Excerpted from the Institutional Animal Care and Use Committee
Guidebook developed by Applied Research Ethics National Association
and the National Institutes of Health. NIH Publication number
92-3415. The full text of this document is available at
http://grants.nih.gov/grants/olaw/iacuc_guidebook/iacuc_guidebook.htm
C-1. Policies, Procedures
and Responsibilities
Introduction
Under PHS Policyand USDA Regulations,
the IACUC must inspect all institutional animal facilities every
six months. These inspections provide an ongoing mechanism for
ensuring that the institution maintains compliance with the applicable
animal care and use policies guidelines and laws. They can also
benefit programs for animal care by serving an educational function
for the animal care personnel, research staff and IACUC members.
Also, by giving the facility personnel a prior warning, the IACUC
can assist an institution to prepare for subsequent visits by
outside inspectors. The interaction of an IACUC and the animal
care personnel at their institution should be constructive, and
not adversarial, as both ultimately share the same goals of good
animal care.
Staffing and Scheduling
Inspection
The IACUC must schedule the inspections of facilities. This may
be accomplished by assigning specific facilities to subcommittees
which must contain at least two members as required by the USDA
Regulations. No IACUC member should be excluded should he/she
wish to attend a particular inspection, and additional ad hoc
consultants may be used. The inspection team must have a working
knowledge of the Guide and USDA Regulations in order to fully
evaluate the facilities which are being inspected. Section C-2
of this Guidebook also provides general guidance in this regard.
It is helpful for the team to have a prepared list of the categories
to be inspected, such as sanitation, food and water provisions,
animal identification, waste disposal, animal health records,
environmental control, staff training, etc.
The IACUC may determine whether the supervisory personnel of various
facilities should be notified of the date and time of an inspection.
Advance notification allows individuals to be available to answer
questions, but an unexpected visit shows the facility during usual
operations.
Performing Inspections
An updated list of all facilities to be inspected should be maintained
by the IACUC. All proposals submitted to the IACUC must contain
details of all locations at which animal research is to be performed.
The USDA Regulations require inspection of the centrally designated
or managed animal resource facilities as well as any other animal
containment facilities in which animals are kept for more than
twelve hours. PHS Policy requires inspection of all surgical facilities
and areas in which animals are maintained longer than 24 hours.
It is helpful to keep a list of all facilities by room number,
use, species and deficiencies noted in the last inspection. For
satellite areas a contact person is useful. For facilities with
multiple rooms, a map will assist the inspectors.
Notes should be taken throughout the visit to assist in preparation
of the final report. Apparent deficiencies should be discussed
with the person in charge of the facility to ensure that the team's
perception of the situation is correct. In some cases an apparent
deviation will be due to the experimental proposal in process,
for example, withholding of food prior to surgery.
Documentation
After the visit a formal report is prepared. Any deficiencies
must be categorized as minor or significant. The latter is defined,
by USDA Regulations and PHS Policy, as one of significant threat
to animal health or safety. A plan and timetable for correction
of all deficiencies must be included in the final report. All
individuals to be involved in the corrections should be consulted
to ensure that the plan is realistic. If the institution is unable
to meet the plan, the IACUC through the Institutional Official
must inform Animal and Plant Health Inspection Service (APHIS)
officials within fifteen working days of the lapsed deadline.
If the activity is federally funded, the relevant agency also
must be informed.
The report must be reviewed and approved by a quorum of the IACUC,
and in cases involving USDA Regulations, be signed by all those
who accept the report. Minority views should be included in the
final document. A copy is then sent to the Institutional Official
and must be kept on file for a minimum of three years. It is often
useful for the report to be delivered in person in order to emphasize
the findings and plans for action. Annually, the institution must
notify OPRR of the dates of the semiannual inspections and the
dates the report was submitted to the Institutional Official.
Program Evaluation
Both the PHS Policy and USDA Regulations include a requirement
that semiannually the IACUC conduct an evaluation of the animal
care and use program. Neither of these documents includes specific
guidance regarding the mechanisms or procedures to employ in conducting
this evaluation. OPRR has recommended that institutions use the
Table of Contents of the Guide, exclusive of the facility and
physical plant chapters, as an outline for program evaluation.
The USDA Regulations refer institutions to other portions of those
Regulations as a basis on which to conduct this program evaluation.
Key aspects of an animal care and use program that should be emphasized
in the semiannual evaluation include IACUC functions and procedures,
including proposal review practices, provisions for dealing with
whistle blower" or other concerns regarding animal care and
use, and the procedures employed to meet reporting requirements.
