Rose-Hulman Institute of Technology
Laboratory Animal Care and Use
Policies and Procedures
Revised: November 15, 2005
Approved: November 16, 2005
I. Purpose
This document describes policies and procedures for Laboratory Animal Care and Use at
Rose-Hulman Institute of Technology.1 These policies and procedures have been developed to
ensure the humane treatment and welfare of laboratory animals used in research and teaching,
and to ensure compliance with federal, state and local laws. The policies and procedures
outlined in this document apply to all activities (research, research training, teaching,
experimentation, and biological testing) involving the use of live vertebrate animals on RoseHulman’s campus. Rose-Hulman’s Animal Care and Use program is based on the Animal
Welfare Act, and the Public Health Service (PHS) Policy on Humane Care and Use of
Laboratory Animals (rev. 1986) both of which are incorporated herein and attached as
appendices A and B respectively.
II. Governmental Animal Care and Use Regulations
In 1966 Congress passed the Animal Welfare Act (PL 89-454) and the United States
Department of Agriculture (USDA) was named the responsible agency. In 1973, the Public
Health Service (PHS) published the first Public Health Service Policy on Humane Care and Use
of Laboratory Animals. In 1979, PHS Policy required each animal-using recipient of funds to
have a PHS Assurance and a committee (IACUC) to maintain oversight of its animal care
program. In 1985 the U.S. Government Principles for the Utilization and Care of Vertebrate
Animals Used in Testing, Research and Training was promulgated. In 1985, Congress passed
the Health Research Extension Act (P.L.99-158) and amendments to the Animal Welfare Act. In
1986, the PHS Policy was revised. The Office of Laboratory Animal Welfare has oversight
responsibility for the PHS policy. Between 1989 and 1991, the USDA promulgated additional
amendments to the Animal Welfare Act. In 1996 the 7th edition of the Guide for the Care and
Use of Laboratory Animals (The Guide), was revised by the Institute of Laboratory Animal
Research and published by the National Research Council.
III. Institute Animal Care and Use Committee (IACUC)
A. Authority
The IACUC derives its authority from the law. It is mandated by the Health Research
Extension Act of 1985 and the Animal Welfare Act. The law requires the CEO of an
organization to appoint the IACUC. The President at Rose-Hulman will appoint IACUC
members. The IACUC will report to a designated Institute Official (IO), also appointed
by the President.
B. Committee Composition
The PHS and USDA policy mandates the first five (5) committee members with an
additional requirement that not more than three (3) of these five (5) members may come
from the same administrative unit of the Institute. The Rose-Hulman IACUC will consist
of the following 9 members (8 voting):
1
Italicized text refers to a regulation or policy to which the reader may refer if desired.
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1. One Doctor of Veterinary Medicine with training or experience in laboratory
animal science and medicine who has direct or delegated program authority and
responsibility for activities involving animals at the Institute.
2. One practicing scientist from Rose-Hulman experienced in research involving
animals
3. One member from Rose-Hulman whose primary concerns are in a non-scientific
area
4. One public member, not affiliated in any way with the Institute and not an
immediate family member of a person affiliated with the Institute, to represent
general community interests in proper care and use of animals who neither works
with laboratory animals, nor has responsibility for administering an animal care
and use program
5. Chair of the IACUC committee. The Chair of the IACUC serves at the request of
the Institute Official.
6. One Rose-Hulman scientist with statistical or analytical experience (From Math,
Chemistry, Chemical Engineering, or Physics)
7. One Rose-Hulman scientist with biology background
8. The Institute Environmental Health and Safety Coordinator
9. One secretary appointed by the chair (non-voting member)
C. Term of Appointment and Changes in Appointment
The Term of appointment for IACUC voting members will be for a period of up to 3
years. Terms will be staggered such that approximately 2/3 of the committee will be
retained from year to year. Any proposed changes to the composition of the committee
will be submitted to the Chair and Institute Official. The Institute Official will inform the
President of the proposed change and the President will take appropriate action, notifying
the Chair, Institute Official, and committee members affected. The composition of the
committee will not deviate from Section B. above.
D. Responsibilities of the IACUC
The IACUC is responsible for overseeing and evaluating all aspects of animal care and
use at Rose-Hulman, and to ensure activities are in compliance with the Animal Welfare
Act and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory
Animals. The responsibilities outlined below will be carried out in accordance with these
regulations:
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1. Review, at least once every six months, the Rose-Hulman program for the
humane care and use of animals. Prepare and submit the evaluation report to
Institute Official.
2. Inspect, at least once every six months, all Rose-Hulman animal facilities
including satellite facilities, satellite holding facilities (a facility outside of a core
facility or centrally designated area in which animals are housed for more than 12
hours), and areas in which surgical manipulations are performed. Deficiencies,
where found, will be classified as “significant” or “minor” and a plan and timeline
for correction will be documented. A significant deficiency is one that is, or may
be, a threat to the health and safety of the animals. Prepare and submit the facility
inspection report to the Institute Official.
3. Provide a copy of the IACUC evaluation reports for items 1. & 2. above to Office
of Laboratory Animal Welfare (OLAW) upon request. Committee will report to
USDA, in writing, all significant deficiencies remaining uncorrected beyond the
scheduled correction date within 15 business days of the original correction date.
The IACUC will submit this report through the Institute Official, to the Animal
and Plant Health Inspection Service (APHIS) and to any federal agency funding
the activity as described in the Institutional Animal Care and Use Committee
Guidebook.
4. Review all concerns involving the care and use of animals at Rose-Hulman
Institute of Technology
5. Make recommendations to the Institute Official regarding any aspect of the
animal program, facilities or personnel training.
6. Review, approve, or require modifications to, protocols for live vertebrate animal
care and use activities. A complete review of all activity (protocols) is required at
least once every three years for PHS and annually for USDA.
