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Animal Utilization Protocol Checklist

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					                                 Animal Utilization Protocol Checklist


This checklist is provided to facilitate approval of the protocol. Please check all boxes.
If a section does not apply please indicate with N/A.




                                                   1
                                             SECTION
               SECTION                                   WHAT NEEDS TO BE DONE
                                                                                                   X
Section 1    Identification                     All must be completed
Section 2    Research/Teaching Staff            All must be completed
             Working with Animals
Section 3    Funding                            For Research only
Section 4    Date                               Proposed start date and end date. Note that the
                                                protocols can be approved for up to three years
                                                but an annual renewal form must be submitted if
                                                request is longer than one year.

Section 5    Justify the Use of Animals in      For Research protocols a and b only. Teaching
             these Experiments                  protocols complete all sub-sections.

Section 6    Description of Project             CCAC description and Lay description should be
                                                completed

Section 7    Experimental Protocol              All must be completed
Section 8    Classification of Experiments      Please refer to Categories of Invasiveness chart
                                                at the beginning of Section 8.

Section 9    Procedures Summary                 A and E compulsory
                                                B,C, and D – only if applicable

Section 10   Project and Facilities             All must be completed
             Management

Section 11   Training and Experience of         All must be completed
             Research Staff

Section 12   Endpoint Analysis Form             Complete all that applies
Section 13   Signature of Researcher            Must be signed by main investigator

Section 14   Signatures of Individuals          All listed in Section 2 must read and sign
             Working Under this Protocol
                                    LAKEHEAD UNIVERSITY
                                   ANIMAL CARE COMMITTEE


                             ANIMAL UTILIZATION PROTOCOL



                                   APPROVAL - OFFICE USE ONLY
          Species             Quantity   Category           PROTOCOL #
                                                            Replaces Protocol #
                                                            Annual Expiry Date
                                                            Protocol Expiry Date

CHAIR, ANIMAL CARE COMMITTEE: _________________________                       DATE: __________________

UNIVERSITY VETERINARIAN: ____________________________                         DATE: ________________


                                   SECTION 1 - IDENTIFICATION

Name                                                    Department
Rank/Position                                           E-mail address
Office Phone #                                          Lab Phone #
Home Phone #                                            Emergency Phone #




 Title:

 Type:    Check all applicable:
                                  Teaching              Q                Research          Q
                                  Ongoing Project       Q                New Project Q
                                  Pilot Study           Q                Other (ie breeding)Q




                                                    4
5
           SECTION 2 - RESEARCH/TEACHING STAFF WORKING WITH ANIMALS

           Name               Department              Ext.      Co-investigator,            *After-hours
                                                                Technician,                 emergency contact
                                                                Undergrad Student,          (at least one phone
                                                                Graduate Student,           number is required,
                                                                Other                       NOT AN
                                                                                            UNDERGRAD
                                                                                            STUDENT)




*NOTE THAT THE ANIMAL CARE STAFF, THROUGH CONSULTATION WITH THE VETERINARIAN, ARE OBLIGATED TO
TREAT OR EUTHANIZE ANIMALS IN DISTRESS. EVERY ATTEMPT WILL BE MADE TO CONTACT THE RESEARCHER ,
ALTHOUGH THE DECISION OF THE VETERINARIAN IS FINAL. PLEASE ENSURE THAT WE ARE ABLE TO CONTACT
YOU OR A PERSON DESIGNATED TO HANDLE EMERGENCIES, AFTER HOURS.

                       SECTION 3 - FUNDING (For Research Protocols Only)

 Source/Agency(s)             *Scientific Review             Funding                    Date Awarded
 (use full titles)            (Y/N)                          (Pending/Awarded
                                                             $ amt is NOT required)




*Non-peer-reviewed applications require a separate review for scientific merit. Fill out Appendix A.

                                        SECTION 4 - DATE
                 (The AUP has up to a three year life span requiring annual update.)

 Proposed start date of research (year/month/day)

 *Expected finishing date (year/month/day)


*Note: finishing date should be June 30 for Research Protocols
       finishing date should be June 30 for Teaching Protocols
SECTION 5 - JUSTIFY THE USE OF ANIMALS IN THESE EXPERIMENTS

FOR ALL PROTOCOLS: a) Why must animals be used in these experiments (as opposed to
computer models, tissue culture, or microbes for example)? Have you considered alternative
replacements to animal use?




b) Justify the number of animals requested based upon a statistical rationale, citations from the
literature, or previous research. Numbers used should reconcile with the table in Section 8.




