Northern Arizona University IACUC Policy Manual
I. Introduction
The Northern Arizona University Institutional Animal Care and Use Committee
(IACUC) follow federal regulations to establish policies for the care and use of
laboratory animals. Regulations followed include the Animal Welfare Act (AWA), the
United States Department of Agriculture (USDA) Policy Manual and public statements,
the Guide for the Care and Use of Laboratory Animals, OSHA and EPA regulations
among others.
The AWA authorizes the USDA to regulate the use of warm-blooded vertebrates in
research and teaching. The AWA sets standards for many aspects of animal research
including housing and feeding requirements, veterinary care, animal transport, and
IACUC oversight of all aspects of animal research. The overarching goal of the AWA is
to standardize a high level of humane care and use of research animals. This includes
minimizing pain or distress in research animals and also mandates that research using
animals is ultimately valuable to human or veterinary science. The principal investigator
(PI) and IACUC must ensure that the correct animal model and number of animals are
used to maximize applicable data while using the fewest animals as possible. All
alternatives to the use of animals in research must be considered. The AWA is a complex
document and the USDA periodically issues policy statements to clarify aspects of the
AWA. These policy statements are found at the USDA Animal Care website. Laboratory
mice and laboratory rats and birds are not currently covered by the AWA, but this
exemption is under review.
The "Guide for the Care and Use of Laboratory Animals” is a document published by the
Public Health Service (PHS) in conjunction with the Office of Laboratory Animal
Welfare (OLAW). The "Guide", much like the AWA, discusses the humane care and use
of animals in research and extends coverage to all vertebrate animals. The Guide must be
followed for all studies conducted with PHS funding. All institutions that receive PHS
funding for animal research must file an "Assurance Statement" with the PHS describing
how the institution will comply with the Guide. Non-compliance with the Guide will be
reported to OLAW for all National Institutes of Health (NIH) funded protocols. Noncompliance may result in loss of funding or possible repayment of grant funds.
The NAU Policy on the Humane Care and Use of Animals was formulated to reflect the
university's commitment to the humane care and use of animals and compliance with
federal regulations. The university policy extends the provisions of both the PHS policy
and the AWA to the use of all vertebrate animal species in research and teaching The
IACUC oversees compliance with this policy and uses the following methods to ensure
compliance:
1. Semi-annual review of animal care and use programs;
2. Semi-annual inspection of animal care and use facilities;
3. Preparation of reports of care and use program and facilities evaluations;
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4. Making recommendations to the Institutional Official (IO) regarding any aspect of the
animal program, facilities, or personnel training;
5. Reviewing and approving, requiring modifications in, or withholding approval of
proposed and ongoing protocols using research animals;
6. Recommending suspension of animal-based activities which are not in compliance
with federal standards.
These actions support research and teaching activities by:
1. Assuring investigators, educators, granting agencies, and the public of a sincere and
methodical review of the humane care and use of research animals;
2. Facilitating involvement of the Institutional Veterinarian and other scientists in
application of new experimental animal procedures and problem solving.
II. Specific IACUC policies
A. Procedural Requirements for Protocol Submission
Requirements for an IACUC Protocol
An IACUC protocol is required for any vertebrate animal activity unless animals are only
observed in field studies. Thus, if any teaching or research occurs that alters the animal's
behavior, a protocol must be approved before such activities occur. In general, protocols
are not required for non-invasive displays such as ornamental fish tanks, etc.
Principal Investigator (PI)
The PI must be a NAU Faculty member or equivalent, or adjunct faculty with approval of
the chair and dean for the specific department at NAU. PI status may also be obtained in
certain cases with approval by the IACUC and IO.
Field Studies
The same regulations that apply to animals within NAU animal facilities apply to
vertebrate animals studied in the field. Thus, a protocol is required for any activity which
involves more than observing animals in their natural environment. This includes but is
not limited to trapping, tagging, exclusion netting, etc.
Tissue
In addition to oversight of the humane care and use of laboratory animals, the IACUC
and institutional compliance officer oversee use of animal tissues used at NAU. To
ensure compliance with several state, federal, and international regulations, the following
policies apply to tissue use at the university.
1. If no other institution has taken responsibility, and the receiving institution’s researcher
will be working with the live animals, even on foreign soil, then submission of an
IACUC protocol is required.
2. If the tissue will be collected in the US or another country under an approved
Institution's IACUC or equivalent, a copy of the protocol approved letter with NIH
assurance number will be requested. These documents will be submitted for review by
the NAU Biosafety Officer and the IACUC chair or designated reviewer. If the protocol
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meets NAU standards and has all required permits and/or documentation, then no
additional action is required.
3. Tissue transfers that do not involve collection from or handling of live animals are
considered to be the responsibility of the NAU Biosafety Office with regard to biological
safety risks, and the responsibility of the IACUC with regard to compliance with
import/transportation regulations.
1. Tissue submitted for clinical analysis by private individuals (i.e. veterinarians) does
not need IACUC approval.
2. Tissue submitted by private individuals (i.e. veterinarians) for research does need
IACUC approval.
Veterinary Protocol Review
Federal regulations require that a veterinarian with training or experience in laboratory
animal medicine be consulted during planning of protocols with potentially painful or
distressful procedures. Veterinary review should help detect potential problems that may
slow IACUC review, thereby expediting the review process. If the veterinarian does not
approve of procedures in a protocol, an investigator may appeal the veterinarian’s
decision by submitting the protocol to the IACUC with an attached written rationale for
the disagreement. It may be necessary to employ external consultants to resolve such
disputes.
Process for Routine Protocol Approval
Investigators submit an electronic copy of the new or renewal protocol to the IACUC
chair and a signed hard copy to the Research Annex. The IACUC chair or designee
disseminates the protocol electronically to the entire committee and a qualified reviewer
is designated. IACUC members have 2 weeks (14 calendar days) to read protocols and
voice concerns to the designated reviewer or call for a full committee review. If no
IACUC member calls for a full committee review, the protocol may undergo an
expedited review in which the primary reviewer, the chair, and the veterinarian approve
the protocol. Any minor concerns that IACUC members express electronically become
conditions for full approval of a protocol. Other than calling for full committee review,
members may not vote on the disposition of a protocol electronically; voting must occur
at a convened meeting at which a quorum of members is present. If any member of the
IACUC calls for a full committee review, the protocol is reviewed at the next convened
IACUC meeting. Following either an expedited or full committee review, a review letter
is generated outlining conditions that must be met before the protocol will be approved.
Decisions of the committee at that time dictate whether the protocol is approved, required
modifications (to secure approval), or rejected.
B. Protocol Sections
Level of Pain and Distress
The USDA has established categories of pain and distress which animals may experience
in research. An investigator must designate which level they feel is applicable for each
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protocol. In general, only the highest pain category which applies to a protocol is
designated. If the IACUC disagrees with an investigator's choice of category, they may
request the investigator reconsider classification. Specific categories defined by the
USDA are (note, there is no category "A"):
B
C
D
E
Animals bred or held for use in procedures but not yet used for such purposes.
