Secretary's Animal Care & Ethics Committee

If your project involves animals and it meets the definition of “Animal Research” for “recognised research purposes” as defined by the Animal Research Act 1985, then Animal Ethics approval is likely to be required. If you are planning to use the Secretary’s ACEC and need assistance in determining whether or not you need ACEC approval for your project, contact secretary.acec@dpi.nsw.gov.au

Animal Research

The Act defines animal research as any procedure, test, experiment,  inquiry, investigation or study in connection with which an animal is used and, without limiting the generality of the foregoing, includes any procedure, test, experiment, inquiry, investigation or study in the course of which:

(a)  an animal is subjected to:

(i)  surgical, medical, psychological, biological, chemical or physical treatment,

(ii)  abnormal conditions of heat, cold, light, dark, confinement, noise, isolation or overcrowding,

(iii)  abnormal dietary conditions, or

(iv)  electric shock or radiation treatment, or

(b)  any material or substance is extracted or derived from the body of an animal.

Animal research does not include any procedure, test, experiment, inquiry, investigation or study which is carried out in the course of:

(c)  the administration of veterinary treatment to an animal for the purpose of protecting the welfare of the animal, or

(d)  the conduct of normal animal husbandry operations.

Recognised Research Purposes

The object of the Act is to protect the welfare of animals used in connection with research and authorisations provided under the Act are granted only for recognised research purposes. Recognised research purposes include purposes involving the use of animals for research, teaching, testing and the production of biological products.

Under the Act, a recognised research purpose means:

(a)  the purpose of acquiring, demonstrating or developing knowledge in the field of medical, veterinary, agricultural, behavioural or biological science,

(b)  the purpose of acquiring, demonstrating, exercising or developing techniques used in the practice of medical, veterinary, agricultural, behavioural or biological science,

(c)  the purpose of developing or testing substances intended for therapeutic use (within the meaning of the Therapeutic Goods Act 1989 of the Commonwealth), or

(d)  any purpose prescribed for the purposes of this paragraph.

Under the Act, corporations which use animals in research and teaching in NSW must apply to DPI Compliance Systems & Accreditation Programs for Accreditation as an Animal Research Establishment. This includes government organisations such as local councils and government departments conducting research within NSW.  Corporations are defined as businesses registered with ASIC and have an Australian Company Number (ACN). Please note that wildlife surveys are considered as animal research so if your business is conducting wildlife surveys and has an ACN, the business is required to be accredited under the Act.

Similarly, a person who supplies animals for use animals in research and teaching in NSW must apply to DPI Compliance Systems & Accreditation Programs for an Animal Supplier’s Licence. Please note that holders of Animal Supply Licences also need to apply to an Animal Ethics Committee (AEC) for approval to supervise their supply of animals for research purposes.

For further information on accreditation, please see the Animal Ethics Infolink or email bfs.admin@dpi.nsw.gov.au

The Secretary’s ACEC will only oversee projects for individuals or businesses that do not require accreditation under Division 2 of the Act or for small corporations which are accredited under the Act as an Animal Research Establishment and or are a Licenced Animal Supplier but do not have their own AEC.

The use of animals in research and teaching, such as field trials, product testing, the production of biological products, wildlife surveys, environmental studies, and observational studies of wildlife may only commence when an Animal Ethics Committee (AEC) has reviewed and approved an application to conduct research; the approval from the AEC has been received in writing and an Animal Research Authority (ARA) has been issued and received. Animal research in NSW can only be conducted under a current ARA.

Under the NSW Animal Research legislation:

• in order to conduct animal research in NSW, researchers must submit an application to an AEC for project approval prior to commencing research.
• the maximum time period for project approval is usually up to three years.
• an Animal Research Authority (ARA) is issued for a project once it has been approved by the AEC. Following receipt of the ARA by the researcher, the project may commence.
• the ARA lasts for maximum 12-month period under the NSW Animal Research legislation.
• an ARA can be renewed by providing an Annual Report for the project for AEC approval.
• the Annual Report must be submitted in time for the AEC to be able to review and approve it at a meeting scheduled prior to the project ARA expiry date. This allows the AEC to review the report and approve the project to continue for another 12 months and issue a new Authority before the expiry date.
• if you wish to continue a project after the 3-year period, you must submit a new application for the project.
• at the end of the project it is mandatory to submit a Final Report.

