CCAC Assessment Program

1. Introduction

   
   
   The humane care and use of animals should be the prime concern and responsibility of all those individuals using animals for research, teaching or testing.
   
   The Canadian Council on Animal Care (CCAC) was formed in 1968 to develop policies and ethical guidelines governing experimental animal care and use, and a meaningful program of surveillance of the care and use of these animals. The CCAC is an autonomous and independent body, primarily financed jointly by the Canadian Institutes of Health Research and the Natural Sciences and Engineering Research Council and partially financed by a system of cost recovery from government facilities and private institutions. The CCAC works with the scientific community to achieve optimal levels of animal care and to ensure responsible animal use, while at the same time being accountable to the Canadian public by providing accurate composite information on experimental animal care and use on a national basis.
   Surveillance of the care and use of research animals in Canada is achieved through the Assessment Program, a peer review system operated by the CCAC with the collaboration of the Canadian Federation of Humane Societies (CFHS).





2. Quality Assurance

   
   
   The primary objective of the CCAC Assessment Program is to provide quality assurance for the care and use of experimental animals on a national basis. Effective surveillance protects animals, promotes animal welfare and ensures the quality of science that uses animals. CCAC surveillance is accomplished by a volunteer peer review process with local oversight by institutional Animal Care Committees (ACCs) and based on peer written guidelines. The CCAC Assessment Program receives, and continues to depend on, the support, cooperation and good will of many individuals in educational institutions, private sector companies, government departments, and Canada's animal welfare community.
   
   The CCAC strives to ensure universal oversight of animal care and use in all institutions in Canada using animals for research, teaching, testing or other biological or medical purposes. The CCAC continues to work towards optimal standards for all experimental animal facilities in Canada and to foster awareness of and sensitivity to ethical animal care and use amongst Canadian animal users and caretakers.
   
   
   
   

3. Structure of the Assessment Program

   
   
   The Assessment Program involves professionals and volunteers who work together to ensure that all participating institutions, regardless of size or purpose, are assessed in a fair and consistent manner. The Program also ensures that institutions respond appropriately to recommendations to improve their animal care and use programs.




1. CCAC Secretariat

   
   
   The members of the CCAC Secretariat provide information and guidance on experimental animal care and use matters to institutions participating in CCAC programs. With regard to the Assessment Program, certain members have more specific duties:



• the Assessment Directors are responsible for scheduling, conducting and following up on assessment visits, and for selecting appropriate scientific members for assessment panels, in consultation with the Assessment Coordinator; community representatives on the panels are nominated by the CFHS.



• the Assessment Directors are responsible, in collaboration with the Assessment Coordinator, for the overall operation of the Program and for the timely production of assessment reports and responses to implementation reports made by assessed institutions.



• the Assessment Coordinator is responsible, in collaboration with the Assessment Directors, for the quality and consistency of all documents and communications produced by the Assessment Program, including all reports, correspondence and assessment policies and information bulletins.



2. Assessment Panel Members

   An assessment panel is usually composed of a veterinarian, at least one other scientific member and one community representative nominated by the CFHS, with an Assessment Director serving as an ex officio member. These peer review panels are constituted and function according to the CCAC Assessment Panel Policy (March 1999) and the Policy on Confidentiality of Assessment Information (March 1999).
   
   The scientific member(s) of an assessment panel is (are) chosen by an Assessment Director from a pool of individuals with experience and special knowledge in various aspects of experimental animal care and use. These individuals include: laboratory animal veterinarians and scientists; animal care specialists; research scientists from a wide variety of fields including agricultural, biological and health sciences; as well as specialists from other fields, when appropriate. They are selected, as much as possible, with reference to the nature of the research, teaching or testing at the institution to be assessed. The CFHS nominee is usually drawn from a member society in the local area of the institution to be visited. All panelists serve voluntarily and without remuneration except expenses.