In addition, the institution's occupational health program, veterinary
care procedures and personnel qualification review process should
be evaluated. Specific procedures to accomplish program evaluation
may include presentations by appropriate individuals, e.g., the
institutional veterinarian , occupational health personnel, etc.
Written institutional policies such as standard operating procedures
may be reviewed and modified if necessary.
Program evaluation deals principally with administrative aspects
of the animal care and use program. In most instances these aspects
will not change nor need to be modified with the same aspects
of the facility or physical plant. Thus, when large changes are
made in program aspects, a comprehensive evaluation by the committee
should be conducted, while the review of that aspect six months
later may be merely a brief evaluation of its implementation to
date. Ongoing review of established practices allows the opportunity
for institutions to detect a gradual change in practices from
written procedures, thereby allowing modification of one or the
other as appropriate. Institutions that are AAALAC accredited
will find their pre-site visit package helpful in identifying
areas for inclusion in the semiannual evaluation.
Occupational Health
Purpose of Occupational Health
Programs
The health of individuals working in animal care Programs is an
area of institutional concern. PHS Policy and the Guide identify
the need for an occupational health program for all personnel
who work in laboratory animal facilities or who have substantial
animal contact. The emphasis of such a program is the prevention
of illness, but it also includes provisions for early diagnosis
and treatment when such illnesses occur.
Elements of an Occupational Health Program
An effective program will have the following components: 1) replacement
medical evaluation; 2) periodic medical surveillance; 3) educational
component; 4) provisions for treating illness or injury; and 5)
provisions for consultation with other professional staff. The
specific elements will be dictated by the extent and nature of
the employee's exposure [see table].
Replacement and periodic medical evaluations: Replacement evaluations
are conducted to ensure that the individual is capable of the
demands and exposure of the job, and also to provide a medical
reference baseline. The evaluation may include: clinical history,
physical examination, spirometry, baseline tests such as TB test
and serum sample collection, appropriate immunizations, educational/instructional
component and appropriate feedback to the employee on all test
results. Specific tests will depend on the species of animals
and the nature of the procedures employed.
Periodic evaluations allow detection of early stages of disease,
updating of immunizations and a re-evaluation of medical restrictions.
A uniformity in the evaluation of different individuals and the
same person at different times is important to enable accurate
comparisons to be made. These comparisons may allow a possible
problem to be identified and corrected before it becomes a major
health hazard.
Education
There are ethical and legal requirements to inform individuals
of health risks and precautions which affect them. This must be
part of an employee's overall orientation and job training. Some
institutions rely on formal courses.
Barber, A.A (1987). University
administration of animal care and use programs. Laboratory
Animal Science 37(special issue): 93-96.
NAL call number: 410.9 P94
Descriptors: animal welfare, administration, policy, animal experiments.
Bascom, R. (1997). Developing and
implementing personnel safety programs Part 1: Occupational health
and safety program in a research animal
facility. Lab Animal 26(6):
23-26.
NAL call number: QL55 A1L33
Descriptors: five key institutional activities, administration
support for health and safety programs, hazard recognition, institutional
trends for health and safety, who is at risk, developing and implementing
a work plan, control strategies, tracking program effectiveness.
Bowman, P.J. (1991). A flexible occupational health and safety
program for laboratory animal care and use programs. AALAS
Bulletin 30(6): 15-17.
NAL call number: SF405.5 A23
Descriptors: zoonoses, PHS policy, factors likely to dictate type
and degree of hazards, list of type of personnel that should be
included in program, categories of risk, facets of an occupational
health programtimelines for physical exams, TB skin tests, chest
x-rays, immunizations, serum banking, allergies, injuries, Q Fever.
Bowne, G.W. (1999). Financial management
in an animal research facility. Lab Animal 28(1): 33-37.
NAL call number: QL55 A1L33
Descriptors: budget development and maintenance, cost analysis,
review of major costs in an animal facility, expenditures, income,
equipment and amortization, tracking and monitoring costs, Circular
A-2, basic points for saving money, repairing a deficit.
Carey, R. (1990). Public responsibility
in medicine and research conference on administration, education
and the animal care committee. Journal of Medical Primatology
19(1): 75-6.
NAL call number: QL737 P9J66
Descriptors: animal welfare, legislation and jurisprudence, laboratory
animals, research, ACUC.
Donnelly, T.M. (1996). Hazardous
chemicals and anesthetics in the laboratory animal facility.
Lab Animal 25(4): 39-41.
