Animal ethics approval - why is it required and who needs it?

Why?

Animal ethics approval is required under the law.
Under the Animal Welfare Act (1993) the University requires a licence authorising it to carry out animal research. All animal research must conducted in accordance with the NHMRC Australian Code of Practice for the care and use of animals for scientific purpose 6th edition, 1997

If the institution and researchers do not comply with licensing conditions the University will be at risk of losing its licence and be unable to continue any research using animals (see Animal Research Legislation for more detail on this)

Download the Animal Welfare Act at http://www.thelaw.tas.gov.au

The purpose of the Australian code of practice for the care and use of animals for scientific purposes is to ensure the humane care of animals used for any scientific purpose (including teaching).

The Code establishes Animal Ethics Committees to verify that the case for animal use is justified and to ensure adherence to the principles of Replacement, Reduction and Refinement – the three Rs

Refer to section 1 of the Code for detail on the criteria used by the AEC to determine if a project is justified and for details on the principles of the 3 Rs. Download the Code of Practice at http://www.nhmrc.gov.au/publications/synopses/ea16syn.htm

Who?

University staff and students must obtain approval from the Committee if they wish to carry out an investigation that involves vertebrate animals or cephalopods which are alive or which are to be killed specifically for the investigation. Approval must be obtained for both research projects and teaching exercises. This applies also to pilot studies, preliminary trials, collaborative projects (ie work undertaken with another institution that may or may not hold ethics approval from that institution) and work undertaken on sabbatical at another institution (including overseas institutions).

When animals are to be collected from the wild, or studied in their normal environment, permits may be required from the relevant government department. In some cases, eg. Department of Parks and Wildlife, permits will not be issued until the investigator has had his/her project approved by the Committee.

Where research projects are being conducted totally at another institution, approval from that institution may be required in addition to approval from the University of Tasmania Committee.

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How do I complete an animal ethics initial application form?

Hints for completing an initial application form:

1. Ensure you are using the most recent version of the application form. Download the most recent version from the website

2. Insert your answers in the fields provided below each question. Use the tab key to move through the form.

3. A response is required for each question. Write "Not applicable", if necessary.

4. Endnotes are provided to assist you in the completion of this application form. They are a guide to help you provide important information to include for the AEC. Please use the information provided to avoid unnecessary delays in the assessment of your application. To view notes, move the cursor across or click your mouse twice on the endnote number.

5. Applications must be written in plain English . It is important for applicants to remember the composition of the AEC. Applications must be written primarily for an interested, intelligent person without a scientific background, not for a specialist. The use of specialist language is not helpful to the committee and may delay processing of an application while explanations are sought. Where scientific language is unavoidable, it must be supported by a suitable lay description or a glossary of terms. It is not appropriate to include sections from grant applications containing excessive detail of procedures unrelated to the use of animals.

6. Your application should give the AEC sufficient information to satisfy the Committee that the proposed use of animals is justified and complies with the principles of Replacement, Reduction and Refinement.

7. In assessing applications it is often difficult for the AEC to obtain a clear picture of what happens to individual animals from the beginning to the end of the project. The AEC must assess the impact on animals of all procedures and of the project as a whole. The application should therefore focus on what is happening to animals and what is being done to ensure their well-being . It is important that this information is presented in a way that shows clearly what is happening to individual animals from the beginning to the completion of a project.

8. The impact of procedures needs to be clearly detailed. The investigator should provide a step by step examination of all treatments (substances, dose rates, routes, volumes, anaesthetics, surgical procedures etc) and the expected effects. Flow charts or sequence of events tables are often of assistance. In addition, factors that will impact on animals such as housing (type, duration, opportunity for social interaction) should be considered.

9. The application should also explain clearly why the use of animals is justified, why the species and number of animals have been chosen and that the qualifications of personnel are suitable for the procedures to be performed.

10. It is highly recommended that you ask a colleague and a person with a non-scientific background to read the application before it is submitted.

