1
Page 1 of 8 plus attachments
OLD DOMINION UNIVERSITY
Institutional Animal Care and Use Committee (IACUC)
PROGRAM OF ANIMAL CARE AND USE
Revised and Approved September 22, 2004
________________________________________________________________________
I. INTRODUCTION:
The program of animal care and use is intended as a general statement of principals,
guidelines, and description of capabilities. It is designed in accordance with applicable federal
regulations and guidelines published by the U.S. Public Health Service.
II. FACILITIES:
Old Dominion University’s Animal Facility is located in the Mills Godwin Building, Rooms 405
- 409 and Room 318. These rooms are used for housing animals on a continuous basis.
Occasionally, rabbits or mice are housed in a walk-in incubator in Room 216. The Room 406 409 complex contains 7 smaller rooms (numbered A-F) served by hallways, including dedicated
animal rooms, a cleaning/storage area, a room for storing bedding and other supplies, and a small
office. All of the animal rooms in Rooms 406 and 409 are supplied with water through an
automatic watering system. The office provides desks for the facilities manager and his/her
assistant. This office is also the Official Repository of the protocols and administrative forms,
memos, letters, meeting minutes and other relevant IACUC documents and files.
Room 318 consists of one primary room, approx. 29 ft long by 12 ft. wide, where rats are
housed, and an entrance-way used for access as well as storage of feed and bedding for the
animals. This is used primarily for rats and periodic isolation of incoming animals. Diagrams
illustrating the floor plans of the facilities including these 2 major animal housing areas, are
attached.
The heating and air conditioning system for the main facility rooms are part of the central system
of the Mills Godwin Building. It is regulated to provide an average air temperature of 25o C. (±
2o C.); relative humidity is not controlled. Air is filtered both at the main blower unit located in
Room 405 and via HEPA filters located in the ductwork immediately outside the main entrance
to the facility, Room 406. New HEPA filters were installed in 1999 and replaced yearly since
then. A signal lamp is installed over the door way to indicate the status of the filter. Cleaning
and/or replacement of the HEPA filters is scheduled to be done at least once/year, or earlier if
needed. Auxiliary heaters are located in rooms 409A, 409E, 409F, 406E and 406F. The latter
two units are regulated to provide the reptiles housed in those rooms with additional heating
required for their maintenance.
2
Page 2 of 8 pages
PROGRAM OF ANIMAL CARE AND USE (continued)
_____________________________________________________________________________
Lighting in all animal rooms is provided by "dayglo" fluorescent lamps mounted below the
ceiling. The lamps are on a timer. Lighting in rooms 406C and 406D are on separate timers to
allow additional control beyond that provided by the main timer.
The use of the various rooms in Room 405 - 409 are as follows:
405
Incinerator and freezer for holding carcasses, tissues, etc.,
scheduled for incineration.
406
A:
Office area
B:
Feed/bedding supplies
C:
Faculty Research (nude mouse colony)
D:
Faculty Research Andrology mice) and breed mice for various needs
E:
Faculty Research (snakes)
F:
Faculty Research (snakes)
407
409
Room 318
Room 216
Wash area for washing cages, pans, other animal
A:
B:
C:
D:
E:
F:
Rats
Work/preparation room
Hamster housing room
Rabbit housing room
Rats, cotton rats, other exotic animals or cage storage as needed.
Rabbit housing room
Rat Housing Room (for Psychology Research)
Walk-in incubator used periodically to house rabbits and/or mice
serving as hosts for the deer tick, Ixodes scapularis (vector of
Lyme disease) during tick feeding.
The use of these rooms is not absolute and it is possible that certain rooms may be
reallocated for different uses in the future. However, the placement of the watering system and
the size of certain cage racks limits major reallocation of animals without radical changes in the
structure of the facility.
The facility is equipped to house rabbits, mice, rats, hamsters and reptiles. Exotic species
(e.g., wild rodents) may also be housed under strict isolation if space is available. Exotic species
can only be housed if there is no risk of infection to the animal handlers and the other animals in
the facility.
The facility serves to provide housing and care of all animals in accordance with
applicable federal and state regulations regarding animal care. It receives animals purchased by
3
Page 3 of 8 pages
PROGRAM OF ANIMAL CARE AND USE (continued)
____________________________________________________________________________
investigators, verifies that animals have been received in accordance with purchase orders, and
that the received animals have been acquired through a licensed vendor or dealer. Incoming
animals are checked for health status and, where appropriate, are placed in quarantine until they
are safe to be released to the general colony
Animals are housed in legal size cages according to NIH guidelines for size and body
weight of each individual species. Periodic checks are made to insure that animals have not
outgrown their cage limits. Special housing is provided for pregnant rabbits, including a
"breeding box"; this is placed in a large ( 2 ft X 2.2 ft; interior dimensions) and only the pregnant
female is placed in this oversized cage. Similarly, special housing is provided for pregnant rats.
The incinerator in Room 405 is used to dispose of animal carcasses, tissues, organs,
animal wastes from the facility or animals used in teaching (formalin fixed).
The facility does not have a permanent quarantine room. Certain rooms are used
temporarily as required to serve as quarantine rooms to accommodate in-coming animals.
Occasionally, one room in the third floor facility, room 318, is used for this purpose.
III. PERSONNEL:
The operation of the animal facility involves a hierarchy of personnel under the overall
guidance of the IACUC. These personnel include, in order of supervisory responsibility, the
following:
1. Faculty Supervisor:
3. Facility Manager:
Dr. Daniel E. Sonenshine,
Department of Biological Sciences,
Room 216A/202H (Tel. X 3595).
