Animal Ethics Committee
Reporting Requirements for Investigators
Adverse Events and Incidents
An Adverse Event is a situation where welfare compromise to animals falls outside the approved conditions of the project.
If an adverse event occurs, the person primarily responsible for the conduct of the experiment on an ongoing basis (senior researcher or a student) must:
- As soon as practicable (approximately 48 hours) the event should be reported to (i) the Animal Welfare Officer (AWO) by ringing or texting 0418 638 417 as well as (ii) the manager of the facility (Bioresources or PIRL) in which the event occurred, and (iii) the Primary Investigator named on the application relevant to the event.
- An incident report must be submitted within 3 days on our in-house database system Emus. It is the responsibility of the person who was involved in the incident to ensure this occurs.
- The AWO will investigate and advise of any interim arrangements required, generally in consultation with the researchers and senior colleagues within SAHMRI Veterinary Services. This may involve modifications to procedures, urgent medical or husbandry or treatment intervention or, in exceptional cases, suspension of the project.
- All adverse events are reported in writing to the AEC by the AWO either to the next meeting, or if necessary out-of-session through the AEC Chair.
For each active project, details of the animals used must be returned to the AEC each year. Continuation of all projects is subject to receipt of written annual reports that should advise on:
- What progress has been achieved;
- Any problems that may have interfered with progress of the project;
- How many animals have been used;
- Whether the wellbeing of the animals is consistent with that anticipated in the proposal;
- Whether any changes are envisaged;
- Whether the project is meeting its aims.
The current reporting period runs from 1 January – 31 December 2020. There are two separate forms for reporting; progress report and a final report. Final reports are required to be completed as soon as possible after project completion and emailed electronically to the AEC secretary ( firstname.lastname@example.org). Progress reports and 2020 final reports must be submitted to the AEC secretary by the 28th June 2021. Forms can be downloaded from the forms sections below.
Useful links and information
The purpose of the Code is to promote the ethical, humane and responsible care and use of animals for scientific purposes. The Code provides an ethical framework and governing principles to guide decisions and actions of all those involved in the care and use of animals for scientific purposes. The Code details the responsibilities of investigators, animal carers, institutions and animal ethics committees (AECs), and all people involved in the care and use of animals, and describes processes for accountability.
The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) contains useful information on best practice, new technologies and approaches to minimise the use of animals and improve animal welfare (the 3Rs).
Scheduled Animal Ethics Committee Meetings and Submission Dates for 2021
Applications and any requested reports must be received at least 21 days prior to a meeting to be considered at that meeting.
|Submission Date||Meeting Date|
|Tuesday, 12 January 2021||Tuesday, 2 February 2021|
|Tuesday, 23 February 2021||Tuesday, 16 March 2021|
|Tuesday, 6 April 2021||Tuesday, 27 April 2021|
|Tuesday, 18 May 2021||Tuesday, 8 June 2021|
|Tuesday, 29 June 2021||Tuesday, 20 July 2021|
|Tuesday, 10 August 2021||Tuesday, 31 August 2021|
|Tuesday, 21 September 2021||Tuesday, 12 October 2021|
|Tuesday, 2 November 2021||Tuesday, 23 November 2021|
When is an Application Required?
An application needs to be submitted for any planned work that will involve animals that will take place on SAHMRI premises.
Note that an application does NOT need to be submitted for work that is taking place at an animal facility that is not part of SAHMRI. The relevant AEC at that external site will require an application and that committee will assess it.
Guidelines for Preparing New Project Applications
Refer to the Guidelines when completing your application. The guidelines are attached to the Research Project Application Form.
- Include a detailed background of the work leading up to the application including relevant references.
- Use figures and flow charts where possible to detail what happens to all animals.
SAHMRI Veterinarians (Dr Anna Acuna – Bioresources, Dr Chris Christou – PIRL and Dr Chris Brown – AWO) may be able to assist you with the preparation of your application.
Guidelines for Preparing New Breeding Applications
For breeding applications, please ensure a SAHMRI animal passport form has been completed. We will not accept alternative animal passport forms as our experience is they do not contain sufficient detail.
For rodent breeding applications, please first check with the Bioresources Manager if the breeding of the line can be accommodated on the generic breeding approval (SAM401.19). As all rodent breeding in Bioresources is managed centrally, we have AEC approval to cover much of the breeding work. The Bioresources Manager can be contacted via email – email@example.com
Submission of Applications
Please follow the process outlined below when submitting new applications:
- Forms are to be sent as PDFs by email to firstname.lastname@example.org. Paper copies or Microsoft Word documents will not be accepted.
- The SAHMRI Application Forms must be used. Applications will not be accepted that are submitted on forms from other institutions.
- Do not send more than one PDF. All attachments must be merged into a single PDF. If the final document is too large, discuss with the AEC secretary by email alternative ways to submit the document. Do not send documents through third-party providers, such as Dropbox.
- Applications must be received at least 21 days prior to a meeting to be considered at that meeting. This is to enable sufficient time for the application to be pre-screened and adjustments to be made before the Agenda is finalised.
