The Canadian Council on Animal Care (hereinafter referred to as “CCAC”) is the national organization that is responsible for setting and maintaining standards for the care and use of animals in science in Canada.
The CCAC requires that institutions conducting animal-based research, teaching or testing establish an animal care committee and that it be functionally active.
Trinity Western University (TWU) is committed to the humane and ethical care and use of animals. To ensure that the highest standards in the care and use of animals for research, teaching and testing are upheld, Trinity Western University has established an animal care committee (ACC), herein known as the Institutional ACC (IACC).
This committee is responsible to the Vice Provost, Research and Graduate Studies (VPRGS), the senior administrator responsible for animal care and use for Trinity Western University. The IACC’s Terms of Reference are congruent with the Canadian Council on Animal Care (CCAC) Policy Statement on Terms of Reference for Animal Care Committees (March 2006). The CCAC requires that institutions conducting animal-based research, teaching or testing establish an animal care committee and that it be functionally active.
The committee approves animal housing facilities and arrangements, procedures and protocols involving the use of animals for research, teaching and testing under the auspices of Trinity Western University. The committee’s operations are governed by these Terms of Reference, but need not be limited to them, and are regularly reviewed to ensure compliance with Trinity Western University standards and the CCAC Guidelines and Policies.
The Committee (or its designates, the veterinarian(s) and Biology Lab Manager) has the authority, on behalf of the VPRGS, to:
- Stop any objectionable procedure if it considers unnecessary distress or pain is being experienced by an animal;
- Stop immediately any use of animals which deviates from the approved use, any non-approved procedure, or any procedure causing unforeseen pain or distress to animals; and
- Have an animal killed humanely if pain or distress caused to the animal is not part of the approved protocol and cannot be alleviated.
- Establish and implement policies and procedures for all activities involving animals and animal care, including post-approval monitoring of animal use protocols.
- Investigate reports of non-compliance with the IACC Terms of Reference or complaints of improper treatment of animals under the aegis of Trinity Western University, with reports of breaches directed to the VPRGS
The Chair of the IACC, the veterinarian and facility manager, must have access at all times to all areas where animals are or may be held or used. If an animal requires treatment, removal from a study or euthanasia, according to the veterinarians’ professional judgment, the veterinarians have the authority to proceed with any necessary emergency measures, whether or not the animal user or IACC Chair are able to be contacted. The veterinarian and IACC may also choose to delegate such responsibilities to one or more senior animal care staff member(s), such as the facility manager.
- Ensure that no University research, testing or teaching program involving animals (including field studies) be commenced without prior IACC approval of a written animal use protocol (hereinafter referred to as “AUP”); no animal may be acquired or used prior to this approval;
- Ensure no animals be held for display or breeding purposes, for eventual use in research, teaching or testing projects without prior IACC approval of a written animal use protocol;
- Require all animal users to complete an animal use protocol form (content requirements are listed as an appendix to this document).
- Ensure that each research project has been found to have scientific merit through independent peer review before approving the project; for teaching protocols, the committee will ensure that a review of pedagogical merit has been carried out.
