UCLA's Animal Care and Use Program
Regulatory Requirements
UCLA's animal care and use
program is guided by a complex set of federal and state laws, regulations, and
guidelines, and by additional institutional policies implemented to
systematically address federal requirements and as the result of a voluntary
accreditation process.
The Public Health Service
Policy on Humane Care and Use of Animals
(PHS Policy) and USDA Animal Welfare Regulations
(AWRs) provide the primary regulatory basis for the existence and function of
the Institutional Animal Care and Use Committee (IACUC), which must be
established at any institution that receives PHS funding for vertebrate
animal-based research, and/or which conducts animal-based research involving
vertebrate animal species regulated by the USDA AWRs.
PHS Policy requires that all
institutions base their animal care and use programs on the Guide for the
Care and Use of Laboratory Animals
(the Guide), and that euthanasia be consistent with the most current
American Veterinary Medical Association (AVMA) Guidelines on Euthanasia.
The PHS Policy also endorses the US Government Principles for the Utilization
and Care of Vertebrate Animals Use in Testing, Research and Training,
which form the foundation for ethical and humane care and use of laboratory
animals in the United States
UCLA is also subject to
additional standards that go above and beyond the regulatory requirements by
maintaining accreditation through the Association for Assessment and
Accreditation of Laboratory Animal Care (AAALAC) International. Since 1984, the
UC Office of the President has mandated that all UC campuses obtain
accreditation through AAALAC.
Depending on the nature of a
protocol (for example, studies involving biohazardous agents, radioactive
materials, or threatened/endangered animal species), other federal, state, and
local laws, regulations, and policies may also be applicable.
The regulations are set forth
with the ultimate goal of ensuring replicable, generalizable research data.
This, in turn, requires standardization of care and humane treatment of
animals. Stressed or unhealthy animals make poor study subjects--they do not
provide good data and can introduce uncontrolled variability in the research
results. If valid, reproducible data cannot be obtained, the use of animals
cannot be ethically justified. The established laws and regulations, therefore,
function to prescribe a commonly understood basis for ensuring that humane
standards are maintained for the care of animals.
The Institutional Official
Each institution must identify
an Institutional Official (IO) who is legally authorized to commit, on behalf of
the institution, that the requirements of the PHS Policy and USDA AWRs will be
met. The IO is appointed by the Chief Executive Officer of each institution (at
UCLA, the Chancellor) and must be assigned institutional responsibility to
commit the financial and other resources to ensure compliance with the governing
regulations, as well as to initiate and/or codify institutional policies and
procedures to promote high-quality science and animal well-being.
The IO is responsible for
providing general oversight and direction of the institutional animal care and
use program. This includes taking the lead in creating a dynamic, compliant,
and responsible institutional culture, and establishing an expectation of
quality scientific research while promoting the humane use and well-being of
animals used in research. To accomplish these goals, the IO must appoint and
empower key personnel to provide day-to-day oversight of the program as well as
the resources required to ensure quality science and promote animal well-being.
The IO is additionally designated the responsibility to appoint members to the
ARC.
The Animal Research Committee
At UCLA, the IACUC is referred
to as the Chancellor's Animal Research Committee (ARC). The ARC reports to the
Institutional Official, as required by federal regulations. The Committee's
specific responsibilities are spelled out in PHS Policy IV.B and USDA AWRs
section 2.31(c):
- The ARC must review the
institution's program for humane care and use of animals at least once every
six months, using the Guide and USDA AWRs as the basis for
evaluation.
- The ARC must inspect all
of the institution's animal facilities at least once every six months, using
the Guide and USDA AWRs as the basis for evaluation. "Animal
facilities" includes any and all buildings, rooms, areas, enclosures, or
vehicles, including study areas,
used for animal confinement, transport, maintenance, breeding, or
experiments inclusive of surgical manipulation.
- The ARC is also
responsible for preparing reports of the evaluations as described above, and
submitting the reports to the Institutional Official. The reports must
contain a description of the nature and extent of the institution's
adherence to the Guide, PHS Policy, and USDA AWRs, and must
specifically identify any departures from these regulations. If program- or
facility-related deficiencies are noted, the reports must contain a
reasonable and specific plan and schedule for correcting each deficiency.
