Research Integrity and Compliance

Document Currently Under Review

Current Status: Approved And To Be Published 15 September 2017

Applying for Animal Research Ethics Procedure

Policy Code: RS1923

Purpose

The purpose of the Applying for Animal Ethics Approval Procedure is to guide researchers through the Animal Ethics Approval application process.

This process will help researchers to meet their responsibilities in regards to the responsible care and use of animals for scientific research or teaching purposes.

Scope

This procedure applies to:

  • All staff, including sessional staff, employed by the University or any controlled entity;
  • All persons, including Adjunct and Honorary staff engaged in research under the auspices of the University or any controlled entity;
  • All students of the University who engage or have engaged in research and/or research related activities, related to their studies, while enrolled at the University.

Definitions

Term Definition
Activity A term used specifically in relation to animal ethics for any action or group of actions undertaken that involves the care and use of animals.
Animal Ethics Committee (AEC) A University Committee established in accordance with the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes 8th edition, to oversee and approve animal use in research.
Application A request for approval from an Animal Ethics Committee (AEC) to carry out a project or activity. An application may be for commencement of a project or activity,or an amendment to an approved project.
Approved A category review outcome for a project approved to commence
Approved with comment A category review outcome for a project that has been approved to commence, but with comment from the relevant Committee
Approval Withheld A category of approval used in relation to a project application which requires that ethical issues be satisfactorily addressed and the application resubmitted to the relevant Committee before the project can commence.
Australian Code for the Care and Use of Animals for Scientific Purposes 8th Edition (2013) Provides guidelines for the ethical use of animals in research and teaching, and outlines the requirements for the function of an institutional Animal Ethics Committee
ARC Australian Research Council
Compliance Acting in accordance with the relevant Code, National Statement and/or Regulation
Conditions of Approval Conditions outlined in the Australian Code for the Care and Use of Animals for Scientific Purposes which must be adhered to, in order to ensure continued approval for projects involving animal research
Governing Body The Governing body refers to the National Health and Medical Research Council/ Australian Research Council
GMO Genetically Modified Organisms
IBC Institutional Biosafety Committee
Incident/Adverse/Unexpected event Any outcome that may have a negative impact on a participant, the welfare of animals, or the researcher, and was not foreseen in the approved project
Monitoring The process of verifying that the conduct of research conforms to the approved proposal.
NHMRC National Health and Medical Research Council
Not Approved A category review outcome for a project that has not been given Committee approval to progress
Provisional Approval A category review outcome for a project approved subject to particular issues being satisfactorily addressed as directed by the relevant Committee
Risk The function of the magnitude of harm and the probability that it will occur
Standard Review Standard application process for ethics approval
Terms of Reference Terms of Reference show how the scope of the Committees will be defined, developed, and verified
Variation Any proposed amendment or modifications researchers might wish to make to an approved project. All variations require approval from the Committee

Actions

Research requiring review by the Animal Ethics Committee

 In accordance with the Australian code for the care and use of animals for scientific purposes, 8th Edition (2013), all activities that involve the care and use of animals for scientific purposes must:

  • Be subject to ethical review, approval and monitoring by an AEC;
  • Commence only after approval has been granted by an AEC;
  • Be conducted in accordance with the AEC approval;
  • Cease if approval from the AEC has expired, is suspended or is withdrawn.

All those involved in the care and use of animals for scientific purposes must be aware of the relevant Commonwealth, state and territory legislation.

AEC Standard Application Process

Researchers should complete the following steps to gain AEC approval for Standard Applications:

  STEPS WHO IS RESPONSIBLE? COMMENTS
1 Complete an Application

Principal Researcher

Research Team

Ensure the application form is fully completed and signed by the entire Research Team.

 

Research Services can be consulted in regards to the administrative aspect of an application.

 

Supervisors will mentor research students throughout the development of their animal ethics application and will provide guidance throughout the application process. They will sign off on the application as Principal Researcher.

 

Please Note: If any GMOs will be involved in the project, the researcher(s) must submit an application to the IBC.

2 Supplementary documentation

Principal Researcher

Research Team

Attach copies of any required supplementary documentation.

