Policy on the Care and Use of Animals in Research and Teaching

Purpose

This policy sets out the standards, requirements and responsibilities that apply to activities involving animals for research, teaching and testing purposes at the University of Ontario Institute of Technology (Ontario Tech).

Definitions

For the purposes of this Policy the following definitions apply:

“Animal Care Committee” (ACC) oversee the ethical treatment of experimental animals used in research, teaching and testing at the University.  The ACC strives to meet or exceed the expectations of the Canadian Council on Animal Care (CCAC) and requirements of the Ontario Animals for Research Act.

“Animal Utilization Protocol (AUP)” is the application form which animal users are required to complete and submit to the ACC for review.  The AUP form is intended to provide the ACC with information about activities in individual laboratories and classrooms.  This information is required for the ACC to meet its legal and ethical responsibilities. 

“Canadian Council on Animal Care (CCAC)” is a national peer review agency responsible for setting and maintaining standards for ethical use and care of experiment animals used in research, teaching and testing in Canada.  Compliance is monitored through its assessment program.

“Ontario Animals for Research Act” all experiment animals used in research, teaching and regulatory testing in Ontario fall under the auspices of the Ontario Animals for Research Act and compliance is overseen by the Chief Veterinary Inspector of the Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA). 

“Major modification” are substantive issues which in the opinion of the committee, constitute as ethical, scientific or regulatory issues that are barriers to approval and must be satisfactorily addressed prior to issuing study approval  major modifications required.  To name a few, these issues can relate to technique, study design and/or animal welfare.

“Minor modification” are less substantive issues that require resolution or clarification, but are not immediate barriers to approval.

“Replacement, reduction and refinement (3R’s)” stand for replacement, reduction and refinement.  The 3 R’s are accepted ethical principles for experimental animal use and care in research.  Replacement refers to the method to avoid or replace the use of animals where an animal would have been used.  Reduction refers to a strategy that will result in fewer animals being used for research.  Refinement refers to modification of husbandry or experimental procedures to minimize pain and distress of animals used for research.

“University” means the University of Ontario Institute of Technology (Ontario Tech).

“University Member” means any individual who is:

• Employed by the University;
• Registered as a student, in accordance with the academic regulations of the University;
• Holding an appointment with the University, including paid, unpaid and/or honorific appointments; and/or
• Otherwise, subject to University policies by virtue of the requirements of a specific Policy and/or the terms of an agreement or contract.

Scope and authority

This Policy applies to all research, teaching or other programs or activities involving the care and use of animals or animal tissues that is:

1. Conducted by any individual or group affiliated with the University;

2. Undertaken under the auspices of or in affiliation with the University, or in University owned facilities, or using University equipment, or resources.

Individual researchers and teachers, consultant veterinarian(s), and animal care personnel are responsible for conducting research and teaching activities in compliance with this policy. Researchers and teachers are also responsible for educating students on the rationale for and application of this policy, and for ensuring that student activities carried out under their supervision are approved in compliance with this policy.

The Vice-President Research & Innovation (VPRI), working in collaboration with the senior administrative team, Deans, and the Animal Care Committee (ACC), is responsible for ensuring that the University’s responsibilities in this area are met, that appropriate animal care and use operations are in place, and that all activities are conducted appropriately and in accordance with institutional and legislated policies and regulations.

The Vice-President Research & Innovation (VPRI), or successor thereof, is the Policy Owner and is responsible for overseeing the implementation, administration and interpretation of this Policy.

Policy

The university is committed to the ethical care and use of animals for research, teaching and testing purposes when such activity promises to contribute to the understanding of fundamental biological principles or to the development of knowledge with a reasonable expectation of benefit for humans or animals (Canadian Council on Animal Care policy statement).

In doing so, the University will be guided by the three tenets of replacement, reduction and refinement (3R’s) in animal use, in order to minimize the harm to animals.  To this end, the University, through the VPRI, will coordinate efforts to ensure that appropriate animal care and use operations are in place and are in compliance with the Ontario Animals for Research Act and its associated regulations, the Canadian Council on Animal Care (CCAC) policies and guidelines, and all other applicable standards and regulations set out in Section 4.