- The ARC is responsible for
reviewing and, if warranted, investigating concerns involving the care and
use of animals at the institution. These concerns may be identified by
members of the IACUC during routine program reviews and inspections, or may
be the result of public complaints or reports of noncompliance from
laboratory or research facility personnel.
- The ARC is authorized to
make recommendations to the Institutional Official regarding any aspect of
the institution's animal program, facilities or personnel, to ensure
regulatory compliance.
- The ARC must review and
approve, require modifications in (to secure approval), or withhold approval
of proposed activities related to the care and use of animals. Once
approved, all activities are subject to ongoing review at least annually,
with a complete re-review required every three years. The following general
criteria must be considered during the review of animal use protocols:
- Rationale and purpose
of the proposed use of animals.
- Justification of the
species and number of animals requested. Whenever possible, the number
of animals requested should be justified scientifically.
- Availability or
appropriateness of the use of alternatives to the use of animals,
including less-invasive procedures, other species, isolated organ
preparation, cell or tissue culture, or computer simulation.
- Adequacy of training
and experience of personnel in the procedures used.
- Unusual housing and
husbandry requirements.
- Appropriate sedation,
analgesia, and anesthesia.
- Unnecessary
duplication of experiments.
- Conduct of multiple
major operative procedures.
- Criteria and process
for timely intervention, removal of animals from a study, or euthanasia
if painful or distressful outcomes are anticipated.
- Post-procedural care,
including methods to protect animal well-being and to minimize
post-operative pain/distress.
- Method of euthanasia
of disposition of animal.
- Safety of working
environment for personnel.
- Similarly, the ARC is
required to review and approve, require modifications in (to secure
approval), or withhold approval of proposed significant changes regarding
the use of animals in ongoing activities. The ARC uses the same criteria
described above to assess proposed significant changes.
- Finally, the ARC must be
authorized to suspend an activity involving animals if the IACUC determines
the activity is not being conducted in accordance with the approved research
protocol or with other applicable provisions of the USDA AWRs, the Guide,
the institution's Assurance, or PHS Policy. In the event an activity is
suspended, the ARC and the Institutional Official will review the reasons
for the suspension and determine the appropriate corrective actions.
The Attending Veterinarian
Adequate veterinary medical
care is an essential component of UCLA's research program and is mandated by
both the PHS Policy and USDA AWRs. The Attending Veterinarian (AV) is the
individual with legal responsibility for the health and welfare of animals at
UCLA. To fulfill this legal accountability, the veterinarian has the authority
to make decisions on behalf of the animals in the event that their health or
welfare becomes compromised. At UCLA, the Campus Veterinarian assumes the role
of the AV but may delegate many of his responsibilities to other veterinary
staff.
An adequate veterinary care
program must include a number of components, including: (1) sufficient
facilities, equipment, personnel, and infrastructure to provide adequate care;
(2) daily observation of all animals to assess their health and well-being; (3)
availability of emergency, weekend, and holiday animal care; (4) adequate
guidance and training of personnel who care for animals; (5) provisions for
appropriate pre-and post-procedural animal care; (6) use of appropriate methods
to prevent, control, diagnose, and treat diseases and injuries; and (7)
providing training in techniques for animal handling, aseptic surgical
technique, and other standard research procedures.
The OPRS/ARC Staff
The OPRS/ARC
staff are the full-time representatives of the ARC and primarily assist the
Committee in carrying out its federally mandated functions. This includes
maintaining accurate and detailed records of review and meeting minutes;
scheduling and attending facility inspections; preparing and distributing
research proposals for ARC review; providing training to investigators, ARC
members, and other personnel; and advising ARC members, researchers, and other
relevant University officials/departments of any regulatory changes. In
addition to supporting the Committee, the OPRS/ARC staff also serve a crucial
role as a liaison between the ARC and the research community; in this role, the
staff assist investigators with completing their research applications,
interpreting ARC or regulatory requirements pertaining to their research, and
facilitating discussions and meetings to resolve animal-use concerns.
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