Texas State University Protocol Approval Application and Information
Animal Care and Use Policy
Texas State University
Revised: 05/04/00
Official UPPS No. 02.02.05
Issue No. 2
Effective Date: 06/18/97
Review: January 1 E3Y
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02. Institutional Policy for Care and Use of Animals in Teaching and Research
03. Procedure for Appointment of the Institutional Official and the IACUC
04. Procedures for Applicaton for Approval to Use Animals, Meetings, and Voting of the IACUC
05. Procedure for Inspection, Procurement, Maintenance, and Disposal of Animals
06. The Animal Rights Movement
07. Major Responsibilities Associated with this Document
01. POLICY STATEMENTS
01.01
We at Texas State are committed to excellence in undergraduate, graduate, and continuing education, through the preservation and transmission of knowledge, as well as the generation of knowledge through research, scholarship, and creative expression. The following procedure contributes to the implementation of this policy.
*01.02
Texas State recognizes the importance of the use of animals in its education and research programs. The use of animals is vital both for understanding basic biological and agricultural processes and in developing diagnostic, therapeutic, and preventive approaches for human and animal diseases. It is the policy of the University that all animals used in education and research must be provided humane care and treatment.
01.03
The University is committed to maintaining the highest possible standards for the care and use of animals. The University endorses as its own the "United States Government's Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training." The University, including its investigators, researchers, teachers, students and staff, accepts responsibility for determining that research and education involving the use of animals fulfill the principles outlined in the aforementioned document.
01.04
The purpose of this policy statement is to establish and standardize procedures and regulations concerning the procurement, maintenance, handling, and disposal of all live animals for education and/or research purposes by Texas State.
01.05
Specifically, adherence to the policy set forth in this document will insure that Texas State is in compliance with regulations established by the Federal Government under the Animal Welfare Act, as described in section 01.06 and with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, whether or not federal funding is involved.
*01.06
The Animal Welfare Act is found at 7 U.S.C. 2131 et. seq. The Act's implementing regulations are published in 9 C.F.R., Title 9, Subchapter A, Parts 1-4, and are administered by the U.S. Department of Agriculture. The Animal Welfare Act regulates the transportation, purchase, sale, housing, care, handling, and treatment of animals used in research, for exhibition, and sold as pets. The Act specifically includes dogs, cats, nonhuman primates, guinea pigs, hamsters, rabbits, wild animal species, and any other warm blooded animals that the Secretary of Agriculture determines are being used or intended for use for research, testing, experimentation, exhibition purposes, or as pets. Beginning June, 1990, farm animals used in biomedical research were subject to inspection under the Act.
The Animal Welfare Act is administered by the U.S. Department of Agriculture (USDA), specifically, the Regulatory Enforcement and Animal Care Branch of the Animal and Plant Health Inspection Service (APHIS). Research facilities are subject to unannounced inspections by USDA personnel and are required to furnish annual reports that include, in addition to other information and assurances, the common names and numbers of animals used listed by procedures involving (a) no pain or distress, (b) pain or distress for which appropriate anesthetic, analgesic or tranquilizing drugs were used, and (c) pain or distress for which the use of appropriate drugs would adversely affect the procedures, results, or interpretation of the research. Routine procedures such as injections are exempt from the reporting requirements. The report must certify that anesthetic, analgesic, and tranquilizing drugs were used appropriately during research and testing, and that the principal investigator has considered alternatives to painful procedures. Noncompliance with USDA standards for the humane handling, treatment, and transportation of animals may lead to substantial fines and/or suspension of animal research activities.
The PHS Policy on Humane Care and Use of Laboratory Animals incorporates the changes in the Public Health Service Act (PHS Act) mandated by the Health Research Extension Act of 1985, Public Law 99-158. The PHS Policy, frequently referred to as National Institute of Health (NIH) Policy, requires that each institution receiving PHS funds for research involving animals submit detailed information regarding the institution's program for the care and use of animals (including all vertebrate animals) to the Office of Protection from Research Risk (OPRR). This information is in the form of an Animal Welfare Assurance and must be resubmitted at least every five (5) years. Significant changes in existing assurance status or problems encountered in implementing this policy must be reported immediately to the OPRR. The PHS requires institutions to use "The Guide for the Care and Use of Laboratory Animals" (The Guide) as a basis for developing an institutional program for activities involving laboratory animals. The Guide was developed in 1962 by the National Academy of Sciences Institute for Laboratory Animal Resources (ILAR) under contract with NIH. Its sixth revision was completed in 1996. Its purpose is to assist scientific institutions in using and caring for laboratory animals in ways judged to be professionally appropriate. It is a long-standing NIH policy that grantees and contractors using live vertebrate animals in projects or activities supported by NIH should be guided by the recommendations in this publication.
