ANIMAL CARE AND USE PROGRAM REVIEW FORM (for interim visits) SECTION 2. ANIMAL CARE COMMITTEE FUNCTIONING This section should be completed separately for each Animal Care Committee (ACC) and subcommittee responsible for animal care and use policies and/or protocol review, as identified in Section 1, question 114. Name of the animal care committee or subcommittee for which this section will be completed: The CCAC program requires that institutions conducting animal-based research, teaching, testing or production establish an ACC, and that it be functionally active. Each committee’s operations must be governed by formal Terms of Reference, based on the 2006 CCAC policy statement on: terms of reference for animal care committees. REPORTING LINE AND ACC COMPOSITION Please refer to the introductory section and section 1 of the 2006 CCAC policy statement on: terms of reference for animal care committees. 200. To whom does the ACC report? Name and Title (Dr., Mr., Ms., etc.): Position: Mailing address City, Prov., Postal Code Phone: , ( ) , - ext. Email: 201. If this person is not the senior administrator responsible for animal care and use for the entire institution, please explain the reporting structure: Program Review Form – Interim Visits Section 2 Page 1 CONFIDENTIAL 202. Have the Terms of Reference of the ACC been updated according to the 2006 CCAC policy statement on: terms of reference for animal care committees? Yes Yes and No No Please elaborate if your answer is "Yes and No" or "No": 204. Chair of the Animal Care Committee: Name and Title (Dr., Mr., Ms., etc.): Position: Mailing address City, Prov., Postal Code Phone: , ( ) , - ext. Email: 205. Are ACC members provided with orientation materials and training opportunities to better understand and fulfill their role? Yes Yes and No No Please specify: 213. Is there a specifically designated employee (or employees) of the institution with sufficient time and experience to provide active and effective support for all of the committee’s activities (often known as an ACC coordinator)? Yes Please provide the name(s) and qualifications of the person(s): Yes and No Please elaborate: No Please elaborate: Program Review Form – Interim Visits Section 2 Page 2 CONFIDENTIAL 214. Please indicate the services provided by the ACC coordinator(s): Organizing ACC activities (e.g. meetings, site visits) Contributing to the orientation/training of ACC members and providing relevant resources and information Receiving new animal use protocols, amendments and renewals and assisting protocol authors Producing ACC documentation (e.g. meeting minutes, site visit reports) Drafting of letters to animal users (e.g. letters on ACC decisions, protocol renewal reminders) Managing protocols, including renewals and amendments Contributing to the process of producing and updating ACC policies, forms and other documents Contributing to the institutional post-approval monitoring process Contributing to the process of producing and updating standard operating procedures (SOPs) Tracking the training of animal users Other services – please specify: AUTHORITY The authority of the ACC is defined in section 2 of the 2006 CCAC policy statement on: terms of reference for animal care committees. The ACC must be satisfied that all animal use within its jurisdiction is in compliance with institutional policies, CCAC guidelines and policies and municipal, provincial and federal regulations. 217. Has the ACC encountered any difficulties in exercising its authority? Yes Yes and No No Please elaborate if your answer is "Yes" or "Yes and No": RESPONSIBILITIES The responsibilities of the ACC are defined in sections 3, 4 and 5 of the 2006 CCAC policy statement on: terms of Program Review Form – Interim Visits Section 2 Page 3 CONFIDENTIAL reference for animal care committees. Meetings Please refer to section 4 of the 2006 CCAC policy statement on: terms of reference for animal care committees. 220. How often has the ACC met in formal, minuted meetings in the past three years? 221. Please provide the dates of the meetings held in the past 12 months (year/month): Site Visits 223. a) Does your institution have an animal facility or facilities? Yes No If yes, is all animal care and use undertaken within purpose-built animal facilities, or appropriate outdoor areas (as opposed to laboratories or other research, teaching or testing areas)? Yes No b) If there are animals that are used or housed in laboratories or other research, teaching or testing areas, please indicate how many such areas exist and summarize the types of animal use and housing that take place in them. c) Are there any institutional policies or procedures governing animal use and housing in laboratories or other research, teaching or testing areas, or governing animal transfer between animal facilities and research/teaching/testing areas? Yes No If yes, please append