Animal
Care and Use Policy UPPS No. 02.02.05
Issue
No. 4
Effective
Date: 09/12/2011
Review:
January 1 E3Y
01.01 Texas
State University-San Marcos 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 Texas State’s policy to provide all animals
used in education and research with humane care and treatment.
01.02 Texas
State is committed to maintaining the highest possible standards for the care
and use of animals. Texas State endorses as its own, the "United States
Government's Principles for the Utilization and Care of Vertebrate Animals Used
in Testing, Research, and Training." Texas State, 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 01.05 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
U.S. Department of Agriculture administers the Animal Welfare Act (7 U.S.C.
Sections 2131-2159) and its implementing regulations, published in 9 C.F.R.,
Title 9, Subchapter A, Parts 1-4. 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. Non-compliance 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 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). At least every five years, the
university must resubmit this information in the form of an Animal Welfare
Assurance. The university must report significant changes in existing assurance
status or problems encountered in implementing this policy to the OLAW
immediately. 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. In 1962, the
National Academy of Sciences Institute for Laboratory Animal Resources (ILAR)
developed the Guide under contract with NIH. Its purpose is to assist
scientific institutions in using and caring for laboratory animals in ways
judged to be professionally appropriate. NIH policy dictates that grantees and
contractors using live vertebrate animals in projects or activities supported
by NIH use the recommendations in this publication for guidance.
01.06 The
policy set forth in this document will be changed as required by future changes
in federal law.
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 a containment outside a core facility or centrally-designated
or managed area that houses animals for more than 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 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 Texas State has
adopted for laboratory animal care.
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. Representatives of
this organization make periodic visits and inspections to assure the
institution meets the standards. Representatives of this organization make
periodic visits and inspections to assure the institution meets 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 (AVMA) – The
recommendations of the AVMA Panel on Euthanasia are the prime reference for
methods of euthanasia of animals. The methods of euthanasia by the AVMA Panel
on Euthanasia are considered acceptable by both the NIH Policy and the Animal
Welfare Act.
n. Quorum
– A majority (more than half) 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. The
AAALAC provides voluntary peer review and awards accreditation of laboratory
animal care facilities and programs meeting its rigid standards.
1) Space
Requirements – Generally, animals shall receive adequate space for
normal movement, changing position (standing, lying down, turning around, and
other physical activities), and body maintenance (grooming, etc.) with respect
to their size, age, condition, and expected confinement duration. Subject to
justification and committee review, the institution may approve modifications
for specific experiments, such as metabolism studies involving a limited number
of animals. The institution will ensure working pens, fencing, and other
retention or holding facilities are free of harmful objects or protrusions to
avoid unnecessary pain, harm, or fear to the animal.
2) Transportation
– The institution will ensure loading equipment and transport vehicles
are built and maintained to prevent animal and personnel injuries, and protect
animals against extreme heat or cold conditions as the Livestock Conservation
Institute guidelines (trucking guide and poultry handling) recommend,
considering intensity, trip length, and weather conditions.
3) Outdoor Maintenance and Protection – Animals should be maintained under conditions compatible with general comfort, health and well being. To help protect animals from weather extremes, the institution will provide appropriate shelter and shade and a thermo neutrality comfort range to a reasonable extent. Outdoor protection considerations may include breed background or adaptation, accessible natural protection, and other factors.
4) Nutrition
– Minimal animal nutritional requirements are provided as outlined in the
National Academy of Sciences publications of nutrient requirements for domestic
animals. As part of research objectives, the institution may justify
significant deviations from published requirements. In extreme cases (such as
prolonged withholding of essential nutrients), a full justification and review
will be required.
5) Sanitation
– The institution will keep animal facilities clean and will remove
animal excrement on a reasonable periodic basis. It will not force animals to
lie in their own excrement or that of other animals. When areas become
excessively wet and boggy (to the degree that jeopardizes health or
significantly inhibits normal movement) due to precipitation or feces or urine
accumulation, the institution will remove the animals. In instances where
animals are not in direct contact with excrement (pits or litter-drop systems),
some excrement accumulation is acceptable. The accumulation of harmful odors
and gases (such as ammonia) should be minimized.
6) Animal
Identification – During research studies, the institution will
identify each animal individually and retain its identity, using ear tags, neck
chains, and other methods. 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 with major consideration given to humane and sanitary care
in handling and treating animals, including castration, dehorning, and other
cultural practices.
