RCR Framework Interpretations: Breaches of the fundamental principles, policies and guidelines of the Canadian Council on Animal Care

What process should the Institution’s designated point of contact for RCR matters (RCR contacts), the Animal Care Committee (ACC) and the institutional Senior Administrator follow when a concern arises with respect to a possible breach of the fundamental principles, policies or guidelines of the Canadian Council on Animal Care (CCAC)?

For ease of reading, the response to this question has been divided into sections.

  1. Introduction

    The majority of scientific activities using animals at CCAC certified institutions are conducted in accordance with the fundamental principles, policies and guidelines of the CCAC.

    Researchers have a responsibility to comply with CCAC’s fundamental principles, policies and guidelines and the failure to comply may constitute a breach of the Tri-Agency Framework: Responsible Conduct of Research (RCR Framework).

    When a concern arises of a potential breach, the RCR contact, the ACC and the institutional Senior Administrators must work together to ensure due process and address any animal welfare issues.

    This interpretation seeks to clarify the roles of the RCR contact, the ACC and the institutional Senior Administrators when responding to such concerns.

  2. What are the fundamental principles, policies and guidelines of the CCAC?

    At the heart of all CCAC principles, policies and guidelines is the fundamental requirement to treat animals used for research, teaching, and testing with the highest standards of care. Examples of policies and guidelines developed by the CCAC include certification of ethical animal care and use programs, general guidelines on animal care, procedures, and program management and various animal guidelines on species of interest.

    For more information on CCAC’s fundamental principles, policies and guidelines, please consult the Guidelines and Policies section on CCAC’s website and Section F below.

  3. Who is responsible for addressing an allegation that a researcher may have breached CCAC’s fundamental principles, policies or guidelines and the RCR Framework?

    The RCR contact, the ACC and the institutional Senior Administrator must work together when an allegation arises that a researcher may have breached the requirements of the fundamental principles, policies and guidelines of the CCAC and the RCR Framework. Addressing any animal welfare issues within an institution is a shared responsibility. Good communication between the RCR contact, the ACC and the institutional Senior Administrator is therefore essential.

    The RCR contact, the ACC and the institutional Senior Administrator should work together to develop procedures to determine when and which allegations can be handled by the ACC and which should be raised with the RCR contact to address in accordance with the institution’s policy on responsible conduct of research.

    If it is decided that an animal welfare issue should be addressed via the institution’s RCR policy, the RCR contact should ensure that an inquiry and, if necessary, an investigation, is carried out in a timely fashion and that animal welfare is protected throughout.

  4. Should all concerns related to compliance with the requirements of CCAC’s fundamental principles, policies and guidelines be addressed through the RCR process and involve the institution’s RCR contact?

    In certain situations, it may be possible for the institution’s ACC to directly address concerns without the involvement of the institution’s RCR contact, for example, an overdue annual report. The ACC and the RCR contact should discuss these situations on a case-by-case basis before determining how to proceed or, if they occur frequently, establish written procedures to address the most common situations.

  5. If it is decided that an animal welfare issue should be addressed via the institution’s RCR policy, what are the roles and responsibilities of the RCR contact, the ACC and the institutional Senior Administrator?

    • E.1. RCR contact-specific responsibilities
      If it is decided, as per part C of this interpretation, that an animal welfare issue will be addressed according to an institution’s RCR policy, then the RCR contact or their delegate is responsible for addressing the issue through an inquiry and/or investigation.

      In exceptional circumstances involving significant animal health, safety, or other risks, the relevant institutional officials (e.g., ACC Chair, Institutional Veterinarian, and/or institutional Senior Administrator), are responsible for determining whether any immediate action is necessary and for informing the RCR contact as soon as possible.

      The process of conducting an inquiry and, if needed, an investigation requires the Institution’s RCR contact to work closely with the ACC, interview relevant parties, assess the facts of the matter, and make a determination as to whether a breach of CCAC’s fundamental principles, policies and guidelines and the RCR Framework occurred.

      In the event that the inquiry and/or investigation confirms that a breach has occurred, the RCR contact, in collaboration with the relevant institutional officials, is responsible for: a) ensuring that measures for rectifying or mitigating the breach are carried out; b) imposing a recourse, if warranted, against those who were found to have committed a breach; c) informing the CCAC of any relevant information related to a breach that has impacted animal welfare, including any measures taken to mitigate the breach; and d) reporting to the Agencies, through the Secretariat on Responsible Conduct of Research, when Agency funds are involved.