any relevant documents as Appendix 2I. 224. Are all of the facilities (purpose-built animal facilities and laboratories and other research/teaching/testing areas) where animals are housed or used visited, at least once a year, by at least some of the ACC members? Yes Program Review Form – Interim Visits Yes and No Section 2 No Page 4 CONFIDENTIAL Please elaborate if your answer is "Yes and No" or "No": Protocol Review Each ACC has an ethical, scientific, and social responsibility to apply protocol review and approval criteria in a fair, equitable and consistent manner. This requires the provision of complete and appropriate information by the protocol author. All aspects of the review process, including protocol approval status, amendments, clarifications, modifications, and renewals must be documented, regardless of the category of invasiveness. The protocol review process must be consistent with the CCAC guidelines on: animal use protocol review, section 3 of the 2006 CCAC policy statement on: terms of reference for animal care committees and the CCAC policy statement on: animal-based projects involving two or more institutions. Ethical Review Process 229. Provide an indication of how many new protocols are approved and how many protocols are renewed on a yearly basis: 231. Briefly describe the steps involved in the review and approval of protocols. If more than one committee is involved, please indicate this clearly: 238. Do all annual renewals include the following elements (section 3g of the 2006 CCAC policy statement on: terms of reference for animal care committees)? The number of animals used in the preceding year; The number of animals needed for the year to come, with a justification; A brief progress report, describing any complications encountered relative to animal use, any amendments to the original protocol, and any progress made with respect to the Three Rs of replacement, reduction and refinement of animal use; A brief report on the adequacy of the endpoints for the protocol, an on any complications encountered or refinements made relative to protecting animals from pain, distress or mortality; Any other changes from the original protocol. Yes Yes and No No Please elaborate if your answer is "Yes and No" or "No": Program Review Form – Interim Visits Section 2 Page 5 CONFIDENTIAL 241. Does the ACC approve any amendment to a protocol before it is implemented and, for any major amendments to a protocol, require that a new protocol be submitted? Yes Yes and No No Please elaborate if your answer is "Yes and No" or "No": 242. Are protocols ever approved on an interim basis? Yes 247. No Are there any animal-based collaborations with other groups or institutions? Yes Yes and No No Please elaborate if your answer is “Yes” or "Yes and No", and describe what the ACC does in these cases: 248. Are pilot studies that use small numbers of animals encouraged in the development of new methods, approaches or products? Yes - Approximately what percentage of the protocols reviewed by this ACC are pilot studies? % Yes and No No Please elaborate if your answer is "Yes and No" or "No": 249. Describe the process used to review, approve and follow up on these studies, and provide one or two examples: Peer Review of the Scientific Merit of Research Projects Research projects involving the use of animals should be peer-reviewed for their scientific merit according to the CCAC policy statement for: senior administrators responsible for animal care and use programs, the 2006 CCAC policy statement on: terms of reference for animal care committees and the Program Review Form – Interim Visits Section 2 Page 6 CONFIDENTIAL CCAC policy statement on: the importance of independent peer review of the scientific merit of animalbased research projects. 252. Is any animal-based research undertaken by the institution? Yes 253. No Does the ACC always check, working with the institution’s research administration, that a research project has been found to have scientific merit by independent expert peers before a protocol is given final approval? Yes Yes and No No Please elaborate if your answer is "Yes and No" or "No": Review of the Pedagogical Merit of Teaching Projects Teaching projects involving the use of animals should be reviewed for their pedagogical merit (see the CCAC policy statement for: senior administrators responsible for animal care and use programs, and section 3c)vii) of the 2006 CCAC policy statement on: terms of reference for animal care committees). 