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Animal Ethics

The Use of Animals for Research or Teaching Purposes:
Frequently Asked Questions

Contents

Animal ethics approval - Why and who needs it

Why do I need approval from the Animal Care and Ethics Committee (ACEC)?

The NSW Animal Research Act (1985) and the Animal Research Regulation (1995) stipulate that approval must be obtained from the institutional Animal Care and Ethics Committee (ACEC) before animals are used for research or teaching. This legislation was introduced to protect the welfare of animals, by ensuring that their use in research and teaching is always humane, considerate, responsible and justified. NSW legislation incorporates the "Australian Code of Practice for the care and use of animals for scientific purposes”.

What is the ACEC?

The ACEC is a Committee established by the University in accordance with the NSW legislation. Its membership includes the following categories:

Category A:  Veterinarians
Category B:   Researchers experienced with the use of animals for scientific or teaching purposes
Category C: Members who are members of or are nominated by an animal welfare organisation
Category D:  Independent members who are not associated with animal-based research, and not associated with the institution except under defined circumstances.


Who needs ACEC approval?

You will need approval from the ACEC if you propose to undertake a research or teaching project, product testing or other experimental study in which animals are used. An animal is defined as any vertebrate (other than a human being) and includes mammals, birds, reptiles, amphibians, and fish.

ACEC approval is obtained by the Chief Investigator on behalf of all those involved with animals on a particular project. The Chief Investigator must be a member of staff of the University, Hunter-New England Area Health Service, Avondale College, Wildthing Environmental Consultants or other Accredited Research Establishments for which the University of Newcastle ACEC acts as the nominated ACEC.

What about students?

When a project involves a student proceeding to a higher degree, the Chief Investigator listed in the application must be the student's supervisor. For a practical class involving the use of animals, the staff member responsible for that class is the Chief Investigator. The group of students participating in the class is identified by the Chief Investigator in the application to the ACEC and is covered by the ACEC approval. However, the responsibility for ensuring the accuracy of the information contained in that application rests solely with the Chief Investigator.Top

Application forms - Obtaining a copy and which one to use

All application forms for the ACEC can be downloaded from the animal ethics website or by contacting the University of Newcastle Research Services.

Which application form do I use?

Initial Application form For new projects, or as a "Repeat Initial Application" for a project entering its fourth year. Under NSW legislation, an Animal Research Authority may be issued for a maximum of one year.
Renewal Application form For annual review and renewal of approval for an ongoing project. Approval may be renewed only twice via submission of a Renewal Application form. To continue ethics approval beyond three years, a Repeat Initial Application form is required.

Variation Application form
(Change to the approved protocol)

 For minor variations or amendments to an approved project only, ie. when the amendment to the approved protocol does not change the classification of the severity of the experiments, and where the ethical implications of the variation have already been considered as part of the Initial Application for the project.

Variation Application form
(Addition of person)

 To add an investigator or teacher to those authorised to use animals on an approved project
Observational Studies form To provide the ACEC with sufficient information to assess whether animal ethics approval is required for activities involving the observation of vertebrate animals. In many cases, the necessity for animal ethics approval is not clear.
Final Report This report is required on completion or discontinuation of an approved project.

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Completing an animal ethics application

What do I need to do first?

Before obtaining approval for research projects involving animals, you should first:

Question if you need to use animals at all?
Do the potential benefits of the research justify animal use? Think about alternatives; e.g. computer simulations, cell culture techniques.

Can you use cadaver tissue?
The use of tissue from freshly euthanased animals by a researcher is a legitimate mechanism for reducing the number of animals required for research/teaching purposes. Thus this practice is encouraged. Prior animal ethics approval is not required for this practice provided that:
  • The animal is euthanased as part of another approved process (eg. part of another currently approved protocol, in the abattoir), AND
  • The animal is euthanased by a person authorised to do so (eg. under a current Animal Research Authority, because of the nature of their employment etc), AND
  • The researcher has no input into the treatment or handling of the animal prior to its euthanasia or death, AND
  • The researcher has no input into the manner or timing of euthanasia of the animal.

Consider the expected effects on the animals
You should examine, step by step, the expected effects on the animals of each treatment or procedure in the proposed protocol (e.g. substances, dose rates, routes, volumes, anaesthetics, surgical procedures, restraint etc). In addition, assess other factors that will impact on the welfare of the animals (e.g. housing, environmental factors, duration of use). If the project will cause the animals any pain and distress that cannot be minimised, consider again whether it is necessary to use animals.

