
          2. the IACUC, through the IO will report such corrective action with a full explanation of the circumstances surrounding such suspension or situation to the appropriate federal office. 
        6. The IACUC shall issue reports to the IO at least once every six (6) months upon completion of the required semiannual evaluations. These reports will be maintained by UTSA and made available to the appropriate federal office upon request. The reports must contain a description of the nature and extent of UTSA’s adherence to the Guide, the Animal Welfare Laws and the PHS Policy, must identify specifically any departures from the provisions of the Guide, the Animal Welfare Laws and the PHS Policy, and must state the reasons for each departure.  The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, consistent with the PHS policy, and, in the judgment of the IACUC and the IO, is or may be a threat to the health or safety of the Animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency. If some or all of UTSA’s facilities are accredited by AAALAC International or another accrediting body recognized by PHS, the report should identify those facilities as such.
      4. Suspected Misuse or Abuse of Animals/Sanctions for Non-Compliance
        1. Anyone who witnesses possible Animal mistreatment, instances of non-compliance with this policy, or any unauthorized use of Animals, should report that activity through any of the following channels:
          1. His/her supervisor;
          2. The University veterinarian or Chairman of the IACUC;
          3. The IACUC office (210-458-7733, iacuc@utsa.edu);
          4. The Office of Research Integrity (210-458-6587); or
          5. Anonymous complaints may be made by calling UTSA’s Compliance Hotline 1-877-888-0002, or submitting  the report over the internet to a neutral, anonymous website: https://www.reportlineweb.com/UTSA.
        2. Credible reports that an individual has engaged in alleged Animal mistreatment or in allegedly unauthorized or non-compliant activities involving Animals will warrant an investigation by the IACUC and could result in any of the following:
          1. Temporary or permanent suspension of an activity involving Animals as provided in Sections C. 3 or 4 of the Procedures part of this policy,
          2. Imposition by the IACUC of various sanctions authorized by law or policy, including, but not limited to, the suspension of any or all of the individual’s existing Animal protocols;
          3. Further review and the imposition of corrective actions and sanctions by the provost in consultation with the IO and the appropriate department chair, dean; and/or
          4. Independent disciplinary action imposed by the individual’s supervisor, if warranted.

      X. SPECIAL INSTRUCTIONS FOR IMPLEMENTATION


      None


      XI. FORMS AND TOOLS/ONLINE PROCESSES


      Institutional Animal Care Program IACP website: http://vpr.utsa.edu/oric/iacuc/


      XII. APPENDIX


      None


      Editorial Amendment: September 26, 2013