259. Is any animal-based teaching undertaken by the institution? Yes 260. No Describe the process used to evaluate the pedagogical merit of animal-based teaching, including any reviews or recommendations from outside agencies (provincial ministries of education, Canadian Veterinary Medical Association or other professional associations), institutional/departmental course or curriculum reviews, and the role of the ACC. Review of the Regulatory Requirements for Testing Projects Regulatory testing projects involving the use of animals should be reviewed based on the current relevant regulatory framework (see the CCAC policy statement for: senior administrators responsible for animal care and use programs, and section 3c)viii) of the 2006 CCAC policy statement on: terms of reference for animal care committees). 261. Is any animal-based regulatory testing undertaken by the institution? Yes Program Review Form – Interim Visits No Section 2 Page 7 CONFIDENTIAL 262. Describe the process used to check on current regulatory requirements, and provide examples of any exchanges with regulators on replacing, reducing or refining animal use in tests. Review of Policies, Guidelines & Standard Operating Procedures (SOPs) Please refer to sections 3m and 5a of the 2006 CCAC policy statement on: terms of reference for animal care committees. 265. How often does the ACC review institutional policies on animal care and use? Procedures for Monitoring Animal Care & Use – Post-Approval Monitoring To ensure that protocols are undertaken in practice as approved in principle by the ACC, each institution must establish procedures for post-approval monitoring of animal use protocols and define the roles, responsibilities and lines of communication of the members of the animal care and use program in the monitoring process. Please refer to the CCAC policy statement for: senior administrators responsible for animal care and use programs and sections 2 and 5a) of the 2006 CCAC policy statement on: terms of reference for animal care committees. 269. Describe how the ACC ensures that animals are only acquired/used for ACC-approved protocols, and that the numbers of animals acquired do not exceed the numbers approved by the ACC: 270. a) Describe how the ACC monitors animal care and use in the institution on an ongoing basis, and in particular what mechanism(s) is (are) in place for monitoring protocols to ensure that they are undertaken in practice as approved in principle (post-approval monitoring): b) Is this mechanism defined in the Terms of Reference or in an appended document? Yes Yes and No No Please elaborate if your answer is "Yes and No" or "No": 271. Describe the way in which animal health or welfare concerns are recorded by animal care staff and reported to the veterinarian (append an animal incident report or similar forms as Appendix 2J), and how this information is then conveyed to the ACC, as appropriate. Program Review Form – Interim Visits Section 2 Page 8 CONFIDENTIAL 273. Comments or additional information: APPENDICES Please provide the following appendices and use the checklist to indicate that they have in fact been included. If you are not including one or more of the requested appendices, please briefly explain why for each. Appendix 2A: A list of all ACC members, clearly indicating the name and title of each member, their affiliation and their role on the ACC. Identify ex officio members by an asterisk (*). Appendix 2B: A copy of the Terms of Reference of each animal care committee and subcommittee, with an indication of the last revision date. Appendix 2C: The minutes of the last two meetings of each animal care committee, as well as other examples of minutes, if needed, to provide good examples of protocol review discussions and of other ACC work. Appendix 2D: A copy of the document describing the animal use protocol review process, including interim approval process, if separate from the Terms of Reference. N/A Appendix 2E: A copy of the document describing the process for the peer review of the scientific merit of research projects which have been subjected to little or no peer review, if applicable, and if separate from the Terms of Reference. N/A Appendix 2F: A copy of the peer review form used for research projects, which have not been reviewed by agencies employing peer review, if applicable. N/A Appendix 2G: A list of all standard operating procedures (titles only). Please highlight the standard operating procedures developed or revised since the last CCAC visit. Appendix 2H: The list of all protocols for the past two years, presented in the format of the CCAC Animal Use Data Form (AUDF). All data must be included. Appendix 2I: A copy of any institutional policies or procedures governing animal use and housing in laboratories or other research, teaching or testing areas, or governing animal transfer between animal facilities and research/teaching/testing areas. N/A Appendix 2J: A copy of an animal incident report or similar forms used to record any animal health or welfare concerns. Additional Appendices (specify): Program Review Form – Interim Visits Section 2 Page 9 CONFIDENTIAL Please explain if you are excluding any of the requested appendices: Program Review Form – Interim Visits Section 2 Page 10 CONFIDENTIAL