University of Toronto

Animal Use Protocol

All animals used in research, teaching or testing at the University of Toronto must be included in an approved and current Animal Use Protocol on file with the University of Toronto Research Services. Copies of relevant protocols are also on file in the Division of Comparative Medicine. Protocol forms and application / approval process information are available at the following web site: http://www.research.utoronto.ca/for-researchers-administrators/ethics/animals-in-research/

It is important that you use the current Animal Use Protocol form and the information requested is complete. THE FACULTY OF MEDICINE AND PHARMACY ANIMAL CARE COMMITTEE IS RESPONSIBLE FOR REVIEWING AND APPROVING ANIMAL USE PROTOCOLS. This committee meets the first Wednesday of each month. Protocols must be submitted a minimum of one week prior to the meeting to allow for distribution and review.

The committee is unable to accept "late arrivals." The original signed and completed protocol should be delivered to the DCM office (Room 1236, MSB) for processing by 4:30 p.m. on the Wednesday preceding the scheduled meeting. An electronic copy of the Animal Use Protocol must also be submitted to dcm.protocols@utoronto.ca. Remember that it will take 4-6 weeks for the protocol to be processed.

FACULTIES OF MEDICINE & PHARMACY ANIMAL CARE COMMITTEE

Scheduled Meetings for 2011-2012

Location:

• BLACK SEMINAR ROOM, Donnelly Centre for Cellular & Biomolecular Research (September 2011 – AUGUST 2012)

Protocol forms and information are available at the following website: http://www.research.utoronto.ca/for-researchers-administrators/ethics/animals-in-research/

Please submit one (1) signed original to DCM Main Office and a PDF copy by e-mail to dcm.protocols@utoronto.ca

Protocol form guidelines

The Faculty Advisory Committee on Animal Services requests that you ensure that all changes to protocols made during previous submissions be incorporated into your next submission. In addition, any necessary changes requested by the committee must now be made on the Animal Use Protocol form, not appended to the existing protocol. No emails will be accepted by the dcm veterinarians. If changes are required, the reviewed Animal Use Protocol will be returned to the PI to make the necessary changes and can then be resubmitted for approval. If you, as PI, are not preparing the protocol yourself, please make sure that the person preparing it is fully aware of these requirements and has access to previous protocol amendments.

As a result of input from the Canadian Council on Animal Care, a new protocol form has been adopted by the University of Toronto Animal Care Committee. The form is available at http://www.research.utoronto.ca/ethics/pdf/animal/animal1.pdf. As of May 1, 2012 only Animal Use Protocols on this new form will be accepted.

It is important that your protocol reflects the study as you plan to conduct it. Say what you plan to do and then do it. When there are MINOR modifications to an already approved protocol (e.g. changes in number of animals to be used, location of experiment or changes in personnel) modifications requested by completing the University of Toronto AUPF Amendment Form (PDF) and submitting it to the Faculty of Medicine and Pharmacy Animal Care Committee (DCM Office, Room 1236 MSB). The form is reviewed by the Local Animal Care Committee and then forwarded to the Office of Research Ethics for processing and approval.

Categories of Invasiveness in Animal Experiments (1991) from CCAC policies

The following list of categories provides possible examples of experimental procedures which are considered to be representative of each category:

1. 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.

2. 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.

3. 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.

4. 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 Guidelines on Antibody Production). CCAC also refers users to the "Additional Information") 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.

5. 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).