Table of contents
Terms of reference for NRC's Animal Care Committees
The NRC Animal Care Committees (ACC) oversee the ethical treatment of experimental animals used in research at NRC. Each ACC strives to meet or exceed the expectations of the Canadian Council on Animal Care (CCAC).
1.1 The Canadian Council on Animal Care (CCAC) requires that institutions conducting animal based research, teaching or testing establish an animal care committee (ACC), and that it be functionally active. To meet these expectations and NRC's own ethical standards, the NRC's ACCs review and consider for approval the ethical acceptability of animal-use protocols. NRC's ACC's operations are governed by the CCAC Terms of Reference but are not limited to them.
These ACC's Terms of Reference have been tailored to reflect and refer to the NRC's animal care and use programs, and its policies, practices and procedures.
2.1 NRC's ACCs report directly to the Senior Administrator responsible for animal care and use for the institution; at NRC this would be a Director General (DG) or the Vice-President (VP). The CCAC policy statement on: senior administrators of animal care and use programs (2008) will be consulted for details on the roles and responsibilities of the institution and its senior administrators.
2.2 NRC employees who are considering research involving animal subjects are encouraged to contact their ACC at the earliest stage of protocol design. Research using animals must be approved in writing by the appropriate NRC ACC before any animals can be ordered or work can begin.
2.3 Animal research that is to take place off-site but involves NRC researchers still requires approval from an NRC ACC.
2.3.1 Research Centres, Branches or Programs that have research labs on the premises of another CCAC-accredited organization may, with their Senior Administrator's authorization, elect to fulfill their obligation of ACC review by having an NRC scientist sit on the host ACC or they may assemble a full committee at this "satellite" site, or another approach that ensures NRC standards are met.
2.4 Contract/service animal research that is performed in NRC animal facilities, but does not involve NRC researchers, still requires approval from an NRC ACC.
2.5 Animal research that receives NRC financial assistance, as through the NRC Industrial Research Assistance Program (NRC IRAP), can choose to rely on the review of a CCAC-accredited ACC functioning at the institution where the work is to be performed.
2.6 Animal research that is to take place off-site using NRC equipment but that does not involve NRC researchers does not require approval from an NRC ACC. In this situation, the Research Centre, Branch or Program that owns the equipment would need to receive written assurance, via the relevant animal care and use program, that those using the equipment have CCAC accreditation.
2.7 In the event that an animal facility is operated on leased NRC property, the Research Centre, Branch or Program's animal care and use program would need to receive written assurance that the animal users have CCAC accreditation. Only animal work involving NRC personnel would be reviewed by an NRC ACC, which would include representation from the organization operating the animal facility.
2.8 Research Centres, Branches or Programs that do not have an existing ACC may on occasion require the use of animals in their research. In such situations, the most appropriate NRC ACC will be asked, usually via the NRC Senior Veterinarian, to assist their colleagues by reviewing their applications.
3.1 Members, including Chairs, are appointed to the ACCs by the relevant Senior Administrator, in consultation with their ACC Chair, the NRC's Senior Ethics Officer and the Secretary General when appropriate. Prospective will normally provide their resume to ACC who in-turn will forward this to the senior administrator for their consideration.
3.2 ACC members will normally be appointed for terms of no less than two years and no more than four years (renewable once only up to a maximum of eight consecutive years, normally). This maximum should not be exceeded, except in the case of very small institutes (i.e. those that have 3 or fewer animal users). This does not apply to ACC members who must be part of the ACC because of their role within the institution (ex officio members): the ACC Coordinator, the veterinarian(s) and the animal facility manager/supervisor. The complement of the committees will vary and will be determined by the needs of each Research Centre, Branch, or Program but should include.