Recent amendments in the Animal Welfare Act address such issues as exercise for dogs, care of nonhuman primates to insure their psychological well-being, the composition and duties of an Institutional Animal Care and Use Committee (IACUC; See Section 02.04), adequate veterinary care and responsibilities of the attending veterinarian, training of all personnel using laboratory animals in humane methods of animal maintenance and experimentation, and record keeping. (See Section 02.07).
02. INSTITUTIONAL POLICY FOR CARE AND USE OF ANIMALS IN TEACHING AND RESEARCH
02.01
Definitions
a. Animal. Any live, vertebrate animal used or intended for use in education, research, research training, experimentation, biological testing, exhibition or for related purposes.
b. Animal Facility. Any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation. A satellite facility is any containment outside of a core facility or centrally designated or managed area in which animals are housed for more than twenty-four (24) hours. This includes all buildings, structures, farms, fish tanks, and other facilities owned or used by Texas State, such as federal and state fish hatcheries.
c. Animal Welfare Assurance or Assurance. The documentation from an institution assuring institutional compliance with Public Health Service (PHS) policy.
d. Guide. Guide for the Care and Use of Laboratory Animals, PHS, 1996 edition or succeeding revised editions.
e. Ag Guide. Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, First Edition, 1988, developed by the Consortium for Developing a Guide for the Care and Use of Agricultural Animals.
f. IACUC. A quorum of the Institutional Animal Care and Use Committee.
g. Institution. Southwest Texas State University.
h. Institutional Official. An individual who signs, and has the authority to sign, Texas State's Assurance, making a commitment on behalf of Texas State that the requirements of PHS and USDA policy are met.
i. Public Health Service. The Public Health Service or PHS includes the Alcohol, Drug Abuse, and Mental Health Administration; the Centers for Disease Control; the Food and Drug Administration; the Health Resources and Services Administration; the National Institutes of Health; and the Office of the Assistant Secretary for Health, Department of Health and Human Services.
j. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. The U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training were developed by the Inter-agency Research Animal Committee (IRAC). These principles are consistent with the guidelines that have been adopted for laboratory animal care and use at Southwest Texas State University.
k. American Association for Accreditation of Laboratory Animal Care. The American Association for Accreditation of Laboratory Animal Care (AAALAC) provides voluntary peer review and awards accreditation of laboratory animal care facilities and programs which meet its rigid standards. AAALAC judges animal care by the standards set forth in the Guide for the Care and Use of Laboratory Animals, the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, The Animal Welfare Act, and other standards. Periodic return visits and inspections are made by representatives of this organization to assure that the institution continues to meet the standards. The NIH in its current policies, accepts AAALAC accreditation as the best means of demonstrating conformance with NIH requirements for animal care and use.
l. Good Laboratory Practice Act. The Good Laboratory Practice (GLP) regulations pertain to nonclinical laboratory studies done in support of applications or marketing permits for products regulated by the Food and Drug Administration (FDA). The GLP regulations, as they apply to the use of animals, address such issues as construction and maintenance of facilities, quarantine and isolation, disease and diagnosis and treatment, animal identification, caging and routine care, sanitation, and documentation requirements.
m. American Veterinary Medical Association Panel of Euthanasia. The recommendations of the AVMA Panel on Euthanasia are the prime reference for methods of euthanasia of animals. The methods of euthanasia recommended by the American Veterinary Medical Association (AVMA) Panel on Euthanasia are considered acceptable by both the NIH Policy and the Animal Welfare Act.
n. Quorum. A majority of the members of the Institutional Animal Care and Use Committee (IACUC).