- Review and assess all animal use protocols with particular emphasis on the CCAC policy statement on: Ethics Of Animal Investigation and CCAC Guidelines on: Animal Use Protocol Review as well as on all other relevant CCAC guidelines and policy statements and, where necessary, require further supportive information from the investigator/teacher or meet with the investigator/teacher to ensure that all members of the committee understand the procedures to be used on the animals. The committee must also ensure that all procedures using animals comply with CCAC guidelines and, if at variance, require justification for the variance on scientific grounds;
- Ensure that animal users update their protocols with any modifications they intend to make, and approve any modifications to a protocol before they are implemented. The committee must ensure that animal users report any unanticipated problems or complications, as well as on the steps they have taken to address the problem(s);
- Review all protocols annually; The IACC requires the submission of a new protocol after a maximum of three consecutive renewals;
- Document all IACC discussions and decisions in the committee minutes and on attachments to the protocol forms;
- Ensure that all IACC members and animal users have the opportunity to become familiar with the CCAC Guidelines and CCAC policy statements on: Ethics of Animal Investigation and all other CCAC guidelines and policy statements, federal, provincial or municipal statutes that may apply, as well as Trinity Western University requirements. Guidelines and policy statements can be accessed at the following web address: http://www.ccac.ca/en_/standards/
- Ensure appropriate care of animals at all stages of their life and in all experimental situations and that veterinary care is available;
- Establish procedures, commensurate with current veterinary standards, to avoid unnecessary pain and distress, to use anesthesia and analgesia properly and effectively, to provide appropriate post-operative care, to consider animal welfare, including environmental enrichment;
- Ensure that policies to provide for a system of animal care that will meet University needs are established and implemented, and include:
- the requirement that all animal care and animal experimentation are conducted according to CCAC guidelines and policies, and to any federal, provincial and Trinity Western University regulations that may be in effect;
- ensuring adequate animal care and management of the animal facilities, in particular by verifying that there is a person clearly designated to be in charge of animal care and management of the animals facilities, who is a member of the IACC and who should keep the other IACC members updated on the activities within the animal facilities;
- The training and qualifications of animal users and animal care personnel; veterinarians and animal care staff must receive continuing education in their field. Animal users must receive appropriate training according to the CCAC guidelines on: institutional animal user training, 1999; The Trinity Western University training program details can be accessed using this link (http://www.twu.ca/research/research/animal-care/default.html)
- An occupational health and safety program for those involved in animal care and use which can be found here https://intranet.twu.ca/safety/default.aspx.
- Standards of husbandry, facilities and equipment;
- Standard operating procedures (SOPs) for all activities and procedures that involve animals, including animal care, facility management, and animal use SOPs. The IACC should receive all SOPs and ensure that all necessary SOPs are produced and regularly reviewed. The approved AUPs and SOPs are posted to a secure server (https://.owncloud.twu.ca) for access by IACC members and PIs.
- Procedures for euthanasia;
- Encourage the use of pilot studies with few animals when possible; Animal users should report results from the pilot studies to the IACC, no matter whether or not they wish to pursue the study.
- At least two (2) scientists and/or teachers experienced in animal care and use, who represent the major animal-using divisions of the University;
- A veterinarian, experienced in experimental animal care and use;
- A faculty member whose normal activities do not depend on or involve animal use for research, teaching or testing;
- At least one (maximum two) person(s) representing community interests and concerns, with no University affiliation and not involved with animal use for research, teaching or testing;
- A technical staff member actively involved in animal care and/or use;
- A student;
- The person with overall responsibilities for the facilities (ex officio);
- The institutional Animal Care Coordinator who provides administrative support to the committee. (ex officio);
As the need arises, the Committee is free to co-opt other persons to the IACC, especially for the review of protocols or to solicit expert advice. Examples may be representatives from Occupational Health and Safety, Biosafety, biostatisticians, ethicists or Communications and Marketing.
Members are nominated by University personnel and the IACC membership. Nominations are reviewed and approved by the VPRGS.
Members must reflect the constituency they have been nominated to represent and be in a position to allocate time to fulfill committee responsibilities.
Term of Appointment
The term of appointment is for two years, renewable only up to a maximum of eight consecutive years of service. This does not apply to IACC members who must be part of the IACC because of their role within the institution (ex officio members): the IACC Coordinator, the veterinarian(s) and the animal facility manager (if applicable). The Faculty of Natural & Applied Sciences (hereinafter referred to as FNAS) Dean or designate, having overall responsibility for the animal facilities, must be on the IACC.
Election of Chairs
The Chair will be elected for a two-year term from the Committee membership and to avoid potential conflicts of interest, must not be
- The FNAS Dean or designate;
- A University clinical veterinarian;
- An animal health or veterinary personnel charged with compliance with CCAC guidelines; or
- Involved with a significant number of protocols approved by the Committee.
Staff Support for the Committee (IACC Coordinator)
This will be provided through the Office of Research and Faculty Development (ORFD).