a) NRC researchers or Industrial Technology Advisors (ITA) experienced in animal care and use, who may or may not be actively using animals during their term on the ACC. There should be a minimum of two members and representation of all the major animal-using divisions of the Research Centre, Branch, or Program or, as in the case of NRC IRAP, the ACC should have appropriate regional representation;
b) A veterinarian experienced in experimental animal care and use, who is being provided with continuing education/training opportunities in experimental animal care and use (ex-officio, voting member);
c) The NRC's Senior Veterinarian to act as an observer and resource to the ACC and in to support the Senior Ethics Officer in corporate accountability on animal care. (ex-officio, non-voting member unless also serving the ACC veterinarian as described above). This member will participate, subject to operational requirements, via teleconference or videoconference;
d) An employee whose normal activities have not, at any point in their career, depended on or been involved with animal use for research, teaching or testing;
e) At least one person representing community interests and concerns, and who has no affiliation with the institution, and who has never been involved in animal use for research, teaching or testing (for larger committees, the appointment of two or more community representatives is generally more appropriate);
f) Manager /supervisor of the Research Centre, Branch or Program's animal research facility ex-officio, voting member); and
g) A technician actively involved in animal care and/or use within the Research Centre, Branch, or Program. In a small facility the technical staff position may be filled by the same person charged with managing/supervising the facility.
h) The ACC coordinator (the institutional employee who provides support to the ACC).
3.3 The senior administrator to whom the committee reports must not be a member of the ACC, but there can be a representative of the senior administration on the committee.
3.4 Normally, ACCs benefit from having occupational health and safety and biosafety representatives. As NRC IRAP does not house animals, this may not be applicable for this program. ACCs can also benefit from the presence of biostatisticians, ethicists and those responsible for communications.
3.5 The Chair should not be directly involved in the management of the Research Centre, Branch or Program animal facility, nor be the veterinarian, nor be involved in the preparation of a significant number of the protocols to be reviewed by the committee, in order to avoid potential conflicts of interest.
3.6 Provision should be made to invite other persons to participate on the ACC as the need arises.
3.7 A reasonable quorum, such as a majority of the members, will be established for ACC meetings, and the quorum must include community and veterinary representation. Normally, the Chair will be present at all meetings.
3.8 Meetings should be scheduled at times that are convenient for all members, including community representatives. Committee members shall not participate in the review of their own protocols or annual reviews.
4.1 The responsible Senior Administrators are ultimately responsible for ensuring that high ethical standards are in place in their animal care and use programs.
4.2 The ACC will have the authority, on behalf of the responsible Senior Administrator, to:
a) Require that amendments to approved protocols be submitted to the ACC and be approved before being implemented;
b) Stop any procedure if it considers that unnecessary distress or pain is being experienced by an animal;
c) Stop immediately any use of animals that deviates from the approved use, any non-approved procedure, or any procedure causing unforeseen pain or distress to animals; and
d) Require that an animal be euthanized if pain or distress caused to the animal cannot be alleviated.
4.3 The Chair of the ACC and the veterinarian(s) will have access at all times to all areas where animals are or may be held or used.
4.4 Each Research Centre, Program or Branch will establish procedures for post-approval monitoring of animal use protocols and will define the roles and responsibilities of the members of the animal care and use program in the monitoring process. The program will be formally captured in their policies and procedures manual.
4.5 The ACC is the body responsible for determining and working to correct breaches of compliance with approved animal use protocols and SOPs. Breaches of compliance that cannot be corrected by the ACC working with the concerned animal users and veterinary/animal care staff must be referred to the responsible Senior Administrator, which must inform all members of the animal care and use program about sanctions that will be taken by the administration in the event of serious breaches of compliance.
4.6 The ACC delegates to their veterinarian(s) the authority to treat, remove from a study or euthanize, if necessary, an animal according to the veterinarian's professional judgment. The veterinarian will attempt to contact the animal user whose animal is in poor condition before beginning any treatment that has not previously been agreed upon and will also attempt to contact the ACC Chair. But the veterinarian will have the authority to proceed with any necessary emergency measures, whether or not the animal user and ACC Chair are available. A written report should be sent by the veterinarian to the animal user and to the ACC following any such event.
4.7 The veterinarian and ACC may also choose to delegate certain responsibilities to one or more senior animal care staff member(s).