7. Review, approve, or require modifications to, protocols that propose significant
changes regarding the use of animals in ongoing activities.
8. Be authorized to suspend an activity involving animals in accordance with
specifications in IV.C.6 of PHS Policy (i.e., an activity that is not being conducted
in accordance with applicable provision of the Animal Welfare Act, the Guide, the
Institute’s Assurance, or PHS Policy.) This action may be taken only after review
of the matter at a convened meeting of a quorum of the IACUC and a vote for
suspension by the majority of the quorum present. The Institute Official, in
consultation with the IACUC, shall review the reasons for suspension, take
appropriate corrective action, and report that action with a full explanation to
OLAW.
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9. Submit an annual report to OLAW through the Institute Official if Rose-Hulman
holds a PHS Assurance. This report details changes in the animal care and use
program, IACUC membership, dates of semiannual review and reports submitted
to the Institute Official.
10. Submit annual report (on or before December 1 each year) to APHIS, AC
Regional Director for Indiana. Form 7023 will be prepared by the IACUC and
signed by the IO. This report includes assurances to the USDA that animal care
and use are at professionally accepted standards, that alternatives to painful
procedures have been considered and that Animal Welfare Regulations have been
followed.
E. Training for the IACUC
1. Each new IACUC member will receive a copy of Rose-Hulman Institute of
Technology Laboratory Animal Care and Use Policy, and the Institutional Animal
Care and Use Committee Guidebook for review and reference.
2. Rose-Hulman subscribes to the Veterans Administration web site,
http://www.researchtraining.org designed to help institutions meet requirements
for research training mandates. Each IACUC member will review course
materials for “Essentials for IACUC Members” and subsequently pass the course
exam. Rose-Hulman’s Environmental Health and Safety Officer is the
administrator of this web site and will have access to training records for the
Institute.
F. IACUC Proceedings
1. Meetings
A meeting of the IACUC will occur once per month during the academic year and
as needed during the months of June through August. The IACUC Chair will
provide the Rose-Hulman community with the meeting schedule in September of
each year. The Chair of the IACUC may also call special meetings as required.
Questions regarding the meeting schedule should be addressed to the IACUC
Chair. The IACUC Chair will develop the meeting agenda and preside over the
meetings. Protocols to be reviewed will be distributed to IACUC members no
later than 10 working days in advance of the monthly meeting.
2. Quorum
In order to conduct official business throughout a convened meeting of the
IACUC, a quorum of voting members must always be present. ”Quorum” is
defined as a majority (>50%) of the voting members. If the number of committee
members present falls below the quorum for any reason, official business must be
tabled until a quorum can be reconvened.
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3. Minutes
a) The Secretary for the Committee will document the proceedings of the
IACUC meetings which will serve as the official record. These minutes
will be in sufficient detail to show attendance at the meetings; actions
taken by the IACUC; the vote on these actions, including the vote count
(for, against, and abstaining); the basis for requiring change in or
disapproving a protocol; and a summary of deliberations leading to a
decision.
4. Conflict of Interest
a) No IACUC member may participate in the IACUC review or approval
of an activity in which that member has a conflicting interest, except to
provide information requested by the IACUC. Possible examples of
conflict of interest include cases where:
(1) a member is personally involved in the activity
(2) a member has a personal bias that may interfere with impartial
judgment
(3) a member’s access to funding or intellectual information may
provide an unfair competitive advantage
(4) a member is involved in a competing research program
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b) If the investigator submitting a protocol believes that an IACUC
member has a potential conflict, the investigator may request that the
member be excluded from the review process by submitting a written
request to the IACUC Chair.
c) When an IACUC member believes he/she has a conflict of interest, the
voting member will notify the Chair in writing and recuse him/herself
from voting and/or review as appropriate.
d) The IACUC Chair will determine how to resolve the disclosed conflict.
In some situations, the member will be recused from voting only; in
others it may be more appropriate to exclude the member from the
review, discussion, and vote.
G. Recordkeeping
1. IACUC meeting minutes will be retained for a period of 6 years. Meeting
minutes will include a record of attendance, activities of the committee, and
Committee deliberations.
2. Protocols and proposed significant changes to protocols will be retained for a
period of 3 years beyond the end date of the animal activity. All protocols
submitted to the IACUC, whether approved or used, will be retained. The official
protocol records will be kept in the IACUC Chair’s Office.
3. Semiannual IACUC reports of the Animal Care and Use Program at RoseHulman and the Institute facility inspection report will be kept on file in the
IACUC Chair’s Office.
4. Animal health records will be kept in the animal facility for a minimum of 3
years. The Animal Care Facility Manager will ensure these records include the
appropriate data and are in compliance with the Guide and Animal Welfare
Regulations. Records will be accessible to PHS, APHIS and funding agencies for
inspection or copying, and the IACUC during the semi-annual inspection.
5. The PHS Assurance document will be kept on file in the IACUC Chair’s Office.
6. Annual reports to PHS (submitted to OLAW) and the USDA (submitted to
APHIS) will be kept on file in the IACUC Chair’s Office.
7. A copy of USDA registration will be maintained in the IACUC Chair’s Office.
8. Suspensions and noncompliance require notification of PHS and/or USDA as
appropriate. The IACUC will be responsible for reporting these situations in
accordance with the procedures outlined in the “Institutional Animal Care and
Use Committee Guidebook”.
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IV. Program and Facility Review
The PHS Policy and Animal Welfare Regulations (AWRs) stipulate that the IACUC must
review the program for humane care and use of animals at least once every six months, using the
Guide as the basis for evaluation.
