PROCEDURE

/ Animal Ethics Procedure
Operational Responsibility: / Research Integrity, Governance & Systems
Related Policy: / Research Integrity Policy
PROCEDURE STATEMENT
INTENT / The intent of this procedure is to outline the processes, resources and infrastructure at RMIT University (RMIT) to promote ethical and responsible animal research and teaching practices at RMIT. State legislation and the National Health and Medical Research Council (NHMRC) Australian Code of Practice for the Care and Use of Animals for Scientific Purposes 8th Edition 2013 (the Animal Code) govern the use of live non-human vertebrates and higher-order invertebrates in research and teaching. The relevant state Government Department regulates the use of animals in research and teaching and audits the operation of Animal Ethics Committees, the use of animals in approved projects, and inspects animal facilities.
The procedure identifies the resources, infrastructure, professional development and education opportunities and the policies and procedures available to researchers to ensure their conduct is consistent with institutional policies and procedures, industry regulations, and legislation.
This procedure also outlines how the Animal Ethics Committee (AEC) operates to assist RMIT researchers in the care and use of animals in teaching and research activities consistent with the Animal Code, legislative requirements and current best practice. To this end the RMITAEC has the responsibility of reviewing and approval all teaching and research involving animals at any campus, including fieldwork and wildlife studies undertaken off-campus.
SCOPE / Applicable to all staff, students, visiting researchers, honorary and adjunct appointees and non-RMIT organisations using RMIT facilities undertaking or supporting research at all RMIT campuses and external research locations.
EXCLUSIONS / Research not reasonably considered to be the responsibility of RMIT

PROCEDURE STEPS AND ACTIONS:

Procedure (including Key Points) / Responsibility / Timeline
  1. Research Ethics at RMIT
The University provides an environment that supports best research practice that is consistent with relevant codes and legislation and encourages an environment that enables high quality research that is ethical and conducted with a high degree of integrity. All research and teaching at RMIT that involves animals requires prior approval from the RMITAEC.
Integral to an environment that nurtures high quality research and research practices is a rigorous and robust process for the ethical review and approval of projects as well as a framework of high quality education, professional development opportunities, policies and procedures and resources for research. Implementing this framework assists researchers to meet their responsibilities and minimises the occurrence of researchers and research administrators deviating from acceptable research practices.
  1. Responsibilities
Animal Ethics Committee: have a primary responsibility to ensure, on behalf of the institution for which it acts (RMIT), that all activities relating to the care and use of animals are conducted in compliance with the Animal Code. TheRMITAEC achieves this by being responsible for robust review of all applications for animal use in research and teaching, and has responsibility to actively promote the welfare of animals in research and teaching at RMIT.
Animal Facility Management Committee: is responsible for the management of the RMIT animal holding facilities.
Facility Manager: is the person(s) responsible for the day to day activities of RMITanimal housing facilities, including but not limited to standard laboratory animals and aquatic animals. This person(s) provide advice to the AEC on the capabilities of the variousanimal facilities, in terms of technical expertise and space availability.
Animal Welfare Officer (AWO): is a veterinarian who provides high level technical advice to the AEC and support to research and teaching staff (and students) during the routine care and use of animals. The AWO’s primary role is to ensure that the high standards of animal welfare as prescribed by RMIT are maintained in all teaching and research activities, and is appropriately qualified to fulfil these duties. The AEC may direct the AWO to inspect animal holding facilities and field research sites in addition to the continual monitoring of AEC approved research projects. Consistent with the powers granted under section 24D of the POCTA Act, the AWO may act without specific instruction from the AEC if required.
Deputy Vice Chancellor, Research and Innovation (DVC R&I):is a person who is responsible for the overall institutional governance with respect to the care and use of animals in research and teaching activities. Oversight of the AEC and animal welfare at RMIT is delegated by the DVCR&I to the Chair of the RMITAEC and the Director, Research Integrity Governance and System (RIGS). The Chair and Director have oversight of both the AEC and of all official communications with the Department.
Designated Person: is a person who is experienced in research and research practice management. In performing their role they have a responsibility to conduct preliminary investigations of all formal allegations of conduct that deviates from institutional research policy and procedure and conclude whether a prima facie case of research misconduct exists.
Licence Holder:is RMIT. As detailed under section 26 (2) of the POCTA Act, the licence holder nominates a natural person(s) to be responsible for any procedures carried out on any RMIT premises.
Licence Nominees: are a person(s) nominated by the licence holder for each Scientific Procedures Premises Licence (SPPL) or Scientific Procedures Fieldwork Licence (SPFL). As the licence nominee, they are ultimately responsible for ensuring scientific procedures are conducted in accordance with the conditions of the licence.
Principal Investigator: must be a member of RMIT staff, or a person deemed acceptable by the AEC. The Principal Investigator is responsible for the overall management and conduct of an individual project.
Researchers and Research Administrators: are any persons at RMIT who are engaged in the conduct or administration of research or learning and teaching practices involving animals. They have a responsibility to understand and apply the relevant policies and procedures and any other relevant regulations and/or legislation that may be applicable to their learning, work or research. Researchers have ultimate responsibility to submit an application to the AEC, and to obtain written approval from the AEC, prior to the commencement of any research or teaching involving animals. Further, as a condition of AEC approval, researchers must submit an annual report on the progress of their studies at the conclusion of each calendar year for the life of the project.
RMIT University:has a responsibility to provide an environment that supports responsible and best research and teaching practice that is consistent with the Australian Code for the Responsible Conduct of Research 2007 (the Code) and the Animal Code.
  1. Relevant Legislation and Guidelines
The Australian Code for the Care and Use of Animals for Scientific Purposes 8th Edition 2013 (the Animal Code), and the Prevention of Cruelty to Animals Act 1986 (Vic) (the POCTA Act) and associated regulations outline the appropriate use of live non-human vertebrates and higher-order invertebrates for research and training purposes.
Where RMIT researchers conduct research in locations interstate, in the field or at other institutions, they should be aware they may be subject to different legislation, codes and regulations and may need to seek ethical approval from another Animal Ethics Committee.
  1. Role of the Animal Ethics Committee
The RMITAEC’s role is to approve justified animal use on behalf of the SPPL/SPFL licence holder (RMIT).
All use of live non-human vertebrates and higher-order invertebrates for research and teaching is reviewed by the RMITAEC. Any animal (regardless of origin) can only be used in teaching or research with explicit RMITAEC approval. The RMITAEC:
(i)Applies the principles outlined in the Animal Code.