5. ACC responsibility
It is the responsibility of each NRC ACC to:
a) Ensure that no research or testing project or teaching program (including field studies) involving animals be commenced without prior ACC approval of a written animal use protocol; further to this, that no animals be acquired or used before such approval;
b) Ensure that no animals be held for display or breeding purposes, or for eventual use in research, teaching or testing projects, without prior ACC approval of a written animal use protocol, except where current CCAC guidelines provide for exemptions. The ACC should also be aware of other animal-based activities, such as commercial or recreational activities, within NRC Research Centre, Program or Branch, and work with the persons responsible for these activities to ensure that animal care and use is undertaken according to appropriate procedures;
c) Require all animal users to complete either an approved NRC - animal use protocol form, which contains the information currently required by the CCAC, or a comparable form that has the approval of the home ACC;
d) Ensure that, for research projects, a peer review of scientific merit is carried out; if the review is not carried out by an external, peer review agency, the ACC will require that it be obtained according to the CCACs policy statement for senior administrators responsible fand animal care and use programss The institution will work with the ACC to ensure that an appropriate mechanism for the peer review of scientific merit is in place. For protocols that fall under CCAC's Level E category of invasiveness procedures, at least one of the scientific reviewers must be external to NRC;
e) Review and assess all animal use protocols, with particular emphasis on the CCAC's Guide to the Care and Use of Experimental Animals the Ethics of Animal Investigation policy statement and the guidelines on: animal use protocol review as well as on all other CCAC guidelines and policy statements and, where necessary, require further supportive information from the investigator/teacher or meet with the investigator to ensure that all members of the committee understand the procedures to be used on the animal;
f) The committee will also ensure that all procedures comply with CCAC guidelines, and, if at variance with those guidelines, require justification for the variance on scientific grounds;
g) ACCs will discuss protocols and make decisions on them during full committee meetings, rather than through individual reviews, and will attempt to reach decisions by consensus;
h) In the absence of consensus a majority rule will be taken and the minority opinion(s) noted in the ACC meeting minutes;
i) An ACC may delegate the responsibility of interim approvals 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 chair of the ACC. However, such interim approvals must be subject to discussion and final approval at a full meeting of the committee. Interim approvals will only be used infrequently, and the interim review process, including exchanges between the ACC and protocol authors, will be documented and will then be subject to discussion and final approval at a full meeting of the committee;
j) Each ACC will define its protocol review process, with or without (a) protocol review subcommittee(s), in its Research Centre, Branch, or Program-specific Policy and Procedures Manual. This process will include, or refer to, clear instructions to protocol authors, to ensure that all animal users in how the ACC works, when it meets, how to fill out and submit a protocol form and what to expect after submission of the form;
k) 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;
l) Minor modifications, as defined by the ACC in their policies and procedures, will be approved, at a minimum, by the Chair of the ACC or a delegate;
m) Major modifications, as defined by the ACC in their policies and procedures, will be approved, by the entire committee;
n) For any major substantial changes to a protocol, require that a new one be submitted. ACCs will define, in writing, their own criteria as to what constitutes a major change to a protocol;
o) Ensure that animal users report any unanticipated problems or complications, as well as on the steps they have taken to address the problem(s), to the ACC;
p) Review all protocols annually, i.e., within a year of approving the project, and approve any modifications to a protocol before they are implemented; annual renewals will be approved by at least a scientist, a veterinarian and a community representative and will be brought to the attention of the full ACC for its information. The ACC may choose to use a shorter protocol renewal form, but no matter what form is used, all protocol renewals must emphasize:
i. the number of animals used in the preceding year;
ii. the number of animals needed for the year to come, with a justification;
iii. a brief progress report, describing any complications encountered relative to animal use (unpredicted outcomes, and any animal pain, distress or mortality), any amendments to the original protocol, and any progress made with respect to the Three Rs of replacement, reduction and refinement of animal use;
iv. a brief report on the adequacy of the endpoints for the protocol, and on any complications encountered or refinements made relative to protecting animals from pain, distress or mortality; and
v. any other changes from the original protocol.