Animals used in non-painful or distressing procedures. This includes brief
physical restraint, injections or venipuncutre, banding, etc.
Animals used in potentially painful or distressing procedures in which appropriate
anesthesia, analgesia, or tranquilizers are used. This category includes all
surgery.
Animals used in potentially painful or distressing procedures in which anesthesia,
analgesia, or tranquilizers are not used as they would interfere with the study.
Personnel and Training
All individuals participating in animal research at NAU must be listed in the protocol
which they will be involved This includes investigators, post-doctoral fellows, and
students. The 1985 Animal Welfare Act requires training for persons working with
animals. At NAU, the Institutional Veterinarian and the Animal Care Supervisor
administer the IACUC training program. Typically this training is achieved by
completing the CITI training course titled Investigators, Staff and Students: Basic Course
found on the online CITI webpage. Other options for satisfying training requirements are
available in certain special circumstances. Everyone who contacts animals is required to
participate in training that includes regulations hazards and zoonotic (i.e rabies, plague
etc.) risks associated with animal work. Additional training specific to each protocol and
species is usually required. Anyone performing invasive techniques on a vertebrate
species must document adequate training in surgical and anesthetic techniques and
understanding of the principles of asepsis, anesthesia, and analgesia. IACUC regulatory
training must be repeated at least every 3 years. Protocols will not be approved unless
evidence of training for all personnel is provided. If training is not repeated after a three
year period and is past due by 2 months or greater, the PI will be notified that the
protocol will become inactivated by a specific date (90 days past due) and that no
additional research may be conducted until full compliance with training requirements is
met.
Animal Characteristics and Numbers
All species to be used must be individually listed in a protocol. For wildlife trapping,
investigators must list the species on which work will be performed if trapped. The
number of animals should be the minimum needed but must be adequately justified.
Some studies use too few animals to obtain meaningful data, thereby diminishing the
value of the animals which were used. Statistical methods have been developed for
estimating sample sizes to assure the study will use enough animals to identify a
difference between groups if one exists. The statistical method to be used, the expected
variance, and the chosen level of certainty must be included in the proposal where
appropriate. Many investigators evaluate the data as they are being collected (e.g.,
Wald's Sequential Probability ratio test). This allows one to terminate the experiment as
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soon as a significant result is obtained. When feasible, the IACUC encourages such
designs. For some studies, such as pilot studies, statistical analysis is not possible and the
investigator may make an educated guess as to the number of animals that will be
required. For other uses, such as teaching, a power analysis is not applicable but rather,
the number of students and nature of the course will dictate animal numbers. Estimates
must include all animals and describe whether they are purchased, captured (wild animals
from the field), or bred in the research facility for each protocol.
The IACUC realizes it is often difficult to prospectively offer exact details of the number
of animals that will be required. Thus, the IACUC will allow an investigator to exceed
the number estimated for each year by 5%. Should an investigator or educator require
more than 5% more animals than listed in the IACUC protocol, they must submit a
modification request to the IACUC justifying the need for more animals.
Animals Husbandry
Vertebrate animals must be housed in the NAU Research Annex and cared for by the
Annex staff unless other arrangements are previously approved by the IACUC.
Occasionally, animals may be housed in other areas or cared for by other personnel.
Regulations require scientific justification and previous IACUC approval to house warmblooded vertebrates outside of the approved facilities for more than 12 hours. In these
cases investigators must justify the variance and document that housing conditions and
husbandry meet Federal regulations.
Animal housing areas must be clean and uncluttered. Animal room doors must fit tightly
within the frame to prevent escape and/or injury to animals. All surfaces which animals
come in contact with must be smooth, non-corrosive and readily santized. An exception
is granted for clean single use items such as rodent nestlets, or other items such as bird
perches if sanitation is adequate. Only items related to the daily animal care are to be
stored in holding rooms. Such items include feed in sealed containers, trash in sealed
containers, mops, brooms, etc. All components of the animal facility should be cleaned
regularly and disinfected as appropriate to the circumstances and at a frequency based on
the use of the area and the nature of likely contamination.
Food and bedding materials must be stored in closed containers to avoid contamination
and the potential spread of disease. These containers should be cleaned and sanitized on
a regular basis. If food is not stored in its original bag, its milling date or purchase date
(if the milling date is unavailable) must be clearly indicated on the food container. With
proper storage, food can generally be used up to 6 months after the milling date (1 year
for canned food). However, the shelf-life of food can be shortened by several factors,
including temperatures above 70oF, extreme humidity, light, oxygen, and pests. Food for
species which require vitamin C such as guinea pigs, has a shelf-life of only 3 months.
To avoid contamination, food must be provided in feeders which prevent contact of food
with feces and urine. Animals must have access to "potable, uncontaminated drinking
water according to their particular requirements." To avoid microbial crosscontamination, the Guide recommends either refilling unsanitized water bottles only if
they are returned to the same cage from which they were removed. Watering devices
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should be checked daily to ensure proper operation and must be washed and sanitized at
least weekly.
Temperature and humidity must be monitored and recorded daily to ensure compliance
with regulations. Humidity should be maintained between 30 to 70%.Unless previously
approved by the IACUC, temperatures must be appropriate to the species as outlined in
the Guide. Temperature extremes can affect research results, alter an animal’s
performance, or lead to compromised health or death.
Soiled bedding should be replaced as necessary to keep animals clean and dry. Bedding
changes can vary from daily to weekly depending on animal density, cage size, urinary
and fecal output, and experimental conditions. Cages must be cleaned and sanitized on a
regularly scheduled basis. The frequency of cage sanitation may vary depending on
specific husbandry practices, such as bedding type, cage type and size, animal density,
and frequency of bedding changes. Cages should be sanitized at least once a week unless
the IACUC approves a deviation from this frequency.
Ventilation supplies adequate oxygen, removes thermal loads from animal enclosures,
dilutes gaseous and particulate contaminants, adjusts room humidity, and creates pressure
differentials between adjoining spaces. Several factors can affect the minimum
ventilation rate but an acceptable standard for animal rooms is 10-15 fresh-air changes
per hour. Extra-vivarium facilities are frequently not capable of providing 10 – 15 freshair changes per hour; the maximum number of animals allowed in a study area should be
reduced proportionately.
In general, lighting should be diffused throughout an animal holding area and be
sufficient for the well-being of the animals, allow good housekeeping and adequate
inspection of animals, and safe working conditions for personnel. Factors such as light
intensity and wavelength, circadian rhythms, animal pigmentation and light exposure
history, body temperature, hormonal status, age, species, sex, and animal stock/strain
should be considered in determining appropriate illumination.
Unnecessary noise in study and holding areas should be minimized. As per the Guide,
"to the greatest extent possible, activities that might be noisy should be conducted in
rooms or areas separate from those used for animal housing" and that "radios, alarms, and
other (noise) should not be used in animal rooms unless they are parts of an approved
protocol or an enrichment program."