Dr. Ruth Ann MacQueen, Midway
Veterinary Hospital(paid consultant,
approximately 2 hours/month);
backup is Dr. M. W (Tooki) Myers
Ms. Kelley Proctor
4. Work Study Student Assistants:
To be named (20 hrs/week)
5. Half-time Animal Caretaker
To be named (10 hrs/week)
2. Consulting Veterinarian
Qualifications of the personnel are provided in their individual file folders maintained in
the repository of records in the facility. Provisions are made for training new personnel as well
as upgrading the training of existing personnel with at least one of the following:
4
Page 4 of 8 pages
PROGRAM OF ANIMAL CARE AND USE (continued)
1. Complete a Web-based training course and test using the EVMS LATA program.
PI’s will be given the password upon request. This will be used primarily for P.I.s.
Certification of completion became mandatory for PIs after January 1, 2003 in order
to continue to use animals and submit protocols for IACUC review.
2. For students and part-time Animal Facility personnel, view the animal care videos
maintained at the ODU audio-visual center. These include videos on the proper
handling of a) rabbits and b) rats. Individuals viewing these videos must complete
IACUC Protocol form B showing that they have viewed the videos and completed the
test. The form must signed by the Animal Facility Manager or the PI to whom the
students are assigned before this will be accepted as meeting the qualification
requirement.
3. Students and part-time Animal Facility personnel may substitute acceptable course work,
e.g., animal physiology, wherein techniques for handling vertebrate animals are taught.
4. Complete specialized training courses, e.g., AALAS certification.
5. The facility will provide instruction in animal related hazards, including potential
zoonoses, injuries from animals or other risks to animal facility personnel. Procedures
for reporting and treating injuries will follow the Biological Sciences Chemical Hygiene
Plan. A specific form, the “Accident Report Form” must be filled out so that the incident
can be logged and the employee treated.
No one is allowed to handle animals unsupervised unless they have had exposure to
proper procedures as described above. The animal facility manager assures that new individuals
have proof of training.
ANIMAL USE AND ORIGIN:
1. Use of animals: The Animal Facility is responsible for all animals housed in the
various animal rooms. Animals are assigned to specific investigators for teaching or research
use in accordance with existing protocols. Investigators are expected to notify the facility
manager when they have completed their use of assigned animals. Animals no longer in use
revert to the facility and are considered as part of the stock population.
Investigators are expected to notify the facility manager in a timely manner when
planning experiments requiring use of animals approved by their protocols so that sufficient
individuals can be available when needed. The ODU animal facility is not obligated to maintain
any animals unless requested to do so by faculty members. In practice, a standing stock
population of the common species will always be maintained to insure a supply of individuals
when needed. Faculty members are expected to advise the facility manager regarding the
number of individuals of a particular species that they anticipate using and that they wish to have
available at all times. This information is needed to enable the Animal Facility staff to plan for
future animal use. It is also used to compute per diem charges.
The ODU animal facility is not obligated to maintain any animals unless requested to do
so by faculty members. In practice, a standing stock population of the common species will
5
Page 5 of 8 pages
PROGRAM OF ANIMAL CARE AND USE (continued
_____________________________________________________________________________
always be maintained to insure a supply of individuals when needed. Faculty members are
expected to advise the facility manager regarding the number of individuals of a particular
species that they anticipate using and that they wish to have available at all times. This
information is needed to enable the Animal Facility staff to plan for future animal use. It is also
used to compute per diem charges.
The goal of the in-house breeding program is to maintain sufficient stocks of standard
species and strains so as to be able to supply a sufficient number of these animals to investigators
for their research or teaching needs. Animals are purchased from external sources (licensed
vendors) when the animal facility breeding program in unable to provide such needs naturally.
Breeding of rats, mice, hamsters and rabbits is done by the facility personnel and is
encouraged as the primary means for insuring a supply of disease-free, low cost research
animals. Breeding boxes are available for use with rabbits. Animals are purchased when there is
a need for a special breed not normally maintained by the facility or when the indigenous supply
is inadequate to meet teaching/research needs of a particular investigator.
Animals are purchased by the faculty users with funds from their teaching or research
budgets. The Animal Facility does not expend its own resources to purchase animals.
ANIMAL CARE:
1. Food and Water: Animals are supplied food and water ad libitum. Water is supplied
to all rats, hamsters and rabbits via the automatic watering system. Water is supplied to the mice
via water bottles.
2. Sanitation (Cage Cleaning). Dry saw dust litter is placed on top of paper liners in the
waste pans of animal cages at intervals of 2 or 3 days. Contaminated litter is removed and
discarded in large, sealed plastic cans lined with plastic garbage bag liners. When full, the sealed
bags are removed from the facility by the caretakers and transported to the loading dock of the
Mills Godwin Building via the elevator.
Cages and pans are cleaned according to a regular schedule. Pans are cleaned every 2 or
3 days by transporting them to the cleaning facility, Room 407, and washing them in the sink
with a water solution containing chlorine bleach and a detergent. A measuring cup is used to
measure the amount of chlorine disinfectant per gallon of water needed to insure thorough
sanitation. Written instructions for measuring out the correct amount of chlorine disinfectant per
gallon of water are posted on the wall behind the sink. Rabbit cages are cleaned at intervals not
to exceed 2 weeks. To clean the cage, the animal is relocated into an unused, clean cage, and the
contaminated cage is transported to the cleaning facility. The grate is removed, scrubbed
thoroughly with the chlorine disinfectant/detergent solution in the sink and placed against a wall
to dry. The cages are washed with water containing the chlorine disinfectant and detergent over
the center floor drain, and then hosed down with the high-pressure washer. Rat cages are
cleaned at intervals of every 3 weeks. Rat cages are washed in the sink with chlorine disinfectant
6
Page 6 of 8 pages
PROGRAM OF ANIMAL CARE AND USE (continued
measured with the dip stick as described above as well as with soap and water. Cages are
allowed to dry following washing and then returned to their racks and rooms of origin.
