Animal ethics process

Purpose

To ensure that animal research and teaching practices at RMIT are ethical, responsible and consistent with institutional policy, legislation and guidelines.

Scope

This process applies to all research conducted by RMIT researchers unless approval is obtained from another institution where this is appropriate.

Definitions

Adverse Event: Any event that has a negative impact on the wellbeing of an animal, which is anticipated by the researcher and included in the ethics application, see also ‘unexpected adverse event’ (defined below)

Amendment: A variation to an approved ethics application.

Animal: For this process and based on Victorian state requirements, an ‘animal’ means:

(a) a live member of a vertebrate species including any

(i) fish or amphibian; or (ii) reptile, bird or mammal, other than any human being or any reptile, bird or other mammal that is below the normal mid-point of gestation or incubation for the particular class of reptile, bird or mammal; or

(b) a live adult decapod crustacean, that is

(i) a lobster; or (ii) a crab; or (iii) a crayfish; or

(c) a live adult cephalopod including

(i) an octopus; or (ii) a squid; or (iii) a cuttlefish; or (iv) a nautilus.

Animal Code: The Australian Code for the Care and Use of Animals for Scientific Purposes under Part 3 of The Prevention of Cruelty to Animals Act 1986 and Regulations 1997, and as a funding requirement of the National Health and Medical Research Council and the Australian Research Council.

Committee: Any Animal Ethics Committee constituted in line with the Australian Code for the Care and Use of Animals for Scientific Purposes.

Animal Facility Manager: The person(s) responsible for the day to day activities of RMIT animal housing facilities, including but not limited to standard laboratory animals and aquatic animals. This person(s) provide advice to researchers and the RMIT Animal Ethics Committee on the capabilities of the various animal facilities, in terms of technical expertise and space availability.

Animal welfare: An animal’s quality of life, which encompasses the diverse ways an animal might perceive and respond to their environment, ranging from a positive state (when an animal is healthy, comfortable, well nourished, safe, able to express innate behaviour, and not suffering from pain, fear, and distress) to a negative state (where an animal is in pain, experiencing fear or distress). Good animal welfare requires disease prevention and veterinary treatment, appropriate shelter, management, nutrition, humane handling and humane killing.

AWO - the Animal Welfare Officer: An RMIT staff member who provides veterinary support and advice on animal welfare to researchers and the institution.

Chairperson: The Chairperson of the RMIT Animal Ethics Committee

Code: The Australian Code for the Responsible Conduct of Research

Delegated Researcher: Where the Principal Investigator is on leave they will delegate another research named on the ethics application to fulfil their responsibilities as regards the ethical aspects of the project.

Department: The State Government department responsible for enforcing compliance with the Animal Code. In 2016, this is the Biosecurity division, in the Department of Economic Development, Jobs, Transport and Resources in Victoria.

Deputy Chairperson: The Deputy Chairperson of the RMIT Animal Ethics Committee

Designated Person: the person performing the role of the Designated Person as defined in the Code; the Executive Director, Research Office is the Designated Person for RMIT as nominated by the Vice-Chancellor.

External Approval: Approval received from an animal ethics committee that is not listed on an RMIT held Scientific Procedures Premises Licence (SPPL).

External Project: A research project that is the sole responsibility of another institution

Facilities: Places where animals are kept including yards, paddocks, tanks, ponds and buildings.

Licence Holder: RMIT is the licence holder. As detailed under section 92 of the Prevention Of Cruelty To Animals (POCTA) Regulations, the licence holder will ensure compliance with the conditions on the licence and relevant codes of practice. As detailed under section 26 (2) of the POCTA Act, the licence holder will nominate a natural person(s) to be responsible for any procedures carried out on any RMIT premises (licence nominee).

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.

Line Manager: A person with managerial or supervisory responsibilities.

Minister: The appropriate State Government Minister. In 2016, the Victorian Minister for Agriculture.

POCTA Act: Prevention of Cruelty to Animals Act 1986 (Vic)

POCTA Regulations: Prevention of Cruelty to Animals Regulations 2008 (Vic)

Principal Investigator: The researcher with overall responsibility for the conduct of the research project.

Project: A scientific activity or activities that involves the use of animals in scientific procedures that form a discrete piece of work. A project cannot commence until it has been approved by an AEC.

RMIT Committee: The RMIT Animal Ethics Committee in Victoria. For more information see the Animal Ethics Committee Terms of Reference on the RMIT website.

Scientific Procedures: As in Section 3 of the Prevention of Cruelty to Animals Act 1986.

Secretary: The Secretary to the RMIT Animal Ethics Committee

SPFL: Scientific Procedures Fieldwork Licence.

SPPL: Scientific Procedures Premises Licence.

Unexpected Adverse Event: Any unexpected adverse event in which animal welfare has been impacted beyond what has been identified in the approved project, see also Adverse Event (defined above).

Process steps

1. Animal ethics at RMIT

1.1. All research and teaching at RMIT that involves animals requires prior approval from the RMIT Animal Ethics Committee (the RMIT Committee).

1.2. RMIT University provides professional development, resources, processes and infrastructure that support researchers to know when they require ethical approval, and to gain and conduct research in line with ethical approval and with relevant codes, legislation and RMIT policy.