When a sick animal or any animal care problem is identified reasonable attempts to
contact the PI and primary students involved will be made. Contact methods will usually
include emails, or phone calls. PIs are expected to provide reliable contact information to
the IACUC for these reasons. The PI will be requested to evaluated the animals or
situation and provide a timely response to the IACUC and Annex manager.. If the
Attending Veterinarian or Annex staff determine that an animal’s health and welfare is an
immediate concern, they may take action up to and including euthanasia of the animals
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without PI response in emergency situations or if the PI fails to respond in a timely
manner.
Any unplanned euthanasia events for HEALTHY animals (i.e. those not covered by an
approved protocol) MUST be preceded by 24 hours advance notice (or 2 weeks if the PI
is unavailable) of impending unplanned euthanasia of healthy animals to PI and
secondary contact responsible for the animals. If the PI objects, he/she must contact the
IACUC Chair or Institutional Veterinarian immediately to request additional
consideration.
Suspension of Animal Care Privileges
In some cases, PIs and their students are allowed to provide daily care for their research
animals. This variance from standard husbandry practices is a privilege. If animals are
not cared for or the care is not documented as per Annex Standard Operating Procedures
(SOPs), federal regulations and guidelines and/or the approved IACUC protocol, this
privilege may be revoked. If the privilege is revoked, Annex personnel will assume care
of the animals and will charge the current established per diem rates for this care. A PI
may petition the IACUC to resume care of their research animals if they document steps
taken to ensure prior problems with animal care or documentation of care have been
resolved. This request should be sent to the IACUC chair and describe any training
received since the incident, how the problem was corrected and steps taken to ensure
problems will not recur.
Husbandry Record Keeping
Daily records of animal care, room maintenance, and environmental conditions must be
posted in the study area and be kept updated by responsible personnel. At a minimum,
these records should include the species and number of animals, cage/bedding changes,
feeding and watering of animals, temperature/humidity, and cleaning of the secondary
enclosure. The format of the modified log should be kept on file and should correctly
indicate the tasks performed and the frequency of each task.
All cages must have a cage card properly labeled with: protocol number, cage number or
animal identification, genus and species, date received, hatched or arrived, company or
area from which the animal was procured, and the PI. The primary animal care provider
should provide telephone numbers either on the cage card or on the animal holding room
door. The cage card should be used to record dates of procedures like blood draws and
surgeries. Cage cards are never thrown away. If a card becomes full, a new card with
identical information will be placed in front of the old card. Providing experimental
information on the cage card allows care providers specific information when performing
daily animal health checks.
Animal care is required by law and must be performed every day, including weekends,
holidays, and even in the event of emergencies (The Animal Welfare Act: section 3.32,
3.54, and 3.57, and The Guide for the Care and Use of Laboratory Animals: page 46
Emergency, Weekend and Holiday Care). Often there are circumstances that make this
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challenging. The Annex will provide care for a set per diem when needed—but please, if
possible, give Annex staff several days of advance warning if this service is required.
If animal care IS missed by the PI or designees, the NAU IACUC requires that
the Research Annex personnel must assume care for the animals in question. A per diem
charge of $10.00 PLUS the current animal/cage per diem rate may be charged to the PI
until satisfactory alternative care procedures are established.
Unexpected Deaths and Reports
Unexpected deaths (or injuries or sicknesses requiring veterinary attention) of
experimental animals in your care must be promptly reported to Dr. Pauline Entin and
Charles Drost, IACUC Co-Chairs. This requirement helps assure the proper use and care
of research animals, and maintains NAU’s compliance with reporting procedures
required by OLAW (NIH Office of Laboratory Animal Welfare) and other regulatory
agencies. This report should include the animal species, number of animals, protocol
number if possible, PI, date of death(s), clinical symptoms and cause of death(s) if
known.
OLAW does, at times want to hear informally about incidents where animals die because
of one time equipment failure or other unpredicted events. OLAW wishes to know what
happened and what steps the IACUC and investigator have taken to eliminate recurrence.
Additionally OLAW requires formal reporting of animal deaths if the study is NIH
funded and requests communication involving certain issues even with non-funded
studies, to demonstrate a quality IACUC process. If there is an animal welfare issue then
it is required to be reported to PHS and other agencies involved.
It is the Principal Investigator’s personal responsibility to assure that ALL research
animals recovering from anesthesia and surgery in PI’s laboratories or field sites are
monitored by trained personnel until animals are fully recovered (stable vital signs, able
to right themselves, move about, groom, drink and eat) and that any pain/ discomfort is
treated as needed with appropriate analgesics.
All unexpected deaths of animals must be reported within 2-3 days to:
Dr. Pauline Entin
IACUC Chair
Biology Box 5640
NAU- Flagstaff Campus
Office: 928-523-4123
Email: Pauline.Entin@nau.edu
Charles Drost
USGS Southwest
Biological Science Center
Flagstaff, AZ 86001
928 556-7187
Email: Charles_drost@usgs.gov
Examples of “unexpected death” that should be reported include: death due to equipment
malfunction, inadequate husbandry procedures (lack of proper feeding, watering,
temperature regulation, ventilation, cage sanitation, etc.), and death due to inadequate
peri-surgical and/or post-surgical monitoring. Any of these unexpected deaths may cause
unrelieved pain or suffering. The IACUC is obligated by federal regulations to
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investigate unexpected deaths and relevant procedures corrected to assure the highest
standards of animal welfare at NAU.
Examples of an “expected death” that would not need to be reported include: normal
euthanasia at end of a terminal experiment, anesthesia related mortality, unexpected
surgical error resulting in death (but no unrelieved pain), and animals dying of natural
causes (eg. old age).
Maintaining Animals in Study Areas
Under certain circumstances, the IACUC may approve housing of animals in an
investigator’s laboratory for periods longer than 12 hours. When this occurs, animals
must receive care equivalent to that provided in the Research Annex and in compliance
with all animal welfare regulations. All husbandry and record keeping requirements must
be met whether animals are housed in the Research Annex or in alternate areas. IACUC
certification of such an area is valid only if acceptable standards are maintained. Daily
record sheets must be maintained and submitted to the Research Annex monthly and at
the end of each study. Animal care personnel will provide care and management of
satellite animal facilities on a per diem charge system unless previous arrangements have
been approved by the IACUC. If alternate arrangements have been approved, animal
care must be equivalent to that provided by the animal care staff. Failure to maintain
such animal care standards will result in animal care staff resuming daily care on a per
diem basis. Due to increased efforts and costs involved in servicing an alternate animal
facility, per diem rates may exceed those charged in the Research Annex. All facilities
housing animals must have the capacity to optimize animal care including cage
sanitation, food, bedding, and waste storage areas, personnel hygiene facilities, and an
animal treatment area.
The IACUC is required to inspect all animal facilities, including but not limited to, areas
where animals are maintained for periods longer than 12 hours, at least once every six
months. Under most circumstances, this also includes field stations where animals are
housed for more than 12 hours. USDA inspectors are also required to inspect any areas
where regulated species are housed for more than 12 hours, including field stations. The
IACUC must be notified when animals are no longer housed in the study area.
