ANIMAL ETHICS COMMITTEE

Researchers and Applicants SEE KEY POINTERS FOR SUBMITTING AN APPLICATION Section B.

CONTENTS

A. Use of Animals

B. Approval of Applications including KEY POINTERS and DEADLINES

C. Application for Minor Change of Protocol including additional animals – form 1476

D. Animal Users Permits – form 113

E. AEC Annual Statistics Return and Annual Progress Reports- form 141

F. Guidelines for the use of Animals in Research – form 700

G. The use of Animals in Teaching – link to document

H. Submission deadlines/ meeting dates – link to document

A. USE OF ANIMALS

All experimentation on or holding of animals by Institute personnel must be approved by the AEC before any experimental work is done using animals whether for teaching or for experimentation purposes. In this context, experimentation and holding includes:

(i) the use of involvement of animals in research projects or experiments, irrespective of the source of funding;
(ii) the use of animals in undergraduate laboratory classes;
(iii) holding, breeding or any other keeping of animals for Institute purposes;
(iv) fieldwork, including capture and release after marking.

Student Research
In the case of a student project, the supervisor is to be the applicant with the student named as also involved. University degree candidates located at another institution require ethical clearance from the IMVS AEC as well as the institutional committee at the place where research is conducted.

Dual Clearance
In cases where staff of the Institute wish to undertake activities involving animals on the premises of another organisation, ethical approval will be required from the IMVS AEC and the AEC of the parent organisation.

Similarly, people from other organisations wishing to use animals for scientific purposes on premises of the IMVS will require ethical approval from their parent organisation and also from the IMVS. In these cases application should be made on the application form of the host organisation to the AEC of that organisation. A copy of the application should be sent to the IMVS AEC at the same time to avoid delays in approval. The IMVS AEC does, however require the first page of the IMVS Application for Ethics Approval of Project Involving Animals to be submitted.

B. APPROVAL OF APPLICATIONS

Key Pointers when Submitting and Ethics Application.

• It must be understood by lay person (i.e. imagine describing to a parent, grandparent). New members may join the committee and not be familiar with previous applications.

• Avoid scientific and clinical jargon

• The reason for doing the study must be clear (i.e. what are the primary objectives, it should not sound like a “having a look at” type of study)

• Be clear about what actually happens to the animals.

• Be clear about what is actually being measured (this is important for the power calculation Q16 which is essential in most instances).

• Make sure there is a flow diagram showing the experimental plan. Are all the controls necessary?

• Make sure the numbers add up (Q 17and flow diagram).

• It is important to use the appropriate number of animals (not too many, not too few). This can only be ascertained by a power calculation (Q 16). (see footnote # Q 16 below).

• Give some detail (Q 34) on ethical questions (why these animals, alternatives, level of pain, numbers required). Reduction, refinement, replacement are key issues. Also, consider pilot studies

• Limit the excessive detail on methods unrelated to what actually happens to the animals.

• Limit attachments (the application should be free standing and independent of the last protocol).

It is important that read the code of practice. The head of Department is ultimately responsible and must be satisfied with all aspects of the application.

If your research involves the use of a standard model, consider submitting a Standard Operating Procedures (SOP) for review by the committee which will simplify future applications

# Q 16 Footnote Justifying animal numbers

To do this you have to know or estimate the variability of your quantitative measurements.
If certain numbers have worked in the past, fine, but still show how the N value
is reached. Justifying numbers should read something like.
One of the primary measurements in this study is "-serum xyz" which can be measured with a CVof “ ----“. Applying the power calculation to get a difference between test and control of at least (say 20%) shows a group size of (n= ---) will be
required to obtain a difference at p<0.05, using a power of 0.80 (quoting the type of statistics you will apply).

Application Forms

Applications for AEC approval should be completed on the appropriate application form, available at this website.

