Senate Agenda - EXHIBIT V - December 10, 1999



1. 1998 Annual Report

The 1998 Annual Report to Senate from the University Council on Animal Care is attached as Appendix 1 (unavailable in electronic form on the Web.)

2. Revised Protocol Form

Appendix 2 (shown below) was approved by the University Council on Animal Care. Revisions to the Protocol Form include the following changes to Section B:

Senate Agenda, December 10, 1999 - EXHIBIT V, Appendix 2



A. Introduction

The University Council on Animal Care (UCAC) is responsible to Senate for all aspects of procurement, maintenance, and the use of animals in research, teaching or testing. The UCAC shall ensure adequate review according to the procedures in this document.

All applications for the use of animals will be reviewed by the Animal Use Subcommittee (AUS). Appeals of decisions of AUS are made directly to UCAC.

Review of applications will ensure that procedures are in accord with the regulations of the Animals for Research Act (Ontario) and the guidelines of the Canadian Council on Animal Care (CCAC) particularly those contained in the "Ethics of Animal Experimentation" document.

The procedures described here apply to all instances of research, teaching or testing involving vertebrate animals performed at The University of Western Ontario, its affiliated hospitals and research institutes, to field research that involves more than simple observation (e.g., trapping, artificial provisioning, etc.) and to University faculty members carrying out research as principal investigators at another institution or field station.

Failure to comply with these procedures will result in not receiving approval for the project by the UCAC. As warranted by the severity of circumstances, this may also include revoking of University approval for research and teaching involving animals and notification of this decision to Department Chairs, Institute Heads, as well as appropriate granting and licensing agencies.

B. Procedures

1. The researcher or instructor must complete a UCAC "Application to Use Animals" form. Only a faculty member or Animal Care and Veterinary Services (ACVS) veterinarian may submit an application.

2. Meetings of AUS are scheduled so as to avoid unnecessary delays in processing of applications. However, applicants normally should allow 45 days for review. Studies may not commence nor can assurances be sent to granting agencies until approved by AUS and signed by the Director of Animal Care and Veterinary Services (DACVS) as Executive Officer of UCAC or the Chair of UCAC AUS or designate

3. AUS is obliged to examine not only animal use, care, procedures etc., but also the scientific rationale and contribution to knowledge of the proposed studies. Where it is not obvious that such a scientific peer review will not be provided by a peer review granting agency ies, two written peer reviews must be obtained from scientific peers within or outside the AUS; the investigator may suggest reviewers. Qualified reviewers may be selected from outside the UWO community.

The AUS will request external peer review for animal use protocol applications that are based on funded peer reviewed research only when the animal use is categorized at a level E of invasiveness according to CCAC guidelines or only when a majority of AUS members feel that the specifics of animal use have not been adequately justified or explained. Such review should be restricted to the scientific issues relating to animal use, including number of animals requested and procedures to be carried out and their relationship to the goals and objectives of the research program.

4. Studies will be approved for a period of one year or less. A maximum of three one-year renewals may be obtained after which time a new and complete UCAC protocol form must be submitted.

5. The individual researcher or instructor must inform AUS of any changes to approved studies by submitting a within-year-modification form (WYM). Where these involve significant changes in animal utilization or the direction of the research, new application forms must be reviewed according to the procedures outlined herein.

6. In exceptional circumstances, a feasibility study using up to 5 preparations (maximum of 10 animals for recipient/donor experiments), may be approved on the joint recommendation of the AUS chair and DACVS an AUS community member and an ACVS veterinarian. A complete application may not be submitted before completion of the feasibility study and the results must be included in the new application.

7. Pursuant to existing policy of the University and of the broader scientific community, the application should be considered the intellectual property of the researcher, available only for CONFIDENTIAL use by authorized reviewers and not for distribution.

8. No studies may commence, nor will assurances to funding agencies be forthcoming, until the entire review process is complete. Approval of studies is indicated ONLY by notification from the DACVS as Executive Officer of UCAC, or in the absence of the DACVS, a delegated veterinarian from ACVS Chair of AUS or delegate.

9. The University veterinary staff is responsible for the ongoing assessment of animal handling and care. Problems with animal handling and procedures will normally be resolved through consultation between the investigator and staff veterinarian.

In instances when an animal is in unnecessary distress or pain, or when an animal's welfare is jeopardized, the veterinary staff is charged, on behalf of UCAC, to take appropriate action to rectify the situation. Such action may include halting animal use. Any action taken will be after reasonable attempts to: a) inform the researcher of the action to be taken, and b) minimize loss of experimental data and research progress.

9.1 Where problems of animal handling or procedures continue, the DACVS and the AUS Chair will meet as soon as possible with the investigator to identify and discuss the specific problem(s). Any agreed plan to resolve the problem(s) will be documented at this meeting.

9.2 Where a resolution has not been achieved, or where problems of animal handling or procedures continue, the matter will be referred to the AUS and the investigator invited to the AUS meeting at which the matter will be discussed.

9.3 The investigator will be informed in writing of the decision of AUS which may include a recommendation to UCAC to withdraw approval for the project. Where such a recommendation is made, the DACVS as Executive Officer of UCAC will determine whether or not animal use may continue during any period of appeal.

10. The UCAC will serve as a board of inquiry in the event that a decision taken by the AUS is challenged by a member of faculty or the ACVS veterinarian and to consider complaints from the animal user research community regarding the operation of the AUS. Appeals of AUS decisions may be made to UCAC in writing, within 30 days of a decision. Appeals will be considered by a regular meeting of the UCAC and will be granted upon a two-thirds vote of the members in attendance. The applicant may seek external reviews in support of the appeal. When acting in this capacity as an appeals board, all non-voting members of UCAC who also sit on AUS (those being the Director of ACVS and the Chair of AUS) or their alternates, will absent themselves from Council's proceedings unless invited to present information related to the appeals.