Animal Procurement
Vertebrate animals may be purchased or captured (wild animals in the field) only when
part of an approved IACUC protocol. This includes field studies and feeder animals for
carnivorous species. The Institutional Veterinarian and/or Research Annex office must
be notified of all animals to be purchased, caught, bred, or otherwise obtained before they
are brought on campus. This is to ensure availability of adequate housing, prevent
acquisition of unapproved animals, and preclude introduction of inappropriately obtained
animals. Any animal transportation across state lines or importation from international
sources must comply with all applicable regulations and must occur through approved
ports. Research animals originating from NAU and transported across state lines or
international boundaries must have a recent examination and be issued a health certificate
from a USDA accredited veterinarian. Documentation of appropriate paperwork from the
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state or country of origin, relevant United States Fish and Wildlife Services (USFWS) or
Animal Plant Health Inspection Service (APHIS) permits, and customs inspections must
be filed with the IACUC for any animal importation.
Feeder Animals
Feeder animals for carnivorous animals should be included on protocols as animals to be
used. The investigator should provide the following additional information about feeder
animals:
1. The source of feeder animals;
2. Length of time they will be held prior to use;
3. Justification for the number requested;
4. How these animals will be maintained until use.
Biohazardous Agents/Radioisotopes/Recombinant DNA
Approval from the appropriate committees must be granted before a protocol is submitted
to the IACUC. Check with the IACUC chair or Institutional Veterinarian if there
questions on this matter.
Significant Manipulations/Pain Categories D-E
Federal regulations prohibit performing potentially painful procedures without adequate
analgesia unless scientifically justified and previously approved by the IACUC.
Anesthesia alone may not provide sufficient analgesia and all potentially painful
procedures must be planned in consultation with the Institutional Veterinarian prior to
submitting the protocol to the IACUC. Paralytic agents may not be used in animals
without concurrent adequate anesthesia and strong scientific justification. The
Institutional Veterinarian must review protocols with potential painful or distressful
procedures.
Surgery
If surgeries are part of a protocol, the following must be considered:
1. Surgery on non-rodents must occur in the Research Annex surgery suite. Rodent,
avian, and ectotherm surgeries may occur in this suite or in investigator's laboratories if
the surgery is performed in a clean, readily sanitized, area used only for surgery and
previously approved by the IACUC. All survival surgeries must be performed
aseptically, using sterile instruments and gloves. All surgical areas must be disinfected
prior to and between surgeries to decrease contamination.
2. Non-survival surgeries do not require strict asepsis but must occur in dedicated, clean,
non-cluttered surgical areas.
3. Surgical instruments must be sterile. Heat sterilization, i.e. autoclaving or glass bead
sterilization, is ideal. Chemical sterilization with agents such as gluteraldehyde can be
used. Instruments must be thoroughly rinsed with sterile saline or water after chemical
sterilization before being used for a surgical procedure. Chemical sterilants should be
replaced as per label instructions or when contaminated with blood or other body fluids.
Appropriate contact time with chemical sterilants is critical. Heat-sensitive instruments
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or implants can be sterilized by ionizing radiation or ethylene oxide gas. Alcohol is not
adequate to sterilize instruments or implants.
4. All surgeries must be performed using adequate anesthesia/analgesia. Anesthetic
depth must be regularly monitored for adequacy and monitoring must be documented.
Major vs. Minor Surgery
Minor surgery is any procedure that does not enter a body cavity and causes minimal
physical impairment (superficial incisions, peripheral vascular cut downs, and
subcutaneous implants, etc.). Major surgeries, therefore, are those that enter cranial,
abdominal, or thoracic cavities or have potential to cause physical impairment
(orthopedics, etc.). Multiple major survival surgeries are not allowed on animals without
strong scientific justification and previous IACUC approval. Multiple major survival
surgeries involving two different protocols require approval from USDA officials.
Consult with the Institutional Veterinarian if you have questions regarding techniques
appropriate for these situations.
Post-Surgery or Procedural Care
After anesthesia, an animals vital physiologic parameters must be monitored until the
animal has fully recovered . This usually means until they are able to maintain
themselves in sternal position and are no longer in danger of death due to inability to
prevent aspiration, etc. Post-procedural care must include analgesia unless scientific
justification for withholding analgesics is previously approved by the IACUC.
Administration of analgesics to an animal during anesthetic recovery may prolong
recovery or endanger the animal's life. Consult with the Institutional Veterinarian when
planning post-anesthetic analgesia.
Surgical Logs
Surgical logs must be kept for all animals undergoing surgery. The logs must include the
protocol number, species, animal identification, surgical procedure, anesthetic regime,
post-operative analgesia, and discussion of any intra- or post-operative complications.
Assurance of Review of Existing Literature
Regulations require investigators to consider alternatives to potentially painful
procedures in animals and to document that research does not unnecessarily duplicate
previous studies. Alternatives to consider include in vitro assays, less "sentient" species
(insects rather than mammals, etc.), and computer models. The USDA's Policy 12
specifically outlines acceptable means by which an investigator can document sufficient
consideration of alternatives. Policy 12 states a database search is the best method for
complying with these requirements. When a database search is the primary means of
meeting this requirement, the narrative must, at a minimum, include:
1. The names of the databases searched;
2. The date the search was performed;
3. The period covered by the search; and
4. The key words and/or the search strategy used.
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Under Policy 12, certain alternatives to database searches are acceptable if databases are
inadequate. Under these circumstances (as in highly specialized fields of study),
conferences, colloquia, subject expert consultants, or other sources may provide relevant
and up-to-date information regarding alternatives in lieu of, or in addition to, a database
search. Sufficient documentation, such as the consultant's name and qualifications and
the date and content of the consult, should be provided to the IACUC to demonstrate the
expert's knowledge of the availability of alternatives in the specific field of study.
If a database search or other source identifies a bona fide alternative method (one that
could be used to accomplish the goals of the animal use proposal), the written narrative
must provide justification as to why this alternative was not used. Investigators may not
quote themselves as expert consultants for fulfilling the purpose of this requirement.
Permits
Investigators must provide the IACUC with copies of required permits (USFWS, or other
federal, state, tribal, or local agencies) relevant to the protocol. Ultimate responsibility
for obtaining the required permits rests with the PI and permit copies must be on file in
the IACUC office before studies commence. As discussed above, this includes required
importation/transportation permits.
III. General IACUC Policies
Scientific Justification
Many non-standard techniques require scientific justification. Acceptable justification
may be accomplished by one of the following methods:
1. A small pilot study (usually 6-10 animals per group) may be performed to document
the need for a non-standard practice. Results are reviewed by the IACUC before granting
final approval for the variance. Arguments that grants will not cover pilot studies are not
accepted; the IACUC is sensitive to this issue but must ensure regulatory compliance.
Financial considerations are not allowed to influence the humane care and use of animals.
2. A literature review that conclusively demonstrates conventional methods will not
work for the study may be submitted with the protocol.
3. The IACUC may "grandfather” previously accepted techniques if the investigator
provides compelling evidence that newer techniques will deleteriously affect the study.