A. Program Review
The IACUC is responsible for evaluating the Rose-Hulman Institute of Technology
Animal Care and Use Program and for providing the Institute Official with a formal
report of that evaluation. The IACUC will evaluate the following aspects of the RoseHulman Animal Care and Use Program during the semi-annual evaluation:
1. IACUC membership
2. functions and procedures (including protocol review)
3. facility inspection process
4. provisions for reviewing and investigating concerns regarding animal care and use
5. recordkeeping practices
6. methods employed to meet reporting requirements
7. occupational health and safety program
8. veterinary medical care program
9. personnel qualifications and training
B. Facility Review
Rose-Hulman, through its IACUC, is responsible for all animal-related activities
regardless of where animals are maintained or the duration of the housing. The IACUC
must have reasonable access to these areas for the purpose of verifying that activities
involving animals are being conducted in accordance with the protocol approved by the
IACUC. All animal housing facilities will be inspected in the semiannual review and are
subject to random inspection. Animal housing facilities include containment areas such
as satellite facilities and study areas where animals are housed for more than 12 hours,
areas in which surgical manipulations are performed, and holding facilities.
1. Staffing and Scheduling Inspection
a) Facility Inspection Team- While the entire IACUC is responsible for the
review, the IACUC Chair, Veterinarian, and at least one other IACUC
member will constitute the Facility Inspection Team. By law, any
IACUC member who wishes to participate on the Team may do so.
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b) The IACUC Chair will notify the Facility Manager of the date and time
of an inspection. The Facility Manager is expected to be present at
inspections to answer questions posed by the IACUC.
2. The IACUC will evaluate the following categories during the semi-annual review:
a) Location
b) Construction
c) Room/Cage
d) Cage/Run
e) Sheltered or Outdoor Housing
f) Behavioral Management
g) Food and Water
h) Bedding
i) Sanitation
j) Environmental Health and Safety
k) Pest Control
l) Emergency, Weekend, & Holiday Animal Care
m) Animal Identification and Records
n) Nomenclature
o) Personnel
p) Specialized Space
C. Documentation and Reporting
1. The IACUC will prepare a written report of the semiannual program review and
facility inspection and submit it to the Institute Official. While a designated
inspection team may perform the facility review, the report must be reviewed and
signed by a majority of the IACUC members. The report must describe the
institution’s adherence to the Animal Welfare Regulations, the PHS Policy, and
the Guide, and identify specifically any deviations from these documents. The
report will also indicate whether or not any minority views were filed. Minority
views must be included in the final document. The report must be kept on file for
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a minimum of 3 years.
2. Deficiencies identified in these reviews will be designated by the IACUC as
“minor” or “significant”. A significant deficiency is defined as a situation that is,
or may be, a threat to animal health or safety. The IACUC, in consultation with
individuals to be involved in corrective action, will develop a reasonable and
specific plan and schedule with dates for correction. Through the IO, the IACUC
will promptly report to OLAW any significant or continuing noncompliance with
the PHS Policy or any significant deviation from the provisions of the Guide.
3.
IACUC will report to USDA, in writing, all significant deficiencies remaining
uncorrected beyond the scheduled correction date within 15 business days of the
original correction date. IACUC will submit this report through the Institute
Official, to the Animal and Plant Health Inspection Service (APHIS) and to any
federal agency funding the activity.
V. Animal Environment, Housing and Management
The Animal Care Facility Manager, appointed by Rose-Hulman, will be responsible for
ensuring the animal environment, housing, and management is in accordance with the Guide.
The Guide provides recommendations that are written in general terms and require the
application of sound professional judgment (i.e., current best practices). Variances from Guide
recommendations in animal care and husbandry will be evaluated by the Facility Manager to
determine whether there is clear scientific justification or rationale for an alternative approach to
accomplish a Guide standard. The Animal Care Facility Manager will be responsible for
keeping the IACUC and the Veterinarian informed of any variances from the Guide standards.
These variances are subject to approval by the IACUC.
A. General Considerations for Housing and Management of Animal Facilities
The Guide states: Proper housing and management of animal facilities are essential to
animal well-being, to the quality of research data and teaching or testing programs in
which animals are used, and to the health and safety of personnel. A good management
program provides the environment, housing, and care that permit animals to grow,
mature, reproduce, and maintain good health; provides for their well-being; and
minimizes variations that can affect research results. BEFORE purchasing and housing
animals in the Rose-Hulman Animal Care Facility, Principal Investigators must consider
the following and consult with the Animal Care Facility Manager.
1. Animals must be housed in a manner that facilitates the expression of speciestypical behavior and minimizes stress-induced behaviors. For social species,
housing systems should be designed to accommodate pair or group housing of
animals.
2. Adequate animal husbandry practices and health maintenance are facilitated by
well-constructed and maintained caging or housing systems. Cages should:
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a) allow for conspecific (within species) social interaction within or
between enclosures, adequate ventilation, and observation of animals
with minimal disturbance
b) provide a safe and secure environment that permits the normal
physiologic and behavioral needs of the animals to be expressed
c) enable ready access to food and water receptacles and be constructed of
materials that balance the needs of the animal with sanitation
d) be constructed with materials that resist corrosion and withstand chipping, cracking or rusting; Unsealed wood may be acceptable for use as
perches or other climbing structures, resting areas, or in the construction
of perimeter fences, runs and pens, but wooden items need to be
replaced periodically because of wear, damage, and to achieve adequate
sanitization.
e) meet size requirements/recommendations provided in the AWRs and the
Guide; Cage complexities, vertical height of the cage, and the cage
design can influence how an animal uses the cage space provided. The
cage must provide sufficient space so that, at a minimum, the animal
can turn around and express normal postural adjustments. The animal
must have sufficient clean and unobstructed space to move and rest in.
Use of wire bottom cages is discouraged for rodents, especially on longterm studies or in larger and older animals, as it may cause foot injury.
Use of wire bottom cages should be scientifically justified and approved
by the IACUC.