 

Example of documentation that may be required:

  • Evidence of approval from external agencies
3 Approval by Faculty/Centre delegate

Principal Researcher

Research Team

Head of School

Deputy Head of School

Associate Dean of Research

Ethics Coordinator

Applications must be reviewed, signed and approved for submitting to the AEC by the relevant staff within the Faculty:

  • Principal Researcher
  • Research Team
  • Head of School
  • Deputy Head of School
  • Associate Dean of Research
  • Faculty Ethics Coordinator
4 Submit the Application for informal review (Optional)

Principal Researcher

Research Team

Should they wish to, researchers are able to submit the application at least two weeks prior to the due date for informal review and feedback by the AEC.

Make changes recommended by the feedback from the AEC and submit to Research Services by the due date for the next meeting.

Note: this earlier review and feedback does not constitute approval or otherwise of the application

5 Application submission

Principal Researcher

Research Team

Head of School

Deputy Head of School

Associate Dean of Research

Faculty Ethics Coordinator

Ensure the application has been reviewed and includes all required signatures:

  • All researchers involved in the project
  • Head of School
  • Deputy Head of School
  • Associate Dean of Research
  • Faculty Ethics Coordinator

 

NB. In the case of an application for a student research project, the Principal Supervisor must sign off as the Principal Researcher. The Principal Supervisor takes on all of the responsibility that this entails.

 

Submit one completed and signed hard copy of the application, including all attachments, to Research Services for presentation at an AEC meeting.

 

Email the application, with attachments, to Research Services  research.ethics@federation.edu.au .

 

 

Ensure the application is submitted to Research Services by the due date and time. Late submissions will be carried over to the next AEC meeting.

AEC Out of Session Review Application Process

Researchers should complete the following steps to gain AEC approval for Out of Session reviews:

  STEPS WHO IS RESPONSIBLE? COMMENTS
1 Out of Session application review Principal Researcher Research Team

Out of Session application review consideration of an ethics application with an urgent deadline is available under exceptional circumstances.

 

Requests for Out of Session reviews should be directed to Research Services.

 

The Chair AEC will determine if the application will be considered for an Out of Session review.

 

A scheduled Out of Session review may be cancelled if the required Committee quorum is not achieved.

Outcomes

No research project involving the use of animals can proceed without official written approval from the AEC.

When the application has been reviewed by the AEC the researchers will receive notification for the AEC of one of the following outcomes:

OUTCOME WHAT THE OUTCOME MEANS
Approved No further action required.  Full approval allows the researcher(s) to commence the project on the commencement date outlined in the notification.
Approved with Comment

No further action required, however the researcher(s) should note the comments made by the Committee.

 

Approved with Comment is deemed as full approval and allows the researcher(s) to commence the project on the commencement date outlined in the notification.

Provisional Approval

The researcher/s must address the provisions outlined in the notification in the form of an email, letter or memo listing the project reference number, a response to each of the issues raised and clearly explaining how each of the matters has been addressed. The researcher(s) should also supply a copy of any supporting documentation requested by the Committee.

 

Research Services will receive the researcher’s

response to addressing the provisions and confer with the AEC Chair before issuing the researcher with a notification of the outcome. The Chair will determine if approval from the AEC or just the Chair is required, and whether the former can be determined by circulation. The research should not commence until full approval has been received in writing.

Approval Withheld

The Researcher(s) must address the issues outlined in the notification and submit this information to another AEC meeting.  The issues will need to be addressed in the form of an email, letter or memo listing the project reference number, a response to each of the issues raised and clearly explaining how each of the matters has been addressed.

 

The researcher(s) should also supply a copy of any supporting documentation the Committee has

requested.

 

The Committee will assess the researcher(s) response to the issues raised and a notification of outcome will be issued.

Not Approved

This will mean the AEC considers that the issues regarding the project are so major that the project cannot proceed in its current form.

 

Generally, when an application is not approved, the applicant will be provided with information as to why the AEC rejected the application.

 

The researcher(s) will then be required to submit a new application to a subsequent AEC meeting.

 

The new application will need to address the major issues outlined in the notification.  The Committee will assess the new application as per the standard process.