NAL call number: QL55 A1L33
Descriptors: list of commonly used hazardous chemicals and anesthetics,
xylene, DMSO, picric acid, formaldehyde, peracetic acid, chloroform,
ether, halothane, nitrous oxide, urethane, common use of each
compound in the lab, hazards associated with chemicals, recommended
protective action, miscellaneous information about each chemical.
Driscoll, J.W. and T.C. Rambo (1989).
Forming an IACUC at a small institution. In Animal Care
and Use in Behavioral Research: Regulations, Issues, and Applications
J.W. Driscoll (ed.), Beltsville, Maryland: U.S. Department of
Agriculture/National Agricultural Library pp. 23-28.
NAL call number: aHV4762 A3A64
Descriptors: universities, regulatory requirements, committee
responsibility, ACUC.
Ellenberger, M.A., and B.F. Corning
(1999). The animal care and IACUC offices: United or divided?
Lab Animal 28(1): 44-47.
NAL call number: QL55 A1L3
Descriptors: missions of an animal care
program and the IACUC, animal care office, administrative support,
advantages and disadvantages of separate vs combined animal care
and IACUC offices, factors involved in determining the suitability
of program for a facility, recommendations for an effective and
efficient IACUC.
Fox, J.G. (1987). Gaining institutional
support. Laboratory Animal Science 37(special issue):
115-117.
NAL call number: 410.9 P94
Descriptors: laboratory animals, animal welfare, animal experiments,
ACUC.
Gordon, B (1987). Unique problems
of animal care and use in small institutions. Laboratory
Animal Science 37(special issue): 127-128.
NAL call number: 410.9 P94
Descriptors: animal welfare, research institutes, animal experiments.
Green, R.J. (1997). Developing
and implementing personnel safety programs part II: Safety training
and education in animal research. Lab Animal 26(6):
27-29.
NAL call number: QL55 A1L33
Descriptors: management responsibility, dealing with time constraints,
on-site training, providing regular updates, modular courses,
maximizing class time, pre-class assignments, employee interaction,
distance learning, computer-based training, top 10 training tips.
Hassall, G. (1999). Committees
and conflict resolution. ANZCCART News 12(1): 1-3.
NAL call number: SF405.5 A3
Descriptors: conflict resolution, definitions, disputes, conflicts,
conflict resolution continuum, mediation, skills, listening, empathizing,
assertiveness, timeliness, mapping, strategies for resolving conflicts.
Herscowitz, H.B. (1987). Institutional
responsibilities. Laboratory Animal Science
37(special issue): 118-119.
NAL call number: 410.9 P94
Descriptors: animal welfare, laboratory animals, ACUC.
Hiiemae, K., H. Rozmiarek, J.F. Williams,
J.E. LeBeau, and M. Ross (1987). Report of a panel discussion
on how to run an effective Animal Care and Use Committee.
Laboratory Animal Science 37(special issue): 39-44.
NAL call number: 410.9 P94
Descriptors: animal welfare, animal experiments, policy, institutions.
Hittelman, J. (1987). Operating
principles for committees on animal research. Laboratory
Animal Science 37(special issue): 97-100.
NAL call number: 410.9 P94
Descriptors: animal welfare, institutions, ACUC.
Holden, F. (1997). Alternatives
committee established at Indiana. The Johns Hopkins Center
for Alternatives to Animal Testing Newsletter 14(3): 6-7.
NAL call number: HV4701 J6
Descriptors: subcommittee to IACUC, communications between researchers
and campus animal protectionists, monthly round table, institutional
support at highest levels, membership includesinformation specialists,
public relations/education representative, departmental representatives,
IACUC liaison, animal protectionist, veterinarian, research assistant.
Holt, M.A. (1996). Institutional
animal care and use issues: creativity and innovation. The
Johns Hopkins Center for Alternatives to Animal Testing Newsletter
13(2): 12-13.
NAL call number: HV4701.J6
Descriptors: animal welfare, committees, innovations.
Institute of Laboratory Animal Resources
(U.S.), Committee on Occupational Safety and Health in Research
Animal Facilities (1997). Occupational health and safety in
the care and use of research animals. Washington, DC: National
Academy Press, 154 p. This document is available at http://books.nap.edu/books/0309052998/html/index.html
NAL call number: RC965.A6O23 1997
Descriptors: Laboratory animal technicians, health risk assessment,
animal health technicians, occupational diseases, prevention,
guidelines, program design and management, physical, chemical,
and protocol-related hazards, allergens, zoonoses, principal elements
of an occupational health and safety program, occupational health
care services.
James, M.L., L.A. Mininni, and L.C.
Anderson (1995). Establishment of an animal alternatives committee.
