1.0 Reason for Procedure(s)

To enable the implementation of the Animal Care and Use Policy (the "Policy"), by
establishing procedures relating to:

1.1 Responsibilities;
1.2 Protocol Review and Approval;
1.3 Education and Training;
1.4 Post Approval Monitoring;
1.5 Peer Review;
1.6 Animal Acquisition, Housing and Disposal;
1.7 Authority to Terminate Animal Use;
1.8 Appeal of Protocol Review Decisions; and
1.9 Non-Compliance.

2.0 Procedure(s)

2.1 Definitions

2.1.1 Abbreviated Protocol for Minimal Animal Involvement means a document submitted by an Animal User for consideration by a subcommittee of the ACC, and containing a brief description of the study which allows for confirmation of minimal Animal use.

2.1.2 Academic Staff Member means:

(a) all Animal Users who fall into one of the categories defined in the University's Procedure entitled "Employee Organizations and Employment Group"; and, for the purposes of this Policy also include:

(b) all Animal Users holding nil-salaried appointments at the University of Manitoba (i.e., adjunct professorships, nil-salaried academic appointments, visiting scientists).

2.1.3 Animal Facilities Staff means personnel working with Animals in Facilities with their primary responsibility being Animal husbandry and/or Facility functioning.

2.1.4 Category of Invasiveness or COI means the categories defined by the CCAC describing the invasiveness of the procedures used on a live Animal. Invasiveness is based on the degree and duration of pain or physical distress associated with the procedure.

2.1.5 Lead Investigator means the Principal Investigator on a grant.

2.1.6 Off-site Housing means locations (other than the Facilities) in which Animals for use are housed.

2.1.7 Principal Investigator means the person identified as such on the Protocol.

2.1.8 Research Personnel refers to personnel, other than the Principal Investigator (PI), identified on the Protocol. Such persons are normally academic staff, visiting scientists, post doctoral fellows, research associates, technicians or students.

2.1.9 Any references in the singular form shall be deemed to include the plural form where the meaning of a section so requires.

2.2 Responsibilities

Implementing and adhering to Applicable Requirements concerning the proper care and use of Animals in research, teaching or testing is an institutional responsibility shared by: the University Administration, including central, faculty and departmental administration; specially appointed committees, including the Committee on Animal Care (CAC) and the Animal Care Committees (ACCs); the Director, Animal Care and Use Program (DACUP), Veterinary Services Staff, Directors of Facilities and Animal Users.
Notwithstanding this shared responsibility, the specific responsibilities of these individuals, groups/units, and committees are as follows:

2.2.1 The Associate Vice-President (Research) (AVPR) is responsible for the implementation of these Procedures.

2.2.2 The DACUP is responsible for providing overall direction to the University's Animal Care and Use Program.

2.2.3 Faculty/School Deans/Directors and Department Heads:

2.2.3.1 Faculty/School Deans/Directors and Department Heads have a general responsibility for the research, teaching or testing carried out in their Faculty/School or Department, and for encouraging and ensuring compliance with Applicable Requirements.

2.2.3.2 Deans/Directors of Faculties/Schools and Department Heads are responsible for the operations of the Facilities under their jurisdiction and for ensuring that they meet all Applicable Requirements. Deans/Directors of Faculties/Schools are responsible for ensuring funding to meet Applicable Requirements with respect to maintenance, upgrade, and long term planning of Facilities under their jurisdiction.

2.2.3.3 Deans/Directors of Faculties/Schools where Animals are used in research, teaching or testing are responsible for establishing a mechanism for assessing the scientific/instructional merit of those projects that are not subject to recognized peer review (refer to section 2.6).

Where a unit (e.g., Research Centre/Institute) reports directly to a Vice-President, these responsibilities are vested in the appropriate Vice-President.

2.2.4 The CAC is responsible for ensuring University-wide understanding of, and compliance with, all Applicable Requirements. The specific composition and detailed terms of reference of the CAC are determined by Senate and must accord with the requirements of the CCAC.

2.2.5 The ACCs are responsible for the ethical review of Protocols and ensuring compliance with the approved Protocols. ACC Chairs have delegated authority for signature, on behalf of the University, of approved Protocols under their jurisdiction. ACC Chairs are responsible to the AVPR. The specific composition and detailed terms of reference of the ACCs are determined by the CAC and must accord with the requirements of the CCAC.

2.2.6 The E-subcommittee of the ACC is responsible for the ethical review of Protocols for "E" Category of Invasiveness and for recommending, through a written report, the approval, hold or denial of the Protocol to the ACC. The specific composition and detailed terms of reference of the "E" subcommittee are determined by the CAC and must accord with the requirements of the CCAC.

2.2.7 The Education Committee is responsible for the development and delivery of the education program as required by the CCAC. The specific composition and detailed terms of reference are determined by the CAC and must accord with the
requirements of the CCAC.