Difference between Animal Research Project Approval Period and Animal Research Authority approval period.

Animal Research Project Approval Period

In order to conduct animal research in NSW, including fauna surveys to determine presence and prevalence of fauna at locations, researchers must submit an application to an Animal Ethics Committee (AEC) for project approval prior to commencing research. If the AEC approves the project, it approves it for a certain period of time – usually 3 years.

Once the project has been approved by the AEC, an Animal Research Authority (ARA) is issued for a project. Following receipt of the ARA by the researcher, the project may commence.

During this project approval period, the researcher is required to submit annual reports prior to each anniversary of the project approval date.

At the end of this project approval period, if the researcher wishes to continue to the project, they need to submit a new project application form to the AEC for approval.

If the researcher does not want to continue the project at or before the end of the project approval period a final report must be submitted to the AEC.

Animal Research Authority Approval Period

The Animal Research Authority (ARA) is the legal document which gives authority for animal research to occur under the NSW Animal Research Act 1985. It certifies an Animal Ethics Committee has approved the project and the procedures described in the project application. Only those people named on an ARA can undertake the procedures approved in the project. Only procedures that have been approved in the project application can be carried out under this Authority,

Under the animal research legislation ARAs remain in force for a maximum 12 months and are only reissued for another 12 months following AEC approval of an annual report. Annual reports provide details of activities undertaken during the Animal Research Authority approval period.

The Annual Report must be submitted in time for the AEC to be able to review and approve it at a meeting scheduled prior to the project ARA expiry date. This allows the AEC to review the report and approve the project to continue for another 12 months and issue a new Authority before the expiry date.

Late submission of annual reports will result in gaps in approval dates as Animal Research Authorities are not back dated.

If an annual report is not submitted within 3 months of the due date, it is assumed the researcher does not want to continue with the project and the project will be closed.

In summary – Projects are approved for 3 years, however, ARAs only last for 12 months. New annual ARAs are only reissued after the AEC has received, reviewed and approved the Annual Report for the project.

Note: It is an offence under the Act to conduct animal research or teaching without the possession of a current ARA.

See Figure 1 for details.

Figure 1. Approval Periods

If you have not used the Secretary’s ACEC before and would like to request they oversee a project that is being planned, please refer to the Guidance  for new researchers applying to use the Secretary's Animal Care and Ethics Committee webpage

In Summary, you must:

1. Contact the DPI Compliance Systems and Accreditation Program unit to see if your business needs to be accredited under the Animal Research Act 1985 to be able to lawfully conduct animal research within NSW. If you have an ACN, this will likely be the case.
   Please email bfs.admin@dpi.nsw.gov.au to check
2. Contact the Secretary’s ACEC to ask if they would be prepared to supervise the type of project you plan to undertake. Please complete the Secretary’s ACEC Access Application Form and email to secretary.acec@dpi.nsw.gov.au. Please note, this is not a project application form, it is a form requesting to use the Secretary’s ACEC. Please wait for a response to this application prior to submitting and paying for a project application.
3. If the ACEC agrees to consider your project application, complete and submit a signed Secretary’s ACEC Sharing agreement as required under the Australian code for the care and use of animals for research purposes 8^th Edition 2013, Section 2.6.
4. Submit a competed New Project Application Form via secretary.acec@dpi.nsw.gov.au
5. If you have not used the Secretary’s ACEC as a Principal Investigator previously you will need to provide a current CV and two written independent references from people you have worked with regarding your experience in the type of research/surveys you plan to undertake.
6. Pay the prescribed $100 fee, as explained in the application form, via the online portal https://forms.bfs.dpi.nsw.gov.au/forms/10678
7. The ACEC will then consider your application at a scheduled meeting, and if approved, an Animal Research Authority (ARA) will be issued for 12 months. You can then commence the project after you have received the ARA.

Please note- the Secretary's ACEC will only oversee projects that are being conducted in NSW.

Forms you will need to submit over the life cycle of a project

Please see the Secretary’s ACEC Forms section below to access the specific forms you need.