02.02
Implementation of Animal Welfare by Southwest Texas State University
a. Institutional Program for Agricultural Animal Care and Use. The following general guidelines have been adopted for the care and use of agricultural animals. The University accepts in principle the National Guidelines, prepared by a consortium of professional organizations, for the care of agricultural animals (Ag. Guide).
1) Space Requirements. Animals shall generally be provided adequate space for normal movement, changing of positions (standing, lying down, turning around, and other physical activities), and body maintenance (grooming, etc.) with respect to their size, age, condition, and expected duration of confinement. Subject to justification and Committee review, modifications may be approved for specific experiments, such as metabolism studies involving a limited number of animals. Working pens, fencing and other retention or holding facilities should be free of harmful objects or protrusions to avoid unnecessary pain, harm, or fear to the animal.
2) Transportation. Loading equipment and transport vehicles must be designed and maintained to prevent injury to animals and personnel. Animals should be protected against injuries, extreme heat or cold conditions and conform with recommendations of the Livestock Conservation Institute guidelines (trucking guide and poultry handling), considering intensity, length of trip and weather conditions.
3) Outdoor Maintenance and Protection. Animals should be maintained under conditions compatible with general comfort, health and well being. Appropriate shelter and shade will be provided to help protect animals from weather extremes and provide a thermoneutrality comfort range to a reasonable extent. Protection from extreme cold weather should be provided when necessary. Outdoor protection considerations may include breed background/adaptation, accessible natural protection, and other factors.
4) Nutrition. Minimal nutritional requirements for animals shall be provided as outlined in the National Academy of Sciences publications of nutrient requirements for domestic animals. Significant deviations from published requirements may be justified as part of research objectives. In extreme cases (such as prolonged withholding of essential nutrients), a full justification and review will be required.
5) Sanitation. Animal facilities should be kept clean and animal excrement removed on a reasonable, periodic basis. Animals should not be forced to lie in their own excrement or the excrement of others. Animals should be removed from areas that have become excessively wet and boggy (to the degree that health is jeopardized or normal movement is significantly inhibited) due to accumulation of feces, urine, or precipitation. In instances where animals are not in direct contact with accumulated excrement (pits or litter-drop systems), some accumulation of excrement may be acceptable. The accumulation of harmful odors and gases (such as ammonia) should be minimized.
6) Animal Identification. Animals should be individually identified, and retain identity during research studies. Ear tags, neck chains, and other methods may be utilized. When branding is merited or essential for identification, freeze branding is recommended.
7) Maintenance and Treatment. Animal care procedures shall meet or exceed those in commercial practices; major consideration should be given to humane and sanitary care in handling and treating animals, including castration, dehorning, and other cultural practices.
8) Standard Agricultural Practices. Certain commercial husbandry procedures that may cause temporary discomfort or pain are performed to sustain long-term welfare of animals. These practices are acceptable as standard procedures provided they are 1) warranted in agricultural production; 2) performed by or under the supervision of capable personnel; and 3) performed with precautions to reduce pain, stress, and infection.
9) Protocols. It shall be the responsibility of the research investigator or instructor to design experiments or activities involving animals to assure compliance with the Ethics of Animal Experimentation and Use and Biologically Sound Experimental Practices for the reasonable care and use of agricultural animals.
10) Surgery. Surgical, metabolic and other physiological and biological studies should be conducted with appropriate facilities, adequate equipment, and under the direction and supervision of qualified personnel for sanitation and protection of animals, including both operative and post-operative recovery.
11) Posted Information and Emergency Procedures. A list of names and points of contact should be displayed, (such as the responsible animal caretaker or the Ranch Manager, key researchers, emergency/weekend telephone numbers, and feeding and inspection schedules) near the entrance to each livestock facility/building/pasture. Instructions should be provided indicating who should be notified in the event of an emergency (i. e., escaped animals, power failure, fire, sick animals, or animals in extreme pain) and reporting procedures regarding concerns about animal welfare. A code of ethics (provided by the IACUC) will be posted near the entrance to each livestock center/unit. Employees will be expected to conduct themselves in accordance with the code of ethics.
12) Concerns Regarding Animal Care/Abuse. People who observe or are informed of animal care which they consider to be substandard, inhumane, or detrimental should immediately report their concern to the chairperson of the IACUC or his/her designated representative (24 hours per day). The concern will be immediately investigated.