- Signatures on the form. Obtain signatures for the Primary Investigator and all other applicants involved with the project.
- Forms submitted without the signatures will invariably be held up.
Presentation to the Committee
For all new applications, the primary applicant, or their designated representative (preferably a co-applicant), may be asked in person at an AEC meeting to briefly explain the experimental plan, as well as outlining the scientific benefit of the work and the costs to the animal involved. The presenter would normally then spend 10-15 minutes with the Committee answering any questions related to their application.
This presentation and discussion have proven to be of great value to the Committee and to the applicant because it greatly improves the understanding of the work of researchers, and researchers have appreciated the opportunity to explain the value of their work.
Submission of Revised Applications
The Committee may request modifications to the original application. If so, the process is as follows:
- Complete the Research Project Application Revision Submission Form with a brief description of the changes.
- Send with the form two copies of the revised Project Application. On one of these copies, highlight the changes in yellow and leave the other copy unmarked. This copy will be used as guidance for changes while the unmarked copy will be put on file if approval is given.
- Send the two applications and the amendment forms as three separate pdfs by email to email@example.com. Paper copies or Microsoft Word documents will not be accepted.
- If the revised application is required to be reviewed by the full AEC, it must be received at least 14 days prior to a meeting to be considered at that meeting.
- If the revised application can be reviewed by the AEC Executive, then it should be submitted as soon as possible.
- For signatures, follow the guidance on submitting Project applications above.
When is an Amendment Required?
- Amendments are required when there is any change to the project.
- Amendments are considered by an Executive Committee, out of session and are communicated through the AEC secretary.
- Amendments that request; more than one third of the original number of approved animals, any change of protocol that increases the welfare classification of pain and distress to the animals and/or the addition of a section or aim to the project which is outside of the original scope of the project is required to be reviewed by the full committee.
- NOTE: The only exception to the above is that new investigators can be added to projects (and investigators removed) without using the amendment form. Instead, contact the Facility Manager and AWO and give them details of the individuals. They will then be recorded as working on that project and assessed for suitability and required training. The information is still reported to, and reviewed by, the AEC but is recorded separately.
Preparation and Submission of Amendments
- Complete the Amendment form with a brief description of the changes.
- Send with the form two copies of the Project Application with the changes. On one of these copies, highlight the changes in yellow and leave the other copy unmarked. This copy will be used as guidance for changes while the unmarked copy will be put on file once approval is given.
- Send the two applications and the amendment forms as three separate PDFs by email to firstname.lastname@example.org. Paper copies or Microsoft Word documents will not be accepted.
- Amendments must be received at least 14 days prior to a meeting to be considered at that meeting.
- Signatures on the amendment form - please print out the signature page on the project amendment form and obtain new signatures for the Primary Investigator and one person designated as the Deputy. Resigning of the form is needed as the project application form has now changed. Signatures should be incorporated as detailed below.
- Forms submitted without the Primary Investigator and Deputy signatures will invariably be held up.
There are two methods that can be used to sign the final pdf forms prior to submission:
- E-signing (Recommended). There are various ways e-signatures can be added to forms. Adobe Reader allows simple e-signing of applications. For details on how to do this click here.
- Signing a hard copy of the signature page. Print out the signature page on the form and obtain signatures for the Primary Investigator and one person designated as the Deputy. Scan and replace this page with the empty signature page in the final pdf. Software like Preview (for Mac OS X) and Adobe Acrobat Pro can be used. If you require assistance with this, please contact the AEC secretary (email@example.com).
Requests to Scavenge Tissue
Scavenge tissue is tissue acquired from animals killed for other purposes, or tissues recovered from live animals that were used for other approved purposes. That is, the animals have not been specifically for the purpose of obtaining these materials. Requests to scavenge tissue must be made electronically. Please consult a Facility Manager who will advise on whether a Tissue Scavenging application is appropriate for your work.
Ethics and Compliance Induction
All researchers working with animals or associated with project licences must complete this induction. There are no exceptions. This is irrespective of whether you have already completed an induction elsewhere.
All users of SAHMRI facilities (including Primary Applicants and Deputies on Project Licences) must complete the online induction (with a minimum 80% pass mark). The induction must be renewed every 2 years.
To undertake the induction via the Online Learning Centre, please click here.
It is WHS requirement for risk assessments to be evaluated for AEC applications and amendments with changes to animal welfare and/or additional procedures or hazardous substances also require an approved risk analysis form. Please contact WHS representatives to determine if your project requires a risk analysis for to be completed and for assistance in completing this form.
Forms to be used for breeding and research projects can be downloaded below:
- Research Project Application Form
- Teaching and Training Project Application Form
- Research Project Application Revision Submission Form
- Breeding Project Application Form
- Rodent Passport
- Amendment Application Form
- Risk Analysis Form
- Risk Management Procedure Form
- Progress Report Form
- Final Report Form
Please convert the completed application form to a pdf before submitting. Ensure all signatures are in place.
Please ensure you do a spell check on any form before submitting. The password that protects the form is: research. Input this password to unprotect the document and perform a spell check function. We advise you to keep the document protected whenever possible so that the format is consistent between applications.