3. Health Care of Laboratory Animals. Qualified Animal Facility personnel examine the
animal populations each day. Any health problem is noted and addressed at that time. Every
effort is made to handle each health care problem by the facility manager, with the assistance of
the consultant veterinarian. Examples of routine problems that normally do not require special
veterinary attention include 1) rabbit ear mites; 2) overgrown tooth; and 3) superficial skin injuries.
Ear mites are contained with miticide; overgrown teeth are clipped with stainless steel clippers; cuts
and abrasions are treated topically with Furazolidone (aerosol) powder and Bacitracin ZincNeomycin sulfate-polymyxcin sulfate ointment. More serious problems, such as diarrhea,
influenza-like symptoms, etc., are discussed with the veterinarian and actions are taken only as
prescribed by the veterinarian. Animals suffering severe distress or pain from a health problem that
cannot be treated in a timely manner are destroyed unless advised otherwise by the veterinarian.
A set of procedures for administering antibiotics in a “herd health manner”, e.g.,
Liquamycin, including the name of the drug, dose (in grams/kg body weight), route, frequency
and duration of administration, is available in the Animal Facility Manager’s office. This
statement of procedures is prominently displayed. Animal care personnel will follow these
procedures when administering drugs after consulting with the veterinarian.
A health care log has been established and is maintained in the Animal Facility
Manager’s office. Health records are maintained on any animal receiving non-routine care so
that information can be passed accurately to the veterinarian when requested. A notice is
posted on the Animal Facility Manager’s office concerning the location of the health care log.
4. Emergency Care of Laboratory Animals. Animals displaying signs of serious
abnormalities require immediate attention and notification of the veterinarian. Examples of
serious problems are: 1) diarrhea; 2) greatly reduced or zero food consumption; 3) nasal
discharge; 4) sneezing and/coughing; 5) physical injury; 6) bleeding; 7) abnormal head tilt.
These and other conditions that are considered serious abnormalities are to be considered
emergencies. The facility manager and all other animal care personnel are required to inspect
the animals daily, including weekends. If a serious condition requiring emergency care is
recognized, the facility manager will notify the attending veterinarian and request assistance
in treating the condition. If another animal care employee is on duty and recognizes the
condition, he/she will notify the Animal Facility Manager who will in turn contact the
veterinarian. If unable to contact the Animal Facility Manager, then the employee on duty
will contact the veterinarian and leave a report via telephone and/or e-mail for the Animal
Facility Manager.
Animals suffering from a serious condition as described above will be treated as
recommended by the attending veterinarian.
If unable to contact the attending veterinarian, animal care personnel will notify the
Principal Investigator for guidance in the treatment of the sick animal. If unable to contact the PI,
Animal Facility Manager, or veterinarian, the animal (s) suffering from the emergency condition
will be euthanized.
7
Page 7 of 8 pages
PROGRAM OF ANIMAL CARE AND USE (continued
5.
Weekend/holiday Care. Routine food and water supply activities are continued
irrespective of the weekend or holiday. This is done by at least one qualified caretaker.
This caretaker also inspects the animal population for health problems. If an emergency condition is
discovered, the animal care personnel follow the emergency procedures as described in item (4)
above. Cage cleaning and other cleaning duties are normally not done at this time (unless required by
an emergency situation).
6. Euthanasia: Euthanasia is different for the different species of animals housed in the
facility. Mice, rats and guinea pigs are euthanized by carbon dioxide gas as described in the
accompanying attachments. Rabbits are euthanized by inoculation (intravenous) of sodium
pentabarital as approved by ODU's veterinarian, or by CO2 gas, as shown in the accompanying
attachments.
7. Disposal of Animal Remains: Euthanized animals or animals that have died from various
causes are destroyed by incineration. The university is approved by a State of Virginia permit to
operate an incinerator for this purpose. The incinerator is inspected periodically to insure that it is
operated in accordance with all applicable state and local ordinances.
OCCUPATIONAL HEALTH AND SAFETY
1. Immunizations. All personnel previously authorized to handle animals were required have a
current tetanus immunization by June 1, 1997. All new personnel must state that have a current
tetanus immunization (within the past 5 years) or they must be immunized before they are allowed
to handle facility animals.
IACUC
1. Membership. The current membership of the IACUC consists of the following members: Dr.
Perry Duncan (affiliated member); Ms. Susan Metosky, representing the Office of Research; Dr.
Barbara Hargrave (affiliated member); Dr. Ruth Ann MacQueen (affiliated member and ODU’s
consulting veterinarian); Mr. Gary Ochsenbein (unaffiliated member); Ms. Kelly Proctor
(affiliated member and Animal Facility Manager); Dr. Robert Ratzlaff (affiliated member); Dr.
Daniel E. Sonenshine (affiliated member and Chairperson); Dr. James Swanson (affiliated
member) and Dr. James Yuan (affiliated member). The veterinarian reports results of visits or
telephone consultations to the Chairperson of the IACUC and to the Office of Research.