                                               7
FOR TEACHING PROTOCOLS ONLY: a) In the case of teaching protocols, provide
pedagogical justification for using animals (eg. Instead of slides/video, or computer programs).
Identify what alternatives to live animals you have considered.




b) What on-site supervision will be provided for the students in this course?




                                               8
c) What animal-related training is provided to Teaching Assistants to ensure they are
adequately prepared for their role in this course?




d) What are students expected to learn from this course which justifies using live animals?




                                               9
e) What is the number of students for each animal (or group of animals) used in this course?




                        SECTION 6 - DESCRIPTION OF PROJECT
               CCAC KEY WORDS (check all those that apply under each column)




                                             10
                                                              GENERAL
             GENERAL        PROCEDURES                                  AGENTS                       SURGERY
Research                    Altered Environment/Expose                  Chemical Exposure            Acute Surgery

Teaching                                                                Freund’s Complete Adjuvant   Survival Surgery

Testing                                    Anaesthetic                  Incomplete Freund’s          Major Surgery

Testing Regulations Apply   Gaseous                                     Immunogenic Agents           Minor Surgery

Acute Studies               Injectable                                  Biohazard Agent              Multiple Surgeries

Chronic Studies                             Analgesic                   Inflammatory Agents          Stereotaxic Surgery

Behavioural Encounters      Buprenorphine                               Pristane                     Cannulation

Behaviour Modification      Acetaminophen                               Radioisotope                 Other

Behaviour Observation       Other                                       Infectious Agents

Reinforcement Motivation                   Euthanasia                   Infection Induction

Pilot Studies Required      Gaseous                                     Tumour Induction

Breeding Colony             Injectable                                  Other

Endpoint Required           Physical

Field Work                               Injection Routes

Outside Animal Facility     IC            IV             ID

Primary Cell Culture        IM            SQ

Recycled Animals            IP            IN

Stress Induction            Marking/Tagging

Tissue/Organ Collection     Monoclonal Antibody

Transgenics                              Restraint

Sentinel Animals            Physical

Environmental Protection    Chemical
Study

Fauna Conservation Study    Polyclon Antibody

Development of              Trapping/Netting
Techniques/Methods

Study of Product Efficacy   Tumour Induction

Sentinel Program            Special Diet

Grafts/Transplants          Water Deprivation

Palatability Testing        Food Deprivation

Digestibility Testing       Gavaging

Validation of non-animal    Weight Monitoring
procedure

Other                       Whole-body radiation

                            Blood removal

                            Blood Sample (small)

                            Other



LAY DESCRIPTION (150 words or less using non-technical language)
                            SECTION 7 - EXPERIMENTAL PROTOCOL

Objectives of the experiment(s).




Briefly describe the experimental rationale.




Purpose of Animal Use (CCAC Categories) - Check ONE ONLY (1-6) below that best describes the
purpose of animal use.

                                               12
G 1.    Studies of a fundamental nature in sciences relating to essential structure or function (e.g. biology, psychology,
         biochemistry, pharmacology, physiology, etc.).
G 2.    Studies for medical purposes, including veterinary medicine, that relate to human or animal disease or disorders.
G 3.    Studies for regulatory testing of products for the protection of humans, animals or the environment.
G 4.    Studies of the development of products or appliances for human or veterinary medicine.
G 5.    Education and training of individuals in post-secondary institutions.
G 6.    Transgenic (T), Mutant (M), Knock-out(K).**

**If you are using transgenic, mutants or knock-outs please attach a sheet which includes the complete nomenclature,
describes the genetic mutation, and lists any know phenotypic abnormalities


Describe the proposed experiments giving all details of procedures to be done on animals.
Use additional pages or attachments only if necessary (do not submit grant proposals). You must
clearly outline procedures and the effect that could or will potentially affect the welfare of the
animal(s). Consult CCAC Guidelines for acceptable procedures.




                                                           13
                                   SECTION 8 - CLASSIFICATION OF EXPERIMENTS

                            SUMMARY OF SPECIES AND CATEGORIES OF INVASIVENESS

The CCAC requires that each experimental protocol be designated Acute or Chronic, and assigned a category of
invasiveness. Examples are:

ACUTE any study involving euthanasia of an animal upon receipt or shortly after a brief period of housing (NO
manipulations or experiments to be performed on conscious animals). E.g. animals euthanised for tissues, or
anaesthetized and not allowed to recover from anaesthesia.