B. Animal Environment
1. Temperature, humidity, air pressure differential and air exchange rate,
illumination level, and noise levels all may affect animal well-being and research
results.
a) The range of daily temperature fluctuations should be kept to a
minimum to avoid large demands on the animals’ metabolic and
behavioral processes. Relative humidity should also be controlled. In
general, an air exchange rate of 10 to 15 changes per hour is considered
an acceptable standard.
b) Light intensity, duration of exposure, wavelength of light, light history
of the animal, pigmentation of the animal and other factors should be
considered when establishing an illumination level in the animal room.
c) Because sound exposure can have variable effects on animals, noise
should be minimized in animal areas.
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d) Environments should be designed to accommodate animals that make
noise, rather than resorting to methods of reducing the noise made by
animals.
e) Reliable methods for monitoring environmental control systems should
be in place, including an after-hours monitoring and response program.
Back-up heating, ventilation, air conditioning, and lighting systems are
highly desirable.
C. Animal Identification
All research animals must be adequately and appropriately identified and records
pertaining to individuals or groups of animals will be maintained by the Facility
Manager. A wide range of acceptable identification methods can be employed,
including:
1. cage cards
2. subcutaneous transponders
3. ear notches and tags
4. collars
5. colored stains
6. individual animal tattoos
D. Animal Records
1. Records may consist of a cage card or may involve detailed individual animal
information, depending principally on the species and research requirements.
Cage cards should include:
a) source of the animal
b) strain or stock
c) names and locations of responsible investigators
d) pertinent dates (especially date animals received and surgery performed)
e) protocol number
E. Animal Diet and Nutrition
1. All animals should receive food that is: palatable, free from contamination, and of
sufficient quantity and nutritive value to maintain their good health. Specific
diets should be selected based on the needs of each species, with special
consideration of the requirements for Vitamin C by guinea pigs and some species
of nonhuman primates. Animals should be fed at least once a day except under
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conditions of hibernation, veterinary treatment, pre-procedural fasts, or other
justified circumstances. In some species and in some circumstances, varying the
diet by providing “treats” can improve animal health and well-being. However,
caution should be exercised that animals do not forsake eating their nutritionally
balanced diet for treats. To help ensure that fresh, uncontaminated food is
provided:
a) bags should be stored off the floor,
b) the milling date should be known (the date or a code is usually stamped
on each bag)
c) the oldest stock should be used first
d) care must be taken to ensure animal food is discarded on expiration or
shelf life expiration date
2. Food Storage -small quantities of food may be kept in animal rooms if stored in
tightly covered, leak- and vermin-proof containers. Containers should not be
moved from room to room.
3. Food Receptacles- Food should be provided in receptacles that are accessible to
all animals in a cage or pen and placed so as to minimize contamination. More
than one receptacle may be necessary for some socially housed animals. Food
receptacles should be easily cleaned and sanitized, and those functions should be
performed on a schedule that meets Guide and AWR requirements. With limited
exceptions, (e.g., neonatal animals or animals with limited mobility) food should
not be placed on the bottom of the cage. Although some species may prefer this
presentation, it results in waste and contamination of the food.
F. Watering
Potable drinking water should be available continuously or provided as often as necessary
for the health and well-being of the animal, considering the animal’s species, age,
condition, and any research requirements. Water may be provided in receptacles (e.g.,
bowls, bottles or via automatic watering systems). Whatever method is used, care should
be taken to ensure that water does not become contaminated and is actually available.
G. Bedding
Bedding may be used in the housing of a variety of commonly used laboratory animals.
Bedding material should be absorbent and free of any substances that might harm the
animals or alter research data. Cedar and untreated softwood products can affect an
animal’s metabolism (e.g., liver enzymes), which may in turn affect immunologic or
other physiologic parameters, and can increase the incidence of cancer. Bedding should
be stored off the floor. Animals may be placed directly on bedding material, a common
practice with many rodent species, or bedding may be placed under a slat-bottom cage.
Bedding should be used in sufficient amounts and changed as often as necessary to keep
the animals clean and dry and the animal room relatively odor free. Care should be taken
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to keep bedding from contacting water tubes as this may lead to leakage of water into the
cage. The frequency of bedding change depends on several factors, including the number
of animals, species, type of caging, and type of bedding.
VI. Facility Maintenance
The Animal Facility Manager will oversee the animal care facility at Rose-Hulman and in
that capacity will ensure the following facility maintenance standards are met. Animal
facility workers (PIs, technicians, students) will address questions regarding operating
procedure to the Animal Facility Manager.
A. Cleaning and Sanitation
Cleanliness and sanitation are essential to the operation of an animal facility. The Guide
and Animal Welfare Regulations set forth recommended frequencies and methods for
cleaning and sanitation of facilities, equipment and accessories. In general, the frequency
and methods should ensure that animals are maintained in a clean, dry environment, free
from exposure to harmful contamination and excessive animal odors. Cleaning agents
that mask animal odors should not be used as a substitute for good sanitation practices.
Cleaning equipment such as mops and buckets should not be moved from room to room
due to the potential for cross-contamination.
The most efficient and effective method of cleaning and sanitizing cages and accessories
(e.g., feeders, water bottles, sipper tubes) is the use of a mechanical washing machine that
provides rinse water temperature of at least 82.2˚C (180˚F) for a time adequate to achieve
sanitization. Alternatively, portable high pressure spray washing and disinfection may be
used. Least efficient and effective is hand washing and disinfection of such equipment. In
general, enclosures and accessories (e.g., cage tops) should be sanitized at least every two
weeks. Solid bottom cages, water bottles and sipper tubes should usually be sanitized
weekly. The supply lines of automatic watering systems should be flushed and
disinfected on a regular basis.
B. Waste Disposal
C. A research animal facility generates a significant amount of waste that must be
removed and disposed of on a regular, frequent basis. All soiled animal bedding and
carcasses from the research facility are considered “medical waste”. Waste containers
with leakproof, tight fitting lids, and a biohazard sign are located in the animal facility.