University Animal Care Committee

1. The University ACC shall oversee all research, teaching and testing conducted at the University involving the care and use of animals ensuring compliance with institutional and regulatory standards. The committee is responsible for coordinating, reviewing and approving the activities and procedures relating to the care of animals, the standards of care and facilities for animals, the training and qualifications of individuals involved in the care of animals, and the procedures for the prevention of unnecessary pain.

2. The committee shall report to the VPRI, and be comprised of researchers and teachers experienced in animal care, as well as staff, students and community members who have not been involved in animal use for research, teaching or testing.  The committee will also work in collaboration with animal users, veterinarians and animal care staff to oversee the ethical and appropriate use of animals.

3. Decisions of the University Animal Care Committee may be appealed to the VPRI in accordance with the process for appeal of a decision of the ACC (002 SOP: Process for Reconsideration or Appeal of Decisions of the ACC)

Activities Involving Animal Use

1. All activities involving the use of animals for research, teaching and testing purposes shall be subject to ethical review, scientific merit, pedagogical review and approval by the University ACC. Researchers and teachers wishing to engage in activities involving animal use must receive written approval from the committee prior to the commencement of their activities. Animals shall not be used for research, teaching or testing purposes until all requirements outlined in this policy, as well as the most current federal and provincial legislation and applicable standards, guidelines, and regulations have been met.

2. Approved activities involving animal use protocols shall be subject to ongoing monitoring by the University ACC, under the Administrative procedure 004: Post Approval Monitoring Program, to ensure that they remain appropriate and continue to meet institutional and legislated standards.

3. Animals used for research, teaching and testing purposes shall be cared for according to current veterinary standards.

Training on Animal Care and Use

1. All persons who care for and use animals for research, teaching or testing purposes must be trained under the auspices of the University Animal Care Committee in the protocols appropriate to the animal species being used, and must demonstrate competence ensuring maximum benefit to the animals.

Non-Compliance

1. The University ACC may stop any action or activity involving the care and use of animals that fails to comply with the approved animal use protocol, federal and provincial regulatory requirements, and/or institutional policies and procedures.

Crisis Management

1. The University ACC shall develop and regularly review a comprehensive crisis management program for the animal facilities and for the animal care and use program in conjunction with the general campus emergency response plan.

 

Monitoring and review

This policy will be reviewed as necessary and at least every three (3) years (unless another timeframe is required for compliance purposes).  The University ACC or successor thereof, is responsible to monitor and review this policy.

Relevant legislation

All activities involving the care and use of animals shall adhere to the requirements of this policy, as well as the most current federal and provincial legislation and all applicable standards, guidelines and regulations set out by the following bodies:

• Animals for Research Act (OMAFRA, Province of Ontario)
• Canadian Council on Animal Care (CCAC) – Good Animal Practice (GAP)
• Occupational Health and Safety Act (R.S.O. 1990) and regulations
• Health of Animals Act
• Containment Standards for Facilities Handling Aquatic Animal Pathogens
• National Aquatic Animal Health Program (co-delivered by DFO and CFIA)
• Canadian Association for Laboratory Animal Medicine (CALAM)
• Canadian Association for Laboratory Animal Science (CALAS)
• Canadian Veterinary Medical Association (CVMA)
• Tri-Agency (Memorandum of Understanding (MOU) on the Roles and Responsibilities in the Management of Federal Grants and Awards)
• Canadian Food Inspection Agency and Fish Pathogens (CFIA)
• Department of Fisheries and Oceans (DFO)
• Any other regulatory body that guides in the care and use of specific animals.