Talk to the Veterinary Manager, Animal Services Unit.
The Veterinary Manager, Animal Services Unit, will be able to advise you on the availability of animals, whether they will be of the appropriate biological status, and whether, given the facilities available, they can be appropriately housed.
Consult with a statistician
A statistician may assist you in designing the experiment to ensure that the maximum amount of valid information is obtained from the minimum number of animals.

How do I fill in the application form?

First, consult the Application Guidelines
The guidelines provide advice on the type of information required by the legislation and the ACEC.
Allow sufficient time for completion
Completion of the application form will probably take longer than you think. Questions contained in the form may raise issues which you have not previously considered, and hence may require some investigation.
Answer all questions as completely as possible
Because of the legislation, applications have a formal status. Applications should be typed and all questions answered. If a question is not relevant, please write "Not Applicable".

Remember to use "Plain English"
Under NSW legislation, all ACEC members must be provided with sufficient information to allow their participation in the assessment of applications. Since the ACEC is composed of people who are not experts in your field, this can only be achieved by the use of plain English in the application. Use everyday language that can be understood by an interested, intelligent person without a scientific background. Assume those assessing your application have either no medical scientific background or no knowledge of your area of research. Avoid using scientific jargon or unexplained abbreviations. The need for plain English is especially important for your description of the aims of your project. Where the use of scientific terminology is unavoidable, you should consider providing an explanation of these terms or a glossary.This glossary is to be used for scientific terminology where lay terms are not available but not as a substitute for lay language.

Common reasons why approval for an application is delayed are failure to adequately describe a project in non-technical terms, and failure to clearly state the hypothesis.

Attachments and Standard Operating Procedures
Omission of essential information is a common cause of delays in the processing of an application. Attachments have been developed for specific proceduresand situations, to ensure that your application includes the required information pertaining to that procedure or situation. You only need to complete those that are applicable to your project. You may choose to develop a Standard Operating Procedure for a procedure that can be used to replace an attachment or a number of attachments to the application form.

Go through the checklist included in the instruction pages of the form
The aim of this checklist is to ensure that all relevant information has been provided to the Committee.

Amend your application as necessary
The checklist may highlight areas of your application that may need to be modified or expanded.

What are the key areas of information that I need to include?
Based upon the information that you provide in your application, members of the ACEC should know:

  • The justification for the animal use.
  • What will happen to the animals and in what time-frame.
  • How what is being done with the animals will affect their welfare.
  • Replacement – have all possible alternatives to the proposed animal use been considered and the reasons for their non-use provided.
  • Refinement - which specific aspects of the project contribute to the impact on animal welfare and how the impact of these aspects of the project will be minimised.
  • Reduction – has it been explained why the proposed numbers are optimal to achieve the desired outcomes.
Whom do I ask for help?

What do I do when my application form is completed?

Check again
It may be helpful to give your application to a colleague or assistant, in your own or an unrelated department. If a person who is not an expert in your field can understand your application, then you have probably written your answers in a form that will be understandable to all members of the Committee.

Pre-review of your draft application
Review of your draft application prior to its submission to the ACEC can facilitate the approval process as areas of your application that may be incomplete can be detected and addressed before its formal consideration by the ACEC. For further information, click here.

Has it been signed?
The declaration in the application must be signed by the Chief Investigator who will be deemed responsible for the welfare of the animals approved under the application. The Alternate Chief Investigator is also required to sign a declaration.

Save your application and any relevant attachments or Standard Operating Procedures as a single document file.
To prepare your document for electronic submission via email, you must save your application, and any relevant attachments, monitoring checklists, Standard Operating Procedure s or documents as a single document file. Save your document as an RTF or Microsoft Word file.

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Submission of your application

When should I lodge my application?

Submission deadlines
The submission deadline for applications is normally the second Monday of the month in which an ordinary meeting is held. Full details of meeting and submission deadlines are posted on the animal ethics website. All documents (both electronic AND paper copies) are to be received by the Research Services by 5:00 pm onthe closing date for the relevant meeting.If all documents are not received, consideration of the application will not proceed.

Forward Planning
Applications should be completed and forwarded to the ACEC well before you plan to start your project. This allows sufficient time for processing by the Committee, and for animals to be ordered by the Animal Services Unit. If an application is submitted by the appropriate deadline and is approved at the following meeting, the minimum time-span from lodgement to approval is approximately 4 weeks. Delays in approval can be expected if the information provided is insufficient, incomplete or presented in scientific/technical language. You can minimise delays by attending the meeting to discuss your application with the Committee.