CHRONIC any study which involves recovery of an animal from anaesthesia after an experiment, and maintenance of
animals in University facilities for more than 2 days (not counting normal conditioning period).


CATEGORY A: Experiments on most invertebrates or live isolates. E.g. tissue cultures, tissues obtained at necropsy, the
use of eggs, protozoa or other single-celled organisms, experiments involving containment, incision or other invasive
procedures on Metazoa.

CATEGORY B: Little or no discomfort or stress. E.g. short-term skilful restraint of animals for observation or examination,
blood sampling, non-toxic injections by intravenous, subcutaneous, intramuscular, intra peritoneal, or oral routes (NOT intra
thoracic or intra cardiac, category C), acute non-survival studies where animals are completely anaesthetized and do not
ever regain consciousness, euthanasia by approved methods following rapid unconsciousness (E.g. anaesthetic overdose,
or decapitation preceded by sedation or anaesthesia), very short periods of food and/or water deprivation.

CATEGORY C: Minor stress or pain of short duration. E.g. minor surgeries or procedures under anaesthesia (cannulation,
catheterization, biopsy, laparoscopy), short periods of food and/or water deprivation and/or restraint causing minimal
distress, behavioural experiments on conscious animals with short-term stressful restraint (MUST NOT CAUSE significant
changes in animal’s appearance, respiratory or cardiac rate, fecal or urinary output, behaviour, or social responses, during
or after procedures).
NOTE: During or after Category C studies, animals must not show self-mutilation, anorexia, dehydration, hyperactivity,
increased recumbency or dormancy, increased vocalization, aggressive-defensive behaviour or demonstrate social
withdrawal and self-isolation.

CATEGORY D: Moderate to severe distress or discomfort. E.g. major surgical procedures conducted under general
anaesthesia, with subsequent recovery; prolonged (several hours or more) periods of physical restraint; induction of
behavioural stresses such as maternal deprivation, aggression, predator-prey interactions; procedures which cause severe,
persistent or irreversible disruption of sensorimotor organization; the use of Freund’s Complete Adjuvant (see CCAC
Guidelines on Acceptable Immunological Procedures); induction of anatomical and physiological abnormalities that will
result in pain or distress; the exposure of an animal to noxious stimuli from which escape is impossible; the production of
radiation sickness; exposure to drugs or chemicals at levels that impair physiological systems.
NOTE: Procedures used in Category D studies should not cause prolonged or severe clinical distress as may be exhibited
by a wide range of clinical signs, such as marked abnormalities in behavioural patterns or attitudes, the absence of
grooming, dehydration, abnormal vocalization, prolonged anorexia, circulatory collapse, extreme lethargy or disinclination to
move, and clinical signs or severe or advanced local or systemic infection etc.

CATEGORY E: Severe pain near, at, or above the pain tolerance threshold of unanaesthetized conscious animals. This
Category of Invasiveness is not necessarily confined to surgical procedures, but may include exposure to noxious stimuli or
agents whose effects are unknown; exposure to drugs or chemicals at levels that (may) markedly impair physiological
systems and which cause death, severe pain, or extreme distress; completely new biomedical experiments which have a
high degree of invasiveness; behavioural studies about which the effects of the degree of distress are not known; use of
muscle relaxants or paralytic drugs without anaesthetics; burn or trauma infliction on unanaesthetized animals; a
euthanasia method not approved by the CCAC; any procedure (e.g. the injection of noxious agents or the induction of
severe stress or shock) that will result in pain which approaches the pain tolerance threshold and cannot be relieved by
analgesia (e.g. when toxicity testing and experimentally induced infectious disease studies have death as the endpoint).




                                                             14
IF IN DOUBT ABOUT THE APPROPRIATE CATEGORY, OR IF THE PROJECT INVOLVES
DIFFERENT CATEGORIES, LIST THE HIGHEST APPLICABLE CATEGORY.

                                                                                  Category of Invasiveness
     Species           Strain            Total # per year      Acute/Chronic      Investigators    ACC’s*




**Transgenics


      *If the Animal Care Committee’s assessment of the category of invasiveness differs from the investigator’s
      the ACC will notify and discuss the discrepancy with the investigator.