2. Functions: The functions of the IACUC are as follows: 1) Review, correct and update as
necessary the ODU Animal Facility Program of Animal Use and Care (copy attached); 2) Review
approve, recommend modifications or reject proposed protocols for use of ODU’s laboratory
animals in teaching and research, including protocols submitted for annual renewal, in accordance
with the Protocol Procedures (Attachment No. 3, Appendix 1 of this Program); 3) List the protocols
approved by the committee since its last meeting; 4) Consider complaints, if any, concerning
aspects of animal use and care and reports, if any, of non-compliance with institutional, state and
federal regulations regarding animal use and care. Suspend protocols found not to be in compliance
8
Page 8 of 8 pages
PROGRAM OF ANIMAL CARE AND USE (continued
upon the recommendation of the full IACUC; 5) Consider recommendations, if any, to the Office of
Research, Graduate Studies and Economic Development for improvement or correction of the
animal program, facilities, personnel training, Occupational health care or other issues concerning
care and use of animals at the university; 6) Note any deficiencies in the program evaluation and, if
any were found, provide specific plans and dates for their correction (separate program evaluation
report); 7) Inspect the entire Animal Facility, note major or minor deficiencies, and establish a plan
with a firm date for their correction; 8) Report the results of IACUC inspection (separate inspection
report).
3. Schedule of Inspections and Program Evaluations. The ODU IACUC shall conduct inspections
of the Animal Facility and shall reevaluate the Program of Animal Use and Care at least once every
six (6) months. The schedule for these inspections and evaluations is on or about 15 March and 15
September in each year. Additional inspections or evaluations may also be carried out by the
IACUC.
Attachments
_______________
The following items have been distributed during previous meetings and should be available to each
committee member in their files. There are no changes in these items since the last committee
meeting.
Appendix 1.
Appendix 2.
Appendix 3.
Appendix 4.
Appendix 5.
Appendix 6.
Appendix 7
Appendix 8.
Appendix 9.
Floor plans for the Animal Facility (2 pages).
Euthanasia
ODU Protocol Review Procedures
Protocol Review Form (Form A)
Qualifications for Working with Animals (Form B)
Annual Review Form (Form E)
Facilities Inspection Report
Protocol Review/Tracking Form.
Health Care Record Log
9
Wash
Rinse
23
ft
Hamsters
Rabbits
Rabbits
Empty at
present
Rats
3
6
feet
Snake/
reptile
colony
Snake/
reptile
colony
Normal
mouse colony
34 ft
Figure 1 Fourth Floor Main Animal Facility Total 1692 Ft2 (excluding hallways and other open
areas)
Nude
mouse
colony
10
Single rat
for
experiments
Rats
Figure 2. Psychology experimental room for rats. 370 ft2
11
Fig. 3. Room 216 showing the location of the walk-in incubator used occasionally to house
rabbits
12
Appendix No. 2. Euthanasia.
1. Cervical Dislocation: Appropriate for mice but only as part of specific research protocols
approved by the IACUC. Restrain the mouse, hold by the tail on a smooth surface, pull tail
gently to stretch mouse, place metal bar (e.g., ruler, scalpel, etc.) firmly across neck, then pull tail
quickly to dislocate neck vertebrae.
2. Decapitation: Appropriate for mice and rats. Requires a quillotine. Restrain the animal, insert
the head into the guillotine up to the base of the neck, then quickly pull handle of knife down across
neck to decapitate. Motion must be rapid and firm to obtain a quick kill.
3. Carbon Dioxide Gas: Appropriate for mice, rats, rabbits and guinea pigs. This method of
euthanasia requires a trash can, trash can liners and a tank of compressed CO2 gas with a long
tube. Place the plastic bag in the trash can, place the animal or animals in the plastic bag,
insert the tube from the CO2 tank, close lid of trash can and wait approximately one hour.
Observe the animal (s) and verify that breathing and heart beats is (are) absent before
disposing of the carcasses.
4. Intraperitoneal (IP) Injection of Sodium Pentobarbital (conc.): Appropriate for rats, mice and
guinea pigs. Requires the reagent (must be current, i.e., not expired), syringe (3 ml) and
hypodermic needles (20 - 23 gauge). The amounts to be injected are 130 mg/kg for mice, 75 mg/kg
for rats or 50 mg/kg for guinea pigs. Inject IP and observe animal until breathing and heartbeat has
stopped before disposing of carcasses. Individual performing this type of anesthesia must be
certified, i.e., must have a current DEA permit.
13
Appendix No. 3
Old Dominion University Protocol Procedures
The following procedure is used to review proposed protocols and approved protocols
requiring revision in objectives or methodologies.
1. Principal Investigator (PI) obtains protocol forms from the Animal Facility.
2. PI fills out protocol forms and submits them to the IACUC Administrative Assistant; if the PI
needs assistance in filling out the forms, he/she contacts the Administrative Assistant, Animal
Facility Manager or the Chairman of the IACUC.
3. Administrative Assistant makes copies of the completed forms and sends each committee
member one copy for review, along with a transmittal form.
4. Protocol Review: Protocol approval normally is done by the Designated Reviewer Method. In
accordance with US Public Health Service policy, all IACUC committee members will receive
all members of the IACUC will receive copies of each protocol and will have an opportunity to
review it. If a full committee review is not requested by any member of the IACUC within the
designated period of time (10 working days), the chairperson of the IACUC (Dr. Sonenshine) will
designate the veterinarian and at least one other member, in addition to the Chairperson (Dr.
Sonenshine) of the IACUC to review the protocol. The designated reviewers shall have the
authority to approve, require modifications in the protocol (to secure approval) or to call for full
committee review of the protocol at a convened meeting of the IACUC. If the latter method is used,
voting to approve the protocol may be done at the convened meeting of the committee. Following
approval by the designated reviewers, the IACUC chairperson will sign the protocol approval sheet
and forward the approval to the faculty member and copies to the file. However, any member of
IACUC may request a full review at a convened meeting of the committee. Voting will not be done
by telephone, E-mail, U.S. mail or FAX or otherwise to obtain members votes outside of a
convened quorum.