Long standing use of now discouraged techniques, per se, does not justify continued use.
The IACUC may require a pilot study to document the required need for antiquated
techniques.
Protocol Modifications
All animal-related activities must be explicitly outlined in the IACUC protocol. Any
changes in animal use which affect animal well-being must be previously approved as a
modification to the protocol. The IACUC Chair and Institutional Veterinarian work in
conjunction to approve minor modifications (e.g. addition of personnel to the protocol,
increase in animal numbers less than 10%). Significant modifications (e.g. those which
may cause an increase in pain or distress, new or additional procedures, an increase in
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animal numbers greater than 10% an addition of animal species, change of PI, etc.), must
be reviewed and approved by the IACUC..
Annual Reports
Annual Reports must be submitted for all protocols. These reports must describe the
number of animals used during the previous year and any problems encountered. They
must discuss means to correct recurrent problems.. The annual report must be submitted
by the anniversary date of the protocol’s approval or the protocol will become
inactivated. Once a protocol is inactivated, no research using animals may legally occur.
Any animals housed will continue to incur per diem charges but may not be used for
research or teaching purpose until the annual report is filed. Failure to file an annual
report within 45 days of the due date will result in expiration of the protocol. Appropriate
oversight agencies will be notified of the protocol’s expiration. A new protocol must
then be submitted, reviewed and approved by the IACUC for research to resume.
Veterinary Care
Laboratory animal technicians or trained students observe animal health and housing
conditions daily. All abnormalities are reported to the Animal Care Supervisor or the
Institutional Veterinarian for evaluation. Clinical treatment of animal disease or injury is
generally initiated only after obtaining the PI's consent. However, in cases involving
animal pain or distress not approved as part of the approved protocol, the veterinarian
may authorize treatment or euthanasia independent of the PI. The veterinarian is not
required to seek approval from the PI, administrators, or the IACUC in order to perform
routine veterinary treatment or euthanize animals for humane reasons. If an investigator
feels that routine veterinary care will hinder a study, this variance must be previously
approved by the IACUC.
Transportation
Any animal transportation across state lines or importation internationally must comply
with all applicable regulations and must occur via approved ports. Documentation of
appropriate paperwork from the state or country of origin, appropriate USFWS or APHIS
permits, and customs inspections must be filed with the IACUC for any animal
importation. All transportation must be previously approved through the IACUC to
ensure proper permits are in place. Research animals originating from NAU and
transported across state lines or international boundaries must have a recent examination
ane be issued a health certificate from a USDA accredited veterinarian. Please contact the
Animal Care Supervisor for more information.
Animal Transport through Public Areas
All animal transportation should be planned to minimize transit time, reduce zoonotic
potential, prevent disease transmission to the Annex, and protect animals from injury.
All animals must be covered when transporting through public areas to preclude
identification or spread of zoonoses. Similarly, cadavers must be transported in double
opaque durable plastic bags and covered. If animals were exposed to biohazardous
materials, follow guidelines put forth by the Institutional Biohazards Committee, the
Recombinant DNA Committee, or to the Radiation Safety Officer.
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Requirements for Transport Vehicles
Transporting animals in vehicles not specifically designated for animal transportation
(e.g., personal or rented vehicles) is strongly discouraged. Contact the Research Annex
for details concerning animal transport in vehicles. The following contains general
guidelines when a commercial transport company is not used:
1. The cargo space must be constructed and maintained to protect the health of the
animals and prevent exposure to exhaust fumes;
2. Animal spaces must have sufficient air supply for the normal respiration of all
animals;
3. Animal space air supply to the shall not be shared with human air supply if there is
risk of aerosol zoonotic transfer;
4. The ambient temperature of the vehicle must be maintained between 45°F and 85°F;
5. The vehicle will be sanitized after transportation of the animals (or before the
transportation of animals if contaminated);
6. If a passenger vehicle is used, place plastic or similar material under the transport cage
to minimize contamination.
Rodent Tail Biopsy
It is often necessary to obtain tissue for DNA analysis in rodents. The terminal tail is
often sampled. The rodent terminal tail does not ossify until approximately 4 weeks of
age. However, recent evidence indicates that sensory pain receptors may be more active
in young rodents than in older animals. As such, some form of analgesia/anesthesia
should be used for rodent tail biopsy. Local anesthetic may be applied topically using
preparations such as EMLA (Eutectic Mixture of Local Anesthetic) cream. Sampling
should be performed using aseptic technique and a sharp scalpel blade. The smallest
possible section of tail should be removed and adequate homeostasis should be ensured.
It is recommended that tail samples be limited to no more than 10 mm of tissue. If
possible, alternative to tail biopsies should be considered: Tissue can be obtained by ear
punching which can also serve as identification, Small quantities of blood from
peripheral veins (e.g., saphenous vein, lateral tail vein) may be used for analysis, PCR
analyses using saliva and hair have also been described.
Animal Identification
Numerous methods for identifying individual animals include tattoos, ear punches, ear
tags, marking pens, and toe clipping. Of these, toe clipping has recently become
controversial as a potential source of long-term pain and distress. Recent rulings by
regulatory agencies have indicated toe clipping should only be performed with scientific
justification, should only be used in small species such as rodents, where other less
invasive methods may not suffice, should only involve one toe, and should only be
performed within 5-7 days of birth.
Expired Medical Materials
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The use of expired medical materials (drugs, fluids, sutures, pharmaceuticals) is
prohibited in survival procedures. Expired materials may be used in terminal experiments
if animals are anesthetized and will not recover from anesthesia. Such materials must be
labeled, "For terminal procedures only." Expired anesthetics or analgesics are not to be
used in any studies as their efficacy cannot be guaranteed.
Use of Pharmaceutical-Grade Compounds
In accordance with USDA Animal Care Policy:
1. Pharmaceutical-grade compounds must be used when available, even in acute
procedures.
2. Non-pharmaceutical-grade compounds should only be used after specific review and
approval by the IACUC for reasons such as scientific necessity or non-availability of an
acceptable pharmaceutical-grade product. Cost savings are not adequate justification for
using non-pharmaceutical-grade compounds in animals.
3. If pharmaceutical-grade compounds are not available and the investigator must mix
their own compounds, they cannot be used in animals until the solution is filtered (i.e. 0.2
μm filtration) and sterilized; the container is labeled with the date and time of
reconstitution; and the solution is discarded after known degradation periods.
Storage of Controlled Substances
Minimum requirements for the storage of controlled substances include:
1. A secure, substantially constructed cabinet with no sign or indication that it is used for
the storage of controlled substances.
2. Controlled Substance Disposition Record(s) must be maintained and available to the
IACUC, veterinarian, NAU officials, and regulatory agencies during business hours.
Ether
In vivo use of diethyl ether is prohibited at NAU unless overwhelming scientific evidence
indicating its necessity is presented to the IACUC before its use. The IACUC may
impose several safety constraints before approving the use of ether.