Contemporary Topics in Laboratory Animal Science 34 (3):
61-64.
NAL call number: SF405.5.A23
Descriptors: animal testing alternatives, committees, programs.
Kasting, G. (1996). Revisiting
medical surveillance in research animal facilities. Lab
Animal (25(4): 27-31.
NAL call number: QL55 A1L33
Descriptors: animal caretaker medical surveillance, occupational
safety, hazard recognition, concepts of workplace surveillance,
components of a medical surveillance program, recommendations,
minimum criteria, reasons for conducting a surveillance program.
Krulisch, L. (ed.) (1992). Implementation
strategies for research animal well-being: institutional compliance
with regulations: proceedings of a conference held in Baltimore,
Md. on December 5-6, 1991 about compliance with USDA regulations
for the well-being of canines and nonhuman primates in research.
Bethesda, Maryland: Scientists Center for Animal Welfare, 178p.
NAL call number: HV4764 I46 1992
Descriptors: enrichment strategies, dogs, nonhuman primates.
Lamborn, C. and M. Denny (1998). Preparing for an animal rights
related crisis. Lab Animal 27(1): 32-35.
NAL call number: QL55 A1L33
Descriptors: crisis management, physical security, research and
animal care policy, public relations, outsourcing your physical
security program, check list for crisis preparation.
Lewis, S.M., B. Leard, J.L. Martin,
and S.A. Martin (1995). An automated feed inventory tracking
system for an animal facility. Lab Animal 24(8): 37-40.
NAL call number: QL55 A1L33
Descriptors: automated data handling, simplified reporting capabilities,
inventory control, GLP accountability, system and user management.
McGarry, M.P., M.A. Imamovic, and
D.J. Piccione. Institutional animal care and use committee
(IACUC) required facility inspections - objectives and implementation.
Laboratory Animal Science 37(4):544 (1987).
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National Research Council (1997).
Occupational health and safety in the care and use of research
animals. ILAR Journal 38(2): 89-93.
NAL call number: QL55.A1I43
Descriptors: laboratory workers, laboratory hazards, occupational
health, animal experiments.
Orlans, F.B., R.C. Simmonds, and W.J.
Dodd (eds.) (1987). Consensus recommendations on effective
institutional animal care and use committees. Laboratory
Animal Science 37(special issue): 11-13.
NAL call number: 410.9 P94
Descriptors: laboratory animals, animal welfare, workshop, research
institutes, training, ethics, animal experiments.
Orlans, F.B., R.C. Simmonds, and W.J.
Dodd (eds.) (1987). Effective animal care and use committees.
Laboratory Animal Science 37(special issue): 1-178.
NAL call number: 410.9 P94
Descriptors: animal welfare, laboratory animals.
Poling, J. (1990). An effective
IACUC: A Johns Hopkins experience. Animal Welfare Information
Center Newsletter 1(4): 1-2,6.
NAL call number: aHV4701.A952
Descriptors: bioethics, animal welfare.
Public Responsibility in Medicine
and Research (1991). Animal Care and Use Programs: Regulatory
Compliance and Education in an Age of Fiscal Constraint
Public Responsibility in Medicine and Research (PRIM &
R), Tufts University School of Veterinary Medicine and Tufts University
School of Medicine, Boston, Massachusetts: PRIM & R, 408 pp.
NAL call number: HV4913.A54
Descriptors: educational material, bibliographies, animal welfare.
Rehbinder, C., P. Baneux, D. Forbes,
H. van Herck, W. Nicklas, Z. Rugaya, and G. Winkler (1998). FELASA
recommendations for the health monitoring of breeding colonies
and experimental units of cats, dogs and pigs. Report of the Federation
of European Laboratory Animal Science Associations (FELASA) Working
Group on Animal Health. Laboratory Animals 32(1):1-17
NAL call number: QL55 A1L3
Descriptors: animal welfare, physiology, breeding standards, cats,
dogs, health status, swine, bacterial infections, diagnosis, data
collection, mass screening, mycoses, parasitic diseases, virus
diseases.
Russell, C.K., F.X. Buckingham, R.
Daniels, L. Bertan, P. Fetty , and D. Klein (1994). Monsanto's
computer animal proposal system (CAPS). Quality Assurance
3(2): 206-10.
