Animal
Care and Use Policy UPPS No. 02.02.05
Issue
No. 3
Effective
Date: 08/14/2008
Review:
January 1 E3Y
01.01 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, agricultural, and ecosystem processes, as well as, 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.
01.02 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.
01.03 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 research purposes by Texas State.
01.04 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.
01.05 The
Animal Welfare Act is found at 7 U.S.C., Sections 2131-2159. 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 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, as amended in 2002. 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 Laboratory Animal Welfare (OLAW). This information is
in the form of an Animal Welfare Assurance and must be resubmitted at least
every five years. Significant changes in existing assurance status or problems encountered
in implementing this policy must be reported immediately to the OLAW. 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.
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. Control of feral animals, nuisance species, exotics,
or other uses outside of the above uses do not require Institutional Animal
Care & Use Committee (IACUC) approval, but may require permitting by other
agencies as appropriate to the taxa.
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 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 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
– Texas State University-San Marcos.
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 Texas State University-San
Marcos.
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 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 Texas State University-San Marcos
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 thermo neutrality 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 will 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 a) warranted in agricultural production; b) performed by or under the
supervision of capable personnel; and c) 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 and 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 or 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 or 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.
13) Agricultural Animals for Market.
The operation of the Freeman Ranch includes animals not used in research,
education, or outreach with the primary purpose of market production. Care of these livestock will meet all
above guidelines and will be likewise inspected alongside IACUC protocol
animals. As market production is
not an IACUC activity, per se, annual activities will be conducted under the
best management practices (BMPs) for the Freeman Ranch with inspections and any
necessary modifications by the IACUC in the absence of a specific IACUC
protocol for these market livestock activities.
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 OLAW 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 OLAW to determine the
adequacy of the University's proposed program for the care and use of animals.
On the basis of this evaluation, OLAW 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 OLAW. OLAW 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 (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 OLAW.
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 the institution’s programs and facilities
(including satellite facilities) for activities involving animals will be
evaluated under guidelines applicable for accreditation by AAALAC, or another
accrediting body recognized by PHS. All of the Institution’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 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 the institution’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 months, in accordance with Section 02.04 d. of this policy
and reports prepared in accordance with Section 02.08 of this policy. The
initial report of the IACUC evaluation shall be submitted to OLAW 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 members, and shall include at
least:
1) one
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; or one Doctor of
Veterinary Medicine experienced in disease prevention and animal health
procedures associated with farm animals;
2) one
practicing scientist experienced in research involving field studies of
vertebrates;
3) one
practicing scientist experienced in large animal nutrition and growth
requirements;
4) one
practicing scientist experienced in research involving laboratory animals;
5) one
member whose primary concerns are in a nonscientific area (for example,
ethicist, lawyer, member of the clergy); and
6) one
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 of the categories may
fulfill more than one requirement. However, no committee will consist of fewer
than six 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 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 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 months upon completion of the required semiannual
evaluations and shall be maintained by Texas State and made available to OLAW
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 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 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 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. The Chair of the IACUC
may intervene in the event of existing threats to animal welfare, departure
from protocol, or other extraordinary circumstances to immediately rectify the
situation prior to the quorum meeting of the IACUC for review.
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 such action with a full explanation
to OLAW.
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 OLAW;
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 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 years after completion
of the activity. All records shall be accessible for inspection and copying by
authorized OLAW 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 months, the IACUC, through the Institutional Official,
shall report in writing to OLAW:
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 times every twelve
months, the IACUC, if it has no changes to report, shall submit a
letter, through the Institutional Official, to OLAW stating that there are no
changes and informing OLAW of the dates of the required IACUC evaluations and
submissions to the Institutional Official.
c. The
IACUC, through the Institutional Official, shall promptly provide OLAW 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 Laboratory Animal Welfare (OLAW). Texas
State recognizes that OLAW 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. review
and approve or disapprove waivers to PHS Policy;
f. conduct
site visits to Texas State.
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 03.01. The IACUC Chairperson will serve in this capacity for a renewable
three 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 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 course during the fall or spring
semesters or during one summer session or salary compensation equivalent to
that of one summer session.
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 or Intramural Funds for Activities Involving Animals. In addition
to the requirements in Section 04.01, individuals seeking extramural 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
Assistant Vice President for Research 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,
inclusive of labor costs associated with maintenance of the animals.
c. Upon
approval of the proposal by the IACUC, the IACUC Chairperson will provide
confirmation of approval for submission 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.
05.01 Inspection
a. All
Texas State animal housing facilities, as defined in Section 02.01 b. will be
inspected at least once every six 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 manipulation of
animals will be inspected monthly by the IACUC Chairperson or an assistant, and
at least once every six 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 to 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 Purchasing 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 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 Chairperson 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;
and
c. Further
examination until proficiency in animal care and knowledge of regulations
regarding animal care is demonstrated.
05.04 Texas
State is committed to best management practices which seek to prevent the spread
or introduction of invasive or non-native organisms, hereafter, biopollution. Researchers
utilizing vehicles, equipment, or other potential vectors of biopollution in
their research or investigations will act in accordance with Hazard Analysis
and Critical Control Point (HAACP) Natural resource management (NRM). The
HAACP-NRM methods for preventing the spread or introduction of nuisance species
provide a long-term benefit to the systems in which our research, education,
and outreach activities are conducted.
05.05 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.
06.01 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.
07.01 Reviewers
of this UPPS include the following:
Position Date
IACUS Chairperson January
1 E3Y
Assistant Vice President for Research January 1 E3Y
07.02 The
policy set forth in this document will be changed as required by future changes
in federal law.
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.
Chair,
Institutional Animal Care and Use Committee; senior reviewer of this UPPS
Associate
Vice President for Research & Federal Relations
Provost
and Vice President for Academic Affairs
President