Neuromuscular Blocking Agents
Use of neuromuscular blocking agents (NMBs) is strongly discouraged; they may not be
used without adequate (i.e. surgical plane) anesthesia. Due to the inherent difficulties in
assessing the level of anesthesia in paralyzed animals, NMBs will be approved only with
strong scientific justification and when the investigator demonstrates ability to monitor
animals appropriately. Controlled ventilation should be established prior to injection of
the NMBs. During paralysis, heart rate and electroencephalogram must be monitored
continuously for signs of insufficient anesthesia (reaction to pain, stress). Core
temperature, blood gases and fluid and electrolyte balance must be maintained during
paralysis. Provision must be made for periodic voiding of the urinary bladder. If the
IACUC is uncertain of qualifications of the investigator to monitor the animals, they may
require the veterinarian to observe and assure sufficient anesthesia.
Restraint
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Restraint limiting an animal's physical movement beyond normal, approved caging
should be used only when less invasive methods are inadequate to meet the goals of the
study. Prolonged restraint is prohibited without frequent observation by animal care or
investigative staff. Animals restrained regularly should be conditioned to the restraint
apparatus prior to study initiation to minimize stress-induced data variation. Restrictions
regarding restraint also apply to wildlife in live traps or mist nets. Use of nets or traps for
wildlife requires consideration of how extraneous species (not of primary interest to the
study) will be handled. For example, migratory birds may be caught in nets designed to
trap rodents. Such netting may, therefore, require permits related to the Migratory Bird
Act.
Food or Water Restriction/Deprivation
Food or water restriction, other than pre-surgical fasting, may be necessary in protocols.
As this has the potential for causing significant distress to the animal, the IACUC has
established the following guidelines;
1. Full Committee Review is required for protocols involving complete food or water
deprivation of 18 hours or more, depending upon the species in question. Due to
individual variation in water requirements, average guidelines for water intake or urine
output are not appropriate.
2. Restricted animals should be monitored daily for health judged by stability of
performance, development of dehydration (skin turgor, mucous membrane drying, urine
output, urine specific gravity, packed red blood cell volume), and signs of stress.
Disturbances of normal activities can signal stress, including changes in normal sleep
cycles, abnormal social interactions, and emergence of abnormal behaviors such as cage
chewing, hair picking, abnormal vocalizations, and aggression. Weight loss must be
monitored and recorded daily. Animals must not lose more body weight than defined in
the approved protocol. In general, the IACUC limits weight loss to 10% unless scientific
justification is approved for exception to this policy. Other parameters for measuring
health appropriate to the species should be monitored in consultation with Institutional
Veterinarian. Rats, for example, tend not to drink when food is unavailable and should
be observed for signs of dehydration. Investigators must communicate with the animal
care staff to prevent animals from receiving improper rations. The staff must be
informed about periods of restriction and deleterious symptoms to be evaluated.
Chronic Implants
Chronic implants, such as intravenous and intracranial catheters, present frequent postsurgical infection challenges. Aseptic surgical technique must be meticulous. Postsurgical catheter access must also utilize sterile technique and one must inject only sterile
solutions using careful aseptic technique. Inoculation of even a few organisms into a
catheter may cause sepsis and death.
Screening of Biological Materials for Viruses
To protect animals and personnel from contagious disease, all biological materials to be
implanted into animals must be certified pathogen-free prior to introduction into the
recipient animals. If such certification is not available, the IACUC may require materials
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to be MAP (Mouse Antibody Production) or PCR (Polymerase Chain Reaction) tested
prior to use or that recipient animals be quarantined throughout the study.
Immunizations
There is considerable debate about immunization of animals. If Complete Freund's
Adjuvant (CFA) is used, investigators must evaluate alternative adjuvants and provide
scientific justification for CFA use. General considerations in immunization include:
A. Complete Freund's Adjuvant induces extensive inflammation and, often, chronic pain.
It may be used only for primary immunization with scientific justification. CFA may not
be used in subsequent immunizations due to extensive tissue necrosis. CFA should be
prepared 1:1 with the antigen solution and injected aseptically in subcutaneous (SC) or
deep intramuscular (IM) sites but not intradermally. Maximum doses are 0.05 ml per SC
site and 0.5 ml for IM injection in rabbits (proportionately less for smaller species). SC
sites should be widely separated to maintain cutaneous blood supply; IM injections
should be via a single injection into a deep muscle. Personnel using CFA should be
cautioned that inadvertent self-injection of CFA may result in painful, chronic
inflammation.
B. Incomplete Fruend's Adjuvant may be used for boosters in CFA immunized animals.
C. Titer-Max, RIBI, and liposomes are effective alternatives to CFA for many
antibodies. Small, sterilized, porous plastic balls (“wiffle balls”) that slowly release
compounds are a widely used method of immunization that preclude necrosis seen with
other adjuvants and negate the requirement for vascular access. Wiffle balls must be
considered for immunization of rabbits. Use of CFA over these alternatives must be
scientifically justified.
D. Footpad injections require scientific justification and previous approval by the
IACUC. CFA in the footpad produces swelling, ulceration, and necrosis. If footpad
inoculation is used, only one foot may be injected. In rodents, this should be a hind foot.
E. Post-injection care of animals should include observation for signs of shock and
appropriate treatment if such reaction occurs. Inflammatory reactions at injection sites
should be reported to the veterinarian for examination and treatment as needed.
F. Ascites Production, induced by intraperitoneal (IP) CFA or pristane injection, is
prohibited by Federal regulations unless in vitro techniques have been shown to be
insufficient for the antibody in question. When ascites is used, animals must be observed
daily and peritoneal fluid drained as necessary to prevent pain and distress. Ascites
should be collected using a 21g or smaller needle, preferably on anesthetized animals,
when abdominal distention approximates that of late gestation. Animals must be
euthanized if their condition deteriorates (emaciation, hunched posture, difficult
ambulation, etc.). Administration of SC or IP sterile saline after ascites collection may
help prevent shock.
Blood Collection
Blood volume withdrawn from an animal should be the minimum required for a study.
Survival venipuncture should be aseptic. Phlebotomists should be trained to minimize
pain and distress for the animal. Exsanguination is a stressful experience and should only
be performed in anesthetized or recently euthanized animals. Specific guidelines for
blood volumes collected are found below.
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Quantities of Blood That Can be Collected from Rodents and Rabbits
Rodents
The standard rule of thumb is that an animal's blood volume is 10% of
body weight. However, a more accurate assumption is that blood volume, while varying
between species, is closer to 70 ml/kg. For a single blood draw, up to 10% of blood
volume may be removed, i.e. 0.21 ml for a 30 g mouse; 2.1 ml for a 300 g rat.
Retroorbital or cardiac bleeding must occur under general anesthesia and be performed
by highly experienced personnel. Bleeding frequency must not be greater than once
every 2 weeks unless previously approved by the IACUC.