q) Require the submission of a new protocol after a maximum of three consecutive renewals;
r) Document all ACC discussions and decisions in the committee minutes and on attachments to the protocol forms;
s) Ensure that all animal users have the opportunity to become familiar with the CCAC's Guide and Ethics statement and all other CCAC guidelines and policy statements, federal, provincial or municipal statutes that may apply, as well as the Research Centre, Branch, or Program requirements;
t) Ensure that all NRC staff involved in the animal research have completed the necessary training, as detailed in the CCAC guideline on "Institutional Animal User Training (1999)";Ensure that animal users update their protocols with any modifications they intend to make and have them approved;
u) Ensure that animal users report any unanticipated problems or complications, as well as on the steps they have taken to address the problem(s), to the ACC;
v) Ensure appropriate care of animals in all stages of their life and in all experimental situations. Veterinary care must be available. Formal arrangements will be made to obtain the services of a veterinarian, at least on a consultative basis, if they are not readily available within the institution. These formal arrangements must be based on the elements contained in the CALAM/ACMAL Standards of Veterinary Care of the Canadian Association for Laboratory Animal Medicine (2007), which define the roles and responsibilities of veterinarians involved in scientific animal care and use programs. The NRC Senior Veterinarian is also available for guidance but, if offsite, does not replace the requirement for local veterinary services;
w) Establish procedures, commensurate with current veterinary standards, to ensure that:
i. unnecessary pain or distress is avoided;
ii. anesthesia and analgesia are properly and effectively used; the only exception to this may be when agents must be withheld as a scientifically-justified requirement of the study, and that this has been approved by the ACC. Painful studies requiring exemption from the use of either anesthetics or analgesia must be subject to particular scrutiny, not only prior to approval, but also during the experiment;
iii. appropriate post-operative care is provided; and
iv. due consideration is given to animal welfare, including environmental enrichment.
x) Ensure that policies to provide for a system of animal care that will meet the needs of the institution are established and implemented, and include:
i. the requirement that all animal care and animal experimentation are conducted according to CCAC guidelines and policies, and to any federal, provincial, municipal and institutional regulations that may be in effect;
ii. 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 animal facilities, who should be a member of the ACC (see Section 1), and who should keep the other ACC members updated on the activities within the animal facilities. Special arrangements may be made for IRAP-supported research where it may be unnecessary for the person in charge of animal care and management to serve on the ACC;
iii. the training and qualifications of animal users and animal care personnel; animal users should receive appropriate training according to the CCAC guidelines on: institutional animal user training, 1999, either within the institution or through the programs of other institutions;
iv. an occupational health and safety program for those involved in animal care and use, in collaboration with the Research Centre, Branch or Program 's authorities on occupational health and safety, that will appropriately protect all those who may be affected by animal-based work, according to CCAC guidelines (see Chapter VIII of Volume 1 (2nd Edition, 1993) of the CCAC Guide or the most recent CCAC guidance on occupational health and safety);
v. standards of husbandry, facilities and equipment;
y) standard operating procedures for all activities and procedures that involve animals, including animal care and facility management SOPs (typically produced by the veterinary and animal care staff), and animal use SOPs (typically produced by animal users, in collaboration with veterinary/animal care staff as needed); the ACC should receive all SOPs and ensure that all necessary SOPs are produced and regularly reviewed;
z) procedures for euthanasia;
aa) Encourage the use of pilot studies with few animals when new approaches, methods or products are being tried, before approving new, large scale protocols. However, pilot projects will still need to undergo ACC review. A description of what constitutes a pilot study can be included in the Research Centre, Branch or Program's policy and procedure manual;
bb) In the case of projects involving proprietary or patentable research or testing insist on close monitoring of animals in order to respect the elements outlined;
cc) For level E category of invasiveness protocols as well as those thought to have a potentially high level of contention, such as the use of animals not typically used in the NRC's laboratories, the NRC's Senior Veterinarian will inform the responsible Senior NRC Communication Advisor and the NRC's Senior Ethics Officer. When it is deemed necessary, action will be taken to prepare an appropriate media communications plan.
dd) Principal Investigators seeking to appeal an ACC decision should bring this to the attention, in writing, to the responsible NRC Senior Administrator who will in turn strike an appropriate committee to review the ACC decision and the PI's concerns. Recommendations will be made to the Senior Administrator who will convey these recommendations to the ACC and ask that they review their decision.