Abstract: Regulations and standards must include the minimum requirements
with respect to veterinary care, sanitation, handling, feeding,
and housing. Part 1 of the Animal Welfare Act regulations was
amended to update, clarify, and expand the list of definitions
of terms and standards. Section 9 CFR, Part 1, contains definitions
and deals with animal welfare, animal housing, dealers, exhibitors,
researc facilities, and humane animal handling. The subjects in
9 CFR, Part 2, pertain to licensing, registration, identification
of animals, records, institutional animal care and use committees,
and adequate veterinary care. Animal welfare, humane animal handling,
pets, transportation, and reporting and recordkeeping requirements
are the subjects listed in 9 CFR, Part 3.
Descriptors: organizational models, animal welfare, clinical laboratory
information systems, computer networks, facility regulation and
control.
Sapolsky, H.M. (1987). Assuring
the effectiveness of animal research committees. SCAW Newsletter
9(1): 7-8.
NAL call number: QL55.N48
Descriptors: laboratory animals, animal experiments, policy, legislation,
ACUC.
Seps, S.L. (1997). An efficient
approach to performing and documenting semiannual institutional
animal care and use committee inspections of animal facilities.
Contemporary Topics in Laboratory Animal Science 36 (2): 51-53.
NAL call number: SF405.5.A23
Descriptors: laboratories, animal experiments, inspection, documentation.
Shepherd, M.J. (1996). Meeting
large regulatory requirements in small institutions. Lab
Animal 25 (9):35-37.
NAL call number: QL55.A1L33
Descriptors: training, personnel, animal experiments, animal welfare,
regulations, programs.
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and prejudice influence the IACUC? Lab Animal 26(5):
23-25.
NAL call number: QL55 A1L33
Descriptors: survey of NIH assured institutions, ethical challenges,
questions included: how does the IACUC handle allegations of non-compliance
or animal mistreatment, does the dollar value of a grant influence
deliberations, what is the perceived role of the community representative-
active voice or seen not heard, does the status of an investigator
influence deliberations, does the species of animal involved influence
deliberations.
Silverman, J. (1994). IACUC handling
of mistreatment or noncompliance. Lab Animal 23 (8):30-32.
NAL call number: QL55.A1L33
Descriptors: laboratory animals, animal welfare, committees, animal
husbandry, policy, monitoring.
Stephens, M. (1989). Oversight
of the care and use of animals in animal behavior research in
the United States. In Animal Care and Use in Behavioral
Research: Regulations, Issues, and Applications J.W. Driscoll
(ed.), United States Department of Agriculture/National Agricultural
Library, Beltsville, MD, pp. 2-8.
NAL call number: aHV4762 A3A64
Descriptors: Animal Welfare Act, ACUC, field research.
Talham, D.J. (1997). A computerized
method for taking animal census. Lab Animal 26(9):
32-35.
NAL call number: QL55 A1L33
Descriptors: manual systems, bar-coded systems, in-house programming,
integration with billing and accounting systems, screen shots.
Talham, D.J., R.W. Murray, G.E. Lee,
and J.M. Linn (1997). In-house development of an integrated
management information system for a laboratory animal facility.
Contemporary Topics in Laboratory Animal Science 36(5):
77-80.
NAL call number: SF405.5 A23
Descriptors: commercial software vs. in-house development, system
objectives, design and implementation, operational areas, protocol
management, animal procurement, animal facilitygenerate delivery
schedules, cage cards, receipt of animals, animal census, billing,
cost accounting.
Thomas, J.A., and M.E. Greene (1994).
Institutional policies and educational programs: Animals in
research. Journal of the American College of Toxicology
13(4): 308-313.
NAL call number: RA1190.J61
Descriptors: laboratory animals, toxicity testing, education,
communication, policies.
Tillman, P. (1994). Integrating
agricultural and biomedical research policies: conflicts and opportunities.
ILAR News 36 (2): 29-35.
NAL call number: QL55.A1I43
Descriptors: livestock, agricultural research, medical research,
committees, guidelines, regulations, animal welfare.
Tillman, P. (1997). Automating
the Institutional Animal Care and Use Committee. ILAR Journal
38(4): 184-189.
NAL call number: QL55 A1I43
Descriptors: productivity, e-mail, WWW, communications, training
materials, privacy, security.
Tillman, P.C. (1985). Microcomputer
assisted management of an institutional animal care and use committee.
Laboratory Animal Science 35(5): 540-541.
NAL call number: 410.9 P94
Descriptors: abstract, clerical aspect,
record keeping, committee organization.
Wolff, A. and P.D. Smith (1994). Compliance
at the institutional and programmatic level. Lab Animal
23 (8): 28-29.
NAL call number: QL55.A1L33
Descriptors: laboratory animals, animal welfare, policy, committees,
animal husbandry, animal experiments, control, project control,
monitoring.
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