- Approved by the Animal Research Review Panel: July 2021
- Page revised: July 2023
Purpose of the guidelines
The NSW Department of Primary Industries (the Department) is the regulatory body that oversees compliance with the Animal Research Act 1985 (the Act). The Act outlines a self-regulatory framework that also requires compliance with the Australian code for the care and use of animals for scientific purposes 8th edition 2013 (updated 2021) (the Code).
Inspections are one of the compliance activities conducted by the Department to ensure that institutions (including accredited animal research establishments and the holders of animal supplier’s licences) and animal research authority holders are complying with requirements of the Code and the Act, to verify the systems and procedures in place at institutions, and to protect the welfare of animals used in connection with research and teaching purposes.
These guidelines are to provide information on what can be expected during a planned regulatory inspection carried out by the Department and the Animal Research Review Panel (the Panel) under the Act.
These guidelines do not apply to independent external reviews that must be arranged by institutions in accordance with their obligations under the Code. However, they may be used to assist institutions and reviewers in informing the process and scope of an independent external review.
Scope of inspections
Inspections are designed to verify the existing processes for effective self-regulation under the Code and the Act. Where applicable, these processes should ensure:
- Effective operation of the Animal Ethics Committee (AEC) within legislative requirements,
- Effective communication between the AEC, animal users and administration in an institution,
- Necessary administrative and other support is being provided to the AEC to carry out its responsibilities,
- Investigators, researchers and animal care staff are complying with the requirements of the Code,
- Effective strategies are in place to promote and monitor the implementation of replacement, reduction and refinement (the 3Rs) within an institution,
- The wellbeing of animals is protected, and
- The facilities meet the requirements of the Code.
Inspections can range from full audits of institutions to being specifically targeted at aspects of operations (e.g. the functioning of the AEC or housing for particular animal species) or individual animal research authorities. This can depend on factors such as the reason for the inspection (e.g. routine inspection vs complaint investigation), the institution’s compliance history, and any current emerging issues.
For regulatory inspections, the inspection team will always consist of at least one inspector appointed under the Act, potentially accompanied by members of the Panel.
Inspectors are registered veterinarians who are appointed by the Secretary in accordance with section 49 of the Act. Inspectors have certain powers, including for entry and seizure, as outlined in section 50 of the Act.
Inspectors will always have proper identification which can be produced upon request.
Animal Research Review Panel
In accordance with section 10 of the Act, members of the Panel can accompany an inspector during an inspection.
Where members of the Panel attend an inspection, the inspector will carry an instrument in writing confirming that they are authorised to attend.
The Animal Research Act 1985 states:
- The Panel may at any time request the Secretary to cause an inspection to be made of the designated land of an accredited research establishment or of the designated land in relation to an animal research authority or animal supplier’s licence.
- The Panel may, by instrument in writing, authorise a member of the Panel to accompany an inspector during the conduct of an inspection referred to in subsection (1).
Disclosure of information
Section 56 of the Act prevents the disclosure of any information obtained in connection with the administration or execution of the Act, except in a limited set of circumstances. This means that all information provided to and collected by the inspection team will not be disclosed, except where authorised under the Act.
The Animal Research Act 1985 states:
- Disclosure of information
A person shall not disclose any information obtained in connection with the administration or execution of this Act unless that disclosure is made—
- with the consent of the person from whom the information was obtained,
- in connection with the administration or execution of this Act,
- for the purposes of any legal proceedings arising out of this Act or of any report of any such proceedings,
- in accordance with a requirement imposed under the Ombudsman Act 1974, or
- with other lawful excuse.
Before the inspection
Inspections are typically scheduled in advance but can also occur without notice. Where an inspection is scheduled in advance, an inspector will contact the institution to arrange an inspection date. Some inspections are scheduled to coincide with a meeting of the AEC.
The inspector will provide information on what to expect for the inspection, including the members of the inspection team, and will ask if there are any specific access restrictions or requests from the facility (e.g., biosecurity considerations).