Animal facility workers must conform to the guidelines set forth in Rose-Hulman’s
Hazardous Waste Management Program. Contact the Environmental Health and Safety
Office for medical waste disposal and questions regarding proper disposal.
D. Pest Control
The research animal facility is an active place, with frequent movement of personnel,
animals, equipment, containers, and food and bedding, creating ideal conditions for the
introduction of pests, including arthropods, birds and wild rodents. Pest control programs
are complicated by the potential for harm to animals and personnel, as well as
interference with research data by many commonly used pesticides.
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A regularly scheduled, documented, pest control and monitoring program is coordinated
through the Animal Facility Manager and managed by the Facilities Department.
E. Emergency, Weekend and Holiday Care
Laboratory animals must be observed by qualified personnel every day, including
weekends and holidays to ensure their health and well-being, as well as to promote sound
research practices. Skilled assistance, including veterinary care, must be readily available
at all times. Names and telephone or pager numbers of those assigned these
responsibilities should be prominently displayed in the facility. The Emergency
Response and Disaster Preparedness Program is part of the Office of Public Safety. This
program contains all relevant information relating to emergency situations on the RoseHulman campus. This program can be obtained from the Director of the Office of Public
Safety at 877-8411.
F. Behavior Management for Laboratory Animals
There are varying requirements for attention to the behavioral management of laboratory
animals, depending on the species of animal and the reference document. The Animal
Facility Manager in conjunction with the Principal Investigator will be responsible for
ensuring that all steps necessary are taken to promote the psychological well-being of the
animals. There must be a documented environment enhancement plan for all non-human
primates. The Guide provides recommendations for:
1. increasing the complexity of the structural environment
2. addressing the social environment of animals
3. promoting the expression of species-typical activity in a cohesive behavioral
management program for all vertebrate species
VII.
Role of the Veterinarian
A. Overview
Rose-Hulman contracts with a local Veterinarian to provide veterinary care for animals
used for research, teaching and demonstration purposes. The veterinarian is considered
the “resident expert” on proper care and handling of laboratory animals and, as such, will
educate and advise the IACUC and Animal Care Facility Manager as required.
B. Responsibilities of the Veterinarian
1. Provide for the health and welfare of animals
2. Ensure the program and care provided to animals complies with standard
veterinary practice
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3. Consult with Animal Care Facility Manager and Principal Investigator regarding
the introduction of new animals into the facility, providing advice on stabilization
periods, isolation, and quarantine
4. Oversee preventive medicine programs such as: immunization against infectious
pathogens, surveillance of colonies for specific infectious microbial agents,
disease prophylaxis utilizing pharmaceutical agents, separate housing of animals
according to species, source or different background microbial floras
5. Monitor animal health, providing adequate diagnostic support through clinical
assessments, laboratory diagnosis and necropsy when required, and treating
animals when illness or injury necessitates veterinary medical care
6. Delegate responsibility for care to trained technical staff using a documented
process, but must always be available to provide rapid diagnosis and treatment
7. Provide guidance in selection and utilization of suitable anesthetic and analgesic
agents and methods of euthanasia; appropriate selection of species for research
projects; and proper performance of surgical procedures and adequate preoperative, surgical, and post-operative care
8. The veterinarian should discuss with investigators the design and implementation
of protocols and may provide written guidelines dealing with these and other
issues. (See New Protocol Submission section IX.C.2)
VIII. Environmental Health and Safety (EHS)
A. Overview
Human environmental health and safety programs and animal colony health and use, as
they relate to animal work, are regulated by federal, state, and/or local laws. RoseHulman Institute of Technology is committed to providing a safe and healthy work
environment. To facilitate this objective, Rose-Hulman has established an Environmental
Health and Safety Management Program, which addresses all relevant EHS issues
involving animal care and use. The health and safety of animal and humans is the
responsibility of all parties involved and depends on effective communication.
B. Scope
All animal facility personnel (e.g. animal caretakers, technicians, students, volunteers,
investigators, veterinarians, facilities maintenance and custodial staff, and security) must
adhere to established Rose-Hulman environmental health and safety programs.
C. Responsibility and Commitment
1. The environmental health and safety of individuals working in animal care and
use programs is the responsibility of Rose-Hulman and requires a commitment
that begins with senior officials and department heads of the Institute.
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2. Principal Investigators, the Animal Facility Manager, and other Supervisors must
promote a higher level of safety awareness through positive leadership and
reinforcement. In order for Rose-Hulman to maintain a safe, healthful
environment for animals, caretakers, and researchers, these individuals must not
permit safety to be sacrificed for any reason.
3. The Institute’s Environmental Health and Safety Coordinator is charged with
oversight of the Rose-Hulman Environmental Health and Safety Management
Program. Questions regarding the environmental health and safety program
related to animal care and use or other EHS issues should be addressed to this
individual.
D. Guidelines for EHS standards for Animal Care and Use Program
Standards for Rose-Hulman Institute of Technology are modeled after guidelines set forth
on pages 14-18 of the Institute of Laboratory Animal Resources’ Guide for the Care and
Use of Laboratory Animals (1996). Copies of this guide may be obtained from the Office
of Environmental Health and Safety or may by viewed on-line at:
http://www.nap.edu/readingroom/reader.cgi?auth=free&label=ul.book.0309053773
1. Personal Hygiene - Laboratory Safety Procedures
All laboratory environmental health and safety compliance is prescribed in the
Institute’s Laboratory Safety and Chemical Hygiene Program.
2. Vaccinations and Exposure Control
All vaccination requirements and exposure control issues are prescribed in the
Institute’s Exposure Control Program.