3. CCAC Assessment Committee

   
   The Assessment Committee, a standing committee of the CCAC, is composed of at least four Council representatives, including one CFHS member. The Chair of Council, Vice-Chair of Council, Executive Director and Assessment Directors serve as ex officio members, with the Assessment Coordinator serving as liaison. The committee is responsible for providing an additional level of consistency and quality control in the Assessment Program by reviewing assessment reports and institutional responses to these reports. It also works towards improvements in the Assessment Program through new or revised CCAC policies. The CCAC status of an institution (see CCAC Policy on Compliance and Non-compliance, revised March 2000) is first proposed by the assessment panel that visited the institution and must then be approved by the Assessment Committee on behalf of the CCAC before being officially assigned.



4. Institutional Animal Care Committees

   
   The local animal care committee (ACC) is the keystone of the Canadian system (the word "care" is sometimes replaced by "care and use", "welfare", "ethics", etc., at the preference of the institution). This committee plays a pivotal role in all institutions using animals for research, teaching or testing.
   
   ACCs must be constituted and function according to formal Terms of Reference based on the CCAC Terms of Reference for Animal Care Committees (revised February 1997). The ACC, which must report directly to senior administrative levels within the institution, is responsible for ensuring that animal care and use procedures comply with CCAC guidelines.
   
   The committee is also responsible for the evaluation of animal use protocols to determine their ethical acceptability (see Section 3 of the Terms of Reference for Animal Care Committees). It is of utmost importance for ACCs to maintain a high profile within the institution, and to ensure that due consideration is given to the ethics of animal experimentation by all those involved. The ACC also must have the authority to stop any procedure or to have an animal killed humanely under certain circumstances (see Section 2 of the Terms of Reference for Animal Care Committees).




5. Assessments of Institutions

   1. What is Assessed?

      
      The composition, functioning and effectiveness of the ACC, and the appropriateness of animal care and use facilities, practices and procedures, are subject to regular review by CCAC assessment panels. Assessments are based on standards set forth in the following documents:
      
      
      • the CCAC Terms of Reference for Animal Care Committees (revised in February 1997);
      
      
      
      • the CCAC Guide to the Care and Use of Experimental Animals, Vol. 1, 2nd Edn., 1993 and Vol. 2, 1984;
      
      
      
      • the CCAC
        • guidelines on: animal use protocol review, 1997;
        • guidelines on: transgenic animals, 1997;
        • guidelines on: choosing an appropriate endpoint in experiments using animals for research, teaching and testing, 1998; and
        • guidelines on: institutional animal user training, 1998;
        
        
        
      • the Canadian Association for Laboratory Animal Medicine (CALAM) statement on Adequate Veterinary Care, 1990;
      
      
      
      • the Report of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, 1993;
      
      
      
      • the Livestock Codes of Practice of the Canadian Agri-Food Research Council;
      
      
      
      • the Laboratory Biosafety Guidelines of Health Canada, 2nd Edn., 1996;
      
      
      
      • any relevant additional guidelines or policies which have been approved by Council and distributed to CCAC constituents.
      
      
      

      Frequency and Nature of Visits

      
      An institution wishing to join the CCAC program may request an orientation visit, which is conducted by an Assessment Director in order to explain the CCAC program and to briefly assess the strengths and weaknesses of the institution's animal care and use practices. If the institution chooses to join the CCAC program, an initial visit may be undertaken by an Assessment Director, followed by an initial visit report with appropriate recommendations, before the institution becomes a full participant in the CCAC program.
      
      Full assessment visits of institutions are normally scheduled approximately every three years at a date that is mutually convenient for the institution and the Assessment Director. When an institution has been assigned a CCAC status of Compliance (see CCAC Policy on Compliance and Non-compliance) after each of two consecutive assessments, it will normally be placed on a five-year assessment cycle. Special visits to an institution by an Assessment Director, with or without panel members, may be undertaken between full assessments if conditions at an institution warrant it, or following a request by the institution. A special visit will be undertaken after three years for institutions placed on the five-year cycle to ensure that the five-year cycle continues to be appropriate.
   
   
   

   2. Assessment Visits

      
      
      1. Pre-assessment documentation
         
         Prior to an assessment visit, the institution is asked to provide each panel member with current information pertaining to:
      
      
      
      • administrative organization and the composition and functioning of the ACC;
      
      
      
      • animal care personnel;
      
      
      
      • animal facilities;
      
      
      
      • animal care practices; and
      
      
      
      • animal use.
      