2.2.8 The Infrastructure Planning Committee is responsible for advising on Facility-related matters. The specific composition and detailed terms of reference are determined by the CAC.

2.2.9 Local Animal Users Committees (the "LAUCs"), where established, are responsible for providing the respective Dean/Director with advice relevant to the Facility under their jurisdiction. The specific composition and detailed terms of reference of the LAUCs are determined by the Dean/Director.

2.2.10 Veterinary Services Staff are responsible for the provision of veterinary and Animal health care and ensuring that Animal welfare needs are addressed; supporting and facilitating the research program; promoting the education of Animal Users; and ensuring compliance with Applicable Requirements.

2.2.11 Directors of Facilities are responsible for: the overall operations of the Facilities, in particular, for the acquisition, daily maintenance and care of Animals in the Facility; ensuring that an approved Protocol is in place before Animals are acquired; ensuring that the actual use does not exceed the number approved by the ACC; providing leadership and advice in the maintenance and planning of Facilities; acting as a resource person to Animal Users regarding new protocol development; and informing the Dean/Director/Vice-President of concerns that may arise in the discharge of his/her duties. Directors of Animal Facilities may vary in terms of reporting structure and title.

2.2.12 PIs are responsible for designing and carrying out their research, teaching or testing activities in accordance with the Applicable Requirements, which include: ensuring an approved Protocol is in place prior to initiation of work or acquisition of Animals; ensuring Protocols are adhered to; ensuring Research Personnel are appropriately trained; educating Research Personnel in the rationale for and implementation of Applicable Requirements; and ensuring that Research Personnel working under their supervision respect and observe Applicable Requirements.

2.2.13 Academic Staff Members with appropriate expertise are also expected to serve, as may be reasonably required, on the university's animal care and use committees including but not limited to the CAC, ACCs, LAUCs, and the Education Committee.

2.2.14 Research Personnel are responsible for carrying out the care and use of Animals in accordance with Applicable Requirements.

2.3 Protocol Review and Approval

2.3.1 Protocols containing A and B COI procedures are distributed for review to three members of the applicable ACC which must include a Clinical Veterinarian, a community representative, and one other ACC member. A copy of the Protocol is forwarded to the applicable ACC Chair. The status of the Protocol review is reported to the full ACC. Copies of all Protocols are available to all ACC members at any time upon request.

2.3.2 Protocols containing C and D COI procedures are distributed to the applicable ACC for review by the full committee at the scheduled ACC meeting.

2.3.3 Protocols containing E COI procedures are only approved by the ACC in exceptional cases and only on the recommendation of the E-subcommittee, which will submit a written report and recommendation to the ACC.

2.3.4 Following review, Protocols will be assigned a classification that either allows use to proceed or which requires additional input or modification prior to use proceeding. Protocols which allow use to proceed will be assigned one of the following classifications: approval; approval subject to; or provisional approval. Protocols which require additional input or modification prior to use proceeding will be assigned one of the following categories: conditional approval or hold. Protocols found to be ethically unacceptable, will be assigned a category of denied.

2.3.5 ACCs are responsible for ensuring that all proposed activities involving the use of Animals have been reviewed for scientific/instructional merit (refer to section 2.6).

2.3.6 An approved Protocol is not to be modified without the written approval of a Clinical Veterinarian and the Chair of the appropriate ACC. An amendment form must be completed by the Animal User when requesting such a modification.

2.3.7 Protocol approvals are valid for one year from the date approved.

2.3.8 Where an Academic Staff Member enters into a collaborative project with researchers at another CCAC approved institution (the "host institution") and the care and use of Animals occurs at the host institution, the following will apply:

2.3.8.1 Where the Academic Staff Member receives products from Animals but does not dictate or participate in the use, the Academic Staff Member is required to complete an Abbreviated Protocol for Minimal Animal Involvement.

2.3.8.2 Where the Academic Staff Member dictates or participates in collaborative research but is not the Lead Investigator (the "LI"), a copy of the approved Protocol from the host institution may be accepted by the ACC.

2.3.8.3 Where the Academic Staff Member is the LI on the project, a University of Manitoba Protocol must be completed even if a Protocol is approved at the host institution.

2.3.8.4 Where the Academic Staff Member is employed at another CCAC approved institution (the "home institution") and also has an academic appointment at the University of Manitoba (i.e., adjunct professorship, visiting scientist, or nil-salaried academic appointment), use of Animals undertaken at the Academic Staff Member's home institution does not require a University of Manitoba Protocol.

2.4 Education and Training

The Education Committee will develop an education program as required by the CCAC.

To ensure Animal Users are competent and thoroughly familiar with the Applicable Requirements, they must participate in the education and training stipulated and provided by the University.