The animal caretaker, principal investigator, and the appropriate departmental chairperson will be notified and corrective action taken if a legitimate concern exists. The IACUC will review the concern at its next regular meeting.
If an animal is discovered to be in significant pain due to injury or other cause, and after a reasonable effort to notify the person responsible for the animal has failed, or those responsible fail to take immediate action, the IACUC chairperson, or a designated representative, has the authority to immediately direct alternative care, administer analgesics, or euthanize the animal as appropriate. Such cases will be reviewed by the IACUC with a report to the appropriate departmental chairperson.
b. Institutional Program for Laboratory Animal Care and Use. The institution will implement policies that will enable it to obtain an approved Animal Welfare Assurance from OPRR in the event that PHS funding is obtained. The Assurance shall be typed on Texas State's letterhead and signed by the Institutional Official. All Assurances submitted to the PHS will be evaluated by OPRR to determine the adequacy of Texas State's proposed program for the care and use of animals. On the basis of this evaluation, OPRR may approve or disapprove the Assurance, or negotiate an Assurance with Texas State. Approval of an Assurance will be for a specified period of time (no longer than five years) after which time Texas State will submit a new Assurance to OPRR. OPRR may limit the period during which any approved Assurance shall remain effective.
1) Institutional Program for Laboratory Animal Care and Use. The Assurance shall fully describe Texas State's program for the care and use of laboratory animals. The PHS requires institutions to use the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for developing and implementing an institutional program for activities involving laboratory animals. The program description will include the following:
a) a list of every branch and major component of Texas State, as well as a list of every branch and major component of any other institution, which is to be included under the Assurance;
b) the lines of authority and responsibility for administering the program and ensuring compliance with institutional policy;
c) the qualifications, authority, and responsibility of the veterinarian(s) who will participate in the program and the percent of time each will contribute to the program;
d) the membership list of the Institutional Animal Care and Use Committee(s)/(IACUC) established in accordance with the requirements set forth in section 02.04 b. of this policy;
e) the procedures which the IACUC will follow to fulfill the requirements set forth in this policy;
f) the health program for personnel who work in laboratory animal facilities or have frequent contact with animals;
g) a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment, or use;
h) the gross square footage of each animal facility (including satellite facilities), the species housed therein and the average daily inventory, by species, of animals in each facility; and
i) any other pertinent information requested by OPRR.
02.03
Institutional Status. Texas State will assure that its program and facilities are in one of the following categories:
a. Category 1 - Accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC). All of Texas State's programs and facilities (including satellite facilities) for activities involving animals will be evaluated and accredited by AAALAC, or another accrediting body recognized by PHS. All of Texas State's programs and facilities (including satellite facilities) for activities involving animals will also be evaluated by the IACUC and re-evaluated by the IACUC at least once every six (6) months, in accordance with section 02.04 d. of this policy and reports prepared in accordance with section 02.08 of this policy; or
b. Category 2 - Evaluated by the Institution. All of Texas State's programs and facilities (including satellite facilities) for activities involving animals will be evaluated by the IACUC and will be re-evaluated by the IACUC at least once every six (6) months, in accordance with section 02.05 a. of this document and reports prepared in accordance with section 02.08 of this policy. The initial report of the IACUC evaluation shall be submitted to OPRR with the Assurance.
02.04
Institutional Animal Care and Use Committee (IACUC)
a. The Chief Executive Officer (Texas State President) shall appoint an Institutional Animal Care and Use Committee (IACUC), as described in Section 03 of this document.
b. The committee shall consist of no fewer than six (6) members, and shall include at least:
1) one (1) Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving laboratory animals at Texas State;
2) one (1) Doctor of Veterinary Medicine experienced in disease prevention and animal health procedures associated with farm animals;
3) one (1) practicing scientist experienced in large animal nutrition and growth requirements;
4) one (1) practicing scientist experienced in research involving laboratory animals;
5) one (1) member whose primary concerns are in a nonscientific area (for example, ethicist, lawyer, member of the clergy); and
6) one (1) individual who is not affiliated with Texas State in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with Texas State.