8) Standard
Agricultural Practices – Long-term animal welfare may necessitate
certain commercial husbandry procedures that may cause temporary discomfort or
pain. The Act accepts these practices 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
– The research investigator or instructor must design animal experiments
or activities that comply with the Ethics of Animal Experimentation and Use and
Biologically Sound Experimental practices for the reasonable care and use of
agricultural animals.
10)Surgery – The
institution will conduct surgical, metabolic and other physiological and
biological studies with appropriate facilities, adequate equipment, and under
the direction and supervision of qualified personnel for animal sanitation and
protection, including both operative and post-operative recovery.
11)Posted Information and Emergency Procedures – The institution will display a list of names and points of contact (i.e., responsible animal caretaker or ranch manager, key researchers, emergency or weekend telephone numbers, and feeding and inspection schedules) near the entrance to each livestock facility, building or pasture. It will provide instructions regarding which personnel to notify in the event of an emergency (i.e., escaped animals, power failure, fire sick animals, or animals in extreme pain) and reporting procedures regarding animal welfare concerns. The institution expects employees to conduct themselves according to the IACUC code of ethics that it will post near the entrance to each livestock center or unit.
12)Concerns Regarding Animal Care
or Abuse – People who observe or are informed of substandard,
inhumane, or detrimental animal care must immediately report their concern to
the IACUC chair or a designated representative (24 hours a day), who will
investigate the concern immediately. The IACUC chair or designated
representative will then notify the animal caretaker, principal investigator,
and the appropriate departmental chair, who will take corrective action if a
legitimate concern exists. If an animal is found 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 chair or a designated representative has the authority to
immediately direct alternative care, administer analgesics, or euthanize the
animal as appropriate. The IACUC will review such cases and issue a report to
the appropriate departmental chair.
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 inspections will be done
alongside IACUC protocol animals. As market production is not an IACUC
activity, per se, Freeman Ranch will use the best management practices (BMPs)
for the annual activities with inspections and any necessary modifications by
the IACUC in the absence of a specific IACUC protocol for these market
livestock activities.
b. The
institution will implement policies that will enable it to maintain approved
OLAW Animal Welfare Assurance in the event that PHS funding is applied for or
ongoing. The institutional official will type the Assurance on Texas
State’s letterhead, sign it, and submit it to the PHS for OLAW evaluation
to determine the adequacy of the university’s proposed animal care and
use program. All Assurances submitted to the PHS will be evaluated by OLAW to
determine the adequacy of Texas State's proposed program for the care and use
of animals. An Assurance is approved for a specified period, not longer than
five years, after which time Texas State must submit a new Assurance to OLAW. On the basis of this evaluation, OLAW
may approve or disapprove the Assurance, or negotiate an Assurance with Texas
State. An Assurance is approved for a specified period, not 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 of any
other institution 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 who will
participate in the program and the percent of time each will contribute to the
program;
d) the
membership list of the 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
AAALAC. The institution will evaluate all of its programs and facilities
(including satellite facilities) for activities involving animals under
guidelines applicable for AAALC accreditation or another accrediting body
recognized by PHS. The IACUC will evaluate all of the institution’s
programs and facilities (including satellite facilities) for activities
involving animals and will re-evaluate these same programs at least once every
six months, in accordance with Section 02.04 d. and reports prepared in
accordance with Section 02.08; or
b. Category 2 – Evaluated by the
Institution. The IACUC will evaluate all of the institution’s programs
and facilities (including satellite facilities) and will re-evaluate them at
least once every six months, in accordance with Section 02.04 d. and prepare
reports in accordance with Section 02.08. The IACUC will submit the
evaluation’s initial report, along with the Assurance, to the OLAW.
02.04 Institutional
Animal Care and Use Committee (IACUC)
a. The
chief executive officer (Texas State president) shall appoint an 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 IACUC. As an agent of Texas State, the IACUC shall, with respect to teaching
and research activities involving animals:
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. At least every six months,
upon completion of the required semi-annual evaluations, the IACUC will update
the reports, making certain to maintain the reports and make them 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 constitute a threat to the animals’ health and safety. 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) have
authorization to suspend any activity involving animals in accordance with
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 review those components related to animal care and
use, and determine whether the proposed projects agree with this document. In
making this determination, the IACUC shall confirm that the institution will conduct
the project in accordance with the Animal Welfare Act insofar as it applies to
the project, and that the project complies with the appropriate Guide unless
the institution presents acceptable justification for a departure. 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 chair or from APHIS.
b. Prior
to the review, each IACUC member will receive a list of proposed projects to
review. All IACUC members will have access to written descriptions of projects
that involve the care and use of animals, and any IACUC member may obtain, upon
request, full committee reviews of those research projects. If full committee
review is not requested, at least one member of the IACUC, designated by the
chair 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, the IACUC may grant approval of those research
projects 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. The IACUC will review this document 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
that protocol 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 used.