      If the process confirms a breach, the RCR contact, in collaboration with institutional officials and with the advice of the ACC, if appropriate, must determine the actions to be taken. Examples of such actions include, but are not limited to:

      • requiring that additional measures be taken to minimize or mitigate harm to animals, if necessary; 
      • taking disciplinary action against those who committed the breach;
      • ensuring that measures to correct the research record are taken, if applicable;
      • requiring those who committed the breach, and possibly other parties at the Institution, to take further training in animal research ethics and RCR;
      • determining how to manage the data that was collected while the individual was in breach of the requirements of the CCAC program; and/or
      • informing the CCAC of any breach confirmed by an inquiry and/or investigation that have impacted animal welfare, including any measures taken to mitigate the breach.

      The institution through its RCR contact must also provide the ACC with any information that the ACC may require to fulfil its mandate under the CCAC program.

    • E.2. ACC-specific responsibilities
      When an animal welfare-related allegation is addressed in accordance with the RCR Framework, the ACC’s specific responsibilities may include:

      1. taking immediate measures to minimize or mitigate harm to animals, in consultation with the veterinarian, if appropriate;
      2. informing the RCR contact of the concern as soon as possible;
      3. jointly determining with the RCR contact whether it is appropriate for the concern to be addressed in accordance with the RCR Framework;
      4. if deemed appropriate for the concern to be addressed in accordance with the RCR Framework, collaborate with the RCR inquiry and/or investigation by:
        1. providing any relevant documents to the RCR contact or their delegate upon request;
        2. responding to questions posed by the RCR contact or their delegate; and/or
        3. providing advice on matters such as how to interpret the CCAC’s fundamental principles, policies and guidelines and appropriate measures for the protection of animal welfare.

      To avoid the perception of conflict of interest, neither the institutional Senior Administrator, nor ACC members nor the ACC Chair should sit on an institutional investigation committee for allegations relating to research that they or their ACC had a role in approving.

      The CCAC gives the ACC the authority and responsibility to approve, reject, propose modifications to, or terminate any research involving animals at the Institution. This responsibility is essential to safeguard animal welfare. If the research is still active when an allegation is raised, the ACC should decide independently, based on the information available to it through communication with the RCR contact, whether to suspend its approval of the research, or allow the research to continue during and even after the institution’s inquiry and/or investigation. The decision will depend on the nature of the allegation and whether the alleged breach has the potential to impact animal welfare.

    • E.3. Institutional Senior Administrator-specific responsibilities
      The institutional Senior Administrator is responsible for the local animal care and use program at the institution. This includes ensuring the Institution has a CCAC certificate of GAP – Good Animal Practice® in place, the ACC has the authority to carry out its mandate, and addressing any ACC concerns that cannot be addressed by the committee alone. The institutional Senior Administrator must also ensure that a mechanism is in place to address situations when researchers disagree with an ACC decision.

  6. What may constitute a breach of the requirements of the fundamental principles, policies and guidelines of the CCAC and therefore a breach of the RCR Framework?

    Possible breaches of the RCR Framework, as it relates to CCAC’s fundamental principles, policies or guidelines include, but are not limited to:

    • Initiating or conducting any work using animals under the auspices of an Institution without a CCAC certificate of GAP – Good Animal Practice®;
    • Initiating or conducting work using animals without ACC approved animal use protocol;
    • Interfering with or obstructing the work of the CCAC program; e.g., providing false information for CCAC assessments;
    • Circumventing, interfering, with or obstructing the work of the ACC;
    • Circumventing, interfering, with or obstructing the work of the attending veterinarian;
    • Conducting a procedure on an animal that is not described in an ACC-approved animal use protocol or any associated standard operating procedures;
    • Incomplete or inaccurate recordings of procedures/activities, including animal health issues, welfare assessment, animal training, mortality, etc.;
    • Allowing personnel (e.g., students, assistants) to independently undertake animal-based activities (e.g., procedures, training of animals) when they have not been evaluated to be competent to perform such activities without supervision; and/or
    • Inaccurate reporting of data to the ACC; e.g., not reporting all animals used or impacted by a study.

  7. Do ACCs have the authority to impose a recourse against a researcher?

    No. The ACC’s authority is with respect to the research itself. The ACC has the authority to suspend or terminate approval of a research project. It is the responsibility of the institution to impose recourse against a researcher, where warranted, and to ensure that researchers meet all requirements of the CCAC program including but not limited to training and competency.

  8. To what extent can an institution share information about RCR inquiries and/or investigations with the ACC and other parties?

    The institution has the responsibility and the discretion to determine what information may be shared about RCR inquiries and/or investigations (i.e. an investigation report) and with whom. Institutional decisions may depend on several factors including, but not limited to, the CCAC program requirements, relevant international, federal, and provincial/territorial legislation and policies, institutional policies, and the provisions of collective agreements.

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