New project applications

• You must submit the relevant New Project Application Form, including online payment
• If it is your first time applying for a project under the Secretary’s ACEC, you will also need to submit:
  • A CV and two written independent references regarding your previous animal research experience and supporting your application.
  • A signed Secretary's ACEC Sharing agreement.

Annual renewal of Animal Research Authority

Animal Research Authorities only last for 12 months. In order to legally continue your project, each year throughout the project approval period, you must submit for a scheduled ACEC meeting prior to the Animal Research Authority expiry date:

• The relevant Annual Report Form, including online payment.

Project renewal at the end of the project approval period

If you wish to continue with an approved project after the project approval period expires, you must submit for a scheduled ACEC meeting prior to the Animal Research Authority expiry date:

• The relevant Final Report Form
• The relevant New Project Application Form, including online payment.

Project completion

After you finish your project, you must submit to the ACEC:

• A Final Report Form

An annual fee of $100 applies to each project. This payment is made when applying for a new project and when submitting an annual report for each project.

Fees for Authorities and Accreditations to allow research to be undertaken on animals under the Animal Research Act 1985 have been approved as exempt from GST. Division 81

Please pay via the online portal when you are about to submit your application. A receipt for your payment will be emailed to you. Please attach the receipt pdf to the email when you are sending your application.

Under the NSW Animal Research legislation, details of animal use in research and teaching must be submitted to the NSW DPI annually by all holders of Animal Research Authorities. The information is collected because it is required by law and is used by NSW DPI for administration of the Act and is stored securely within NSW DPI.

Collation and submission of this animal use information for projects approved by the Secretary’s ACEC is done by the ACEC on behalf of the Accredited Animal Research Establishments and independent researchers. However, the Principal Investigator of a project must include required information in their Project Applications and Annual and Final Project Reports.

Please refer to Guidance for researchers using the Secretary’s ACEC regarding reporting animals used in research annually.

For more information on animal use reporting in NSW, please refer to Form L on the Animal Ethics Infolink. Please note that researchers using the Secretary's ACEC do not need to complete and submit Form L -  this is done by the ACEC.

For projects involving wildlife, please visit National Parks and Wildlife to ensure the appropriate licenses and permits are obtained.

Animal Research collaborations between Contractors and Subcontractors.

Processes described below assist in reducing duplication and provide streamlined approach for collaborative contracted research activities.

Under the Australian code for the care and use of animals for research purposes 8^th Edition 2013 clauses 2.6.2 and 2.6.3, when an establishment or independent investigator seeks to access an external AEC, the use of the AEC must be based on a formal agreement.

If you wish to apply to use the Secretary’s ACEC for the first time to oversee an animal research project, please refer to the Guidance  for new researchers applying to use the Secretary's Animal Care and Ethics Committee webpage.

If you are eligible to use the ACEC, please complete the agreement form below and submit it along with your new application form.

Secretary’s ACEC Sharing Agreement

Which application form to use

Please use one of the forms below when applying for a new project.

The same forms are also used to apply to renew a project to continue for another 3 years at the end of its current 3 year approval period. Please remember if you are renewing a project at the end of its 3 year approval period to also submit a final report for the existing project approval period.

Fauna Surveys

Fauna Survey Project Application Form

Use this form when applying to do vertebrate wildlife fauna research that includes capture and non-capture techniques that may impact on the animal’s behaviour or health. This may include, but is not limited to activities such as:

• fauna surveys for environmental impact assessments
• conservation or threatened species assessments
• fauna monitoring programs
• ecological, biodiversity and distribution surveys
• pre-clearance surveys
• surveys prior to relocation
• radiotracking or tagging wildlife
• wildlife capture, measurement, sampling and/or banding
• camera trapping using white flash and/or lures
• spotlighting and other non-capture observation methods
• behavioural studies using wildlife.

Please note: Spotter catcher/relocation work is not considered animal research under the Animal Research Act 1985 and is does not require animal ethics committee approval. Surveys to determine presence of animals pre land clearance are animal research and requires animal ethics and ethics committee approval.