c. An individual who meets the requirements of more than one (1) of the categories may fulfill more than one requirement. However, no committee will consist of fewer than six (6) members.
d. Functions of the Institutional Animal Care and Use Committee (IACUC). As an agent of Texas State, the IACUC shall with respect to activities in which animals are involved:
1) review at least once every six (6) months Texas State's program for humane care and use of animals, using the appropriate Guide as a basis for evaluation;
2) inspect at least once every six (6) months all of Texas State's animal facilities (including satellite facilities) using the appropriate Guide as a basis for evaluation;
3) prepare reports of the IACUC evaluations conducted as required by PHS Policy, and submit the reports to the Institutional Official. The reports shall be updated at least once every six (6) months upon completion of the required semiannual evaluations and shall be maintained by Texas State and made available to OPRR upon request. The reports will contain a description of the nature and extent of Texas State's adherence to the appropriate guides and will identify specifically any departures from the provisions of the appropriate guides and PHS Policy, and will state the reasons for each departure. The reports will distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which in the judgment of the IACUC and the Institutional Official is or may be a threat to the health or safety of the animals. When program or facility deficiencies are noted, the reports will contain a reasonable and specific plan and schedule for correcting each deficiency;
4) review concerns involving the care and use of animals at Texas State;
5) make recommendations to the Institutional Official regarding any aspect of Texas State's animal program, facilities, or personnel training;
6) review and approve, require modifications in (to secure approval) or withhold approval of those components of activities related to the care and use of animals as specified in this document;
7) review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and
8) be authorized to suspend an activity involving animals in accordance with the specifications set forth in this document.
02.05
Review of Educational and/or Research Projects
a. In order to approve proposed projects or proposed significant changes in ongoing projects, the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed projects are in accordance with this document. In making this determination, the IACUC shall confirm that the project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the project, and that the project is consistent with the appropriate Guide unless acceptable justification for a departure is presented. Further, the IACUC shall determine that the project meets the following requirements:
1) Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals.
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 the absence of sedative, analgesia or anesthesia is justified for scientific reasons in writing by the investigator.
3) Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly sacrificed 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 non-medical 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) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator (Journal of the American Veterinary Medical Association, 1986, Vol. 188, No. 3, pp. 252-268, or succeeding revised editions). Copies of these recommendations are available from the IACUC Chairperson or from APHIS.
b. Prior to the review, each IACUC member shall be provided with a list of proposed projects to be reviewed. Written descriptions of projects that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full committee review of those research projects. If full committee review is not requested, at least one (1) member of the IACUC, designated by the chairperson and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval) or request full committee review of those research projects. If full committee review is requested, approval of those research projects 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 research project in which the member has a conflicting interest (e. g., is 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.
c. The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC.
d. The IACUC shall notify investigators in writing or electronically of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
e. The IACUC shall conduct continuing review of activities covered by this document at appropriate intervals as determined by the IACUC, but not less than once each year. This document will be reviewed on every three years as described in section 07.
f. The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, The Ag. Guide, Texas State's Assurance, or this document. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present.
g. If the IACUC suspends an activity involving animals, the Institutional Official in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OPRR.
h. Applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by officials of Texas State. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC.
02.06
Information Required in Applications and Proposals for Awards. Applications and proposals for awards submitted to external funding sources that involve the care and use of animals shall contain the following information:
a. identification of the species and approximate number of animals to be used;
b. rationale for involving animals, and for the appropriateness of the species and numbers to be used;
c. a complete description of the proposed use of the animals;
d. a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and
e. a description of any euthanasia method to be used.
02.07
Record Keeping Requirements
a. The Institutional Official of Texas State shall maintain:
1) an Assurance which has been either approved or deemed provisionally acceptable by the OPRR;
2) minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations;
3) records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld; and
4) records of semiannual IACUC reports and recommendations (including minority views); and records of accrediting body determinations.
b. All records shall be maintained for at least three (3) years; records that relate directly to applications, proposals, and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three (3) years after completion of the activity. All records shall be accessible for inspection and copying by authorized OPRR or other PHS representatives at reasonable times and in a reasonable manner.