6.1 Animal care committees will meet a minimum of twice per year or as often as necessary to fulfill their Terms of Reference and be satisfied that all animal use within their jurisdiction is in compliance with institutional, municipal, federal and provincial regulations, and CCAC guidelines. Minutes detailing ACC discussions, decisions and modifications to protocols will be produced for each meeting, and must be forwarded to the senior administrator responsible for animal care and use.
7. Site Visits
7.1 The ACC will visit the animal care facilities and areas in which animals are used, in order to better understand the work being conducted within the institution, to meet with those working in the animal facilities and animal use areas and discuss their needs, to monitor animal-based work according to approved protocols and SOPs, to assess any weaknesses in the facilities (ageing facilities, overcrowding, insufficient staffing and any other concerns) and to forward any recommendations or commendations to the person(s) responsible for the facilities and for animal use.
a) Visits of the animal facilities will be conducted at least once a year, and will be documented through the ACC minutes or written reports. Those responsible for the animal facilities will respond to any ACC recommendations in writing, and site visit reports should always be followed on jointly by the Senior Administrator and the ACC.
b) Each member of the ACC should participate in the annual facility visit(s)
c) More frequent ACC site visits will be made as necessary to follow up on any protocols that have raised significant concern during the protocol review process, or where problems have been encountered with a protocol being carried out in practice or with other aspects of animal facility operations; these visits will be carried out by the Chair of the ACC or delegate, accompanied or not by other members or animal care staff.
7.2 In situations where the animal work is performed off-site, including NRC-IRAP-supported projects, alternate arrangements will be made by the ACC to inspect the premises to ensure they conform to NRC standards.
The animal care committee
a) Will regularly review (at least every three years):
i. Its Policies and Procedures Manual in order to reflect the changing needs within the institution, the scientific community, the animal welfare community and society as a whole, and expand its Manual to meet the requirements of its Research Centre, Program, or Branch;
ii. the security of the animals and research facilities;
iii. standard operating procedures (SOP) and the research centre, branch or program's animal care and use policies and make these available to those involved in the animal research; and
iv. 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, and the procedures carried out by the ACC to conduct monitoring;
b) Will maintain liaison with the CCAC Secretariat, and inform the Secretariat of any changes to their program: to the Senior Administrator responsible for animal care and use, the chairperson of the ACC, or the veterinary or senior animal care personnel;
c) Will submit complete and accurate animal use information in the CCAC Animal Use Data Form (AUDF) format for all protocols annually (animal use information for each calendar year must be submitted by March 31 of the following year) and also in pre-assessment documentation;
d) Will develop a crisis management program for the animal facilities and for the animal care and use program, in conjunction with any general research centre, branch or program crisis management plan(s). This program will detail plans in the event of power outages (short and prolonged), work stoppages, fires, natural disasters, large chemical spills and other similar crises, and must include a communications plan for addressing public and media inquiries on issues related to animal use;
e) Should, from time to time, sponsor seminars or workshops on the use of animals in science and the ethics of animal experimentation, and encourage as many animal users, animal caregivers, students, ACC members and other interested parties to attend as possible;
f) Will seek to raise awareness about animal research within the organization in order to demonstrate the organization's efforts in promoting animal welfare and to allay concerns regarding animal experimentation;
g) Will be open to developing and maintaining communication with animal welfare organizations; and
h) Will be prepared to cope with concerns that may develop from time to time.
Approved by NRC's Senior Executive Committee on 25 June 2013
Resource: Corporate Governance Group, NRC-Secretary General's Office