If a faculty member or other scientist conducting research with ODU animals proposes
significant changes or amendments in ongoing research projects, the IACUC will review these
changes or amendments in the same manner as a new protocol. Thus, if a faculty member requests
an annual review for an ongoing project but adds amendments or significant changes in the
protocol, the ODU IACUC will subject this protocol to a full review, in accordance with the
procedures as described above (i.e., normally, by the designated reviewer method).
If the protocol is rejected or approved with qualifications, the reasons for this action must be
written on the action form and returned to the PI. A protocol approved with qualifications must
obtain the acceptance of the recommended revisions from the PI. PI acceptance in writing on the
protocol form constitutes IACUC approval and does not require another review. If the protocol is
rejected, the administrative assistant will return the protocol to the PI for revision and resubmission.
If the PI appeals the rejection or the qualifications, the administrative assistant notifies the
Chairman of the IACUC, who will call a meeting of the committee. In addition, any committee
member may also request a meeting of the committee to review the protocol. A revised protocol
14
that is resubmitted after rejection will be considered as a new protocol and the same procedures that
apply to new protocols will also apply to resubmission's. Similarly, if the PI appeals a qualification
of a previously submitted protocol, this will also be treated as a resubmission. In this case, the PI
must provided additional supporting information to explain why the qualification should be
removed.
If a committee member is unable to review a protocol due to temporary absence, the
chairman may approve the protocol so long as all other members, including the attending
veterinarian, have approved it.
5. If a PI appeals the decision of the committee, the Chairman of the IACUC convenes a meeting of
the committee to discuss the case. The committee must decide if the claims of the PI are legitimate
or not. The committee may reconsider its prior decision and approve the protocol as is, or with
revisions acceptable to the PI. All members of the committee must approve the decision. The
committee may invite the PI to its meeting in order to obtain the maximum information available.
Following its meeting, the Chairman of the IACUC writes to the PI and advises him/her of the
committee's decision. If the decision is favorable, the PI may proceed to carry out the research in
accordance with the protocol. If the committee reaffirms its original decision, there is no further
appeal.
6. Following approval of a protocol by the IACUC, the Chairman signs the protocol and advises
the Administrative Assistance of its acceptance. The Administrative Assistant sends a letter
advising the PI that his/her protocol has been accepted and that the work may begin.
7. Protocols are needed for all laboratory animals housed in the ODU Animal Facility,
regardless of their status as inspectable animals. PI's conducting field work with wild vertebrates
also must submit a protocol if their procedures involve any animal trapping, capture, handling,
tagging or other procedures in which the animal is captured and restrained, even if only for brief
periods.. The protocol submission and review procedure is the same as that involving the
laboratory animals as noted above. Investigators should include documentation of valid permits,
if required, for compliance with state and federal regulations applicable to wildlife (e.g., state
collector’s permit). Field studies involving observational studies in which no animals are
captured and restrained can be excluded
8. Annual Reviews Protocols are normally approved for a period of one year or less, but may be
renewed. One month before the annual review date, the Administrative Assistant sends an
annual review form (Form E of the ODU IACUC Protocol Review Form) to the PI. The form
includes questions concerning changes in personnel, species, numbers of animals used,
objectives and methodologies for the project. The PI completes the form and returns it to the
Administrative Assistant within 10 business days. The Administrative Assistant forwards the
PI's annual review form to the committee for review and approval (along with the transmittal
form). If there are no significant changes, the committee members review and approve the
extension of the project for another year. Every effort is made to complete the review and
approval of the current project so that it may continue without any termination in the project. If
the committee determines that there are major changes in the project, the committee will require
15
a new protocol. In this case, the protocol procedure submission and review process are the same
as for a new protocol.
9. Suspension of an Approved Protocol. The IACUC may suspend a protocol which it had
previously approved if it discovers that the activities are not being carried out in accordance with
the description of the methods in the protocol or when it is not in compliance with USDA
regulations or university policies. Suspension may be done only after a review of the matter at a
convened meeting of the committee at which a quorum is present. Suspension must be
recommended by a majority of the members present. If a suspension is recommended, the
Chairman of the IACUC shall notify the PI and include the reasons for the action taken. The
Chairman shall also notify the PI's department chairperson and the Associate Vice President for
Research (the latter is the cognizant institutional official). If the research in question is being
funded from external sources, the Associate Vice President for Research shall also notify the
sponsor. The protocol shall remain suspended until the IACUC determines that corrective action
has been taken.
10. Qualifications to Work With Animals. Everyone who handles animals must be qualified to
do so. To certify an individual's qualifications, he/she must file a form provided by the IACUC
for this purpose (ODU IACUC Form B). PI’s must take the web-based LATA certification test
designed for EVMS, with inclusion of an ODU module. This requirement became mandatory
after January 1, 2003. Students or technicians who have been or who plan extensive use of
animals in their research and teaching activities also are required to complete the LATA
certification test for the species they use. Certification will be noted on the qualifications form
(Form B). Students with little or no animal experience who rarely or infrequently use animals
may acquire the necessary qualifications by viewing the training videos held on reserve in the
Animal Facility Office and then take a computerized test (also on reserve in this same office). In
addition, further training may be provided by the Animal Facility Manager and/or the faculty
member or scientist supervising the research or teaching activity. After he/she has viewed the
videos and passed the test, the qualifications form (form B) is placed on file in the official
IACUC repository held in the Animal Facility Office. Approval of the certification form (Form
B) is part of the IACUC approval process. Thus, a person receives approval from the IACUC for
the particular type of animal (s) associated with the research or teaching activity described in the
protocol. Additional certification may be required for future studies if different species of
animals are to be used.