02.08
Reporting Requirements during times of PHS funding
a. At least twice every twelve (12) months, the IACUC, through the Institutional Official, shall report in writing to OPRR:
1) any change in Texas State's program or facilities which would place Texas State in a different category than specified in its Assurance;
2) any change in the description of Texas State's program for animal care and use as required by section 02.03 of this document;
3) any changes in the IACUC membership; and
4) notice of the dates that the IACUC conducted its semiannual evaluations of Texas State's program and facilities and submitted the evaluations to the Institutional Official.
b. At least two (2) times every twelve (12) months, the IACUC, if it has no changes to report, shall submit a letter, through the Institutional Official, to OPRR stating that there are no changes and informing OPRR of the dates of the required IACUC evaluations and submissions to the Institutional Official.
c. The IACUC, through the Institutional Official, shall promptly provide OPRR with a full explanation of the circumstances and actions taken with respect to:
1) serious or continuing noncompliance with this document;
2) any serious deviation from the provisions of the appropriate Guide;
3) any suspension of an activity by the IACUC;
4) reports filed under section 02.08 of this document shall include any minority views filed by members of the IACUC.
02.09
Recognition of the Authority of the Office for Protection from Research Risks (OPRR). Texas State recognizes that OPRR has the authority to:
a. request and negotiate, approve or disapprove, and, as necessary, restrict or withdraw approval of Assurances;
b. distribute to executive secretaries of initial review and technical evaluation groups and to PHS awarding units lists of institutions that have an approved Assurance;
c. advise awarding units and awardee institutions concerning the implementation of animal care policy;
d. evaluate allegations of noncompliance with PHS Policy;
e. have the authority to review and approve or disapprove waivers to PHS Policy;
f. conduct site visits to Texas State.
03. PROCEDURE FOR APPOINTMENT OF THE INSTITUTIONAL OFFICIAL AND THE IACUC
*03.01
Appointment of the Institutional Official. The President of Texas State will designate an Institutional Official who has the authority to sign assurances and documents required for Texas State. This official will be the designated Associate Vice President for Research and Sponsored Programs.
03.02
Appointment and Responsibilities of the Chairperson of the IACUC.
a. The Institutional Official will appoint the chairperson of the IACUC.
b. The IACUC Chairperson will be appointed from existing Texas State faculty, will be a scientist with a Ph.D., D.V.M., or M.D. degree, and will have experience in animal research and with federal regulations concerning animal research.
c. The IACUC Chairperson will be responsible for implementing the policy described in this document, as noted in section 05.
d. The IACUC Chairperson will be responsible to the Institutional Official named in section 02.01
h. The IACUC Chairperson will serve in this capacity for a renewable three (3) year term.
03.03
Appointment of the IACUC. Upon the recommendation of the IACUC Chairperson, the Institutional Official will appoint the members of the IACUC committee in accordance with section 02.04 b. The members of the committee will serve for a renewable three (3) year term.
03.04
Compensation for the Chairperson of the IACUC. Compensation for the duties of the IACUC Chairperson shall consist of appropriate release time for the faculty person usually equivalent to the teaching of one (1) course during the fall or spring semesters or during one (1) summer session.
04. PROCEDURES FOR APPLICATION FOR APPROVAL TO USE ANIMALS, MEETINGS, AND VOTING OF THE IACUC
*04.01
Application for Approval to Use Animals. Individuals seeking approval for use of animals shall provide the IACUC Chairperson with a written or electronic proposal indicating in detail the planned use of animals, and will provide evidence to their competence in the handling and use of animals (see section 05.03 b.). The IACUC Chairperson will provide a form for this application.
04.02
Application for Extramural and/or Intramural Funds for Activities Involving Animals. In addition to the requirements in section 04.01, individuals seeking extramural and/or intramural funding for activities involving animals shall include in their proposals the specific information required in section 02.06 above. These individuals will also provide a completed form as indicated in section 04.01.
a. The Associate Vice President for Research and Sponsored Programs shall require approval of the proposal by the IACUC to be obtained prior to the submission of the proposal to the funding agency. The routing cover sheet for proposals shall allow for the signature of the chairperson of the IACUC, indicating approval of the IACUC.
b. Grant funds will be budgeted to cover procurement and per diem costs of animals.
c. Upon approval of the proposal by the IACUC, the IACUC Chairperson will sign the routing sheet and issue a letter to the funding agency indicating approval of the proposal by the IACUC.
