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NSW Government
Animal Ethics Infolink
A NSW Department of Primary Industries and Animal Research Review Panel initiative

Independent external reviews

The Australian code for the care and use of animals for scientific purposes (the Code) requires that all institutions ensure an Independent External Review is conducted every four years. This provides an opportunity for institutions to reflect on, and improve, their processes.

Section 6 of the Code states the following:

Independent external review assists institutions to assess whether the procedures they have established meet the goals set out in the Code, and provides assurance that the institution, through its animal ethics committee (AEC), is delivering effective oversight of the care and use of the animals in its charge. The process should be educational and provide an opportunity for self-assessment so that members of the AEC and those at the institution who have responsibilities for animal care and use are involved in achieving the desired outcomes.

The Code further specifies that an independent external review must be conducted to: “...assess the institution’s compliance with the Code, and to ensure the continued suitability, adequacy and effectiveness of its procedures to meet its responsibilities under the Code.”

Find out more about:

Conducting an independent external review

Institutions and review panels are free to develop their own processes, templates and checklists for the review, provided they comply with the Australian code for the care and use of animals for scientific purposes (the Code).

The NSW Department of Primary Industries (the Department) and Animal Research Review Panel Inspection Guidelines may be helpful in planning the review.

A template is available for use, but its use is not mandatory.

Review panel

Clause 6.2(1) of the Code requires members of the review panel to be:

  • External people who are independent of the establishment and its activities, and
  • Appropriately qualified and/or experienced (relevant to the activities of the establishment).

Reviewers should therefore not be involved currently or previously in any of the design, implementation or maintenance of the research facilities, animals, procedures or activities being reviewed.

The Department also recommends that the review panel:

  • Does not include any disqualified individuals (in accordance with the definition in section 17 of the Animal Research Act 1985),
  • Is made up of a sufficient number of reviewers to effectively assess the institution,
  • Has a strong understanding and awareness of the type of animal research activities being conducted at the institution,
  • Has experience in interpreting and applying the Code, and
  • Has experience in conducting reviews, assessments and/or audits of procedures.

Examples of suitable reviewers could include veterinary practitioners, people with experience in arranging and conducting animal research, governance staff and/or animal welfare officers from other institutions, professional auditors, current or former members of other animal ethics committees (AECs), or representatives of animal welfare organisations.

The Department is unable to assist institutions in locating or selecting a review panel. Institutions could consider contacting industry groups, animal research special interest groups, other institutions conducting animal research, veterinarians or animal welfare organisations.

Conflicts of interest

The Code requires institutions to have procedures and measures in place to ensure the review panel’s independence. Reviewers must declare any actual, potential or perceived interests.
Where a conflict of interest is identified, the institution must consider if the review panel remains sufficiently independent to complete the review, and where appropriate, put measures in place to manage the conflict of interest.

Scope

The review panel should evaluate all processes and people involved in the care and use of animals for scientific purposes for their compliance with the Code and NSW legislation. Institutions must ensure that the review panel has the necessary authority and resources to conduct the review. This includes access to people, information, records and premises, and the provision of reasonable assistance.

Clause 6.6 of the Code recommends that the review covers all activities, including projects, that involve the use and care of animals for scientific purpose including:

  • The application of the governing principles of the Code\
  • The resourcing and effectiveness of the establishment to promote and monitor compliance
  • The ability of the animal research program to be subject to ethical review, approval and monitoring by an AEC
  • The adequacy of support, resources and educational programs for the AEC and the establishment’s staff to meet its obligations of the Code
  • Effectiveness of the monitoring of the wellbeing of animals
  • Management of facilities used to house animals to support and safeguard animal wellbeing
  • The training and competency of all people involved in the care and use of animals for scientific purposes
  • The membership and functioning of the AEC
  • Record-keeping – including applications and reports provided to the AEC, and monitoring records

Report

The review panel must produce a report that documents the findings and recommendations from the review. The report should be shared widely within the institution, and the institution should consider publishing a summary of the report.

A template is available for use, but its use is not mandatory.

Response to the report

Timely action must be taken to address any recommendations made in the report. A written response to the report should therefore be prepared by the institution, outlining when and how each recommendation will be implemented, or justifying why it will not be. The response and implementation plan should also be shared within the institution.

Exemptions

The NSW Department of Primary Industries (the Department) will allow exemptions from the requirement of the Australian code for the care and use of animals for scientific purposes (the Code) for an independent external review in some situations. An exemption may apply if the activities of the institution meet certain criteria, or if a regulatory inspection of sufficient scope has been conducted.

Activities of the institution

If the institution meets both of the following criteria, it will be exempt from carrying out an independent external review:

  1. The institution is overseen by an external animal ethics committee
    An external animal ethics committee (AEC) is considered an AEC operated by another institution or entity, such as the Secretary’s AEC.
  2. The institution does not operate any facilities to house any animals in NSW for use and/or supply in connection with animal research
    This applies if the institution:
    - Exclusively carries out field research in NSW,
    - Only houses animals in NSW at facilities that are operated by another institution that is also an accredited research establishment or licensed animal supplier with the Department and/or
    - Operates primarily as a veterinary hospital, with any animals kept for research purposes being owned by an individual and held only on a short-term basis at the facility with the owner's consent (e.g., for a veterinary clinical trial).

Inspections

Where an inspection is conducted by the Department, the inspector will advise if it can be considered to meet the independent external review requirements of section 6 of the Code. This will be determined by the inspector on a case-by-case basis.

Institutions should note that the Department’s animal research inspection program is risk-based. It is not scheduled to align with the necessary timing for an institution’s own review process and scheduled inspections can be subject to change if new priorities arise. Additionally, inspections may be targeted at aspects of an institution’s operations, and therefore may not be of sufficient scope to meet the Code’s requirements for independent external review.

Notifying the Department

Accreditation and licence applications

Institutions will be required to provide information to the NSW Department of Primary Industries (the Department) about their most recent independent external review during the application process for accreditation as a research establishment, or an animal supplier’s licence (Form R). This includes the renewal of licences and accreditations.

Institutions will be required to advise of the date the last review was conducted and attach both the review report and a summary of actions taken in response to the report.

Institutions who have not conducted an independent external review, or the last review was more than 4 years ago, will still be able to submit the form but will be required to explain why this is the case. The Animal Research Review Panel will then consider this information in assessing the application.

Inspections

Independent external review reports submitted with accreditation and licence applications may inform the risk-based prioritisation of the Department’s regulatory inspections.

Additionally, documents and records relating to independent external reviews may be assessed by inspectors appointed under the Animal Research Act 1985 during inspections.

Outside of these application and inspection processes, institutions are not required to notify the Department at the time an independent external review is completed.