- The Chair, with the assistance of the Animal Care Coordinator, is responsible for adhering to generally accepted operating procedures for meetings as follows:
- Arranging a minimum of two face-to-face meetings per year. Meetings may be initiated by the Chair or the IACC, after consultation with one another; and
- Distributing notice of meeting and agenda at least two weeks before the meeting to all members;
- A quorum at a meeting is a majority of the members and should include veterinary and community representation;
- Committee minutes and reports must be promptly produced and appropriately distributed; minutes of the IACC meetings will be forwarded to the VPRGS, the senior administrator at Trinity Western University responsible for animal care and use;
- Other committee documentation such as exchanges between the committee and animal users must be complete and filed in a timely manner;
- Committee members must be provided with orientation and training opportunities by the University; and
- The Committee must regularly visit (at least once a year) the University animal care facilities to monitor conditions and compliance, meet with animal users to understand their needs and make and report recommendations based on an assessment of the facilities and their use. These visits will be documented through IACC minutes or reports. Those responsible for the animal facilities and for animal use should respond to any IACC recommendations in writing, and site visit reports should always be followed up on jointly by the senior administration and the IACC.
The Animal Care Committee must regularly review (at least every three years):
- Its Terms of Reference to ensure they meet new CCAC guidelines or policies and changing needs within the University, the scientific community, the animal welfare community and society as a whole; recommendations for any changes will be made to the VPRGS;
- The security of the animal and research facilities;
- Standard operating procedures and the University’s animal care and use policies;
- Policies and procedures for monitoring animal care and experimental procedures within the institution, including the identification of the persons responsible for monitoring animal health and welfare; Maintain contact with the CCAC Secretariat and inform the Secretariat of changes in their program;
- Submit the CCAC Animal Use Data Form annually;
- Develop a crisis management plan for the animal facilities and for the animal care and use program, in conjunction with the University’s Crisis Management Plan. It should include a communications plan for addressing public and media inquiries on concerns related to animal use; and
- Should try to achieve and maintain a high profile within the institution and the community to demonstrate the University’s efforts in promoting animal welfare. It should, from time to time, sponsor seminars or workshops on the use of animals in science and the ethics of animal experimentation and be open to developing and maintaining communication with animal welfare organizations.
Animal-Based Projects Involving Other Institutions
Most animal use is undertaken by investigators and teachers working within their own ‘home’ institutions and overseen by their local ACC(s). However, in certain cases, investigators and teachers undertake animal use in one or several ‘host’ institutions. In other cases, various parts of an animal-based project are carried out by several institutions. In such situations, the CCAC Policy on Animal-Based Projects Involving Two or more Institutions must be followed to understand how collaborative animal-based projects should be prepared by investigators and teachers and overseen by institutional ACCs.
Post Approval Monitoring (PAM)
The IACC is responsible for ensuring compliance with its decisions and with the conditions set out in approved protocols and Standard Operating Procedures (SOPs). While the committee will work in a collegial manner with animal users and attempt to correct deficiencies, where there are persistent breaches of compliance or threats to the health and safety of personnel or animals, these must be reported to the IACC Chair. The Chair and IACC must promptly address these issues, through communications with the animal user(s), meetings and site visits. Breaches of compliance that cannot be corrected by the IACC working with the concerned animal users and veterinary/animal care staff will be referred to the VPRGS. The VPRGS is responsible for follow up and appropriate remedies by the process outlined in relevant TWU Policies: Integrity in Scholarship and Research, and Animal Care.
As the IACC is not generally present when animal use protocols are being undertaken, the committee must work with the members of the veterinary and animal care staff to ensure compliance with approved protocols and SOPs. Post approval monitoring will include, but is not limited to: animal tracking via requisition and receipt forms, post-season field reports, and regular documented site visits by the FNAS Dean or designate to ensure approved protocols and SOPs are being adhered to. Copies of all approved protocols and SOPs will be readily available to animal users and staff.
Protocol Review Process
- Protocol forms are available online at http://www.twu.ca/research/research/animal-care/default.html along with an instruction document “How to complete forms”.
- Fully completed applications are to be typed, and then signed by the principal instructor/investigator and his/her Dean. The application, with all supporting documentation, is submitted to the IACC Coordinator (firstname.lastname@example.org) a minimum of 2 months ahead of the desired projects start date.
- The IACC will attempt to accommodate the occasional project/exercise that must be approved on short notice. Failure to appropriately complete the application form may delay approval;
- The IACC Coordinator will assign the application a protocol number and check the form for completion. The form will then be forwarded to the IACC Veterinarian for initial review. The PI may be contacted at this point by either IACC member regarding any questions or concerns they may have to ensure the form is ready for full committee review. Any agreed changes should be made and the form resent as a revised copy;
- The IACC will discuss protocols and make decisions on them during full committee meetings, rather than through individual reviews. Comments from committee members who cannot attend the meeting will be considered;
- The IACC shall attempt to reach decisions by consensus, as opposed to voting;
- All committee discussions, recommendations and decisions shall be documented in the committee minutes and on attachments to the protocol forms;
- The IACC will notify the principal instructor/investigator in writing of the committee’s decision.