*04.03 Meetings of the IACUC.
Meetings of the IACUC will be held semiannually and as required to approve proposals or review programs already in progress. The IACUC Chairperson will provide each committee member with written descriptions of the projects prior to the meetings as described in section 02.05. The IACUC Chairperson will convene these meetings.
04.04
Voting Policy of the IACUC. Voting policy is described above in section 02.05.
05. PROCEDURE FOR INSPECTION, PROCUREMENT, MAINTENANCE, AND DISPOSAL OF ANIMALS
05.01
Inspection
a. All Texas State animal housing facilities, as defined in section 02.01 b. will be inspected at least once every six (6) months by the IACUC or its delegate. The appropriate Guide will be used to determine compliance with Texas State policy. Written notice of non-compliance will be given the responsible person and the Institutional Official.
b. All animal handling facilities, including surgeries, restraining devices, and any structure or device used for the temporary restraint and/or manipulation of animals will be inspected monthly by the IACUC Chairperson or an assistant, and at least once every six (6) months by the IACUC. The appropriate Guide will be used to determine compliance with Texas State policy. Written notice of non-compliance will be given the responsible person and the Institutional Official.
05.02
Procurement
a. Application for approval to use animals will be made prior to procurement of animals for use at Texas State, as described in sections 04.01 and 04.02. Upon approval, the Chairperson of the IACUC will assign the applicant an approval number. All procurement procedures will comply with the appropriate Guide.
*b. The Texas State Director of Procurement Services will be instructed not to process any purchase order for animals, as defined in section 02.01 a., which do not include an approval number from the IACUC.
05.03
Training of persons involved in care and use of animals. Qualified Texas State faculty and/or consultants from nearby facilities such as the University of Texas at Austin which have approved animal care programs will provide training of all persons involved in the care and use of laboratory animals at Texas State. Other training options include written, video or audio programs prepared for this use. The chair of the IACUC will have the authority to administer tests to determine knowledge of animal care and to deny access to and use of animals to persons which have not shown proficiency in animal care. This training will include:
a. Diagnostic testing to determine knowledge of animal care and use;
b. Provision of materials to remediate areas of deficiency in the knowledge of animal care;
c. Further examination until proficiency in animal care and knowledge of regulations regarding animal care is demonstrated.
*05.04
Disposal. Animal carcasses will be disposed of according to the recommendations published in the Guide. Specifically, animal carcasses may be stored prior to disposal in dedicated cool rooms, refrigerators or freezers. Animal carcasses will be placed in plastic bags and transported to containment facilities (dumpsters) for pick up by a licensed, commercial waste-disposal firm. Animals exposed to radioactive materials will be disposed of with radioactive waste.
06. THE ANIMAL RIGHTS MOVEMENT
06.01
Awareness by Administration of Possible Interference with University Animal Care and Use
a. The Institutional Official will be aware that there may be people or organizations which may take action to interfere illegally with legitimate university activities involving the care and use of animals. This official should be informed of such activities elsewhere and be prepared to act in the event of such an occurrence at Texas State.
07. MAJOR RESPONSIBILITIES ASSOCIATED WITH THIS DOCUMENT
07.01
Major responsibilities for assignments associated with this document include the following:
Position Section Date
IACUC Chairperson Review, 01, Jan 1 E3Y 03, 04
Institutional Official Review, 02 Jan 1 E3Y
(Assoc. Vice President
for Research and
Sponsored Programs)*
Manager, Grants Review, 02 Jan 1 E3Y Accounting
07.02
The policy set forth in this document will be changed as required by future changes in federal law.
*08. CERTIFICATION STATEMENT
This UPPS has been approved by the following individuals in their official capacities, and represents Texas State policy and procedure from the date of this document until superseded.
Dr. Dana Garcia, Chair, Institutional Animal Care and Use Committee; senior reviewer of this UPPS
Dr. Billy Covington, Associate Vice President for Research and Sponsored Programs; reviewer of this UPPS
Mr. Robert Cavendish, Manager, Grants Accounting; reviewer of this UPPS
Dr. Robert D. Gratz, Vice President for Academic Affairs
Dr. Jerome H. Supple, President