Completion of the Application Form

Follow the embedded instructions and SEE KEY POINTERS ABOVE

The completed original application form plus 14 copies should be submitted to the AEC Secretary, Veterinary Services Division, IMVS, 101 Blacks Road, Gilles Plains SA 5086. Ph: 8261 1033.

Application for Ethics Approval of Project Involving Animals IMVS 112

Application for Minor Change of Protocol - Additional Animals/Species Change/Procedure Change IMVS 1476

Animal Users Permit IMVS 113

Consideration by the AEC

Consideration of an application by the AEC will normally result in one of the following outcomes:

1. The application is approved immediately.

In this case the Chief Investigator will be informed in writing and given an approval number, which is needed to order animals for the work described in the application.

3. The AEC has queries or concerns and wishes to see a written response to these before considering approval.

4. The AEC asks for resubmission of the entire application where its contents are quite inadequate for the purposes of the AEC.

5. The application is denied approval.

Approval Period and Conditions

Applications are normally approved for 3 years (maximum 4 years), subject to :

• adherence to all provisions of the Australian Code of Practice (http://www.nhmrc.gov.au/publications/synopses/ea16syn.htm) for the Care and use of Animals for Scientific purposes; and
• submission of a satisfactory AEC Annual Statistics Return and Annual Progress Report ( IMVS 141) for each calendar year, due by the end of February of the following year; and
• no adverse occurrences relating to animal use.

C. APPLICATION FOR MINOR CHANGE OF PROTOCOL/ADDITIONAL ANIMALS/SPECIES CHANGE/PROCEDURE CHANGE ( IMVS 1476)

Minor Change of Protocol does not involve a change in the main aims of the project or the asking of a new scientific question.

Additional Number of Animals Requested.

If more than 30% of the original number of animals are required, a full new application must be completed so that the scientific justification as well as the welfare implications can be properly addressed.

Where the increase of number requested is = 10% the application can be considered by the Executive out-of-session.

Extension of Time of less than 6 months can be considered by the Executive out of session.

D. ANIMAL USERS PERMITS (IMVS 113)

All researchers who are involved in any way with use of animals must have a current animal user permit.

All IMVS/RAH based researchers must have an IMVS/RAH AEC Animal Users Permit even if their research animals re not held on IMVS/RAH property.

Animal Users Permit (IMVS 113) must be completed by animal users and renewed yearly. This form is available from the AEC Secretary or from this website.

E. AEC ANNUAL STATISTICS RETURN AND ANNUAL PROGRESS REPORTS ( IMVS 141)

Annual Statistics Return and Annual Progress Reports are required for all approved research projects, breeding programs, teaching units and training courses, including those that are not continuing into the following year.

The AEC Annual Statistics Return and Annual Progress Report (IMVS 141) will be sent to all Chief Investigators at the beginning of each year, for return to the AEC Secretary by the end of February. Failure to submit a satisfactory report may result in withdrawal of AEC approval to carry out animal work.

F. Guidelines for the use of Animals in Research – form 700

Information Headings: General; Animal Ethics Committee; Care and Use of Animals for Scientific Purposes; Communication with the Public; Further Information and Reading.

G. The use of Animals in Teaching – link to document

 Information Headings: General Principles; Responsibility of Teachers

H. Submission deadlines/ meeting dates – link to document

External Links

• Australian code of practice for the care and use of animals for scientific purposes – 7th edition 2004 http://www.nhmrc.gov.au/publications/synopses/eh16syn.htm
• ANZCCART - Australian and New Zealand Council for the Care of Animals in Research and Teaching www.adelaide.edu.au/ANZCCART/
• NHMRC Animal Welfare Committee http://www.nhmrc.gov.au/health_ethics/animal/awc.htm
• NHMRC Publications catalogue – Ethics http://www.nhmrc.gov.au/publications/index.htm
• Prevention of Cruelty to Animals Act 1985 http://www.austlii.edu.au/au/legis/sa/consol_act/poctaa1985360/index.html