Protocol Renewal / Interim Approvals
Protocols are approved for one year. For protocols continuing beyond this period, complete the Annual Renewal Form each year and submit it to the IACC Coordinator. The IACC requires the submission of a new protocol after a maximum of three consecutive renewals (i.e., after the fourth year).
Interim approvals and annual protocol renewals may be delegated to a protocol review subcommittee, which must include at least one scientific member, one veterinarian, and one community representative, one of which should preferably be the IACC chair. Interim approval should only be used infrequently, and the interim review process, including exchanges between the IACC and protocol authors, must be documented and must then be subject to discussion and final approval at a full meeting of the committee.
Any modifications to a protocol must be approved by the IACC before implementation. Minor modifications, such as the addition or removal of animal users or a small number of animals added, can be requested by completing the Amendment Form available online and submitting the form to the IACC Coordinator. Minor modifications may be approved by the IACC Chair or delegate. Major modifications require the submission of a new protocol. Examples of major changes are a considerable increase of the number of animals required, a change of species, use of more invasive or more frequent procedures, or the use of entirely new procedures.
For teaching activities, the Animal Care Policy states that the VPRGS is responsible for ensuring that the pedagogical merit of any animal use is thoroughly examined and documented. This must occur before the IACC can approve the activity.
For research proposals where review has not been carried out by an external, peer review agency, the Animal Care Policy states that the VPRGS is responsible for the review process. Review is to be according to the CCAC policy statement on: scientific merit and ethical review of animal-based research, 2013. Two external reviews of the objectives, hypotheses, methods and contributions of the project will be solicited, by knowledgeable scientists who do not collaborate with the investigator and are not in a conflict of interest. The reviews must be documented and must contain sufficient information to support the reviewers' conclusions.
In- Principle Approval.
Occasionally, IACC approval is required by the funding agency before it will review the application. In such cases, IACC approval should be provisional, pending assurance from the funding agency that the application has high scientific merit.
In the event that a protocol application is not approved by the IACC, the IACC will detail the reasons in writing to the principal instructor/investigator (PI) of the protocol.
If the PI disagrees with the decision and reasons stated, he/she may appeal in writing to the IACC specifying the decision being appealed and the reasons for the appeal. If the IACC review of the PI’s appeal confirms the original decision, the PI may only launch a further appeal on the grounds of allegations that improper process was followed by the IACC in arriving at the decision, or if additional information is available that was not evident during the IACC decision-making process. In this case, the PI may submit an appeal request to the Office of the VPRGS. The matter will be forwarded to the IACC of a neighbouring post-secondary institution with which Trinity Western University has a formal agreement to perform this function. The decision of that institution’s ACC shall be final. The CCAC may be called upon for information purposes; however, appeals cannot be directed to the CCAC.
CONTENT OF THE ANIMAL USE PROTOCOL FORM
Excerpted from the Canadian Council on Animal Care Policy on Terms of Reference for Animal Care Committees
(Supplemental information can be found in the CCAC Guidelines on: Animal Use Protocol Review, 1997).