(ii)Oversees the conduct of the institution’s care and use of animals for scientific purposes, in both a teaching and research context,
(iii)Oversees compliance with the principles of Replacement, Reduction and Refinement as described in the Animal Code,
(iv)Monitors and inspects all animal facilities and comments on plans for changes and developments to animal holding areas,
(v)Monitors all animal use via (but not limited to) the receipt of yearly annual and final reports for all AEC approved projects,
Secretariat and policy support to the AEC is provided by the Research Integrity, Governance & Systems team.
  1. AEC Terms of Reference
The AEC is a Committee of the Deputy Vice-Chancellor, (Research and Innovation), as the Delegate of Council. The Committee has been formed in line with the requirements of the Animal Code and thePOCTA Act.
The terms of reference are based upon the requirements of the Animal Code. Where there is a conflict with the Animal Code or an omission then the relevant section of the Animal Code shall apply.
  1. AEC Membership
The AEC comprises membership as defined under the Animal Code. The Chairperson of the AECshould hold a senior position in the University, and is appointed by the DVCR&I.Normally, the Chairperson will be independent ofthe care and use of animals for scientific purposes. If the Chairperson is an external appointee, they will be given the necessary support and authority to carry out the role.
Normally, a Category B member of the AEC will be appointed as Deputy Chairperson.
Appointments to the various categories are made by the DVCR&I. In addition to the categories of members defined in the Animal Code, there will normally be additional members appointed, including the relevant Facility Manager(s), and the AWO.
The AEC is empowered to solicit independent external advice from time to time on scientific, statistical, welfare or other matters, as required.
  1. Application Process
Application procedure:
(i)Applications to use animals in teaching and research will use the RMITAEC approved forms, and be submitted as per the instructions, provided electronically on the RMIT website;
(ii)The Principal Investigator must be a member of RMIT staff, or a person deemed acceptable by the AEC;
(iii)Applications are to be completed in consultation with the AWO and Facility Manager, to ensure that RMIT has the capacity and technical expertise to house and care for the animals being applied for, where appropriate;
(iv)Applications are to be submitted electronically, according to the schedule of dates provided on the AEC website, to the AEC Secretary. Applications which fail to meet submission dates or other requirements will be held over to the following meeting;
(v)Once approved, an Application will have a maximum approval period of three years from the date of approval;
(vi)Amendments to existing projects, including changes to investigators, animals, protocol or extensions to approval time, must be submitted using the AEC approved forms, and as per the instructions, provided electronically on the RMIT website.
Animal research involving Genetically Modified Organisms (GMOs):
(i)Where animal research involves GMOs, this must be clearly identified on the AEC application form.
(ii)All animal research involving GMOs must also be reviewed and approved by the RMIT Institutional Biosafety Committee (IBC) before commencing.
  1. Monitoring and Withdrawal of Approval
The AEC will monitor the conduct of approved projects through a system of annual and final reporting, review of Adverse Incident Report forms, and with the assistance and advice of the AWO.
As a condition of approval for all projects, researchers must submit an annual report at the end of each calendar year for the life of the project (regardless of the duration of AEC approval for the project). This will be replaced by a final report for the final year in which the project is undertaken. These reports will detail the animals used so far in the project, what progress has been made towards the objectives of the study and any adverse incidents or animal welfare concerns observed over the reporting period. In addition, the final report will provide a conclusion statement of the outcomes of the project, and outline any publications (either submitted or in progress) resulting from the project.
The AEC may withdraw approval for any project. The AECmay do so when:
(i)Through the course of an inspection it is identified that the welfare of animals has been compromised through practice that is inconsistent with the approved project. In this instance the Chairperson, Deputy Chairperson, or AWOmay require that the activities (either the specific activity in question or the full project) cease immediately;
(ii)The AECbecomes aware that an animal is being used in a manner inconsistent with the approved protocol;
(iii)It becomes apparent that the approved protocol has a greater impact on animal welfare than originally understood;
(iv)The Chief Investigator does not fulfil their annual reporting requirements; or
(v)Any other instance of non-compliance with the Animal Code, which the AEC deems of sufficient nature to warrant withdrawal of approval for a project.
Where the AEC has withdrawn approval for a project, the AEC Chairperson will notify the line manager and licence holder, and may also notify the Department if appropriate.
In reviewing cases of non-compliance or situations in which animal welfare has been compromised, the AECmay refer the matter to the institution (the Designated Person at RMIT), or the Department as appropriate, for investigation. Where appropriate, the AECmay refer a matter to the institution (the Designated Person at RMIT) for investigation under the Research Misconduct Procedure.
  1. Multi-Centre Research
If a planned project involves researchers from RMIT and other collaborating institutions (including within Australia and overseas), it is essential that the respective institution’s responsibilities be formally acknowledged via submission of any ethics approvals granted by an animal ethics committee or other relevant review body for review by the AEC. The AEC should review and note the approval, with particular attention concerning the arrangements to protect the welfare of all animals involved.