Conditions of Approval

Each approved project must comply with the Conditions of Approval. These are the conditions outlined in the Australian Code for the Care and Use of Animals for Scientific Purposes, which must be adhered to, in order to ensure continued approval for projects involving animal research. Failure to abide by these conditions may result in suspension or discontinuation of approval and/or disciplinary action.

Failure to comply with the Australian code for the care and use of animals for scientific purposes (2013) and with the Conditions of Approval will result in suspension or withdrawal of approval.

Reporting and Monitoring

The Australian Code for the Care and Use of Animals for Scientific Purposes requires Animal Ethics Committees (AEC) to monitor research projects for which they have given ethical approval in order to ensure that they confirm to the protocol approved.

The principal reason for monitoring research projects in accordance with the Code is to ensure that the activity is not jeopardising the wellbeing of animals.

  REPORTING WHO IS RESPONSIBLE? STEPS
1 Variations to Project Reporting Principal Researcher Any proposed variations or modifications researchers might wish to make to an approved project must be submitted to the AEC for consideration and approval.
2 Incidents and adverse or unforeseen effects Principal Researcher

Incidents, adverse effects and unforeseen events must be reported immediately to Research Services.

Failure to do so will result in discontinuation of approval and/or disciplinary action.  Principal Researchers are responsible for ensuring that these incidents are reported.

Principal Researchers must also provide details of steps (proposed or taken) to deal with such incidents.

3 Annual reports Principal Researcher

It is a condition of approval that the Principal Researcher submits an annual report prior to 15th of January each year from project commencement until the conclusion of the project. The report must be made on the appropriate form, be signed by all investigators, and provide the following information:

  • Details of progress to date;
  • Maintenance and security of records;
  • Compliance with the approved protocol;
  • Compliance with any conditions of approval;
  • Details of any serious or unexpected adverse effects of the research on the care and use of animals which may have occurred, and of
  • Steps taken to deal with these;
  • Changes in the research protocol; and
  • Any other problems relating to the conduct of the project.

Failure to complete and return an annual report by the due date may lead to suspension or withdrawal of ethics approval.

4 Final reports Principal Researcher

It is a condition of approval that:

  • The Principal Researcher submits a final report on completion/discontinuation of a project

This final report will include:

  • A summary of the results of the project,
  • Whether the aims of the project were achieved,
  • Maintenance and security of records
  • Compliance with the approved protocol and
  • Compliance with any conditions of approval.

The final report must also contain:

  • Details of any serious or unexpected adverse effects of the research on the care and use of animals which may have occurred;
  • Steps taken to deal with these;
  • Changes in the research protocol; and
  • Any other problems relating to the conduct of the project.

Failure to complete and return a final report by the due date may lead to suspension or withdrawal of ethics approval.

Auditing

In line with the Code, the AEC has determined that auditing must be carried out and it should relate to all ethics applications. The emphasis of the audit process is on research which involves higher risks.

Audit Procedures

The audit process may be carried out in a variety of ways:

  • Investigators may be invited to attend a meeting of the Animal Ethics Committee to discuss their project and annual report, to provide evidence of the work they have completed to date including documentation and to answer any queries the Committee might have regarding the project;
  • A representative of the AEC may visit field sites, housing facilities and laboratories to inspect facilities;
  • In addition to discussing the conduct of a project with the researchers the audit team may inspect facilities for storing data securely,examine the way data is being maintained including who has access, and consider the way risk and any unexpected outcomes have been managed in the project.

Suspension or Discontinuation of Research

Where the Chair of the Animal Ethics Committee is satisfied that circumstances have arisen such that a research project is not being or cannot be conducted in accordance with the approved protocol, including any conditions of approval, the AEC may withdraw approval and recommend that the research project be discontinued, suspended or that other necessary action be taken.

A researcher must not continue the research if ethics approval has been withdrawn and must comply with any special conditions required by the AEC.