11. The application form seeks information from applicants in order to meet the requirements of the Code of Practice (refer pages 13 and 14 regarding written proposals). Applicants should be familiar with the contents of the Code before completing the application form. The Code is available on line at: http://www.nhmrc.gov.au/publications/synopses/ea16syn.htm

12. If you have any problems or queries, or would like to comment on the form, contact the Secretary of the AEC animal.ethics@utas.edu.au ph 6226 7283.

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How do I submit my application?

All applications may be submitted by email to animal.ethics@utas.edu.au but a signed copy of the completed form is required to be held on file. This should be forwarded to the Secretary, AEC at private bag 01.

Check the website for submission deadlines and meeting dates. Applications must be received by 5pm on the submission deadline to be considered at the next AEC or Executive meeting.

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What happens once my application is submitted?

1. The responsible investigator (RI) will receive an email from the AEC Secretary to confirm receipt of the application and to advise of the AEC number allocated to the project.

2. The application will then be placed on the agenda for the next meeting, this will either be an Executive meeting or a full AEC meeting depending on when the application is received

3. AEC meetings are monthly. All new applications can be approved only at full AEC meetings. Dates for meetings and submission of applications can be obtained from the Committee Secretary or you can download the current list of meeting dates and submission deadlines (27KB word doc).

4. Executive meetings are held approximately a fortnight before Committee meetings. The Executive screens applications to identify ethical concerns and deficiencies before the applications are presented to the Committee. It cannot approve initial or renewal applications but can approve straightforward applications for minor modifications and associate investigator applications at its discretion. The Committee at its following meeting reviews all decisions of the Executive.

5. If the application has been presented at a full AEC meeting, the RI will receive an email from the Secretary within 2 working days after the meeting to advise of the outcome.

6. If the application has been presented at an Executive meeting, the RI will only receive an email from the Secretary if the Executive has identified any areas of concern that should be addressed prior to the full AEC meeting. Applications will automatically be forwarded to the full AEC for consideration after presentation at an Executive meeting.

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Approval - what does it cover?

Approval from the AEC 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 AEC before you proceed with any changes to the approved protocol.

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How do I obtain animals from the Central Animal House?

Ordering Animals from the Central Animal House:

Curator: Dr Eileen Wronski, extension 2684, email Eileen.wronski@utas.edu.au

When large numbers of animals are required for a specific project adequate notice must be given. This is to allow enough time to breed sufficient stock to maintain supply for all researchers. As an example, a minimum of eight weeks notice must be given to allow appropriate breeding of large numbers of mice or rats. If the rats or mice are required at a specific weight then additional time must be allowed for growth to this stage.

If an animal is required in a specific state, eg time mated or fasted, then the staff must be advised in advance. It is best to notify the person in charge of a particular colony of specific requirements. If there are any technical difficulties the staff are well able to discuss these with investigators.

Collecting Animals:

Investigators, when collecting animals, are required to provide the animal house staff with the Animal Ethics Committee approval number for the study. They must also provide an IDR (unless a previous arrangement has been made).

Prior to issue of animals the AEC approval number will be checked on the CAH data base, which gives information on the number of animals approved for use in a study and the number previously/still to be issued.

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What is the role of the responsible investigator?

It is important that all investigators involved with scientific or teaching activities using animals are aware of the role of the responsible investigator. This is detailed in Section 3 of the Code.

The responsible investigator has ultimate responsibility for the project. This includes all matters relating to the welfare of animals used in scientific and teaching activities and also compliance with administrative requirements. Accordingly, joint responsible investigators will not be approved. All correspondence and communication from the Committee is with the responsible investigator.

The responsible investigator for any project must be a member of the University staff on an academic or equivalent grade. When research is to be undertaken by a graduate student the student's supervisor is normally named as the responsible investigator.

All investigators on a project must act in accordance with the Code and are not exempt from responsibility.

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What are the common problems with applications that delay approval?

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

• The application is not written in plain English and clarification is required;

• The use of animals is not adequately justified (see 1.1 of the Code of Practice for the criteria used by the AEC in determining if a project is justified and in weighing up the benefits of the project against the potential effects on the animals)

• The severity of the procedures is not adequately justified.

• The use of non-animal alternatives is not adequately addressed.