Related policies, procedures & documents

Post Approval Monitoring Program and Related documents (Administrative procedure 004: University Post Approval Monitoring Program)
Process for Appeal of Decisions of the ACC (Administrative procedure 002: Process for Appeal of Decisions of the ACC)
University Animal Care Committee Terms of Reference
Purchasing Policy and Procedures
University Emergency Preparedness Plan and Animal Care and Use Crisis Management Plan
Requirements for Working with Animals
Biosafety Manual
Radiation Safety Manual
Integrity in Research and Scholarship
Animal Use Protocol Form
Annual Renewal Request Form
Incident Report Form
Pedagogical Merit
Peer Review Form
Amendment Request Form
Competency Assessment Form: Aquatics Lab
Competency Assessment Form:  Amphibian Lab

Appendix A - Terms of Reference

University Animal Care Committee: Terms of Reference

The University of Ontario Institute of Technology (Ontario Tech) has a responsibility to ensure that effective control is exercised in the care and use of experimental animals. All animals (live, non-human vertebrates) are protected by the Animals for Research Act of Ontario and its associated regulations. In addition to this, provincial legislation, the Tri-Agency Agreement on the Administration of Agency Grants and Awards by Research Institutions requires the University to maintain a valid Certificate of Good Animal Practice from the Canadian Council on Animal Care (CCAC).

Definitions

“Canadian Council on Animal Care (CCAC)” is a national peer review agency responsible setting and maintaining standards for ethical use and care of experiment animals used in research, teaching and testing in Canada.

“University” means the University of Ontario Institute of Technology (Ontario Tech).

Purpose

1. The Animal Care Committee (ACC) oversees all research, teaching and testing with animals. The ACC ensures that the 3R’s (replacement, reduction, and refinement) are considered for any activity involving the care and use of experimental animals and that these principles are upheld to minimize the number of animals used at the University.

2. The ACC is established by the University and responsible for the coordination, ethical review and approval for all proposed uses of animals in research (including field studies), testing and teaching at the University. The ACC shall establish internal policies and procedures to ensure compliance with legislation and the Canadian Council on Animal Care (CCAC) policies and guidelines. The operation of the ACC is governed by the following Terms of Reference.

Authority

1. The ACC reports directly to the Vice-President Research & Innovation (VPRI). The ACC, on behalf of the VPRI has the authority to:

   1. stop any objectionable procedure that causes unnecessary distress or pain to the animal;

   2. stop immediately any animal use that deviates from the approved protocol or non-approved procedure(s);

   3. determine corrective action on breaches of compliance with approved animal use protocols and Standard Operating Procedures (SOPs). The VPRI will be informed when breaches cannot be corrected by the ACC and will determine sanctions that will be taken;

   4. humanely euthanize an animal if pain or distress caused to the animal cannot be alleviated;

   5. conduct post approval monitoring of all research and teaching activities involving animals; and,

   6. have ongoing access to all areas where animals are held or used.

2. The ACC delegates to the consultant veterinarian(s) the authority to:

   1. treat, remove from a study or humanely euthanize an animal according to the veterinarian's professional judgment; and,

   2. proceed independently with any necessary emergency measures, whether or not the animal user and ACC Chair are available.

3. The consultant veterinarian(s), before exercising authority, must attempt to contact the ACC Chair and the animal user whose animal is in question before beginning any treatment that has not previously been agreed upon. The consultant veterinarian(s) will send a written report to the animal user and to the ACC following any such event.

Safeguards and Non-compliance

1. Collegial working relationships must always be protected and promoted, but it is necessary to have in place safeguards to ensure any difficulties experienced with any aspect of animal care or use can be effectively identified and addressed. For serious non-compliance or threats to the health and safety of personnel or welfare of animals, the ACC Chair and ACC must promptly address these issues. Reports of non-compliance may come from the general community at large. Individuals raising such concerns must express their concerns in writing to the ACC Chair. Verbal concerns can be accepted when non-compliance situations require prompt attention; however, written documentation must follow post event. The ACC Chair will address the issues, through communications with the animal user(s), meetings and site visits in accordance with the University Policy on the Care and Use of Animals in Research and Teaching and associated procedures. The ACC, consultant veterinarian(s) and ACC Coordinator will work with the animal user(s) to ensure a resolution. All communications surrounding the event(s) will be documented in the ACC’s Post Approval Monitoring reports.