2.4.1 PIs and Research Personnel are expected to complete the Animal User training course prior to initiating Animal use and to attend a refresher course every 5 years. PIs and Research Personnel are expected to complete wet labs as required. Requirements are based on experience, the procedures being performed, and requirements of the appropriate ACC. Wet labs are to be completed prior to Animal use being initiated where possible and, in all cases, before unsupervised Animal use is initiated.

2.4.2 Animal Facilities Staff must complete the Animal User training course. For newly appointed personnel, a grace period will normally be provided but will not extend beyond 3 months.

2.4.3 Veterinary Services Staff must complete the Animal User training course. For newly appointed personnel, a grace period will normally be provided but will not extend beyond 3 months.

2.5 Post Approval Monitoring

The ACCs, Veterinary Services Staff, Animal Facilities Staff and Animal Users currently are responsible for post approval monitoring. The process currently in place is as follows:

2.5.1 Information Acquisition

2.5.1.1 Procedures as described in Protocols to be subjected to post approval monitoring are flagged by the ACC during the Protocol review process and/or by Veterinary Services Staff at any time.

2.5.1.2 Animal Users inform Veterinary Services Staff when procedures that have been flagged for post approval monitoring will be initiated.

2.5.1.3 Facilities are responsible for informing Veterinary Services Staff when Animals have been ordered or requested.

2.5.1.4 Animal Users are responsible for informing Veterinary Services Staff of unexpected signs of pain, distress or mortality of Animals which occur during the Animal use.

2.5.1.5 Veterinary Services Staff are responsible for informing the ACCs of the results of post approval monitoring activities.

2.5.2 Monitoring

2.5.2.1 Veterinary Services Staff monitor flagged or invasive procedures during rounds or in specially arranged meetings.

2.5.2.2 When Animal Facilities Staff observe the use of procedures which are not approved in the Protocol, a report is made to the Director of the Facility and/or Veterinary Services Staff for immediate action. The Director of the Facility or Veterinary Services Staff will inform the ACC in a timely manner, usually at the next ACC meeting.

2.5.2.3 Records, such as surgical/anesthesia records and mortality data, are monitored by Veterinary Services Staff on a routine basis for indications of unexpected pain, distress or mortality.

2.5.2.4 The ACCs scrutinize Protocol renewals for indications of unexpected pain, distress or mortality.

2.5.3 Problem Solving

2.5.3.1 Unexpected pain, distress or mortality

2.5.3.1.1 In cases where information from direct communications, records or protocol renewals indicate procedures may be causing higher than expected levels of pain, distress or mortality, a Veterinarian (or designate) meets with the Animal User(s) to assess/rectify the problem.

2.5.3.2 Noncompliance

2.5.3.2.1 In the first instance of noncompliance, the ACC Chair or a Clinical Veterinarian meets with the Animal User(s). Education and assistance is the focus of this discussion.

2.5.3.2.2 In cases of repeated noncompliance or serious non- compliance, 2.10 Non-Compliance, is followed.

2.6 Peer Review

2.6.1 To ensure that use of Animals is undertaken only in necessary and valid projects, all projects must be evaluated for scientific or instructional merit. The majority of projects undergo peer review for scientific merit by the sponsor, e.g., proposals to national granting councils/agencies. In cases where the sponsor does not use adequate peer review to assess the quality of the proposed research, the proposal must be independently peer-reviewed and recommended, with documentary evidence of that review submitted to the ACC.

2.6.2 Deans/Directors of Faculties/Schools where Animal use is undertaken are responsible for establishing a mechanism for assessing the scientific/instructional merit of those projects that are not subject to recognized peer review by a sponsor, e.g., a national granting council/agency. The mechanism established must involve at least two persons capable of an independent and critical assessment of the proposed use. The mechanism for each Faculty must be approved by the SCAC.

2.7 Animal Acquisition, Housing and Disposal

2.7.1 An approved Protocol is required before Animals may be purchased, bred or otherwise brought into Facilities or Off-site Housing.

2.7.2 Arrangements for Animal acquisition and housing must be made in accordance with Facility requirements. The approval of a Protocol or the authorization of research funding is no guarantee that the University will be able to breed or acquire, house and care for the Animals specified. If, at the time the use is to be undertaken, the capacity of the Facilities is otherwise fully utilized, the use may have to be modified or rescheduled.

2.7.3 All Animals must be procured, transported and received according to CCAC Guidelines on: procurement of animals used in science. In order to comply with these guidelines, the following must be adhered to:

2.7.3.1 For Animals caught in the wild or donated to the University, the Clinical Veterinarian must receive prior notification and approve receipt of the Animals. All Animals that are wild and are acquired by the University must be obtained and transported in compliance with all applicable wildlife, transport of exotic biota and endangered biota regulations in the jurisdiction of origin, as well as in Canada and Manitoba.