Example: You require 8-week old mice for an experiment to start on 1 August

To obtain 8-week old mice for 1 August, you will need to place an order for these animals 12 weeks prior to that date i.e. at the beginning of May. This allows for the minimum 1 week for mating of parent stock animals, a 3-week gestation period, and then 8 weeks for the animals to reach the required age. Since ACEC approval is required before animals can be ordered, you will need approval for your project by the beginning of May.

If you need ACEC approval by the beginning of May, you will need to submit your application at the beginning of April so that it may be considered and approved at the meeting of the Committee held on the last Friday in April.
Late Applications
Applications for consideration at a particular meeting are normally circulated to ACEC members about 2 weeks prior to the meeting. This allows members sufficient reading time, and to consult with applicants as necessary. If your application is submitted after initial circulation, it will not be considered until the next ordinary meeting. Your application may be circulated as a supplementary paper for an ordinary meeting, or for a policy meeting, only if you provide a written justification for such consideration; ie. why you cannot wait for the next ordinary meeting.

How should I lodge my application?

To make application to the University of Newcastle Animal Care and Ethics Committee, see Submission Instructions.

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The application process

What happens after I submit my application?
Acknowledgment of receipt
You will receive an email acknowledgment of receipt of your application. This will also inform you of the date of the meeting at which the Committee will consider your application.
Invitation to the Committee meeting
In most circumstances, the Chief Investigator for an initial application is routinely invited to attend the meeting of the Committee to discuss their application and to answer any questions that may arise. Co-investigators and additional personnel associated with the project are always welcome.
How will I know what has happened to my application?
Within a few days of the meeting at which the ACEC considers your application, you will receive written notification of the decision of the Committee. If you have attended the meeting, you will be forwarded an extract of the minutes for that meeting, and invited to comment on their accuracy as they relate to your discussion with ACEC members.
What procedures are followed by the ACEC?
All procedures followed by the ACEC for the consideration of applications and for monitoring of research projects are outlined in the policy document "Procedures for the Animal Care and Ethics Committee".

What if there are problems with my application?

Additional information or modifications of the project may be required by the ACEC before approval can be granted.

Attend the Committee meeting
By attending the ACEC meeting, you will be able to answer any questions that members may have regarding your application. Thus, delays or misunderstandings may be circumvented.

Consult with someone
If the ACEC requires further information, it may be useful to consult with someone who was present at the meeting when your application was discussed; eg. Animal Welfare Officer, Secretary to the Committee, Chairperson of the Committee, or a Committee member. Another researcher or one of the University veterinarians may also be able to assist.

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What are the common problems with applications?

Common problems with applications that may result in delays of approval include:

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Approval - What does it cover and what is the ACEC Approval Number?

So now it is approved - What does this approval cover?

Approval from the ACEC covers only those animals, procedures and techniques that are described in your application. In addition, only those persons who have been listed in the application are permitted to work with animals on the project. Prior approval must be obtained from the ACEC before you proceed with any changes to the approved protocol.

What is the "Animal Research Authority"?
Prior to commencement of your research, the NSW Animal Research Act requires you to have:

  1. Approval from an Animal Care and Ethics Committee, AND
  2. Authorisation from your institution to carry out animal research for the purpose of a particular research project. This authorisation is provided in the form of an “Animal Research Authority”. The Authority is issued by your institution on the recommendation of the ACEC.

How long is approval for?
Under the legislation, approval from the ACEC is valid for a period determined by the Committee, but which cannot be for a period of more than 12 months. The exact period of approval is detailed in the Animal Research Authority issued by your institution.

ACEC Approval Number - What do the numbers mean?
Approved projects are allocated an ACEC Approval Number. For example - 111 1208. The first part of the number (111) is the ACEC number allocated to the project. This number will be maintained for the life of the project. The second part (1208) indicates the date when approval for that project ceases - in this example, on the last day of the twelfth month in 2008. Approval would have commenced not more than 12 months previously; ie. not earlier than 1 January 2008.

Example:
For a project that was approved by the ACEC on 30 June 2007 and allocated the ACEC number 111, and which will proceed for three years commencing on 1 January 2008, and concluding on 31 December 2010:
Initial application: From 1/1/08 to 31/12/08 ACEC Approval Number: 111 1208
Upon first renewal: From 1/1/09 to 31/12/09 ACEC Approval Number: 111 1209
Upon second renewal: From 1/1/10 to 31/12/10 ACEC Approval Number: 111 1210

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How do I get renewal of approval?

Approval for a project that continues for longer than 12 months may be renewed following submission of a renewal application to the ACEC. Approval may be renewed only twice; ie. Initial approval plus two annual renewals of approval. Should approval be sought after the third year, you will be required to submit a new initial application to the ACEC. The renewal application process also fulfils the legislative requirement for submission of annual progress reports to the ACEC for continuing projects.