3. Female Caretakers
a) Serological samples shall be taken on all women handling high-risk
species (i.e. cats) prior to beginning work to avoid confusion about the
significance of various positive antibody tests in case of subsequent
pregnancy.
b) Female caretakers, especially those of child-bearing age, without
immunity to toxoplasmosis (cat scratch fever), should not be exposed to
possible toxoplasmosis infection from infected species or contact with
cats.
c) Working with hazardous agents, in particular exposure to the possible
inhalation of toxic chemicals, in the first trimester of pregnancy is
discouraged.
d) Personal Protective Equipment shall be worn at all times with additional
precautions outlined by the principal investigator or supervisor prior to
the start of the project.
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4. Personal Protective Equipment
Please refer to on Rose-Hulman’s Personal Protective Equipment Program. A
copy of this standard may be obtained from the Office of Environmental Health
and Safety (OEHS).
5. Infectious Diseases
Infectious diseases also pose a significant risk depending on the species and health
status of animals involved and the level of exposure to them by animal care
personnel. Infectious diseases to which animal care personnel may be exposed
include:
a) viral infections, such as contagious ecthyma, the hepatitides, and
Cercopithecine herpes virus 1 (Herpes B);
b) rickettisal diseases, such as Q fever and cat scratch fever;
c) bacterial diseases, such as tuberculosis, salmonellosis, and shigellosis;
1. protozoal diseases, such as toxoplasmosis, giardiasis, and
cryptosporidiosis; and fungal diseases, such as dermatomycosis
6. Zoonoses
Zoonoses are diseases that can be transmitted from animals to humans and may be
acquired through various routes. In many cases the animals show little, if any, sign of
illness. Animal contact includes contact with animal products, the animal itself or a
byproduct of the animal. Careful monitoring and quarantine of any animals with
potential viral or bacterial infections or parasitic infestations are crucial components
of any animal care and use program. It is important to immunize animal care
personnel against tetanus. Routine tuberculosis testing is essential and measles
vaccination may also be appropriate for workers exposed to nonhuman primates.
a) Individuals whose work involves exposure to or handling of animals
and animal tissues, body fluids and cell cultures should be aware of the
possibility of illnesses that may be transmitted by contact with animals.
b) The routes of infection include ingestion, inhalation, penetration of
broken or unbroken skin, wound penetration, and contact with the
mucous membranes of the eyes, nose and mouth via the following:
(1) animal bites and scratches
(2) contact with animal tissues and cultures, body fluids and excreta
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(3) inanimate objects that are contaminated by the animal or animal
contact
(4) exposure to aerosols produced as a result of activities such as
cleansing of cages
c) All known human exposure to a zoonotic disease is considered an
accident and must be reported by the employee to the principal
investigator or their supervisor for appropriate medical treatment and
investigation. An Employee and Supervisor Incident/Accident Report
must be filed.
d) If a zoonotic disease is suspected in an animal, the principal investigator
or supervisor, and the IACUC Chairman shall be notified immediately
for appropriate action. No Incident/Accident Report must be filed.
e) All personnel are advised to contact the principal investigator or
immediate supervisor for additional guidance and detailed information
on specific zoonoses. Special attention shall be given to appropriate
animal handling procedures, personal hygiene and protective
equipment.
E. Animal Care after Human Accident
1. An animal may require special procedures to identify the risk of human exposure
to diseases. All samples, animals or equipment involved in a human injury shall
be preserved and have special identification to aid in further testing and/or
procedures.
2. The principal investigator or supervisor and the IACUC Chairman should be
notified immediately for appropriate care of the animal, investigation of the
incident and corrective action.
3. If the animal is used for teaching or research, medical information and care
required shall be relayed to all participants specific to the animal type and use.
F. Incident/Accident Investigation and Reporting
4. All work related incidents, work related injuries/illnesses and work related near
misses, or those incidents/accidents that appear to have no apparent adverse
effect, shall be reported immediately by the employee to their immediate
supervisor or the Principal Investigator.
a) The Principal Investigator must ensure that the appropriate department’s
Site Coordinator files an Incident/Accident Report with the Office of
Risk Management.
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b) If the Principal Investigator, immediate supervisor or other department
or administrative personnel are unavailable, the employee should call
the Rose-Hulman Public Safety Office (877-8911) to report incidents
involving work related injury and/or property damage. Please refer to
the Risk Management Office for procedures, detailed instructions and
review of the appropriate claim forms.
IX. Personnel Training and Documentation
A. Animal Research Training Program
All staff working directly with laboratory animals or in the animal care facility must be
qualified to do so in order to ensure the humane treatment of animals. The PHS Policy
and Animal Welfare Regulations (AWRs) mandate that personnel be trained and
demonstrate competency in proper animal care and use procedures. Competencies
required of animal care personnel vary according to their job responsibilities.
Therefore, Rose-Hulman Institute of Technology has developed an Animal Research
Training Program (ARTP) consisting of training modules tailored to the needs of
animal care personnel. Individuals must complete the ARTP modules described below
PRIOR to working with laboratory animals:
1. Core Module. This training module is required of all animal care personnel (PI,
all animal facility workers, students, and technicians)
a) Animal welfare laws, regulations, policies, guidelines
b) The Rose-Hulman Animal Care and Use Policy and protocol form
c) The role of the IACUC
d) The basic needs of each species of animal (housing, food, water,
bedding, social interaction)
e) Behavior and appearance of healthy animals
f) Cage card information and animal health record maintenance
g) Proper handling and care for the various species of animals used by the
facility
h) Proper pre-procedural and post-procedural care of animals
i) Recognition of pain and distress (including notification of PI, Vet or
Facility Manager)
j) How to report perceived deficiencies in animal care and use
k) Environmental health and safety issues including:
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(1) personal hygiene
(2) prophylactic vaccinations
(3) use of personal protective equipment
(4) potential hazards - to include chemical and microbiologic safety
and handling of waste
(5) physical hazards - work related illness or injury
(6) zoonoses
(7) animal care after human accident
(8) susceptibility of personnel - to include pregnant women, women of
child-bearing age, and decreased immunocompetence
(9) incident/accident reporting and medical treatment
2. Experimental Design and Protocol Preparation Module
This module is for personnel involved directly with experimental design, protocol
preparation and performance of animal research procedures (PI, research personnel,
students assisting with experiments) and will include:
a) The concepts of Replacement (using non-animal models), Reduction
(use fewest number of animals possible), and Refinement (elimination
or reduction of unnecessary pain and distress in animals)
b) Minimizing and alleviating pain and distress: Proper use of anesthetics,
analgesics, and tranquilizers for any species of animals used by the
facility
c) Euthanasia and humane endpoints
d) Aseptic technique, pre-procedural and post-procedural care
e) Surgical techniques and proper pre- and post-operative care
f) Utilization of services and resources (e.g. Animal Welfare Information
Center, National Agricultural Library) available to provide information:
(1) On appropriate methods of animal care and use
(2) On alternatives to the use of live animals in research
(3) That could prevent unintended and unnecessary duplication of
research involving animals
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(4) Regarding the intent and requirements of the [Animal Welfare] Act.
