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.




                     SECTION                                    WHAT NEEDS TO BE DONE                    X
Section 1          Identification                     All must be completed

                   Research/Teaching Staff
Section 2                                             All must be completed
                   Working with Animals
Section 3          Funding                            If applicable

                                                      Proposed start date and end date. Note that the
                                                      protocols can be approved for up to four years
Section 4          Date                               (approval year and three renewals). An annual
                                                      renewal form must be submitted if request is
                                                      longer than one year.

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

                                                      CCAC description and Lay description should be
Section 6          Description of Project
                                                      completed
Section 7          Experimental Protocol              All must be completed
                                                      Please refer to Categories of Invasiveness chart
Section 8          Classification of Experiments
                                                      at the beginning of Section 8.

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

                   Project and Facilities             All must be completed
Section 10
                   Management

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

Section 12         Endpoint Analysis Form             Complete all that applies

Section 13         Signature of Researcher            Must be signed by principal investigator

                   Signatures of Individuals
Section 14                                            All listed in Section 2 must read and sign
                   Working Under this Protocol




                                                     1
                                    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




                                                    2
           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 four year life span allowing three annual updates)

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

 Expected finishing date (year/month/day)




                                                         3
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.




                                               4
FOR TEACHING PROTOCOLS ONLY: a) In the case of teaching protocols, provide
pedagogical justification for using animals (e.g. 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?




                                               5
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?




                                               6
      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)

             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)



LAY DESCRIPTION (150 words or less using non-technical language)




                                 SECTION 7 - EXPERIMENTAL PROTOCOL
 Objectives of the experiment(s).
Briefly describe the experimental rationale.




                                               9
Purpose of Animal Use (CCAC Categories) - Check ONE ONLY (1-6) below that best describes the
purpose of animal use.
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.

                                                            10
11
                             SECTION 8 - CATEGORIZATION 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 on live isolates

Possible examples: the use of tissue culture and tissues obtained at necropsy or from the slaughterhouse; the
use of eggs, protozoa or other single-celled organisms; experiments involving containment, incision or other
invasive procedures on metazoa.

CATEGORY B: Experiments which cause little or no discomfort or stress

Possible examples: domestic flocks or herds being maintained in simulated or actual commercial production
management systems; the short-term and skilful restraint of animals for purposes of observation or physical
examination; blood sampling; injection of material in amounts that will not cause adverse reactions by the
following routes: intravenous, subcutaneous, intramuscular, intraperitoneal, or oral, but not intrathoracic or
intracardiac (Category C); acute non-survival studies in which the animals are completely anesthetized and do
not regain consciousness; approved methods of euthanasia following rapid unconsciousness, such as
anesthetic overdose, or decapitation preceded by sedation or light anesthesia; short periods of food and/or
water deprivation equivalent to periods of abstinence in nature.

CATEGORY C: Experiments which cause minor stress or pain of short duration

Possible examples: cannulation or catheterization of blood vessels or body cavities under anesthesia; minor
surgical procedures under anesthesia, such as biopsies, laparoscopy; short periods of restraint beyond that for
simple observation or examination, but consistent with minimal distress; short periods of food and/or water
deprivation which exceed periods of abstinence in nature; behavioral experiments on conscious animals that
involve short-term, stressful restraint; exposure to non-lethal levels of drugs or chemicals. Such procedures
should not cause significant changes in the animal's appearance, in physiological parameters such as
respiratory or cardiac rate, or fecal or urinary output, or in social responses.

Note: During or after Category C studies, animals must not show self-mutilation, anorexia, dehydration,
hyperactivity, increased recumbency or dormancy, increased vocalization, aggressive-defensive behavior or
demonstrate social withdrawal and self-isolation.

CATEGORY D: Experiments which cause moderate to severe distress or discomfort

Possible examples: major surgical procedures conducted under general anesthesia, with subsequent recovery;
prolonged (several hours or more) periods of physical restraint; induction of behavioral 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
                                                       12
Guidelines on Acceptable Immunological Procedures).

Other examples include 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 behavioral patterns or attitudes, the
absence of grooming, dehydration, abnormal vocalization, prolonged anorexia, circulatory collapse, extreme
lethargy or disinclination to move, and clinical signs of severe or advanced local or systemic infection, etc.

CATEGORY E: Procedures which cause severe pain near, at, or above the pain tolerance threshold of
unanesthetized 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; behavioral studies about which the
effects of the degree of distress are not known; use of muscle relaxants or paralytic drugs without anesthetics;
burn or trauma infliction on unanesthetized animals; a euthanasia method not approved by the CCAC; any
procedures (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).

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.

                                                        13
       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




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




C. Major Surgical Procedures (ensure that details are provided in Section 7)
                                              14
                                                       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.


SECTION 10 - PROJECT AND FACILITIES MANAGEMENT

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




B. Housing of Animals
                                                     15
                                                                           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
                                         Y/N       Comments:
Can enriched care and housing be
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 or parasites? YES NO 


                                                  16
If “YES” and there is a risk of exposure to the above agents or toxins, please contact the
Laboratory and Biosafety Specialist in the Office of Human Resources (807-343-8806) 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           Health &        OR AH AN SS           ST    Experience and/or Other
                          Training       Safety                                      Training
                          Modules        Training                                    (attach details - where,
                          (modules                                                   when, what?)
                          completed)




Key to Courses:

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

Health and Safety             Please contact the Health and Safety Officer in the Office of Human
Training                      Resources to schedule training (807-343-8806)

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

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

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

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

                                                    17
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 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 Research Ethics and Administration Officer at 343-8283. 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?




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




                                                   18
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.)




                                                   19
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?




 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?




                                                  20
    Research Staff/Students:


    Animal Care Staff:




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




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?




                                                 21
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




              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;
                                                 22
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 THREE TIMES (FOR ONE YEAR PERIODS) USING
THE RENEWAL APPLICATION 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


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



                                              23
Name (printed)   Signature   Date




                    24

				
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