How?
Renewal of approval is obtained via submission of either a Renewal Application or a Repeat Initial Application to the ACEC.

When?
You must obtain renewal of approval for your project before its current approval has expired. If approval has expired, or will expire, before the next scheduled meeting of the ACEC, an initial application must be submitted to the ACEC.

Example
Project 111 0808:     Approval ceases at the end of August, 2008. An ordinary meeting of the ACEC is held at the end of August. Therefore, in order to be considered at this meeting, a renewal application must be submitted by the end of July 2008.
Project 112 0708: Approval ceases at the end of July, 2008. There is no ordinary meeting of the ACEC in July. Therefore, in order to obtain approval prior to expiry of approval, the renewal application should be submitted for consideration at the June meeting i.e. by the end of May, 2008.

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What about changes to the project?

Do I need approval?
Since approval for your project covers only those details and procedures described in your application, you must seek approval for any change to these details or procedures, no matter how minor. This approval must be obtained before you proceed with any change. Prior approval must also be obtained for another person who was not listed in the Animal Research Authority to work with animals on the project.

How do I get approval?
You will need to submit a Variation Application form - either the form for the addition of a person or the form for a minor variation to the approved protocol. If there are substantial modifications to the project (ie. major variations), a new INITIAL application will be required.  Submission procedures are identical to those for other types of applications. In normal circumstances, your application will be considered by the ACEC at its next meeting. 

What is a minor variation?
In general, a variation to an approved project is considered to be minor if that variation does not change the classification of the severity of the experiment (described in full in the guidelines to the initial application). Examples might include:

What is a major variation?
In general, a variation to an approved project is considered to be major if that variation results in a change to the classification of the severity of the experiment, and where the ethical implications of the variation had already been considered as part of the Initial Application for the project. Examples might include:

What if I'm not sure?
If you are unsure as to whether the change to your project is classed as a minor or major change, consult the Animal Ethics Officer.

What if I need approval for a change before the next ACEC meeting?
The ACEC has establsihed procedures for  urgent consideration of a variation to an approved project between meetings.

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Obtaining animals

When can I obtain my animals?

You may obtain animals only after you have received written approval from the ACEC for your project, and a copy of the Animal Research Authority from your institution. Animal Services Unit staff normally receive copies of all applications and notifications of ACEC approval, and are unable to issue animals unless the request has a current and appropriate ACEC Approval Number.

How do I get my animals?

Contact the Animal Services Unit
All animals must be ordered and obtained through the University of Newcastle Animal Services Unit. This requirement does not apply to projects where animals are used in the field (eg. trapping of animals for surveys).
ACEC Approval Number
The ACEC Approval Number must be quoted whenever you order animals, whether they are being obtained from University Animal Facilities or from another source.
Remember - animals take time to produce!
You should allow time for breeding and growth of animals that you require, particularly for rodents. The Animal Services Unit has a three-monthly advance order system in place to ensure that the specified animals are supplied at the time when they are required.
How many?
The number of animals you may obtain for your project is limited to that approved by the ACEC. The maintenance of a cumulative record of animals used will alert you to potential cessation of supply.
Where do I get my animals from?
Licensed Animal Supplier
Under the legislation, animals must be purchased only from a licensed supplier. The University of Newcastle is a licensed animal supplier and performs this role through the Animal Services Unit (ASU). If the animals you require are not bred by the ASU, they may be obtained by the Animal Services Unit from an external licensed animal supplier, and supplied to your project via the ASU.
Exceptions
Some animals are classified as "Exempt Animals" under the legislation (livestock, and free-living native and exotic animals); ie. they may be obtained from a source other than a NSW licensed animal supplier. For example, sheep or pigs may be obtained from farmers by the Animal Services Unit for supply to your project. Free-living animal species may be captured under an appropriate National Parks and Wildlife Service license.

Regardless of their source, it is imperative that you consult with the Animal Services Unit regarding the procurement of any animal so that the microbiological status of the other animals held in the animal facilities is protected.

Transfer of animals from one project to another

Animals allocated to one project, but not used for that project, may not be transferred to another project unless the animal facility manager is notified. In addition, animals may not be re-used for another project unless the ACEC approves that second project, and allocates a second ACEC Approval Number.

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Your responsibilities during the conduct of the project

The Chief Investigator is ultimately responsible for the welfare of every animal allocated to an approved project. Nevertheless, all persons involved with the use of animals must accept responsibility for those animals at all times.

Use of animals on a project
Animals allocated under a particular ACEC Approval Number may not be used for any purpose other than the exact procedures stated in the approved application.