g) Completing the Rose-Hulman Protocol Form
3. Species Specific Techniques Module
This module is for personnel involved directly with experimental design, protocol
preparation and performance of animal research procedures (PI, research personnel,
students assisting with experiments) and will be prepared for each species of animal
on campus. Topics will include:
a) selection and procurement of animals
b) husbandry and care
c) handling and restraint
d) identification and records
e) animal health
f) safety and health considerations
g) specific techniques
B. Frequency of Training
1. Animal care and facility personnel must complete the Core Module biannually.
2. Appropriate personnel must complete the Experimental Design and Protocol
Preparation Module biannually.
3. Appropriate personnel must complete Species Specific Techniques either
biannually and each time a new species is introduced into the facility.
C. Personnel Training Records and Documentation
1. A training record will be maintained in the Environmental Health and Safety
Office for each employee working either directly or peripherally with animals.
The Environmental Health and Safety Coordinator will notify employees and their
supervisor when re-certification is required.
2. It is the responsibility of the Facility Manager, Principal Investigators, and other
Supervisors to notify the Environmental Health and Safety Coordinator when new
personnel are hired or existing personnel or students are assigned to work with
animals.
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3. Proper training in humane animal care and use is an important component of the
Environmental Health and Safety Management Program at Rose-Hulman. Its
success is dependent on each employee’s active participation and cooperation in
every aspect of the program.
X. Protocol Submission, Review, and Notification
A. New Protocol Submission
1. All animal care and use procedures at Rose-Hulman Institute of Technology are to
be documented on a “Rose-Hulman Protocol Form” (Attachment A) for review by
the IACUC. The Principal Investigator is responsible for the submission of the
written procedures. He or she may also be asked by the IACUC Chair to attend
the IACUC review proceedings.
2. The law requires that an Attending Veterinarian (AV) be consulted by the PI
when planning procedures in order to provide guidance in matters of animal
medicine/technology and information necessary to complete immobilization,
anesthesia, analgesia, tranquilization, euthanasia, proper performance of surgical
procedures and adequate pre-operative, surgical, and post-operative care in
accordance with current established veterinary medical and nursing procedures.
The PI is to consult with the Attending Veterinarian prior to completing the form.
3. The PI is responsible for obtaining approval and signature from the Attending
Veterinarian, Environmental Health and Safety Coordinator, Animal Care Facility
Manager, and his/her Department Head prior to submitting a protocol form to the
IACUC for review. Signature of each of these individuals is required on the
protocol form before it is considered complete. Electronic signatures will be
accepted.
B. Protocol Review
1. Scope
All activities involving the use of live vertebrate animals on Rose-Hulman’s
campus must be approved by the Institutional Animal Care and Use Committee
(IACUC) before such procedures commence.
2. Review Criteria
Principal Investigators and the IACUC share an equal responsibility to ensure
animal experiment plans and procedures adhere to the following U.S. Government
Principles for the Utilization and Care of Vertebrate Animals Used in Testing,
Research and Training (which encompass both the PHS Policy and the Animal
Welfare Regulations):
a) Principle I: The transportation, care, and use of animals should be in
accordance with the Animal Welfare Act (7 U.S.C. 2131 et. seq.) and
other applicable Federal laws, guidelines, and policies.*
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b) Principle II: Procedures involving animals should be designed and
performed with due consideration of their relevance to human or animal
health, the advancement of knowledge, or the good of society.
c) Principle III. The animals selected for a procedure should be of an
appropriate species and quality and the minimum number required to
obtain valid results. Methods such as mathematical models, computer
simulation, and in vitro biological systems should be considered.
d) Principle IV. Proper use of animals, including the avoidance or
minimization of discomfort, distress, and pain when consistent with
sound scientific practices, is imperative. Unless the contrary is
established, investigators should consider that procedures that cause
pain or distress in human beings may cause pain or distress in other
animals.
e) Principle V. Procedures with animals that may cause more than
momentary or slight pain or distress should be performed with
appropriate sedation, analgesia, or anesthesia. Surgical or other painful
procedures should not be performed on un-anesthetized animals
paralyzed by chemical agents.
f) Principle VI. Animals that would otherwise suffer severe or chronic
pain or distress that cannot be relieved should be painlessly killed at the
end of the procedure or, if appropriate, during the procedure.
g) Principle VII. The living conditions of animals should be appropriate
for their species and contribute to their health and comfort. Normally,
the housing, feeding, and care of all animals used for biomedical
purposes must 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. In any case, veterinary care shall be
provided as indicated.
h) Principle VIII. Investigators and other personnel shall be appropriately
qualified and experienced for conducting procedures on living animals.
Adequate arrangements shall be made for their in-service training,
including the proper and humane care and use of laboratory animals.
i) Principle IX. Where exceptions are required in relation to the provisions
of these Principles, the decisions should not rest with the investigators
directly concerned but should be made, with due regard to Principle II,
by an appropriate review group such as an institutional animal care and
use committee. Such exceptions should not be made solely for the
purposes of teaching or demonstration.