16
Appendix 4.
Date:
IACUC Protocol Number:
(To be assigned by IACUC)
FORM A
Old Dominion University
IACUC PROTOCOL REVIEW FORM
A. ADMINISTRATIVE DATA
Project Title:
Principal
Investigator:
Other Faculty
Involved:
Proposed Starting
Date:
Proposed End Date
(May not exceed 1 year)
Will This Project
Involve:
If yes, date of approval of the
Environmental Health and Safety
Office (attach approval).
Yes
No
1. Use of radioisotopes in vivo?
----2. Use of infectious disease agents? ----3. Use of known carcinogens or toxic
chemicals?
----4. Recombinant DNA
----5. Study conducted at Biosafety ----Level 3 or 4
If the answer is "yes" to any of the above, document approval by the proper
departments (i.e., Radiation Safety) or regulatory committees. In addition, please describe
the procedures for safe handling and disposal of contaminated animals and materials
resulting from this study.
B. ANIMAL REQUIREMENTS
1. Animal Species:
A. Species:
B. Age/weight (or size):
C. Source (identify external supplier if applicable): D. Location where animals will be
held:
E. Estimated number of animals to be used:
17
FORM A (continued)
Title (Continued)________________________________
F. If animals are to be maintained as a standing colony, maximum number at any one time:
C. STUDY OBJECTIVES
Describe briefly (preferably, in non-technical language), the objective (s) of this
study.
D. RATIONALE FOR ANIMAL USE
Explain your rationale for animal use.
1. Justify the appropriateness of the species chosen and the number of animals to be
used.
a) What alternatives to animal use have been considered, e.g., computer and
molecular modeling, in vitro cell, tissue or organ culture, etc? Document with references
from the literature searched for alternatives to using animals to obtain the needed scientific
information. If you have used a computer-based search for valid alternatives via the
Internet, please check from among the following:
______AGRICOLA
_____ CURRENT RESEARCH INFORMATION SERVICE
______ MEDLINE
_____ ANIMAL WELFARE INFORMATION CENTER
(National Agriculture Library)
______ INDEX MEDICUS _____ AIDSLINE
______ AVLINE
_____ CANCERLIT
______ TOXLINE
_____ TOXLIT
______ TOXNET
_____ OTHER (Describe)
Consultation with other experts in area of investigation (List names and addresses):
_________________________________________________________________________
If you have current manuscripts in press, papers presented at scientific meetings, or
other original new references, they may also be included here.
b)
Discuss the appropriateness of the species chosen (why is this species the best
one to use for the proposed study?)
18
Date:
IACUC Protocol No.
FORM A (continued)
Title (Continued)
_______________________________________________________________________________
c)
Provide justification that the number(s) given in this protocol is the minimum
necessary to obtain statistically meaningful results. A reference to an appropriate
statistically methodology or the recommendations of a qualified statistician may be used. If
the services of a statistician were used, provide a brief (2-page) resume of the qualifications
of the statistician.
d)
Give the date you carried out your computerized search, if any, the years covered
in the search, the keywords used in the search routine and a brief narrative description
summarizing your findings, including citations of pertinent references found.
E. DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL
PROCEDURES
Briefly explain the experimental design and specify all animal procedures. A brief
but clear description of the species, numbers of animals, and their distribution into
experimental groups will expedite the review process. If appropriate, a summary table
showing the distribution of animals by experimental groups should be included (attach
additional sheet if needed). This description should be written so as to enable the IACUC to
understand the experimental course of the animal from its entry to its endpoint in the study.
Specifically address the following:
1. Injections or inoculations (Identify infectious agents, adjuvants, doses, sites of
injection, volume, route
of administration and schedules, etc).
2. Blood withdrawals (volumes, frequency, etc.)
3. Non-survival surgical procedures (Note: do not include survival surgery here)
4. Radiation (specify type of radiation or radioisotope, dosage and schedule).
5. Methods of Restraint (collars, vests, harnesses, etc.)
6. Animal Identification Methods (if appropriate) (ear tags, tatoos, collars, cage card,
etc.)
19
Date:
IACUC Protocol No.
FORM A (continued)
Title (Continued)
_______________________________________________________________________________
7. Experimental Endpoint (specify results that will enable animal to be dismissed
from the study; e.g., percentage body weight gain or loss, survival to specified study day,
abnormal behavior, etc.)
8. Building and Room No. where animal procedures will be performed.
F. PAIN OR DISTRESS
Check the appropriate category (s) and indicate the approximate number of animals in each.
Sum (s) should equal total from category B above.
Year 1
Year 2
Year 3
1.
Will animals be subject to any procedure
which could cause pain or distress? If so,
specify the numbers in the adjacent columns.
Yes:________
2.
Year 1
Year 2
Year 3
Year 1
Year 2
Year 3
Will pain or distress be relived by a procedure,
anesthetic, analgesic or tranquilizing drug? If
so, specify the numbers in the adjacent columns.
Yes: ________
3.
No: _________
No ________
Will any animals be subject to unrelieved pain
pain or distress? If so, specify the numbers in
the adjacent columns.
If it is inappropriate to use anesthetics, analgesics and/or tranquilizing drugs, explain
why: (note: routine procedures such as injections, blood sampling, etc., may not require
these drugs)
G. SURVIVAL SURGERY.
If proposed, please complete the following:
1. Type of Surgery. Briefly identify and describe the surgical procedure (s) to be
performed
including the aseptic methods to be utilized.
2. Personnel. Identify the personnel who will perform the surgery and give their
qualifications.
20
IACUC Protocol No.