2.7.3.2 Animals to be acquired through suppliers who are either new suppliers to the University or with whom the University has had prior problems, must be inspected by a Clinical Veterinarian or a designate preferably prior to shipping but before acceptance.

2.7.3.3 An Animal acquisition letter of agreement must accompany Animals upon arrival from sources which do not sell purpose bred Animals.

2.7.4 Animals must be housed in Facilities or at Off-site Housing which are inspected annually by an ACC and approved by the CAC and are in compliance with Applicable Requirements.

2.7.4.1 Off-site Housing is not normally allowed due to the difficulty of monitoring the health and welfare of Animals, husbandry practices, research procedures and Protocol adherence. Exceptions to this may be granted by the ACC if scientific justification is provided.

2.7.4.2 In cases where Off-site Housing has been approved, the Animal User must either: a) comply with requests from the ACC for information regarding the physical nature of the site, methods of Animal husbandry, handling and capture, housing and/or procedures and the Off-site Housing must agree to an inspection by the ACC when requested or; b) provide assurance that the site has a CCAC Good Animal Practice certificate or equivalent. If the Off-site Housing is outside of Canada, a description of the practices and or the name of the agency that assures Animal welfare may be required.

2.7.5 Wherever possible, all procedures on live Animals should be conducted in Facilities. The amount of time Animals are held in laboratories must be minimized and must not exceed 24 hours. Animals cannot be held outside Facilities without ACC approval. Laboratories in which live Animals are held must be inspected annually by the appropriate ACC.

2.7.6 All breeding colonies will normally be managed by the respective Animal Facilities Staff in order to manage breeding colony production, ensure transparency and maintain accurate Animal usage records.

2.7.6.1 The ACC may approve breeding colony management by an Animal User who provides adequate scientific justification. Normally, this would occur only when the breeding itself is an integral part of the research procedures.

2.8 Authority to Terminate Animal Use

2.8.1 Clinical Veterinarians and the DACUP have the authority to: stop any objectionable procedure if it is considered that 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 humanely kill an Animal if pain or distress caused to the Animal is not part of the approved Protocol and cannot be alleviated. Clinical Veterinarians also have the authority to treat, remove from a study or euthanize an Animal, if necessary.

2.8.2 In addition, ACC chairs, or their designates, in consultation with a Clinical Veterinarian or the DACUP, have the same authority as noted in 2.8.1.

2.9 Appeal of Protocol Review Decisions

2.9.1 An appeal of a decision to reject a Protocol shall be made to the DACUP.

2.9.2 The appellant and the ACC Chair will be invited to meet with the DACUP in order to either 1) resolve the outstanding issues or 2) clearly document the issues of disagreement between the ACC and the appellant.

2.9.3 If the ACC Chair and the appellant, in consultation with the DACUP, are unable to come to an acceptable resolution of the differences, the DACUP will refer the appeal, complete with the documented issues, to the SCAC Chair, who with the
advice and approval of the CAC, will establish a sub-committee of three members to hear the appeal and recommend to the SCAC.

2.9.4 In such cases, both the appellant and the Chair of the applicable ACC shall be given an opportunity to appear before the appeal sub-committee.

2.9.5 The decision of the CAC shall be final and binding.

2.10 Non-Compliance

2.10.1 Instances of non-compliance with the Policy or these Procedures shall be brought to the attention of the Chair of the appropriate ACC and the DACUP for documentation and resolution.

2.10.2 If a resolution is not reached or the problem recurs, the DACUP shall advise the Chair of the SCAC who shall attempt to obtain a satisfactory resolution through the appropriate Dean/Director.

2.10.3 Serious instances of noncompliance or repetitive breaches in Policy and Procedures shall be forwarded by the CAC Chair to the Vice-President (Academic) and Provost for disposition.

3.0 Accountability

3.1 The University Secretary is responsible for advising the Vice-President (Research) that a formal review of the procedures is required.

4.0 Review

4.1 Formal Procedure reviews will be conducted every ten (10) years. The next scheduled review date for these Procedures is December 7, 2021.

4.2 In the interim, this/these Procedure(s) may be revised or rescinded if:

(a) the Approving Body deems necessary; or
(b) the relevant Bylaw, Regulation(s) or Policy is revised or rescinded.

5.0 Effect on Previous Statements

5.1 This Procedure supersedes:

(a) all previous Board/Senate Procedures, and resolutions on the subject matter contained herein;
(b) all previous Administrative Procedures, and resolutions on the subject matter contained herein; and
(c) all previous Faculty/School Council Procedures stemming from the Faculty/School Council Bylaw and academic and admission Regulations and any resolutions on the subject matter contained herein.

6.0 Cross References

Animal Care and Use: Policy