Rabbits
The total blood volume of rabbits is approximately equal to 6-8% of the lean body
weight. Allowing for 5% blood volume in the capillary bed, this translates to about 67
ml/kg (1 kg x 0.07 x 0.95 = 67 ml/kg). Acute loss of 25-30% of the blood volume is fatal
in 50% of rabbits undergoing hemorrhage. Up to 15% of the blood volume may be
removed at one bleeding. For example, 40 ml for a 4 kg rabbit (4 x 0.07 x 0.95 x 0.15 =
0.0399 liter = 40 ml). This volume may be extracted weekly. For animals producing
antibodies, however, such bleeding should be restricted to once every 2-4 weeks. If
greater volumes are removed, the hematocrit and serum proteins must be monitored.
Consult with the Institutional Veterinarian for blood collection from other species.
Euthanasia
Euthanasia must be performed as outlined in the AVMA Guidelines on Euthanasia unless
scientifically justified and previously approved by the IACUC. Once euthanasia has been
performed, confirmation of euthanasia by physical means (cervical dislocation for mice,
bilateral pneumothorax, etc.) must be employed to prevent inadvertent recovery. Consult
with the Institutional Veterinarian if you have any questions regarding acceptable
euthanasia methods.
The 2007 AVMA Guidelines on Euthanasia lists euthanasia by cervical dislocation or
decapitation as permissible only in anesthetized animals unless scientifically justified and
previously approved by the IACUC. If the IACUC approves these techniques without
anesthesia, the Institutional Veterinarian shall observe personnel performing the
techniques to ensure proper training. The veterinarian shall document this training via a
memo to the protocol. Cervical dislocation may only be approved for small birds, mice,
rats weighing <200g, and rabbits weighing <1 kg. Decapitation shall only be approved
for rodents, rabbits weighing <1 kg, birds, fish, amphibians and reptiles.
Criteria for Premature Euthanasia
To minimize pain and suffering of research animals, investigators must inform the
IACUC of criteria they will use for premature euthanasia. Frequent criteria used in
animal research are outlined under the "Euthanasia as an Alternative to Death as an
Endpoint" Section of this document. These are not the only acceptable criteria, but each
IACUC protocol must outline which criteria will be used. The veterinarian will make
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reasonable attempts to contact an investigator if presented with an animal in undue pain
and distress or which is moribund. However, the veterinarian has the authority to
euthanize any animal in undue pain or distress
Euthanasia as an Alternative to Death as an Endpoint
The term "death as an endpoint" is confusing. This term does not refer to euthanasia but,
rather, to allowing animals to remain in moribund states until dying spontaneously.
Death may not be used as an endpoint in studies without strong scientific justification and
previous IACUC approval. Rather, euthanasia should be based on objective signs of
moribund status relative to the animal model and experimental protocol. Relevant signs
of moribund status may vary between species and protocols. Investigators are expected
to monitor animals at least daily (including weekends and holidays) for moribund status.
Common symptoms of moribund status in rodents include: rapid, shallow respiratory
rate, rapid muscle atrophy, emaciation, loss of more than 15% of body weight, impaired
ambulation, hunched posture, hypo- or hyperthermia, ulcerative dermatitis or infected
tumors, prolonged inability to remain upright, and severe diarrhea or constipation.
LD50 Testing
LD50 (Lethal Dose to 50% of subjects) tests are controversial among scientists,
legislators, and the public. Classic LD50 test may be approved by the IACUC only when
scientifically justified.
Veterinary Examination of Unexpectedly Moribund or Deceased Animals
Federal law requires that a veterinarian examine animals that die unexpectedly during use
in research or teaching, to ensure detection of problems that may affect other animals.
Examination generally involves necropsy unless the cause of death can be determined by
external examination or evaluation of history or husbandry. Unexpectedly moribund
animals should similarly be examined, both to determine if euthanasia is in order, and to
determine whether other animals may be at risk.
Adoption/Disposition of Excess Live Animals
Animals which are not required for a specific study or which survive a study and are not
infected with potentially hazardous agents may be transferred to another study if humane
and scientific considerations are met, i.e. animals may not be subjected to multiple major
survival surgeries. Animals may be also be adopted at the end of a study if there are no
public or animal health concerns which preclude such adoption, if the investigator and
veterinarian agree to the adoption, and the IACUC does not oppose the adoption.
Occupational Health and Safety
Occupational health and safety is of utmost importance to the NAU IACUC. Regulations
require that the IACUC monitor personnel occupational health programs and training
related to animal use at NAU. All personnel who work with animals are to be trained
about risks of animal use and must complete the occupational health questionnaire.
Those with more than minimal animal contact must also participate in a pre-employment
health screening at Fronske Health Center or through a suitable alternative health care
provider. All individuals who work with animals or potentially infectious animal tissues
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should be vaccinated for tetanus and other agents as applicable. Standard personal
protective equipment (PPE) that should be worn when working with animals include a
laboratory coat (or surgical scrubs) and gloves. Respiratory protection such as surgical
masks, respirators, or the use of biosafety cabinets may be appropriate. Open toed shoes
and sandals do not provide adequate protection and are not to be worn in the laboratory.
IV. Procedures for Conducting IACUC Business
Quorum
A quorum of members must be present for a full committee to conduct business. A
quorum shall be 50% plus one committee member in attendance.
Animal Related Issues Under Investigation
Initial contact will be an email to the IACUC and the Investigator. A letter from the
IACUC Chair will be sent to the party being investigated. This letter shall be written
with reference to the AWA and the Guide in order to provide justification for the IACUC
investigation.
Scientific Merit
Review for scientific merit may be required to determine whether the use of animals is
justified particularly considering that not all protocols received peer review during the
funding process, i.e. internally funded projects.
Electronic Signatures
Electronic signatures are acceptable on all protocol forms.
IACUC Training
All members of the IACUC will receive training in relevant regulations and humane care
and use of laboratory animals. Continuing training will occur at least annually at
convened IACUC meetings or special sessions. This training may be conducted by the
Chair, Institutional Veterinarian, other members, coordinator or invited speakers. Topics
will include regulatory changes, new concepts in humane care and use of laboratory
animals, or new approaches to the NAU animal care program. Specific members may be
periodically asked to attend conferences such as IACUC 101, PRIM&R, etc., and then
conduct training based on the conference.
Duplicate Review
OLAW and the USDA have recently agreed that it is not required that a program be
reviewed by more than one IACUC. Thus, if an NAU investigator is involved in an
animal study at another institution, and the animal work occurs at that institution, the
work does not have to be approved by the NAU IACUC. A copy of the approved
IACUC protocol from the other institution should be submitted to the NAU IACUC and
will be kept on file during the study. If animals are to be housed or received at NAU for
a study that is approved at another institution, the NAU IACUC may require an NAU
protocol or may vote to accept the cooperating institution's approved form.
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Semi-Annual Evaluation of Laboratory Animal Programs and Facilities
Semiannual evaluations of laboratory animal programs and facilities are performed by the
IACUC, between November 1 and April 30, and between May 1 and October 31.
Subcommittees of at least 2 IACUC members perform the inspections; any member
desiring to participate in any inspection will be included. The veterinarian attends
inspections if possible. All animals are inspected, as are all animal holding/housing and
laboratory areas. Any problems in animal care, physical plant, or the care and use
program (occupational health, sanitation, veterinary care, euthanasia, analgesia, etc.) or
failures to comply with USDA and PHS policies are addressed.