i) project title and descriptive procedural keywords or brief description of the procedures to be conducted on animals, as defined in the CCAC Animal Use Data Form;
ii) principal investigators/teachers, and all personnel (post-doctoral fellows, research staff, graduate and undergraduate students) who will handle animals, along with their training and qualifications with respect to animal handling (see point 3m) iii)); in the case of undergraduate students, who may have very little training, close supervision is required;
iii) departmental affiliation;
iv) proposed start date, proposed end date (if the study is to take place over more than one year, the work and numbers of animals for the first year only should be approved, and further work can then be approved in yearly protocol renewal(s) or new protocols - see Section 3g) on protocol renewals);
v) for research or testing projects, funding source(s) and status of funding approval;
vi) for research projects, an indication of whether the project has received peer review for scientific merit;
vii) for teaching programs, a course number and an indication of whether the course has been re-viewed with respect to the pedagogical merit of using live animals; institutional or departmental curriculum committees can be called upon to provide a review of pedagogical merit to the IACC; Appendix 3 of the animal use protocol form is to be completed to better capture information relevant to the ethical review of teaching programs (see Section 12 of the CCAC guidelines on: animal use protocol review);
viii) for testing projects, an indication that the testing has been planned according to the most current regulatory requirements, using guidelines acceptable to the regulatory agency(ies) and which meet the requirements of the CCAC policy statement on: ethics of animal investigation; that the planned animal use not exceed the requirements of the regulatory authorities - if it does, justification for the additional animal use must be provided;
ix) lay summary;
x) an indication of the use of biohazardous, infectious, biological, chemical or radioactive agents in animal-based projects; and, if so, an indication of institutional approval of this use;
xi) category (i.e.s) of invasiveness as defined in the CCAC policy statement on: categories of invasiveness in animal experiments, and Purpose of Animal Use (PAU) as defined in the CCAC Animal Use Data Form;
xii) information with regard to the Three Rs (replacement, reduction and refinement alternatives) of animal use, to include:
xii.1 a description of why sentient animals must be used for the project, of how the applicant arrived at this conclusion (e.g., searches of databases on alternatives), and of possible replacement alternatives (non-animal methods, cell/tissue culture, computer simulations, audio-visual teaching methods, the replacement of sentient animals with animals of lower sentiency, etc.) and justification if these are not to be employed;
xii.2 justifications of the species and numbers of animals to be used over the course of the year, to emphasize reduction of animal use within an appropriate experimental design, while ensuring that sufficient numbers of animals will be used to fulfill requirements for statistical significance/scientific validity in the case of research projects, or for acceptance of regulatory tests;
xii.3 a description of all of the refinements to be employed to protect and enhance animal health and welfare, which may include:
xii.3.1 anesthesia and analgesia, including dosages and methods of use, for all invasive protocols; strong scientific justification must be provided for not using anesthesia or analgesia in the case of invasive protocols;
xii.3.2 other medical treatments as appropriate, as indicated through veterinary consultations;
xii.3.3 housing and husbandry methods, and environmental enrichment as a means to refine animal care; any limitations on environmental enrichment from that normally offered to animals in the institution, based on CCAC guidance, must be justified to the IACC;
xii.3.4 refinements to the procedures to be employed on the animals;
xii.3.5 refinements to the length of time that animals will be held/used;
xii.3.6 any other possible refinements;
xiii) a clear description detailing the procedures that are carried out on the animals (referring to appropriate SOPs as much as possible); the use of graphic representations is encouraged;
xiv) a description of the endpoint(s) of the experimentation, selected according to the CCAC guidelines on: choosing an appropriate endpoint in experiments using animals for research, teaching and testing, 1998 (refer to institutional SOPs, if available and relevant); the person(s) responsible for monitoring the animals and applying endpoints should be identified, and the schedule for monitoring animals and any relevant checklists of signs and symptoms to be used when evaluating the animals should be included; all protocols, even non-invasive ones, must identify endpoints, to ensure that any animals requiring treatment are treated and that animals are not simply kept indefinitely; relevant information for identifying and applying endpoints must be readily available, preferably posted, in the area where the animal-based work is taking place;
xv) a description of capture, restraint, transportation and/or housing of animals used in field studies, as well as any other information pertinent to field studies, such as capture of non-target species, ecological impacts and potential injuries or mortality during capture or transportation, if relevant; wildlife studies should be addressed in a separate appendix of the protocol form, or can have their own protocol form, especially where a significant number of wildlife studies are undertaken (see the suggested wildlife protocol form in Appendix B of the 2003 CCAC guidelines on: the care and use of wildlife) as decided by the IACC;
xvi) the method of euthanasia, if used; justification for any physical euthanasia methods, or for any methods that deviate from those described in the most recent CCAC guidance on euthanasia;
xvii) a description of the fate of the animals if they are not to be euthanized, including the length of time that they are to be held;
any other information considered important or necessary and pertinent, including information or results derived from any relevant previous protocols; the description and use of previous relevant results is particularly important to ensure that methodologies are not simply re-used without learning from any animal welfare problems that were encountered in the past, that the protocol continues to have relevant goals and methodology, and that appropriate refinements to protect and enhance animal welfare are sought and implemented;