Animal Ethics Application Process

Animal Ethics Application Process

New Animal Ethics applications and amendments to already approved protocols are reviewed by the Animal Ethics Committee (AEC) on a five week cycle. 

Preparation

• Visit the REMS SharePoint site videos and instructions of the process.
• Read REMs application guidelines; there are guides for Biomedical Applications and Wildlife Applications.
• If you have never submitted an Animal Ethics application before, read Before You Apply for what to do regarding preparation before you begin the application form in REMs.
• Pre-submission feedback is available – see “Pre-submission feedback” section below.
• If you have questions, you can contact the Animal Ethics Team at animal.ethics@anu.edu.au and/or ANU Vet Services Team vetservices.ris@anu.edu.au.
• Ensure applications are submitted before the submission deadlines for each meeting.

Animal Ethics Protocol Team Responsibilities

It is important to be aware that the primary investigator (PI) on the ethics protocol has ultimate responsibility for all animals involved in a research project and is responsible for the ethics protocol application content.

In addition, all researchers that are responsible for any aspect of the protocol, or will undertake any work under the protocol, must be included on the protocol as co-investigators. PI's must ensure that all co-investigators have done all relevant training and are competent/have the correct level of supervision, and have read and understand the approved protocol, approval conditions and the Code.

All researchers are also expected to meet the state, territory or country legal requirements for animal research and teaching as well as the Code wherever the research is located.

PI’s are expected to ensure the project has the correct licences/permits/other approvals and that the research team and animal care support meets these requirements. The application needs to include information on all that will be required for the project.

Animal Care Facilities must also meet their responsibilities under the Code.

Student and supervisor responsibilities can be found here.

ACT Licencing

As the ANU is registered with the ACT for ‘the use or breeding of animals for the purpose of research and teaching’, an approved animal ethics protocol is a legal document that is also an ACT Animal Use Research Licence.  The ACT legislation (ACT Animal Welfare Act 1992)allows an animal ethics protocol to be approved for up to a maximum of three years. ANU Protocol application submissions in REMS includes a declaration section for PI’s to ensure the application meets ACT licencing requirements.

Inter-state licencing

The ANU is licenced with ACT and states around Australia for wildlife fieldwork research and teaching.

For further information see Before you apply

Application Timing

All animal research and teaching related work must have approval prior to that work commencing. The AEC cannot approve any work retrospectively as per the Code..

Ensure, if protocols are being renewed and animals in care are to be covered by both protocols, that there is no time gap in between the end date of the first protocol and the start of the second by applying early – recommend at least two AEC meetings prior to the first protocol’s end date.

Pre-submission feedback

Other Researchers

Primary investigators are encouraged to write the applications with their investigator team particularly the parts of the ethics protocol that are relevant to the co-investigators specialties or that they will focussing on.

Other researchers (not necessarily at ANU) who have used a similar regime to your research plan can also assist. Researchers are often following an established experimental regime from the academic literature. Publications rarely contain sufficient information, so it can be helpful to make direct contact with the author and ask for advice, particularly where the plan is to use new experiments as part of a comparative study with previous work.
 
Research students should arrange review of their application by their supervisor prior to submission.

Veterinary consultation and feedback

If you have a technical question regarding your application you can contact the ANU Vet Services Team at vetservices.ris@anu.edu.au.

If you would like an ANU Vet to give feedback on your draft application prior to submission, please ensure you provide your draft application at least two weeks before the submission deadline to schedule a review. This can be requested in REMS via the green ‘Submit’ button when your draft is ready. See also Submission Dates.

Ethics Office feedback

If you have a question regarding your application you can contact the ANU Ethics Office’s Animal Ethics Team on animal.ethics@anu.edu.au.

The Animal Ethics Team can also undertake an early review of the application, depending on workload. Plesae request  at least 2 weeks before the submission deadline.  through REMS via the green ‘Submit’ button.

Submitting your protocol for AEC review

Once ready in REMS for AEC review, all protocol and amendment applications must be submitted by the AEC submission deadlines.  

Upon submission the application will be allocated to an AEC meeting and a REMS email will confirm the date. While this is usually the next meeting available, submission by a particular meeting’s deadline does not guarantee review at the next meeting date especially if there is a large volume of applications for review.
If anything further is required for the submission, the Animal Ethics Team will contact you via REMS email.

If you have any questions or concerns at any stage, please contact the Animal Ethics Team, animal.ethics@anu.edu.au.

AEC review process

‘Q&A’ – Pre and post meeting questions
After you submit your application, the AEC will review your application before they meet. If there are any AEC questions and/or requested changes, they will be sent to the PI before the meeting through REMS via REMS email. It will also show on your REMS home page that it has been flagged for researcher action. The process in REMS (for both protocols and amendments) is designed so that researchers can respond by making changes requested directly into protocol document itself.  These changes can be clearly tracked and then once approved used to then create an updated final version of the protocol. Versions will be numbered and will be able to be tracked through the ‘History’ tab. (For further information see the REMS Application Guidelines) You will be given sufficient time before the AEC meeting to respond to the AEC questions and change requests. Pre-meeting questions are usually sent out about a week and a half  prior to the meeting, with responses due  early the following week for AEC pre-meeting review. The AEC may also have questions after their meeting discussion and these will be sent the same way to the PI.

Outcomes
After the AEC meeting, an application may be approved with or without additional conditions and these will be sent out by the Research Ethics Office.

The AEC may have further questions before approval confirmed and these will be send to the researcher via REMS.

The AEC may also request the PI to review aspects of the application in depth, and if complex, usually allow a resubmission at a later meeting to give the researcher additional time. The AEC may also arrange to meet with the PI to discuss or clarify aspects of concern.

Conditions
All approvals have standard conditions that you need to be aware of and ensure are met as legal requirements of approval. The AEC may set some conditions on their approval in addition to the standard conditions for all approvals. Please read these carefully and Primary Investigators must ensure all other investigators are aware of and meet all of the conditions.

If the conditions are unclear or you will need assistance to meet all conditions, please contact the Animal Ethics Team (animal.ethics@anu.edu.au) or the ANU Vet Services Team (vetservices.ris@anu.edu.au).

ACT Licence

Once approved, the approved protocol is also an ACT Animal Use Research Licence for the “the Use or Breeding of Animals for the Purpose of Research or Teaching”. The procedures in the approved protocol MUST be followed as set out and conditions met. This is a legal requirement. Any changes require an amendment application approved by the AEC.

For further information above in ‘Animal ethics Protocol Team Responsibilities’

If you have any questions, please contact the Animal Ethics Team, animal.ethics@anu.edu.au