Complaints and Appeals Procedures

Complaints related to the ethical aspects of research

Complaints or concerns relating to the ethical aspects of a research activity should be directed to Research Services in the first instance. The procedure for investigation would normally be:

  Action Responsible Comments
1 Submission of complaint Staff member Student General Public Complainant submits their complaint or concern in writing to the Ethics Officer in Research Services.
2 Lodgement of complaint with Chair Ethics Officer Ethics Officer lodges the complaint or concern with the Chair of the AEC and notifies the DVC(RI) of the complaint.
3 Chair considers complaint Chair The Chair (or a delegate of the Chair) considers the complaint, including, where necessary, reference to original approved protocol.
4 Chair reports to the DVC(RI) Chair The Chair reports their finding to the DVC(RI)
5 Investigation of complaint DVC(RI) The DVC(RI) orders the investigation of the complaint, if required, under the Staff Conduct Policy and/or the Code for the Responsible Conduct of Research procedures.
6 Notification to the AEC DVC(RI) The DVC(RI) will report on the status of an investigation to the AEC, as required.

Complaints concerning ethics administration and Committee decisions

If a researcher wishes to appeal the decision of the AEC about their research project or express concerns about the ethics administration process, the following action would normally be taken.

  Action Responsible Comments
1 Submission of complaint Applicant Complainant submits their complaint or concern in writing to the Ethics Officer in Research Services.
2 Consideration of complaint

AEC

Ethics Officer Associate Dean Research

The AEC and the Ethics Officer consider the complaint.

The relevant Associate Dean Research may be consulted, if required.

3 Applicant advised of outcome Ethics Officer

The Ethics Officer will advise the applicant of the outcome of the consideration of their complaint.

Responsibility

Researchers must ensure that:

  • No activity involving the use and care of animals is conducted which has not received prior approval by the AEC;
  • All relevant information has been provided to the AEC;
  • All relevant guidelines and legal requirements are complied with;
  • Monitoring requirements are complied with;
  • Proposed protocol modifications and amendments are submitted to the AEC for approval;
  • Adverse events are promptly notified to the AEC.

Researchers are expected to declare:

  • Sources of funding;
  • Commercial sponsorship and/or involvement;
  • Relevant personal and/or competing interests, including consultancies, paid travel, shareholdings, patents or patent applications, etc.

Research Services is responsible for: 

  • Liaising with researchers, the AEC Chair and the AEC;
  • Providing executive support to the AEC;
  • Informing researchers of the outcome of their applications;
  • Coordinating the annual and final reporting for approved projects;
  • Collating annual reports for various Government departments;
  • Reporting to Federation University Australia governing bodies, as required.

AEC is responsible for:

  • Assessing and approving all applications in accordance with the relevant governing documents;
  • Monitoring approved applications throughout their lifecycle;
  • Operating in accordance with the Australian Practice for the care and use of animals for scientific purposes;
  • Notifying the DVC(RI) of any potential issues relating to ethics in research in a timely manner.

Promulgation

The Animal Research Ethics Procedure will be communicated throughout the University via:

  1. an Announcement Notice under ‘FedNews’ website and through the University Policy - ‘Recently Approved Documents’ webpage to alert the University-wide community of the approved Policy;
  2. inclusion on the University Policy, Procedure and Forms website; and/or
  3. distribution of e-mails to Head of School / Head of Department / University staff; and/or
  4. documentation distribution, eg. posters, brochures.
  5. Other - please describe

Implementation

The Animal Research Ethics Procedure will be implemented throughout the University via:

  1. Information Sessions; and/or
  2. Training Sessions; and/or
  3. Other - please describe

Forms/Record Keeping

Title Location Responsible Officer Minimum Retention Period
AEC Application Forms Research Services Director, Research Services 7 years
AEC Approval Notification Forms Research Services Director, Research Services 7 years
AEC Amendment Request Forms Research Services Director, Research Services 7 years
AEC Change of Personnel Request Forms Research Services Director, Research Services 7 years
AEC Project Extension Request Forms Research Services Director, Research Services 7 years
Annual Project Report Forms Research Services Director, Research Services 7 years
Final Project Report Forms Research Services Director, Research Services 7 years
Incident Report Forms Research Services Director, Research Services 7 years
Complaints/Misconduct Report Forms Research Services Director, Research Services 7 years