In Australia, RMIT staff members will remain compliant with the Animal Code at all times, including when at other institutions. While outside Australia, RMIT staff members will remain compliant with the Animal Code at all times where possible.
If the research being conducted involves RMIT investigators that will work with animals under the sole responsibility of another institution, and that work is reviewed by another AEC constituted in accordance with the Animal Code, this research will not be subject to additional review by the RMITAEC. A copy of the application approved by the other institution’s AEC must be submitted to the AEC Secretary prior to any staff member working on an external project.
  1. Reporting
The AEC shall report, in writing, monthly to Council, through the Deputy Vice-Chancellor (Research and Innovation) via Research Committee, on its activities including:
(i)The numbers and types of projects approved and not approved;
(ii)The physical facilities for the care and use of animals within the University;
(iii)Actions that have supported the educational and training needs of AEC members and people involved in the care and use of animals;
(iv)Any difficulties being experienced by the Committee;
(v)Requirements for training staff and students;
(vi)Its current membership;
(vii)Details of any breaches of the Act and the Animal Code.
The AEC also has a responsibility to report to regulatory authorities and should do so in accordance with those requirements. Such reports should be made available to the DVC (R&I) and other committees as appropriate.
  1. Standard Operating Procedures
As prescribed by the Animal Code the AEC can establish Standard Operating Procedures (SOPs) relating to the care and use of animals. SOPs may be referenced in applications to help standardise the application process. New SOPs may not be used unless approved by the AEC, and must be reviewed every three years.
Approved SOPs are made available online to all researchers and AEC members. SOPs should only be used where appropriate.
  1. Adverse events
Any unexpected adverse event, in which animal welfare has been impacted beyond what has been identified in the approved project, must be reported to the AWO, the Facility Manager and the AEC Secretary as soon as it is discovered. An Adverse Incident Report Form must be provided to the AEC Secretary, including details of the incident and any action taken or that will be taken. At the next scheduled AEC meeting this incident and any subsequent actions will be reviewed for a coordinated committee response. Where appropriate, the AEC Chair will notify the line manager, licence holder, and the Department.
  1. Complaints
13.1 - Complaints regarding the use of animals at RMIT.
Where a complaint has been received concerning the treatment of animals at an RMIT facility either by staff, students, members of the public or any other concerned persons, it will be provided to the Designated Person who will work with the AEC to either resolve the complaint or investigate the incident to determine whether a prima facie case of research misconduct can be substantiated.
13.2 - Complaints regarding the operation of the AEC.
Complaints regarding the operation of the AEC should be made in writing directly to the AEC in the first instance. In the event that communication between the AEC and the complainant cannot resolve the complaint,the AEC will form a subcommittee to investigate the facts of the complaint, write a report, and formulate a response. In the event that the AEC subcommittee cannot resolve the complaint, RMIT will provide the complainant with access to a person external to the AEC for review of the operational process followed by the AEC. This will normally be the Designated Person. Following this review, and any recommendations made therein, the AEC may decide to review its process in reaching the decision which forms the basis of the complaint. The ultimate decision regarding the ethical acceptability of an activity lies with the AEC, and must not be overridden.
  1. Facilities
All animal facilities used for research and teaching purposes at RMITwill be inspected and approved by the AEC. Any facilities in Victoria, as required, will be registered with the Department. Both the AEC and the Department regularly inspect these animal facilities to ensure compliance with the relevant regulatory requirements.
  1. Field work and observational studies
Where an institutional researcher wishes to engage in field work, they should be aware that they may require permission from other authorities in addition to AEC approval. A copy of any permits obtained for field work or observational studies should be retained by the AEC prior to commencement of the work. The AEC or authorised delegates have the authority to inspect field work or observational studies.
Supporting Instructions or Documents / Research Integrity Policy
Australian Code for the Care and Use of Animals for Scientific Purposes
Related Documents / Adverse Incident Report Form

PROCEDURE FURTHER INFORMATION

Commencement date / Review date / Secretariat Posting Approval

REVISION HISTORY – section maintained by the University Policy Officer

Revision Ref. No. / Status / Type Amendment / Date Approved / Approval Authority / Resolution Number / TRIM Reference
Approval/Other
V1.0

ACCOUNTABILITIES

Policy Sponsor: / Deputy Vice-Chancellor (Research & Innovation)
Implementation: / Research Integrity, Governance & Systems
Compliance: / Research Integrity, Governance & Integrity, Animal Ethics Committee, Animal Welfare Officer, Animal Facility Manager and researchers
Monitoring and Evaluation: / Research Integrity, Governance & Systems
Development/Review: / Research Integrity, Governance & Systems
Approval Authority: / RMIT Research Committee
Interpretation and Advice: / Research Committee, Animal Ethics Committee, Research Ethics Coordinator
Data Collection and Analysis:

WHO SHOULD KNOW THIS PROCEDURE?

Any researcher undertaking research involving animals at RMIT

EFFECTIVENESS OF THIS PROCEDURE

How will the efficiency and effectiveness of this procedure be measured?

PROCEDURE SUPPORTING INFORMATION