The powers of inspectors under section 50 of the Act allow the inspector to require the production of documents relating to the conduct of animal research or the supply of animals for use in connection with animal research. Additionally, inspectors can examine these documents and take copies, notes or extracts from any document. These powers must be complied with while the inspector is on site at the designated land associated with any accredited research establishment, animal suppliers’ licence or animal research authority.
Inspectors may also request documentation prior to any site visit in order to assist in planning for the inspection. Inspectors may send a list of information and documents requested prior to a site visit, and this can include:
- AEC records (e.g., list of current members, minutes of meetings, terms of reference, operating procedures, inspection records)
- List of currently approved projects and the chief investigators for these
- Descriptions of animal holding facilities and locations
- Agenda papers for the AEC meeting to be attended by the inspection team
- Grievance/complaint procedures
- Emergency procedures
- General husbandry/care procedures
- List of AEC-approved standard operating procedures
- Documents relating to specific research projects (e.g., applications, reports, animal research authorities)
- Most recent annual report of the AEC to the institution
If the institution does not wish to provide these documents to the inspector before the site visit, then the inspector will request that these are compiled in hard copy by the institution to be provided while the inspector is on site at the designated land.
Inspection - site visit
The scope of site visits and inspections can vary depending on the nature of the institution’s activities and the compliance priorities of the Department. The criteria that institutions are inspected against includes the Act, the Animal Research Regulation 2021, the Code, and any additional conditions to which it is subject on its licence/accreditation.
Below are some common activities that can occur during an inspection.
Observing an AEC meeting
The inspection team may observe an AEC meeting to assess the functioning of the AEC in accordance with the requirements of the Code, including e.g., its decision-making, conflict of interest management, administrative support from the institution, and attendance and involvement of members. The inspection team will not contribute to decisions of the AEC during this meeting; however, they may provide feedback on particular agenda items or on the procedures of the committee as the meeting progresses.
If the meeting is being held via videoconferencing, the inspection team may also request to attend remotely.
Inspection of animal facilities
An inspection of animal holding areas and facilities where approved activities are carried out will typically also take place. During this process, the inspection team may review the wellbeing of the animals on site, assess monitoring records, question staff on their work and activities, review emergency procedures, and assess the state and appropriateness of any animal housing.
Exit meeting & feedback
Any serious non-compliance/s or concerns that are identified will be raised by the inspection team as soon as possible during the inspection. Additionally, the inspection team will aim to conduct an exit meeting with relevant staff of the institution to provide preliminary feedback and summarise the initial findings, while giving the institution the opportunity to provide any comments in response to these. The exit meeting may occur as part of the inspection team’s attendance at the AEC meeting, or may be arranged remotely (e.g., over the phone) depending on the circumstances of the inspection.
The inspector will complete a report following the inspection, which will be sent to the institution. The report may include, where relevant, the findings from a review of the institution’s documents before the site inspection. Inspection reports are completed electronically using a checklist.
The report will include any non-compliances identified and will outline corrective actions for these. Additionally, the report may include recommendations and other comments from the inspection team.
The report also includes an overall assessment of whether the inspection team considered the findings of the inspection to be acceptable, unacceptable, or marginal in terms of compliance and the number and severity of the corrective actions needed.
Response and corrective actions
Institutions are asked to provide a written response to the findings of the inspection addressing any corrective actions identified in the report. The response should also include a consideration of any recommendations made by the inspection team.
This response is typically expected within 30 days of the inspection report being provided; however, timeframes can be adjusted where appropriate. For example, serious areas of non-compliance impacting animal wellbeing may be required to be addressed immediately, while longer periods may be allowed for the full resolution of low-risk procedural issues. The inspector will advise of any variations to these timeframes where relevant.
Further correspondence may occur following the provision of the first response, and follow-up written responses may be requested where issues remain unresolved, or the Department or the Panel are not satisfied with the response. Follow-up inspections may also occur to verify compliance and the corrective actions taken.
Serious non-compliance or failure to take timely action in response to defects identified in an inspection report could lead to enforcement action being taken by the Department.
Animal Research Review Panel
All inspection reports and responses received are presented to the next scheduled meeting of the Panel. Comments and feedback from the Panel’s review of the report and response will be communicated to the institution.