Variations from federal and NAU policies are noted as major if they have potential to
deleteriously affect animal or human health or as minor. Final reports of these
inspections must list deficiencies as major or minor, provide a plan of how deficiencies
will be corrected, and state a deadline for correction of deficiencies. Investigators are to
respond to the IACUC in writing with an explanation of how deficiencies will be
corrected.
It is important that a resource director (lab representative) be formally designated for
each animal use area and that each director be thoroughly familiar with the operation of
the resource and applicable standards. The resource director should be present during the
IACUC inspection if possible in order to provide the IACUC with information about
programs and discuss plans and schedules for corrective action of any deficiencies.
Recommendations to the Institutional Official
IACUC semiannual program facility review reports are forwarded to the Vice President
for Research who is the Institutional Official (IO). Reports outline recommendations
regarding the program, facilities, and personnel training and provide deadlines for
correction of deficiencies. The IO must notify the USDA, PHS, or other relevant
funding agencies if major deficiencies are not corrected within 2 weeks of the deadline.
Reporting Deficiencies in Animal Care and Use--"Whistle Blowing"
Any alleged violations of IACUC policy or animal abuse at NAU may be submitted to
any IACUC member, the Institutional Veterinarian, or Institutional Official. Written
allegations should include as much information as possible, including: the date, time,
location, and nature of the violation, animal species and number of animals involved,
identification of animals if possible, and relevant details. While such format is optimal,
verbal allegations of violations will also be investigated. Confidentiality will be
maintained if requested; anonymous reports are accepted if sufficient details are provided
to investigate the complaint. The IACUC will investigate allegations and take appropriate
action to rectify violations. Serious violations will result in protocol suspension and
reporting to the IO and appropriate Federal agencies.
Suspension of Animal Activities
As per federal regulations, the IACUC may suspend an activity that it previously
approved if it determines that the activity is not being conducted in accordance with the
approved protocol. If the IACUC suspends an animal protocol, the Institutional Official,
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in consultation with the IACUC, shall review the reasons for suspension, take appropriate
corrective action, and report that action with a full explanation to relevant Federal
agencies. If the activity is supported by PHS funds, the IACUC, through the IO, must file
a full report to the NIH Office of Laboratory Animal Welfare (OLAW). If there is
sufficient evidence of serious noncompliance, it may be prudent for the IACUC to
suspend an activity pending outcome of a full investigation. In these cases, a preliminary
report will be sent to OLAW and the USDA, through the IO, on the understanding that a
full report will be submitted upon completion.
The IO, in consultation with the IACUC, has the power to impose further sanctions on an
investigator found to be responsible for mistreatment or noncompliance. Each case must
be considered individually and all cases will result in precedents being set, and the
implications of these should be considered. The institution must also consider whether to
announce its findings publicly.
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Animal Care and Use for Researchers Housing Animals
1. Ordering and Procuring of Animals
No vertebrate animals may be ordered or procured for research or teaching at
NAU unless they are part of a previously approved IACUC protocol. To ensure
orders comply with the IACUC protocol and Federal regulations, the Research
Annex must be notified before ordering any vertebrate animals. Occasionally,
investigators capture wild animals for use on campus or procure animals by
means other than ordering from a commercial vendor. These animals must also
be part of a previously approved IACUC protocol and the Research Annex must
be informed of the procurement before animals are brought to campus.
2. Daily Animal Care
Daily care sheets with an area for comments on animal health are required for all
animals (examples attached). Animal records must be completed daily. A clear
chain of animal care responsibilities and a defined mechanism for backup animal
care must be posted. All cages must be properly labeled with: protocol number,
cage number or animal identification, genus and species, date received hatched or
arrived, company or area in which animal was procured and Principle
Investigator’s name. A primary animal care provider’s telephone number must be
posted on the cage card or holding room door. Every animal holding area must
have an accurate and current census. When an animal used for an experiment is
found dead, sick, injured, transferred to a different protocol or adopted it must be
recorded on the animal care records.
3. Animal Health
During the daily health check of each animal one may find an animal in less than
good health. This should be recorded on the care records and the Institutional
Veterinarian must be notified. The Institutional Veterinarian can diagnose the
problem and may prescribe a treatment if needed. If an animal is found dead of
an obvious cause, the death and reason for death should be recorded and the
animal disposed of normally. If the death is unknown it should be recorded and it
is required that the animal be examined by the Institutional Veterinarian or
qualified animal care personnel. The animal should be placed in a refrigerator,
not the freezer until examination. Federal Law requires that the Institutional
Veterinarian be notified about all sick, injured or animals found dead of unknown
causes.
4. Animal Holding Areas
Climate control in animal holding rooms is necessary for the good health of
laboratory animals. The animal area must have a set light cycle, temperature range
and humidity range appropriate for the species.
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(Ie. Temperature (68-72 °F) and Humidity (30%- 70%), light cycle of 12 hours
Dark/12 hours Light).
No human food and beverages should be stored or consumed in the animal
holding area. Refrigerators being used for storing animal food must be labeled
“Not for Storage of Human Food”. Storage or consumption of human food is not
allowed in laboratories, whether or not animals are used in that space. An
exception to this prohibition may be granted if a designated area is defined in
which no laboratory or animal-related activated may occur. Regular laboratory
cleaning schedules should be outlined in SOPs and strictly followed. Items not
directly related to daily care cannot be stored in the immediate animal holding
area. Feed containers must be labeled with the contents and the date the feed was
milled or acquired. In general, food must be used within 6 months of the milling
date. Dirty cages should be removed from the animal area and cleaned as soon as
possible. Neither clean nor dirty cages should be kept in an area near animals.
5. Standard Operating Procedures (SOPs)
Standard Operating Procedures must be clearly posted in each laboratory that
houses animals and should address the following topics;
 Animal handling and care
 Receiving and disposal of animals
 Surgery protocol
 Zoonotic disease potential hazards and preventative measures
 Allergic reactions
 Use of personal protective equipment
 Procedures for dealing with animal bites and potential animal-base toxins
 Cleaning of holding area
 Crisis plan including emergency numbers
 Euthanasia
 Vermin monitoring
6. Surgeries
Surgical areas must be thoroughly cleaned before and after use. All surgeries
must be recorded in a surgical log. Information to be recorded includes the date
of the surgery, animal and protocol identification, animal weight, anesthetic
regimen, surgical procedures and any complications.
Expired pharmaceuticals – Expired analgesics and anesthetics cannot be used in
animals. Other expired items may be used only in terminal procedures. Such
products must be labeled to indicate they will not be used for survival procedures.
7. MSDS / Chemical storage
MSDS (Manufactures Safety Data Sheet) must be present for all chemicals.
These should be stored in a clearly marked binder, visible and known to all
personnel in the laboratory. All liquid chemicals should be stored in leak-proof
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secondary containers to preclude inadvertent leakage and personnel exposure.
Several containers may be stored in the same secondary container, as long as
chemicals are compatible in the event of a leak.
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