FORM A (continued)
Title (continued)
3. Location. Give the building and room location where the surgery will be performed.
4. Post-operative Care. Describe the post-operative care and identify the responsible
individual.
5. Prior Surgeries. Has any surgery been done on any of the study animals prior to being
placed in this study. Yes/No _______. If yes, please explain why it is necessary to do
additional surgeries.
6. Repeat Surgeries. Will more than one survival surgical procedure be done on any on
the animals in this study. Yes/No _______. If yes, please justify.
H. ANESTHESIA, ANALGESIA OR TRANQUILIZATION.
For animals that may experience pain or distress, specify the anesthetics,
analgesics, sedatives or tranquilizers that are to be used. Include the name of the agent
(s), dosage and route of administration.
I. METHOD OF EUTHANASIA OR DISPOSITION OF
ANIMALS AT END OF STUDY.
Indicate the proposed method. If a parenteral agent, indicate the dosage and
route of administration.
J. SPECIAL CONCERNS OR REQUIREMENTS OF THE
STUDY.
List any special housing, animal care requirements or safety requirements (e.g.,
special caging, water or feed or waste disposal).
K. REFINEMENT, REDUCTION OR REPLACEMENT
Describe any provisions in this protocol that refine, reduce or replace the use of
animals. Refinement is defined as an alternative to earlier examples of animal use by
better use and/or modification of existing procedures so that animals are less subject to
pain or distress. Reduction is defined as a lesser number of animals used to obtain
information of a certain amount and precision through sharing of animals, better
experimental design, or changed practices. Replacement is defined as an alternative to
animal use, replacing animal use with some method that does not require whole animals,
21
Date:
IACUC Protocol No.
FORM A (continued)
Title (continued)
__________________________________________________________________________________
e.g., the substitution of insentient materials for animals, substitution of a lower species
less sensitive to pain and distress, etc.
Briefly note whether and how you have employed one or more of these concepts in the
design of this proposal.
L. PRINCIPAL INVESTIGATOR CERTIFICATION
Statement of Responsibility
I acknowledge that federal and institutional regulations require that any significant
changes in my research protocol (i.e., animal model, procedures) must be approved prior to
implementation. I assume responsibility for compliance with such regulations by all personnel
involved with this protocol.
_____ A. I certify that the personnel performing the animal procedures/manipulations
described in this protocol are qualified to handle animals and have been properly trained to
ensure that no unnecessary pain or distress will be caused as a result of the
procedures/manipulations. Attach Form B “Qualifications for Working with Animals.”
_____ B. If survival surgery is to be done, I certify that the individuals listed in Section A
of this protocol have received training in aseptic surgical methods and techniques; proper use
of anesthetics, analgesics and or tranquilizers; and procedures for reporting animal welfare
concerns.
_____ C. If significant, long-lasting pain or distress will result from the procedures
described in this protocol (USDA Form Column D, “Pain or Distress Category”), I certify that I
have reviewed the pertinent scientific literature and have found no valid alternatives to any
procedures described herein.
_____ D. I understand that this protocol is valid for a period not to exceed one year from
the date of approval and that further approvals are required to continue animal use under this
protocol.
SIGNATURE OF PRINCIPAL INVESTIGATOR:
___________________________________________________ ___________________
(Name)
(Date)
____________________________________________________
Printed Name of Principal Investigator
APPROVAL BY INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
____________________________________________________ _____________________
Appendix 5.
22
(Name)
(Date)
Date:
IACUC Protocol No.
Form B
Qualifications for Working with Animals
_________________________________
Please indicate below all student or research assistants, i.e., undergraduate, graduate or
research staff involved with this project. Please indicate for each person the species to be
handled and date by which the person may be considered qualified in the technical skills
required for the undersigned’s research project (s). The technical skills may involve: collection
of blood, administration of anesthesia, tranquilizing or euthanizing agent, or any parenteral
injections as well as oral medications, etc.
1. Name of Student/Postdoctoral Research Associate or Faculty Member
__________________________________________________________________________________
2. Animal Species (Specify animal for which the person has received training):
__________________________________________________________________________________
3. Type of Training Received:
a) Web-based LATA training program* ....................................................................... Date ________
b) Video viewed and understood ................................................................................ Date: _______
c) Computer-driven examination passed ................................................................... Date: _______
d) Direct training by Animal Facility Manager ........................................................................................
_____________________________________________
(Signature of Animal Facility Manager)
___________________
(Date)
d) Direct training by other qualified animal handler
................................................................................
______________________________________________
___________________
(Printed name and signature)
(Date)
4. Tetanus Immunization within preceding five years.
____________________________________________________________________________
(Approximate date immunization received)
5. Signature of Student/Ppostdoctoral RA/Faculty Member
________________________________________________
___________________
(Date)
* If LATA training has been completed and documented, no other training is required.
23
Appendix 6
Form E
Old Dominion University
IACUC Annual Review Form (revised)
This form is used to reactivate an ongoing, IACUC-approved protocol for an additional year if
there are no significant changes in the animal species, number of animals, Principal Investigator, or
methods and procedures. If significant changes in any of these categories are planned, a new
protocol must be submitted to the Institutional Animal Care and Use Committee for an in-depth,
comprehensive review. This form is not required if the project has terminated.