To assist in completing the Fauna Survey Application form, please refer to the Guide for completing the Secretary's ACEC Fauna Survey Application webpage

General Research

General Research Project Application Form

Use this form when conducting animal research using non-wildlife animals for recognised research purposes. This may include, but is not limited to:

• clinical trials
• therapeutic efficacy/safety trials
• food trials
• research testing biological parameters;
• animal behavioural research
• collection of biological products for commercial purposes.

If you are using  privately owned animals, please submit an owner information and consent form template that you will be using, along with your application. You can develop your own template or use the template below, adding the relevant details for the project.

Owner information and consent form template - General Research

Educational Activities

Educational Activities Project Application Form

Use this form when applying to use animals for the purpose of education/training. This may include, but is not limited to:

• ultrasound or dental education workshops
• animal handling courses
• basically, delivery of training of people using animals when this is not part of normal animal husbandry or required for veterinary management of the animal.

If you are using  privately owned animals, please submit an owner information and consent form template that you will be using, along with your application. You can develop your own template or use the template below, adding the relevant details for the project.

Owner information and consent form template - Educational activities

Animal Supply Supervision

Animal Supply Supervision Application Form

This form should be used by establishments wanting to apply for the Secretary’s ACEC to supervise their Animal Supply Licence in order to obtain, breed, keep and supply animals for use in connection with animal research.

For further information on the requirements and exemptions relating to animal supply please refer to the Animal Ethics Infolink.

Any proposed change to a project must be submitted to an ACEC for approval. This includes, but is not limited to changes to personnel, procedures, housing, transport and location, if a specific location has been approved in the project application. Please note that modifications must be approved by the ACEC prior to the changes being implemented.

• Project Modification Application Form
• Fauna Project Procedure Modification Application Form
• Fauna Project Procedure Modification Application Form including use of Drones

Please remember that although projects are generally approved for a 3 year period, Animal Research Authorities are only issued for maximum of 12 months at a time.

In order to be compliant with the NSW Animal Research legislation, Annual Reports must be submitted to the ACEC in time for the ACEC to be able to review and approve it at a meeting prior to the project Animal Research Authority expiring. Following ACEC approval of the report a new Animal Research Authority will be issued for the following 12 months.

Please remember that when you submit an Annual Report, you also need to pay the annual fee of $100 via the online portal below. A receipt will be emailed to you.

If you have a condition on your Animal Research Authority that you need to submit an Annual Register if you have had 'Other participants' or Subcontractors not listed on your current Animal Research Authority work on your project over the last 12 month reporting period, please complete and submit along with your Annual Report the relevant Annual Register of 'Other  Participants' Form.

• Online payment portal

Forms

• General Research Project Annual and Final Report Form
• Fauna Survey Project Annual and Final Report Form
• Educational Activities Project Annual and Final Report Form
• Annual Register of Other Participants and Subcontractors Form - Fauna Survey Projects
• Annual Register of Other Participants and Subcontractors Form - General Research and Educational Activities Projects

Establishments that use the Secretary’s ACEC to supervise their Animal Supply Licence in order to obtain, breed, keep and supply animals for use in connection with animal research must submit a report regarding activities under their ACEC approval on a 6 monthly basis. Reporting is required for the periods 1 January to 30 June and 1 July to 31 December each year.

Please use one of the below forms below for reporting to the ACEC.

• 6 Monthly Animal Supply Reporting Form
• 6 Monthly Animal Supply Reporting and Final Report Form

If your approved project has a condition that requires you to notify the ACEC of specific details prior to commencement of a survey, training course or research collaboration etc, please use one of the relevant forms below and submit to secretary.acec@dpi.nsw.gov.au

• Project Notification Form - General Research
• Project Notification Form - Terrestrial & Aquatic Fauna Surveys
• Project Notification Form - Terrestrial & Aquatic Fauna Surveys, including drones
• Project Notification Form - Educational Activities

Any unexpected adverse events that occur in an approved project must be reported to the ACEC as promptly as practicable.

Unexpected Adverse Events

What is an Unexpected Adverse Event?

The Code defines an Unexpected Adverse Event as: an event that may have a negative impact on the wellbeing of animals and was not foreshadowed in the approved project application.