      
      
      An annotated Checklist of Information to be Forwarded to Assessment Panel Members Prior to an Assessment Visit (September 1999) is sent to the institution before the visit.
      
      Institutions are asked to provide animal use information for assessments and on an annual basis for statistical purposes in the Animal Use Data Form format. The completed form should give an institutional list of the experimental animal use protocols, each with the species and numbers of animals used as well as the purpose of animal use, the Category of Invasiveness (Categories of Invasiveness in Animal Experiments, Appendix XV-B of Vol. 1, 2nd Edn., 1993 of the CCAC Guide) and a brief description/keywords of the procedures conducted on the animals. The information on the form permits assessment panel members to give notice of specific protocols that the panel may wish to examine in depth, and which may include direct discussion with individuals responsible for the protocol during the visit.
      
      
      2. Site visit of the institution
         
         As outlined in the Assessment Visit: Suggested Agenda (November 1998) document, each assessment site visit usually starts with a meeting (initial meeting) of the panel with the ACC and senior administrative personnel of the institution. At this time, the institution's animal care and use program is reviewed, and its implementation of previous CCAC recommendations discussed. Other topics covered during this meeting include functioning of the ACC, any significant changes in facilities, personnel or uses of animals and any other relevant issues as described in the Assessment Visit: Suggested Agenda.
         
         All areas which house or hold animals are visited, as are all areas in which procedures on animals are performed, e.g., surgical suites and laboratory testing areas. During these visits, panels wish to meet with as many animal users and caregivers as possible and specific procedures or techniques may be observed. During the site visit, the panel may be accompanied by (a) member(s) of the ACC, and other institutional representatives.
         
         Following the site visit, and an in camera meeting of the panel members, a meeting (final meeting) with the ACC and senior officials is convened. At this time the panel will emphasize any serious concerns and may request immediate appropriate action if a particular situation so warrants. If there are no serious concerns, a general outline of the panel's observations and of the recommendations, which will be formalized in the subsequent assessment report, is presented verbally at this time.
      
      
      

   3. Assessment Reports

      
      A detailed report of the assessment visit is prepared, including recommendations (see Definitions of Recommendations Made in CCAC Reports, revised September 1996), where necessary, to improve animal care and use to a standard in keeping with CCAC guidelines. The panel members prepare a preliminary report following the visit. A written report is then produced by the CCAC Secretariat, and is approved by the panel and Assessment Committee members prior to being forwarded to the senior administrative official of the institution within ten weeks of the assessment visit. The report and its contents are considered confidential by the CCAC; however, institutional official(s) may distribute copies at their discretion. If the assessment report is to be released publicly in whole or in part, the CCAC must receive prior written notification (as explained in the Policy on Confidentiality of Assessment Information).
   
   
   

   4. Implementation Reports

      
      The institution must submit an implementation report or reports to address the recommendations expressed in its assessment report. Time lines for responses to any Major recommendations are specified when the recommendations are forwarded to the institution. A response to any Serious recommendations must be sent to the CCAC within three months of receipt of the assessment report. A response to Regular recommendations must be sent within six months.
      
      Implementation reports are reviewed by the assessment panel and Assessment Committee members. Their findings are used to assign a CCAC status to the institution. An institution that fails to submit its implementation report(s) may compromise its status.
   
   

6. CCAC Statuses and the Certificate of GAP - Good Animal Practice^®

   
   
   There are four CCAC statuses: Compliance, Conditional Compliance, Probation and Non-compliance. These are defined in the CCAC Policy on Compliance and Non-compliance. Institutions which have been assigned a status of Compliance or Conditional Compliance will receive a CCAC Certificate of Good Animal Practice^® to recognize their efforts in maintaining a quality animal care and use program.
   
   The major research funding agencies in Canada require grantees and their institutions to comply with CCAC guidelines. As stated in the Medical Research Council/Natural Sciences and Engineering Research Council Policy on Non-compliance, continued failure to do so may result in a loss of research grants to the institution.
   
   In addition, contractors performing work for the federal government are required to adhere to CCAC guidelines, as specified in the Public Works and Government Services Canada (PWGSC) Standard Acquisition Clauses and Conditions Manual, Section 5, Subsection A, Clause A9015C: Experimental Animals.

revised March 2000