      **Please provide details (one page) of strain, longevity, phenotypes and unusual qualities

SECTION 9 - PROCEDURES SUMMARY

A. Housing and Handling
                                     Y/N      Type                                            Duration
Special diet or deprivation of
food
Deprivation of water
Stressful environment
Manual or other restraint


B. Summary of Non-Surgical Procedures (e.g. sampling of body fluids, administration of substance
other than anaesthetics/analgesic)

FLUIDS SAMPLED
       Type/Site            Needle Gauge                 Frequency                    Volume




                                                       15
SUBSTANCES ADMINISTERED
        Substance           Dose/Route                   Volume        Frequency             Potential Detrimental
                            Administered                                                     Effects




C. Major Surgical Procedures (ensure that details are provided in Section 7)
                                                       Post-surgical Monitoring and Care
 None                                 Only monitoring required                   Duration:
 Acute/Non-recovery only              Care, treatment required                   Duration:
 Chronic/Animal recovery              Lasting impairment expected                Specify:

D. Relief of Pain
           Procedure             Anaesthesia(agent/route/dosage)           Analgesia(agent/route/dosage)




E. Disposition of Animals
                                                   Euthanasia
 Species    CO2    Inhalant       Anaesthesia &     Barbiturate       *               *         Other   Kept for
                   Anaesthetic    Exsanguination    Overdose      Decapitation   Cervical               further
                   Overdose                                                      Dislocation            experiments




*Please give your justification for using physical methods of euthanasia and detailing the relevant training of
personnel undertaking this procedure.

                                                         16
SECTION 10 - PROJECT AND FACILITIES MANAGEMENT

A. Specify Source of Animals
Commercial Supplier/Name
In House Breeding?
*Other University?
Industry?

B. Housing of Animals
                                                 Housing Room #
Type of caging
Special care
Other arrangements

C. Location of Experimental Procedures
Rooms
*Field Work          Where?
Special
Arrangements
*Fill out Appendix B

D. Enrichment of Animal Care




                                         17
Can enriched care and housing be provided for your animals?
provided for your animals?
Can enriched care and housing be         Y/N       Comments:
provided for your animals?

E. Veterinary Intervention
Can your animals receive normal veterinary care? (attach instructions if
No)

F. Potential Hazards
                           to Animals          to Humans
None                                                                        Type         Dose
Isotope
Carcinogen
Chemical
Infectious Agent

Does your research involve bacteria, viruses, fungi, parasites or animal body fluids? YES NO 

If you checked “YES”, please contact the Laboratory and Biosafety Specialist, or the Health and Safety
Officer in the Office of Human Resources to determine whether biosafety clearance is required.

                SECTION 11 - TRAINING AND EXPERIENCE OF RESEARCH STAFF
                         INVOLVED IN EXPERIMENTS WITH ANIMALS

Please identify COURSES COMPLETED

Name                                CCAC         OR AH       AN SS         ST   Experience and/or Other
                                    Training                                    Training
                                    Modules                                     (attach details - where,
                                    (1-12)                                      when, what?)




                                                      18
Key to Courses:

TM = CCAC Modules CCAC WebCt based training modules. Modules 1-5 are considered core. Please include
                       the completed module numbers in the space above.

OR = Orientation               A very general overview of the function of the animal facility as well as information
     (Core)                    regarding CCAC, OMAFRA and the functioning of the Animal Care Committee

AH = Animal Handling           Familiarization with handling and restraining appropriate species. Only a
     (Core)                    superficial introduction to making injections.

AN = Anaesthesia               A course in injectable and gaseous anaesthesia in the appropriate species.

SS = Survival SurgeryA course in preparation of the animal, surgeon and equipment for aseptic surgery
                            plus post-operative recovery principles.

ST = Special Techniques        Injections, special surgeries, perfusions, etc.

The Animal Care Staff (currently through the Office of Research) offers the two core courses on an as needed
basis. The CCAC WebCt training modules are offered online. The first five modules are considered core
courses and therefore are mandatory for all animal users. To be added to the course list please contact
the Animal Care Supervisor. Please consult with Animal Care Staff if you have individuals who are working
with animals and have not completed the core courses. It is expected that the Animal Handling course will focus
on the species that the individual will be using in their research.