The Secretary’s ACEC understands that adverse events may occur despite every attempt to mitigate their occurrence. They believe unintentional and unexpected are the same thing.  The ACEC will use a ‘common sense approach’ when reviewing adverse events.  When writing project applications, the committee encourage researchers to adopt a risk assessment approach in order to best mitigate for adverse events.

An unexpected adverse event may result from different causes, including but not limited to:

• death of an animal, or group of animals, that was not expected
• adverse effects following a procedure or treatment that was not expected
• adverse effects in a larger number of animals than predicted during the planning of the project or activity, based on the number of animals actually used, not the number approved for the study
• a greater level of pain or distress than was predicated in the planning of the project or activity and
• power failures, inclement weather, emergency situation or other factors external to the project or activity that have a negative impact on the welfare of the animals.

Reporting timeframe for an adverse event

Reporting of an adverse event should be carried out as soon as practicable to the ACEC Executive Officer, ideally within 72 hours of the event.

When to do a Post Mortem Examination?

• When no cause of death is readily apparent.
• When no cause is apparent and the health of more animals is under threat.
• When there is any possible public health implication.

Guidance for reporting Unexpected Adverse Events

For more guidance regarding unexpected adverse events.

Please submit a completed Unexpected Adverse Event Report Form to the ACEC as soon as practicable after the event and preferably within 72 Hours of the event.

• Unexpected Adverse Event Reporting Form

Non-Compliance Events

What is a non compliance?

The Secretary’s ACEC recognises that non-compliance events may be unintentional, due to misunderstanding or miscommunication between various parties of what the ACEC has approved. There are also instances where non-compliance may be intentional. The ACEC would like to help educate researchers to improve their compliance with the legislation and thereby improve the wellbeing of animals used in research and teaching.

Examples of non-compliance may include:

• using trapping methods that were not included in the project application and therefore not approved by the ACEC
• using species of animals not approved by the ACEC
• using higher numbers of animals than were approved by the ACEC
• using procedures that were not approved by the ACEC
• conducting an educational activity using live animals that was not approved by the ACEC.

When to submit a Non-Compliance Report Form?

An animal research non-compliance event should be reported if you become aware of non-compliance in an animal research project overseen by the Secretary's ACEC.  It is in the researcher’s or businesses' best interest to self-report any non-compliance as it helps work out how it occurred, how to regain compliance and how to prevent it occurring again. It also allows the ACEC to investigate, if required, and provide advice for future prevention and how to be compliant with the NSW Animal Research legislation again.

Please submit a completed Non-Compliance Self Reporting Form to the ACEC as soon as practicable after the event and preferably within 72 Hours of the event.

Non-Compliance Self Reporting Form

• Secretary’s ACEC Trapping Policy
• Guidance for researchers on reporting animals used in research
• NSW Animal Research Act 1985
• NSW Animal Research Regulation 2021
• Australian code for the care and use of animals for scientific purposes 8^th Edition 2013
• Biodiversity Conservation Act 2016
• National Parks and Wildlife Act 1974
• Threatened species Conservation Act 1995
• NSW Scientific Licences
• Animal Research Review Panel’s guideline ‘Wildlife surveys’
• Animal Research Review Panel’s ‘Use of Pitfall traps’ guideline
• Animal Research Review Panel’s Emergency Procedures
• Animal Research Review Panel’s radio tracking and GPS tracking guideline
• NSW Environment, Energy and Science Guidelines for carrying out a survey
• Best Practice Guideline for the use of Koalas in Scientific Research
• Hygiene protocols for the control of diseases in Australian frogs NPWS 2008
• Hygiene protocols for the control of diseases in Australian frogs James Cook University 2011
• Threatened species survey & assessment guidelines: field survey methods for fauna (Amphibian)
• Threatened biodiversity survey and assessment – Guidelines for developments and activities (2004 working draft)
• Australian Government  Survey guidelines for Australia’s threatened mammals
• A guide to the care and use of Australian native mammals in research and teaching (NHMRC, 2014).
• NSW Drones in national parks policy
• Protecting trapped animals from heat exposure: the influence of shading on temperature with small metal box traps
• Supplement to above article
• Australian Bird Banders Manual (Lowe 1989)
• Euthanasia guidelines AVMA 2020
• ANZCCART Euthanasia of Animals Used for Scientific Purposes (under revision)