ANIMAL CARE AND USE PROGRAM REVISED: NOVEMBER 20, 2014

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1 ANIMAL CARE AND USE PROGRAM REVISED: NOVEMBER 20, 2014

2 The use of animals for research, teaching and testing is a privilege, one that comes with important responsibilities: to ensure that good science is done; to meet our ethical responsibilities for ensuring that every animal is treated humanely and not subjected to unnecessary pain or distress and; to work to or exceed the accepted standards for experimental animal care and use.

3 All research, teaching or testing using animals conducted by staff or trainees affiliated with the University of Alberta, or involving University resources/ facilities, must be reviewed and approved by one of the University s Animal Care and Use Committees (ACUC) before the project starts.

4 Animal Ethics Policy and Procedures (UAPPOL) Establishes: requirements for the care and use of animals in University research, teaching and testing and, terms of reference for University Animal Policy and Welfare Committee (UAPWC). The Animal Ethics Policy applies to all University staff and trainees.

5 University Animal Policy and Welfare Committee (UAPWC) is a standing committee of the Vice-President (Research) is the institutional animal care and use committee; oversees all animal care and use performed under University jurisdiction delegates responsibility to the ACUCs for reviewing and managing animal use applications; oversees and monitors ACUC work oversees appeals in the case of a negative ACUC decision

6 Committee on Animal Resources (CAR) A subcommittee of UAPWC, which is responsible for: evaluation and planning for existing University animal facilities and new development (construction and renovations) reviewing alternate housing requests identifying research trends involving animal use to facilitate long-term planning for facilities and infrastructure improvements

7 Research Ethics Office (REO) Provides support for, and administration of, all aspects of the ethics review and approval processes for research, teaching and testing involving animals, including ACUC reviews and UAPWC and CAR meetings and processes Reports to the Vice-President (Research) Manages the business processes for the Research and Ethics Management Online (REMO) system

8 Animal Care and Use Committees (ACUCs) 4 Committees, based on research speciality: Biosciences Health Sciences 1 Health Sciences 2 Livestock Wildlife & field studies, etc. Facility: Sciences Animal Support Services Laboratory animals, primarily rodents Primarily less invasive CCAC Category of Invasiveness (B, C); acute non-recovery studies, etc. Facility: Health Sciences Laboratory Animal Support Services Laboratory animals, primarily rodents and larger mammals CCAC Category of Invasiveness C-E; recovery surgery studies, etc. Facility: Health Sciences Laboratory Animal Support Services Swine, poultry & ruminants Facility: Agricultural, Food & Nutritional Sciences Animal Service

9 Governance

10 Canadian Council on Animal Care National organization that sets and maintains the standards for the care and use of animals in research, teaching and testing throughout Canada Endorsed by the Government of Canada, and supported by Canada s major funding agencies and Universities The University Animal Care and Use program complies with CCAC policies and guidelines and maintains a CCAC Certificate of Good Animal Practice.

11 The Three Rs Guides scientists on the ethical use of animals in science. Replacement methods which avoid or replace the use of animals in an area where animals would otherwise have been used Reduction any strategy that will result in fewer animals being used Refinement the modification of husbandry or experimental procedures to minimize pain and distress

12 Animal Services Units Facility Agricultural, Food & Nutritional Science Animal Service (AFNSAS) Animal Housing, Support & Training* Predominantly, research, teaching and testing involving poultry, swine and ruminants Science Animal Support Services (SASS) Predominantly research, teaching and testing involving xenopus, birds, fish, laboratory animals and wildlife Health Sciences Laboratory Animal Services (HSLAS) Predominantly research, teaching and testing involving laboratory animals (mostly rodents) Research methodology (animal model, required veterinary expertise, etc.) is the main determinant of the facility. ACUC review will be conducted by the committee associated with the Animal Services Unit that is best equipped to support a given Animal Use Protocol.

13 Institutional Animal User Training Program (IAUTP) Based on CCAC policies and guidelines Part 1 Part 2 Required by ALL staff & trainees associated with an Animal Use Protocol (AUP); must complete Part 1 training in order to access Animal Module in REMO Offered by REO register and complete online (eclass) Required by staff & trainees who handle animals; Species- and Procedurespecific training Offered by the Facilities contact directly for details For further information on animal ethics training, contact the Research Ethics Office.

14 Institutional Animal User Training Program (IAUTP) Part 1 Training In order to be named in an AUP, regardless of the work performed, researchers (faculty, staff and trainees) must complete Part 1 of the IAUTP. Participants choose the stream (Laboratory Animals, Farm Animals, Fish or Wildlife) that is most appropriate to their research and must complete the quizzes associated with the training with an average of 80%. Individuals who have received formal training elsewhere may apply to have that training recognized. cont d

15 IAUTP Part 1Training Non-Credit Experimental Animal Care and Use Core Course (UAPWC Animal Care Course) Part 1 training covers: regulations and animal welfare; moral, legal and ethical issues; and the concept of the Three Rs (Reduction, Refinement, Replacement) The objectives of this module are: to introduce readers to basic notions in ethics to identify the socio-historical basis of the debate on animal experimentation to define levels of ethical questioning in animal experimentation cont d

16 IAUTP Part 1Training Non-Credit Experimental Animal Care and Use Core Course (UAPWC Animal Care Course) Topics Covered: Group A Modules 1-3 Quiz Basic Principles of Animal Ethics and Welfare, Modules 1-5 Quiz Group B Modules 4 7 Area Specific Animal Welfare Science (Fish, Farm Animals, Wildlife, or Lab Animals) Group C Modules 8 12 Area Specific Animal Care & Use (Fish, Farm Animals, Wildlife, or Lab Animals) Quiz Quiz An average score of 80% is required to pass Part I training. cont d

17 Institutional Animal User Training Program (IAUTP) Part 2 Training Anyone who will handle live animals must be named in an AUP and must also complete species specific training appropriate to the procedures they will perform. Part 2 training is delivered by the animal services units at the U of A: Science Animal Support Services (SASS), Agricultural, Food & Nutritional Science Animal Service (AFNSAS) and Health Sciences Laboratory Animal Services (HSLAS). Individuals who have received formal training elsewhere may apply to have that training recognized.