Most other courses are currently not being offered by our Animal Care Staff, but are available at neighbouring
institutions (see the Animal Care Staff for more details). It is expected that these courses would be offered by
institutions meeting Canadian Council on Animal Care standards. In certain circumstances it might be
appropriate for a researcher to set up a special course for individuals working in their facilities. In this case the
Animal Care Staff (and if necessary the ACC) needs to be made aware of the course syllabus and approve the
procedures to make sure that the necessary records and documentation is kept of individuals taking the course.
Any costs incurred in these courses are the responsibility of the researcher.

                                SECTION 12 – ENDPOINT ANALYSIS FORM

 1. What exactly is the information/data that is being sought or required as a result of the experimental
 procedure being done on the animals?




                                                         19
2a. What is the planned time course for the study?




2b. How does that compare to the expected time course from when the animals are manipulated until they
are expected/might reach the critical period where they experience pain, distress, suffering or death?




3a. Indicate any clinical conditions or abnormalities expected or that could arise as a result of the proposed
study or teaching exercise (e.g. behavioural changes such as increased grooming, vocalization or postural
changes, or physical abnormalities such as anorexia, dehydration, diarrhea, etc.)




                                                       20
3b. In terms of species-specific behavioural changes and physiological signs, what criteria will trigger the
decision to remove an animal from the teaching exercise or experiment, or to terminate the teaching exercise
or experiment?




                                                     21
4a. What is the required monitoring frequency once the critical period in the experiment is reached and
required to ensure the animals can be euthanized before dying? (The baseline parameter is that a normal
animal should be examined at least once per 24 hour time period and a written record should be kept.)




4b. Who will carry out the observations? Do these people require any specific training in order to recognize
the “indicators” discussed above?

    Research Staff/Students

    Animal Care Staff


5. What is the chain of reporting the results of monitoring once the animals are reaching endpoint?




                                                      22
6. The Veterinarian, through the Animal Care Staff, has the authority to euthanize, however, a reasonable
attempt will be made to communicate in advance with the researcher. Who has the authority to authorize
euthanasia in the researcher’s group?




7. Animals that die unexpectedly or are euthanized may be submitted for post-mortem examination. Are
there any special instructions for sample collection that need to be taken from the animal at the time of
euthanasia? If so, please list instructions below.




Other Notes




                                                      23
                 SECTION 13 - YOUR SIGNATURE BELOW INDICATES THAT:

1)   Animals used in this research or teaching project will be cared for in accordance with the
     principles contained in “The Care of Experimental Animals - A Guide for Canada” (Published by
     the Canadian Council on Animal Care), the regulations of the Province of Ontario under The
     Animals for Research Act, 1980, the LAKEHEAD UNIVERSITY Animal Care Committee Policies
     and Guidelines, and other applicable LAKEHEAD UNIVERSITY policies and procedures.

2)   you have considered alternative procedures that do not involve the use of living animals;

3)   you will use the minimum number of animals consistent with the objectives of the described
     research or teaching program;

4)   you have carefully selected the species that you propose to use;

5)   you will use techniques and facilities that are in accordance with the Guidelines of the Canadian
     Council on Animal Care;

6)   you will notify the Animal Care Committee of any revisions of this experimental protocol.



ALL RESEARCH PROJECTS MUST BE REVIEWED FOR SCIENTIFIC MERIT. SEE SECTION 4.

APPROVAL BY THE ANIMAL CARE COMMITTEE IS VALID FOR A PERIOD OF ONE YEAR.
PROTOCOLS MAY BE RENEWED TWICE (FOR ONE YEAR PERIODS) USING THE ANNUAL
RENEWAL FORM.

SIGNATURES ON THE FRONT PAGE OF THIS FORM IMPLY THAT THE LAKEHEAD UNIVERSITY
ANIMAL CARE COMMITTEE, HAVING EXAMINED THE PROPOSAL FOR THE ABOVE-NAMED
PROJECT ON MATTERS RELATING TO ANIMAL CARE AND USE, APPROVES THE
PROCEDURES PROPOSED.



PRINCIPAL INVESTIGATOR                                      DATE




                                                 24
SECTION 14 - SIGNATURES OF INDIVIDUALS WORKING UNDER THIS PROTOCOL

My signature below indicates I have read and understand this protocol, having discussed it with the
investigator listed in section 1 if necessary. I am aware of Canadian Council on Animal Care and
Lakehead University Animal Care Committee policies and procedures as I have completed the
Orientation course offered by the Animal Care Staff. I will notify the primary investigator and the
Animal Care Staff if there are any unexpected problems in carrying out this protocol


 Name (printed)                          Signature                                    Date




Revised 09/01/05

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