02.07 Record
Keeping Requirements
a. The
institutional official of Texas State shall maintain:
1) an
Assurance that OLAW has either approved or deemed provisionally acceptable;
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 semi-annual IACUC reports and recommendations (including minority views);
and records of accrediting body determinations.
b. The institution will maintain all records 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 will 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 that 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 semi-annual 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 non-compliance with this document;
2) any
serious deviation from the provisions of the appropriate Guide;
3) any
suspension of an activity by the IACUC; and
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 non-compliance with PHS policy;
e. review
and approve or disapprove waivers to PHS policy; and
f. conduct
site visits to Texas State.
03.02 Appointment
and Responsibilities of the chair of the IACUC.
a. The
institutional official will appoint the IACUC chair from existing Texas State
faculty. The chair must have a Ph.D., D.V.M. or M.D. degree in a scientific
discipline and have experience in animal research and with federal regulations
concerning animal research.
b. The
IACUC chair will implement the policy as described in Section 05.
c. The IACUC chair will report to the
institutional official named in Section 03.01 and will serve in this capacity
for a renewable three-year term.
03.03 Appointment
of the IACUC: Upon the recommendation of the IACUC chair, 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 chair of the IACUC. Compensation for the duties of the IACUC chair
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 chair 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
chair 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 chair of the IACUC, indicating approval of the IACUC.
b. The
budget for grant funds to cover procurement and per diem costs of animals will
include labor costs associated with animal maintenance.
c. Upon
approval of the proposal by the IACUC, the IACUC chair 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. The IACUC will hold meetings semi-annually and as required to
approve proposals or review programs already in progress. The IACUC chair will
provide each committee member with written descriptions of the projects prior
to the meetings as described in Section 02.05. The IACUC chair will convene
these meetings.
04.04 Voting
Policy of the IACUC: Voting policy is described above in Section 02.05.
05.01 Inspection
a. At least every six months, the IACUC
or its delegate will inspect all Texas State animal housing facilities, as
defined in Section 02.01 b. The IACUC will use the appropriate Guide to
determine compliance with Texas State policy, with written notice of
non-compliance given to the responsible person and the institutional official.
b. Every six months, the IACUC chair or
an assistant will inspect all animal handling facilities, including surgeries,
restraining devices, and any structure or device used for the temporary
restraint or manipulation of animals. The IACUC, the IACUC chair or an
assistant will use the appropriate Guide to determine compliance with Texas
State policy, with written notice of non-compliance given to the responsible
person and the institutional official.
05.02 Procurement
a. Application
for approval to use animals must be made prior to procurement of animals for
use at Texas State, as described in Sections 04.01 and 04.02. Upon approval,
the chair 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 not approve any purchase order for animals, as defined
in Section 02.01 a., that does not include an IACUC approval number.
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 that 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 that 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 that seek to prevent the spread
or introduction of invasive or non-native organisms, hereafter, bio-pollution.
Researchers utilizing vehicles, equipment, or other potential vectors of bio-pollution
in their research or investigations will act in accordance with Hazard Analysis
and Critical Control Point (HACCP) Natural Resource Management (NRM). The HACCP-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:
The Guide contains recommendations for disposal of animal carcasses. Prior to
disposal, the institution may store carcasses in dedicated cool rooms,
refrigerators or freezers. The institution will place animal carcasses in
plastic bags and transport to containment facilities by licensed,
commercial-waste-disposal firms. Animals exposed to radioactive materials are
disposed of with radioactive waste.
06.01 Awareness
by Administration of Possible Interference with Texas State’s Animal Care
and Use
a. The
institutional official shall maintain awareness of people or organizations that
may illegally interfere with legitimate institution 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
IACUC Chair January
1 E3Y
Assistant Vice President for Research January 1 E3Y
and Federal Relations
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
Assistant Vice President for Research
& Federal Relations
Associate Vice President for Research
& Federal Relations
Provost and Vice President for Academic
Affairs
President