Animal Care Approvals

1. Animal Care Approvals Animal Policy & Welfare Program Research Ethics Office University of Alberta

2. Animal Care Committees • Must function in each University or institution that uses animals. • At large institutions, several ACCs may review research. • For the University of Alberta, there are threeAnimal Care and Use Committees: • ACUC: Biosciences • ACUC: Health Sciences • ACUC: Livestock

3. Organizational Structure for Animal Ethics and Facilities at the University of Alberta

4. Animal Care & Use Committees • Review Protocols for: • Research (Biomedical, Agricultural, Wildlife) • Teaching (Labs, demonstrations) • Testing (Drugs, equipment, products) • All users of animals for any purpose (on or off-campus) must have their research protocol approved prior to commencing.

5. Categories of Invasiveness “Protocols must be submitted to an appropriate review committee for all studies and courses which involve the use of vertebrates and some invertebrates in Categories B through E. Cephalopods and some other higher invertebrates have nervous systems as well developed as in some vertebrates, and may therefore warrant inclusion in Category B, C, D, or E.” - Canadian Council on Animal Care

6. Category A Experiments on most invertebrates or on live isolates (does not require review by the Animal Care and Use Committee). 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.

7. Category B Experiments which cause little or no discomfort or stress. POSSIBLE EXAMPLES: • 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.

8. 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. • Short periods of restraint or food and/or water deprivation. • Behavioral experiments on conscious animals that involve short-term, stressful restraint. • Exposure to non-lethal levels of drugs or chemicals.

9. A Note Regarding Category C 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. 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.

10. 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. • The use of Freund's Complete Adjuvant (see CCAC Guidelines on Acceptable Immunological Procedures).

11. Other Examples of Category D • 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.

12. A Note Regarding Category D Procedures used in Category D studies should not cause prolonged or severe clinical distress. ANIMALS MUST NOT REACH A MORIBUND STATE, NOR DIE UNATTENDED.

13. Category E According to University Animal Policy and Welfare Committee (UAPWC) policy, procedures which cause severe pain near, at, or above the pain tolerance threshold of unanesthetized conscious animals are not permitted.

14. Animal Use Protocol (AUP) Application Review Process • Animal Care and Use Committee: Health Sciences meets monthly (10x/year). • Deadline for Submission (3 weeks prior). • Submit application electronically. • Follow instructions on the webpage.

15. After the Protocol Review 1. Full approval (best option) 2. Major revisions required 3. Minor revisions required 4. Defer decision to a later date

16. Certificate of Approval Issued with all applicable funding sources specified. • Approval can apply to more than one grant. • A single grant can apply to more than one Animal Use Protocol (AUP). • Expires in one year.

17. Annual Report • After new protocol is submitted on an AUP, renewals must be submitted annually. The application process then follows a four-year renewal cycle: • Year 2 – Annual Report of an Approved Protocol • Year 3 – Annual Report of an Approved Protocol • Year 4 – Annual Report of an Approved Protocol • Year 5 – Fourth Year Renewal… • In Year 6, the PI begins the cycle again and repeats years 2-5 for the life of the project. • Breeding colonies require a separate report.

18. Minor Modifications The following are accepted by email: • Add/Delete Funding Source • Add/Delete Personnel • Change Protocol Title • Personnel Training Update • Request to Extend Protocol Expiry Date • Request for Increase in Animal Numbers for Breeding Colonies ONLY

19. Release of Funds (ROF) Process When funds are available but the animal work is scheduled for a future date: 1. Complete the Application for a Release of Funds Agreement.2. Submit the application to the Research Ethics Office (REO) and if approved, a Release of Funds Agreement will be forwarded to the PI for signature.3. Once the signed agreement has been returned to REO the Research Services Office will be advised that the PI can be given access to funding referenced in the agreement. NO ANIMAL WORK CAN BEGIN WITHOUT AN AUP APPROVAL.

20. University of Alberta Policies and Procedures Online (UAPPOL) I. Animal Ethics Policy A. Administration of Animal Research Procedure (Roles and Responsibilities) B. Animal Care & Use Committee Appeal Procedure C. Animal Care & Use Committee Scientific & Pedagogic Merit Review Procedure D. Animal Ethics Review Procedure E. Animal Euthanasia Procedure F. Animal Maintenance: Special Requests for Alternate Animal Holding/Housing Procedure II. Animal User Training Policy

21. Institutional Animal User Training Program (IAUTP), Part 1* Principles of Laboratory Animal Science & Ethics Core Topics Include: Animal Care Mandate, Biosafety, Biosecurity, Introduction to Pain Management, Legislation and Compliance, Non-Experimental Variables, Occupational Health & Safety and the Three Rs *All Principal Investigators and their personnel are required to participate.

22. Institutional Animal User Training Program (IAUTP), Part 2* Species-Specific or Procedure-Specific Animal Handling Courses: Cat, guinea pig, mouse, rabbit, rat, summer rabbit/rat, plus aseptic techniques, necropsy and individual techniques. __________ * The Research Ethics Office (REO) maintains the database for training / certifications for both Part 1 and Part 2 courses.