Responsibility for the animals
As a researcher working with animals on an approved project, you are responsible for the welfare of the animals you use. Your responsibilities extend to all aspects of the care and use of the animal during this time. The Chief Investigator is ultimately responsible for the welfare of every animal allocated to an approved project.

Your responsibilities begin from the moment an animal is allocated to the project to the time of disposal of the animal. It does not commence just at the time the "experiment" begins.

Monitoring of animal welfare
The ACEC expects that animals will be monitored on a daily basis, except in those circumstances which makes it impossible to do so and is agreed to by the ACEC. After animals are allocated to a project, the Chief Investigator has primary responsibility for ensuring adequate monitoring of animal wellbeing.

During the period when an animal is allocated to a project, but BEFORE it is used in an experimental protocol, daily monitoring of the animals may be performed as part of the normal husbandry routines performed by Animal Services Unit staff. However, the ACEC expects that a member of the researcher team will monitor the animals allocated to the project at least once weekly, regardless of whether daily monitoring of the animals is performed as part of the normal husbandry routines by Animal Services Unit staff.

AFTER  an animal has entered an experimental protocol, the ACEC expects that normal, healthy experimental animals will be observed by the researchers at least once daily, unless an amendment to this requirement has been specifically approved by the ACEC. The nature of the daily monitoring and the person performing the monitoring would be determined by the level of potential impact on the well-being of the animals. In addition to daily monitoring, the ACEC expects that monitoring of animals in a research protocol will be conducted in accordance with the specific monitoring protocol endorsed by the ACEC for the project.

See ACEC policy on monitoring of animals.

Records
The legislation requires you to keep records of the animals that you use, and everything that you do with the animals allocated to your project. All records associated with the monitoring of animal well-being must accompany the individual animal or group of animals at all times, normally in the red project folder provided by the Animals Services Unit. Specific monitoring checklists must be used for the monitoring of animals following the conduct of procedures.

Identification of animals
All animals must be identified at all times; eg. cage cards, identification tags, collars or microchips. The identification must be linked to the name of the Chief Investigator and the ACEC Approval Number for the project to which that animal is allocated.

Role of Animal Services Unit staff
Once an animal is allocated to your project, Animal Services Unit staff are no longer responsible for the welfare of that animal. That responsibility rests with the Chief Investigator of the project, and subsequently all those working with animals on the project. The Animal Services Unit staff provide for the care of the animal. However, you must be aware of the standard of that care, and you are ultimately responsible for ensuring that the care is appropriate.

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What if something goes wrong?

If there is a problem during the conduct of your project, you must take appropriate action, particularly if an animal is found to be unwell or showing abnormal clinical signs. In this situation, animals must be appropriately assessed and treated, or veterinary advice sought. Examples of unexpected or adverse effects that may occur include:

The legislation requires you to advise the ACEC of any unexpected or adverse effects which impact on the welfare of the animals. The ACEC also expects that an autopsy will be performed if an animal dies unexpectedly. These actions allow for investigation of the incident to prevent its recurrence, and to prevent any compromise to animal welfare and your experimental model. Assistance will be provided by the Committee whenever possible. For further advice and details, see the ACEC policy.

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Use of tissues from cadavers, or tissue sharing

The use of tissue from freshly euthanased animals by a researcher is a legitimate mechanism for reducing the number of animals required for research/teaching purposes. Thus this practice is encouraged. Prior animal ethics approval is not required for this practice provided that:

These guidelines are documented in the ACEC policy.

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More information and contacts

How do I get more information?
Information about the policies and procedures of the Animal Care and Ethics Committee are available from the Animal Ethics website, or from the Animal Ethics Officer.

"Animal research" email list
An email list has been established by the Animal Ethics Unit and Animal Services Unit that is used to disseminate important or urgent information regarding the use of animals in research or teaching at the University of Newcastle. Membership of the list is restricted to those named on current Animal Research Authorities issued for research projects approved by the ACEC.

To subscribe:
Send Email to:  Mary.Bate@newcastle.edu.au
Command in Body of Email: SUBSCRIBE research-animal (insert your full email address)

Examples of command in the body of the email:
SUBSCRIBE research‑animal John.Smith@newcastle.edu.au
SUBSCRIBE research‑animal janew@bigpond.com.au
SUBSCRIBE research‑animal sam.brown@studentmail.newcastle.edu.au

Questions / Suggestions

If you have any suggestions as to how this document may be improved, your input would be appreciated. Contact the Animal Ethics Officer.

To contact us:  Animal Ethics Contacts

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