18 When is Ethics Review Required for Animal Use? Research, teaching and testing involving animals normally requires ethics approval. Typically this refers to activities led or supervised by faculty members (academic research or University courses or training programs). RESOURCE: When is Ethics Review Required (Animal Use)?

19 Exceptions to ACUC Review Requirement Under certain circumstances, ethics approval is NOT required. Register activity with REO by completing an Exceptions to ACUC Review form (rather than prepare a full AUP). Exception Type Category A Invasiveness Studies Other Animal Use (i.e., not research) Details Experiments on most invertebrates and live isolates do not require review (per CCAC) No AUP required, however, there may be human and/or animal health and safety issues that should be addressed For further information on whether an AUP is required, contact the Research Ethics Office before you begin your activities.

20 Animal Use Protocols (AUPs) Completed electronically using the Research and Ethics Management Online (REMO) system The use of formal standard operating procedures (SOPs) is encouraged - Institutional SOPs are available in REMO; other SOPs can be obtained from the Animal Service Units Initial application must be created/ submitted by the PI Renewal is required annually; Amendments are required for any changes to the approved protocol Back to User Training Program

21 AUP Review The review of proposed animal use before it begins is one of the fundamental pillars of the CCAC program and it is the most important responsibility of the ACUC. Before a request to use animals in research, teaching or testing can be approved, the protocol reviewers should be able to satisfactorily answer a series of questions such as those on the next two slides.

22 Well-written AUPs Answer the Following Questions for Reviewers 1 Do you understand why the study should be done? Are you convinced that animals must be used? Has the proposal been independently reviewed for scientific merit? Has the concept of the Three-Rs been addressed? Has the choice of animal species and model, and the number of animals requested been justified? The investigator proposing the animal use should have explained, in language easily understood by every one of the reviewers, including the non-scientific members, the potential benefits, for people or animals, arising from the study. The researcher proposing the animal use should have convincing arguments that there is no other way to obtain the information being sought in the study. If this has not been done, the ACUC must take steps to ensure that a peer review for scientific merit is undertaken. Approval to use animals requires that the use is ethically acceptable and scientifically meritorious. The scientist proposing the study or teaching use of animals must indicate the steps taken to refine procedures and to reduce or replace animals in the study. Not all species are suitable for all studies. The number of animals requested should fit the proposed experimental design. Are there too many animals or perhaps not enough? (Statistical justification should be provided.) cont d

23 Well-written AUPs Answer the Following Questions for Reviewers 2 Do you understand exactly what will be done to each animal and in what sequence? Are you comfortable that the expertise of the people carrying out the procedures is optimal? Are the facilities for performing the study suitable? Have the signs of pain, stress or distress been described? Will euthanasia be carried out in an appropriate, approved manner? The description of the procedures should be clearly written in understandable language. For example, volumes of injections or samplings, and their frequency should be presented in the written protocol, along with a plan for animal monitoring. Will additional training or help be required to carry out the project? Are the facilities appropriate for housing the species proposed? Will there be environmental enrichment for the animals? Are surgical facilities available? What about suitable anesthetic equipment? Are there special housing requirements due to agent use that must be considered for personal safety? Are there measures to relieve these signs, including euthanasia? Humane endpoints should be identified, particularly when it is known that pain and distress are likely to occur, but also when there is the possibility of inadvertent animal injury or pain and/or distress. Do the people involved have the necessary skills to perform euthanasia?

24 Post Approval Monitoring (PAM) Program Post Approval Monitoring includes all of the animal care, monitoring and follow-up that occurs after the AUP is approved. Routine PAM activities include daily animal care, veterinarian rounds and consultations, procedure monitoring and animal health checks. In addition, the PAM program may tour labs, observe procedures and conduct detailed audits of protocols.

25 Post Approval Monitoring (PAM) Program Purpose PAM promotes best practices in animal research, teaching and testing and consistency of practice with approved AUPs and University policy and procedures. Enables Principal Investigators (PIs), ACUCs, animal services units and the University to assess animal care and use in practice and to close any gaps between those practices and approved animal use applications. Conducted as part of our institutional compliance with CCAC requirements.

26 Post Approval Monitoring (PAM) Program - Activities PAM activities are captured at the protocol level in the REMO system and include: Self-assessments, veterinarian reports, ACUC facility tours, ACUC Alternate Animal Housing tours, animal care reports, facility reports. Laboratory visits/ tours (may be random and unannounced, planned or for cause).

27 Contact REO General Inquiries & REMO Support: 308 Campus Tower Street Edmonton, AB T6G 1K8 fax: Phone Kathy Strawson Alice Fritch

28 Animal Care and Use Committee Contacts ACUC/ Function Biosciences Health Sciences 1 Health Sciences 2 Livestock Post Approval Monitoring (PAM) Coordinator Michelle Schrader michelle.schrader@ualberta.ca Shirley Knothe-Riley shirley.riley@ualberta.ca Shirley Knothe-Riley shirley.riley@ualberta.ca Michelle Schrader michelle.schrader@ualberta.ca Donna Taylor donna.taylor@ualberta.ca

29 Links University of Alberta Animal Ethics Policy and Procedures (UAPPOL) Canadian Council on Animal Care (CCAC) The Three Rs Research Ethics Office (REO) Research Ethics Management Online (REMO)

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