2. Non-compliance concerns that cannot be corrected or resolved with the ACC will be referred to the VPRI, who will inform all members of the animal care and use program about sanctions that will be taken by the administration. If the VPRI, has a real or perceived conflict of interest, the University President will determine sanctions.

Membership and Term

1. The ACC is appointed by, and is responsible to the VPRI. ACC members will be appointed for terms of four (4) years and normally renewable only up to a maximum of eight (8) consecutive years of service. This maximum can be waived by the ACC if necessary in order to have appropriate animal user representation. This does not apply to ACC members who must be part of the ACC because of their role within the institution (e.g. ex officio members).

2. The VPRI shall appoint a ACC Chair and ACC Vice-Chair from the complement of the ACC committee. The ACC Chair shall not be directly involved in the management of the animal care facilities, nor be the consultant veterinarian for the University, nor be involved in the preparation of a significant number of the protocols to be reviewed by the ACC in order to avoid potential conflicts of interest.

3. The complement of the committee will include:

   1. a minimum of two (2) scientists and/or teachers experienced in animal care and use, who may or may not be actively using animals during their term on the ACC;

   2. consultant veterinarian(s), experienced in care and use of animals used and housed at the University;

   3. an institutional member whose normal activities, past or present, do not depend on or involve animal use for research, teaching or testing;

   4. at least one (1) person representing community interests and concerns who has had no affiliation with the institution, and who has not been involved in animal use for research, teaching or testing; community representation must be ensured for all ACC activities throughout the year and included on all protocol review subcommittees;

   5. technical staff representation preferably an animal research technician;

   6. at least one student representative (graduate and/or undergraduate);

   7. the ACC coordinator (University Research Ethics Officer) who is responsible for the coordination of all animal care related activities and providing support to the ACC;

   8. a representative of the senior administration reporting to the VPRI (Director, Office of Research Services); and,

   9. a representative for occupational health & safety and biosafety.

Responsibility

1. The ACC’s responsibilities include but is not limited to:

   1. ensure policies and guidelines are established in accordance to CCAC, provincial legislation and institutional standards to ensure appropriate care and use of animals at the University;

   2. ensure that written ACC approval is obtained prior to animal use or acquiring animals for research, teaching or testing projects. ACC approval must also be obtained prior to breeding or holding of animals for research, teaching or testing projects;

   3. ensure that ACC approval of a written animal use protocol is obtained prior to breeding, research, teaching, production or testing (including field studies) involving animals. For other animal based activities within the institution, the ACC will work with the individuals responsible for the activities to ensure appropriate procedures for animal care and use;

   4. require the completion of an animal use protocol by the animal user and ensure that the protocol includes the nature of all procedures to be used on the animal, the number and type of animals to be used and the anticipated level of discomfort or distress that the animal will likely experience. In addition, other key sections identified in the CCAC guidelines on Terms of Reference for Animal Care Committees must be included in the animal use protocol;

   5. review all animal use projects to ensure compliance with the University policies, CCAC guidelines, and applicable regulatory requirements at a full committee meeting;

   6. Confirm that each research project has undergone an independent peer review and has been found to have scientific merit, prior to issuing ACC approval. For non-peer reviewed projects, the ACC Administrative Procedure 003 Peer Review Process must be followed;

   7. review, propose modifications, reject or approve any amendments to an approved animal use protocol. ACC approval is required prior to implementation of any changes. Any major changes to an approved protocol will require submission of a new protocol to the ACC. A major change includes the following: considerable increase in the number of animals, change of species, addition of more invasive procedures and use of entirely new procedures compared to the original approved procedures. The ACC can deem changes as major at their discretion;

   8. review and approve annual renewals prior to study expiry. All renewals must be reviewed and approved by a scientist, consultant veterinarian(s) and community member and decisions will be reported back to the full ACC. A new submission will be required after a maximum of 3 consecutive renewals;

   9. document all ACC discussions and decisions in the committee minutes;

   10. participate in continuing education and training for the matters relating to animal use in research;

   11. ensure appropriate veterinary care is available commensurate with current veterinary standards, and consistent with the Standards of Veterinary Care as defined by the Canadian Association for Laboratory Animals Medicine (CALAM/ACMAL).