*For guidance throughout these Principles, the reader is referred to the Guide for the Care and Use of
Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences.
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3. Protocol Review Procedure
a) Rose-Hulman will conduct a full committee review of all animal care
and use protocols. The IACUC Secretary will provide each committee
member with a copy of protocol(s) to be reviewed at the IACUC
meeting ten (10) working days prior to the meeting. Situations may
arise when an investigator requires an accelerated review (e.g.
significant change to a protocol). The IACUC Chair may call a special
meeting of the IACUC to accomplish an accelerated review; however,
Rose-Hulman will still conduct a full committee review.
b) Each committee member will complete an “Rose-Hulman Protocol
Review and Evaluation Record” (Attachment B) and come to the
meeting prepared to discuss their evaluations. The IACUC Secretary
will document IACUC deliberations and reviewers comments.
c) At the discretion of the Chair, the IACUC may request that the Principal
Investigator (PI) be available to the committee during the review
process to answer clarifying questions.
d) There will be instances where the PI is also a member of the IACUC.
In these cases the PI will be recused from protocol review and voting by
the Chair (see “Conflict of Interest”).
e) When the protocol submitted is part of a PHS grant proposal or award,
the IACUC will request a copy of the vertebrate animal section of the
grant proposal to compare to the protocol. It is imperative that the
protocol the IACUC approves is consistent with the information
submitted to PHS.
4. Categories of IACUC Actions
a) Approval
The IACUC has determined that all review criteria, based on PHS Policy
and the Animal Welfare Regulations have been adequately addressed by the
investigator. The protocol is approved with a majority vote (> 50%) of the
quorum present. A quorum of the voting IACUC members (5) must be
present before any action (except defer review) can be taken on a protocol.
b) Modifications Required
The IACUC requires modifications to the protocol before granting
approval. Protocols requiring modification will be returned to the PI along
with the “Rose-Hulman Notification of Protocol Review” form (see below)
to allow the PI to amend and resubmit the protocol to the IACUC or the
IACUC Chair as applicable.
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c) Defer or Table Review
The protocol requires clarification or other information in
order for the IACUC to make a judgment (e.g. External
consultation required, committee members with certain
expertise are not present, etc.)
C. Resubmission of Rose-Hulman Protocol Form
1. Modifications Required as Result of IACUC Review
a) Minor Modifications Required
When the IACUC determines that minor modifications to the protocol are
required, they may elect to approve the protocol pending revision, empower
the Chair to review the revised protocol, and take final approval action.
The PI will receive notification that minor revisions are required. The
revised protocol is to be re-submitted to the IACUC Chair for final action.
b) Significant Modifications Required
When the IACUC determines that significant modifications to the protocol
are required, the PI will receive notification that the revised protocol is to
be submitted to the entire IACUC for further review.
2. Substantive Changes in Approved Protocol
The Rose-Hulman protocol is specific and unique in a number of ways including
animal species, persons performing procedures, techniques to be used, method of
euthanasia (if required), method of anesthesia (if required), etc. If there are
changes in these or any other substantive information within the protocol during
the project period, the PI is required to modify the protocol and submit it as a new
protocol for review.
D. Review of Previously Approved Protocols
1. Rose-Hulman protocols will be approved for a period of one year from the project
start date indicated on the approved protocol form.
2. Sixty (60) calendar days prior to the expiration date of the protocol, the Secretary
of the IACUC will send an “Rose-Hulman Protocol Status” form (Attachment D)
to the PI for each active protocol. The PI is required to complete the form and
return it to the IACUC Secretary within thirty (30) calendar days. If the protocol
is to remain active, the IACUC will review the status and determine if an
administrative extension of one year will be granted to the PI. Should the
protocol require substantive changes, the IACUC will require the submission of a
new protocol. A protocol may be administratively extended twice for a total
project period of up to three (3) years. After two administrative extensions, a full
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IACUC review is required.
E. Notification to Principal Investigator
The IACUC Chair will send the “Rose-Hulman Notification of Protocol Review” form
(Attachment C) to the Principal Investigator with a copy to the Institute Official, detailing
the IACUC’s decision to approve, require modifications, or defer review for a protocol.
If the protocol is approved the notification will include the protocol number and approval
date. Reviewer’s comments will be provided to allow the Principal Investigator to
address concerns and/or make changes to the protocol as required.
XI. Evaluation of Animal Care and Use Concerns
A. Concerns
Any concerns regarding the humane treatment and/or welfare of laboratory animals used
in research and teaching on Rose-Hulman’s campus should be promptly reported to the
IACUC Chair or one of the IACUC members. IACUC members will forward concerns
to the IACUC Chair. Rose-Hulman publishes a list of committee assignments each year
which includes the IACUC membership. The IACUC membership and campus contact
information will also be posted in the Animal Care Facility.
B. Personnel Training
Personnel working with animals will be properly trained in animal care and use and will
be instructed during that training to promptly report deficiencies in animal care or use to
the IACUC.
C. IACUC Review
The IACUC will review and investigate stated concerns. If a deficiency is discovered,
the IACUC will outline a plan and timetable for correction. If “significant” deficiencies
or serious instances of noncompliance are discovered, the IACUC will take appropriate
action including, but not limited to, suspension of active protocol(s), and notification of
the appropriate Federal oversight agencies.
D. Records
The IACUC will keep a log of concerns reported, corrective measures taken, and date of
resolution.
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REVISION HISTORY
November 15, 2005
Page 2 III. B. Committee Composition; “The Rose-Hulman IACUC will consist of the following
10 members (8 voting)” change to “The Rose-Hulman IACUC will consist of the following 9
members (8 voting)”
Page 3 III. B. Committee Composition; item 8 deleted, 9 and 10 renumbered to 8
and 9.