• Answers are not provided to ALL questions;

• There is inadequate or insufficient information, especially with respect to procedures.

• The numbers of animals applied for does not tally with the description of the experiment in the text of the application

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How long is approval granted for?

Approval periods are determined by the Committee in their assessment of each individual project. The length of approval will be detailed on your AEC approval permit.

In general, the AEC will give approval for three years subject to the review of an annual report. If a project is to continue to a fourth year a final report (which will be the final report under that project number) and an initial application must be submitted. The reasons for this requirement are:

(i) Many projects undergo substantial changes in procedures and personnel over a three- year period;

(ii) This procedure allows Committee members to re-examine the total project, taking into account any changes in scientific knowledge or societal expectations.

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When can I start my research?

You may only commence your project once you have received advice of approval in writing from the AEC Secretary.

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What if I will be involved with research at another institution?

You will need to complete a Notification of Involvement with an External Institution form.

If the other institution has given the project ethics approval and all the animal work will be done there then the form, a copy of the application to the other institution's Animal Ethics Committee and their approval letter need to be submitted to the AEC before you can commence work on the project. It is essential that the other Ethics Committee is properly constituted according to the NHMRC – check with the Secretary if you are unsure.

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How can I detail the numbers of animals to be used when I am trapping wildlife and I don't know exactly what animals or how many I will catch?

Estimating exact numbers for wildlife projects can be difficult and the Animal Ethics Committee does take this in to consideration. This information is required under the Code of Practice however so you will need to provide an estimate.

Make the best estimate you can and explain on the application form why it is not possible to be more accurate eg. Trapping has not been carried out in this area before . You will need to keep the AEC regularly informed if the numbers exceed your estimate or animals you did not specify in the application are trapped. If the project runs into a second year you will be expected to be more accurate with your trapping estimates when you apply for an annual permit.

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Do I need ethics approval even if I am only observing animals?

Yes. You will need to obtain formal Animal Ethics Committee approval for any project involving live vertebrate animals or cephalopods.

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What if an unexpected death or adverse effect to my animals occurs?

As detailed on your approval permit, you must inform the AEC as soon as possible of any adverse events detailing the event and the action that has been or will be taken. In addition a post-mortem must be carried out and the AEC given a copy.

In the first instance, it is best to contact the Animal Welfare Officer. He will advise you on the report that you will need to provide to the AEC.

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What do I do if my research involves the use of recombinant DNA, potential pathogens, radioactive isotopes or other hazardous substances?

You must submit an application to the UTAS Institutional Biosafety Committee (a sub committee of the University's OH&S Committee). Information can be accessed on the following web page: http://www.admin.utas.edu.au/hr/ohs/ibc.html

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How long does it take to get AEC approval?

Applications should be completed and forwarded to the AEC well before you plan to start your project. If an application is submitted by the submission deadline and is approved at the following AEC meeting, the absolute minimum time-span from lodgment to approval is approximately 2 weeks however the average time that the approval process takes is approximately 6 weeks.

Delays in approval can be expected if the information provided is insufficient, incomplete or presented in scientific/technical language. See What are the common problems with applications that delay approval? (link to this ) for details of the common things that hold up approval.

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How do I make a change to my project once it has been approved?

If an investigator wishes to modify an investigation in any way (eg: use additional animals, use another species, introduce new procedures) an “Application for Modification of an Approved Investigation” form must be submitted. If major changes are proposed an ‘initial application' is required.

There is special provision for lecturers who require additional animals for teaching exercises. As class numbers cannot always be predicted accurately, a variation of approx. 10% on the number approved will be issued. In order to regularise the issue of additional animals investigators must complete a ‘modification' form when they obtain these animals.

The modification form can be downloaded from the forms section of the Animal Ethics webpage. Deadlines for the submission of modification forms can be found under the list of meeting dates on the Animal Ethics webpage.

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How do I add a new investigator to my approved project?

Additional investigators on projects require Committee approval. To add a new investigator, you will need to complete an “Application to add an associate investigator” form. Both the responsible and the new investigator must sign this form.

Investigators who are inexperienced in the procedures being used must receive close training and supervision until they are competent in these procedures.