   12. promptly notify the CCAC Secretariat and the Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA) of any program changes;

   13. submit and complete the CCAC and OMAFRA Animal Use Data Form before the yearly deadline;

   14. establish a crisis management plan for animal care and use facilities; and

   15. implement the Post-Approval Monitoring (PAM) program and ensure established procedures are in place.

Research Involving Multiple Institutions

For off-site research, researchers are also responsible for obtaining the necessary ethics approval from any ACC or authorities that oversee research at the other institutions. An ethics review and approval or equivalent is required at each institution responsible for carrying out the research under its auspices regardless of where the research is conducted or led prior to study commencement.

Meetings, Monitoring Visits and Inspections

1. The ACC will meet at least twice per year or more frequently as is necessary to fulfil their Terms of Reference and be satisfied that all animal use within their jurisdiction complies with institutional, municipal, federal and provincial regulations, and CCAC policies and guidelines. Meeting minutes will detail all ACC discussions, decisions, modifications to protocols, site and inspection visits, that will be forwarded to the VPRI.

2. All ACC members will complete a general site visit to all facilities where animals are used, in order to better understand the work being conducted within the institution. The general site visit, by all members of the ACC, will occur once a year and can be completed individually or as a group.All ACC members will complete a general site visit to all facilities where animals are used, in order to better understand the work being conducted within the institution. The general site visit, by all members of the ACC, will occur once a year and can be completed individually or as a group.

3. The Post Approval Monitoring Committee will have scheduled visits, which will be held on average every 6 months on a date mutually agreeable to by all parties concerned including the consultant veterinarian and animal users.

4. At the discretion of the ACC, monitoring visits and inspections to the animal facilities can increase in frequency.

Quorum and Decisions

1. A quorum at ACC meetings shall be a simple majority of the committee members and shall include at least one community representative as well as the consultant veterinarian(s). Decisions are made by consensus.

2. All delegated reviews must be approved by the ACC Chair/Vice-Chair, the consultant veterinarian(s) and community member. The final approval will be issued by the ACC.

Training and Education

1. Training opportunities are required for new ACC committee members to provide an understanding of the institutional animal care and use program, animal user facilities, institutional policies and procedures, CCAC guidelines and OMAFRA regulatory requirements.

2. All ACC members should complete the CCAC’s Modules on the Core Topics of the Laboratory Animal/Teaching Stream of the CCAC Recommended Syllabus. The University will also provide ongoing training and education for ACC members.

3. All persons who care for and use animals for research, teaching or testing purposes, and the consultant veterinarian(s) must receive training under the auspices of the University Animal Care Committee in the protocols appropriate to the animal species being used. They must demonstrate competence ensuring maximum benefit to the animals. This would include, continuing education in their field; (scientists/study directors, post-doctoral fellows, graduate students and research technicians)

Terms of Reference Review

1. The ACC Terms of Reference, standard operating procedures and policies will be reviewed as necessary, and at least every three years (unless another timeframe is required for compliance purposes). The ACC and Office of Research Services are responsible to monitor and review these terms.

Policies with Specific Reference to ACC Terms of Reference

CCAC Policy Statement for: Senior Administrators Responsible for Animal Care & Use Programs, 2008
CCAC policy statement on: terms of reference for animal care committees, 2006
CCAC Assessment Report: University of Ontario Institute of Technology, April 4, 2012

Other Policies Procedures & Guidelines

CCAC policy statement on: scientific merit and ethical review of animal-based research, 2013
CCAC training modules on: Institutional Animal User Training Program
CCAC guidelines on: choosing an appropriate endpoint in experiments using animals for research, teaching and testing, 1998
CCAC guidelines on: animal use protocol review, 1997
CCAC policy statement on: ethics of animal investigation, 1989
University Animal Care and Use of Animals in Research and Teaching, 2013
University 004 Administrative Procedure: University Post Approval Monitoring Program
University 002 Administrative Procedure: Process for Reconsideration or Appeal of Decisions of the ACC