Project Title: __________________________________________________________________
IACUC Protocol Approval Number: _______________________________________________
Principal Investigator: ___________________________________________________________
1. What is the current status of the project: Completed:____ In progress: ____________
2. If the project is to be continued, give the projected date of completion: ________________
3. Has the species of animal changed, or is expected to change? Yes _____; No ______
3. Have you made or do you expect to make significant changes in the methods or procedures
used in this research? Yes: _________; No: ____________
4. Has the Principal Investigator for this project changed, or is the P.I. expected to be changed?
Yes: ___________; No: ____________
5. Have there been changes in any other personnel assigned to the project (if yes, attached the
Qualifications for Working with Animals form, Form B)? Yes: _____; No: ______
6. Certification. I certify that the use of all animals involved in this project will not be
subjected to pain or distress without the use of appropriate anesthetic, analgesic or
tranquilizing drugs and that the project will be carried out to the best of my knowledge within
the provisions of Public Law 89-544, as amended by the Animal Welfare Act (Public Law 99196) and described in Secx. 495 of the Health Research Extension Act of 1985.
______________________________________________
Signature of Principal Investigator
____________________________________________
Typed name of Principal Investigator
______________________________________________
Signature of IACUC Chairperson
__________________________
Date
___________________________
Date
24
Appendix 7
FACILITY INSPECTION REPORT (revised March 13, 2002)
Significant (Major) Complaints*
Minor Complaints**
Date of Report:
Signature of IACUC Members:
Dr. Perry Duncan: ____________________; Dr. Barbara Hargrave: _____________________
Ms. Susan Metosky (Compliance Officer):_________________________________________
Dr. Ruth Ann MacQueen (veterinarian) ___________________________________________
Mr. Gary Ochsenbein: _________________: Dr. Robert Ratzlaff ______________________
Dr. Daniel E. Sonenshine (IACUC Chair): __________________________________________
Dr. Lloyd Wolfinbarger: ________________________________________________________
Examples of Significant (Major Deficiencies): Problems that affect the health and welfare of
the animal population, put animal health at risk.
Examples of Minor Deficiencies: Problems that do not affect the health or welfare of the animal
population and do not put the health of any of the animals at risk. Might cause minor discomfort.
Specific Plan for Correcting Deficiencies:
Name of
Type
Deficiency
(Significant or minor)
Brief description
of work to be done
Completion date
25
Appendix 8
PROTOCOL REVIEW/TRACKING FORM
Old Dominion University
Institutional Animal Care and Use Committee
Protocol Number:____________________
Date Submitted: ____________________
Project Title (brief) _____________________________________________________________
Principal Investigator: ___________________________________________________________
New Protocol: _______________________
Annual Review: ______________________
Submitted for Review by Designated Reviewers on (date): ______________________________
The designated reviewers consulted with one
another (date or dates) ____________ and
made the recommendation given below:
1. Name of Reviewer No. 1 _________________________________ Tel No. ( )______________
Recommendation: Approve: ___ ; Require Modifications ___; Request full IACUC review: ____
Brief statement of modifications requested or reason for full committee review: _______________
(attach additional page if more room is needed)
Signature of reviewer: ____________________________
Date: ______________________
2. Name of Reviewer No. 2 _________________________________ Tel No. ( )______________
Recommendation: Approve: ___ ; Require Modifications ___; Request full IACUC review: ____
Brief statement of modifications requested or reason for full committee review: _______________
(attach additional page if more room is needed)
Signature of reviewer: ____________________________
Date: ______________________
3. Veterinarian: _________________________________ Tel No. ( )______________
Recommendation: Approve: ___ ; Require Modifications ___; Request full IACUC review: ____
Brief statement of modifications requested or reason for full committee review: _______________
(attach additional page if more room is needed)
Signature of veterinarian: _______________________________
Date: ________________
Submitted for review by entire IACUC (minimum 5 members, including Chair and veterinarian)
The entire IACUC met on (date): ____________________ The committee vote was: Yes __ No ___
IACUC decision: Approve: _______________; Amend: ________________ Reject: ___________
Explanation of reason for committee action/comments if vote is amend or reject
Reviewed and Approved by IACUC Chairperson: ________________________________________
(Type or Print Name)
Signature: ____________________________________; Date:________________________
Notification of Principal Investigator (date): _____________________________________________
26
Appendix 9.
Health Care Record Log
1. Animal Species and tag number: _____________________
2. P.I: ________________________
3. Abnormality/Illness: ___________________________________________________
Record of Observations
1. Date: __________
Observation:________________________________________________________________
___________________________________________________________________________
_____________________________________________________________
2. Date: __________
Observation:________________________________________________________________
___________________________________________________________________________
_____________________________________________________________
3. Date: __________
Observation:________________________________________________________________
___________________________________________________________________________
_____________________________________________________________
4. Date: __________
Observation:________________________________________________________________
___________________________________________________________________________
_____________________________________________________________
5. Date: __________
Observation:________________________________________________________________
___________________________________________________________________________
_____________________________________________________________
6. Date: __________
Observation:________________________________________________________________
___________________________________________________________________________
_____________________________________________________________
7. Date: _________
Observation:________________________________________________________________
___________________________________________________________________________
_____________________________________________________________
8. Date: __________
Observation:________________________________________________________________
___________________________________________________________________________
_____________________________________________________________
27
PREGNANT/NURSING ANIMAL LOG
1.
2.
3.
4.
5.
Animal Species and tag number: ________________
P.I: __________________________
Date Mated: ___________________
Date Delivered: ________________
Number of babies: ______________
Record of Observations
1. Date: _____________
Number of babies: ______________
Observations:_______________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
_______________________
______________________________________________________________
2. Date: _____________
Number of babies: ______________
Observations:_______________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
_______________________
______________________________________________________________
3. Date: _____________
Number of babies: ______________
Observations:_______________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
_______________________
______________________________________________________________
4. Date: _____________
Number of babies: ______________
Observations:_______________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
_______________________
______________________________________________________________
5. Date: _____________
Number of babies: ______________
Observations:_______________________________________________________________
___________________________________________________________________________
_______________________________________________________________________