1.3. In Australia, RMIT researchers 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 provided that such compliance does not breach any relevant local legislation. Research cannot be conducted in other Countries as a mechanism of avoiding compliance with the Animal Code. For advice on this, contact the Secretary.

2. Gaining animal ethics approval

2.1. Use of animals in research:

2.1.1. Any animal can only be used in research at RMIT with explicit RMIT Committee approval.

2.1.2. The Principal Investigator will:

     2.1.2.1. Be a member of RMIT staff, or a person deemed acceptable by the RMIT Committee;

     2.1.2.2. Apply using the RMIT Committee approved forms provided on the RMIT website.

     2.1.2.3. Discuss applications with the Animal Welfare Officer and Facility Manager(s), to ensure that RMIT has the capacity and technical expertise to house and care for the animals, as appropriate;

     2.1.2.4. Submit applications electronically to the Secretary in line with the instructions provided on the RMIT website.

2.1.3. Submission dates are provided on the RMIT Committee website. Applications which fail to meet submission dates or other requirements will be held over to a following meeting;

2.1.4. A project has a maximum approval period of three years from the date of approval.

2.2. Use of animals in teaching

2.2.1. All use of animals in teaching requires ethics approval. The process for gaining this approval is the same as in Section 2.1.1 – 2.1.3.

2.3. Animal research involving Genetically Modified Organisms (GMOs):

2.3.1. Researchers will clearly identify where animal research involves GMOs, either as GM animals or exposure of animals to GMOs, on the animal ethics application form.

2.3.2. Researchers using GMO animals will also apply for and gain approval from the RMIT Institutional Biosafety Committee (IBC) before commencement of the project. See Research involving GMOs process.

2.4. Field work and observational studies

2.4.1. Researchers who engage in field work will gain any required permissions from other authorities, in addition to RMIT Committee approval.

2.4.2. Where required, the researcher will submit a copy of any permits obtained for field work or observational studies to the RMIT Committee, before starting the work. The RMIT Committee will retain a copy of any permits provided.

2.4.3. The RMIT Committee, or authorised delegates, has the authority to inspect field work or observational studies.

2.5. Multi-Centre Research (in Australia and Overseas)

2.5.1. Where RMIT is responsible, in part or full, for the research and the planned project also involves researchers from other institutions:

     2.5.1.1. The ethics applications will formally acknowledge the respective institutions’ responsibilities and provide detailed information on the arrangements to protect the welfare of all animals involved.

     2.5.1.2. An RMIT researcher will submit any ethics approvals granted by a Committee or other relevant review body for review to the RMIT Committee.

2.5.2. Where the research is the sole responsibility of another institution and the planned project also involves researchers from RMIT:

     2.5.2.1. The RMIT Committee will not review research that is the sole responsibility of another institution (i.e. an external project), provided the research is reviewed by another Committee constituted in line with the Animal Code.

     2.5.2.2. RMIT researchers involved in an external project will submit a copy of the application approved by the other institution’s Committee to the RMIT Secretary for acknowledgement, before undertaking any scientific procedures on animals.

3. Review of applications

3.1. The RMIT Committee reviews all applications and amendments for animal use in research and teaching activities at RMIT in line with relevant codes, legislation, policy and processes.

3.2. The RMIT Committee will inform the Principal Investigator of the outcome of the review in a timely manner.

4. Amendment to an approved application

4.1. Amendments are required where researchers plan to vary any aspect of their approved project, including changes to investigators, number or type of animals used, protocols or extensions to approval time.

4.2. Researchers will gain RMIT Committee approval for an amendment prior to implementing the change.

4.3. Researchers will seek approval for an amendment to extend ethics approval before the approval period has expired. Research activities that require ethical approval will not continue when such approval has expired.

4.4. For amendments to projects approved by an RMIT ethical review body:

4.4.1. The Principal Investigator will submit an application for an amendment electronically, in line with the forms and any applicable instructions and/or schedule of dates provided on the RMIT Animal Ethics website. Applications which fail to meet any applicable submission dates will be held over to a future meeting.

4.4.2. The Principal Investigator may contact the Secretary or the Chairperson to request urgent review, where an amendment is time critical. The Chairperson determines if the Animal Code allows for an out of session review to be carried out prior to the next available Committee meeting.

5. Reporting

5.1. The Principal Investigator will submit an annual report at the end of each calendar year for the life of the project (regardless of the duration of animal ethics approval for the project).

5.2. The annual report will detail the project progress over the past 12 months including: 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 (including details regarding the nature of the animal welfare concern and the frequency if it is repeated).

5.3. Ongoing approval of a project is conditional upon the submission of annual reports.

5.4. In the final year of a project, the Principal Investigator will submit a final report within six months of the end of the approval period.

5.5. The final report will detail: the total numbers of animals used in the project; the progress made towards the objectives of the study; any adverse incidents or animal welfare concerns observed over the reporting period (including the number and types). The report will also provide a conclusion statement of the outcomes of the project, and outline any publications (either submitted or in progress) resulting from the project.

5.6. Annual and final reporting will be undertaken using the RMIT Committee approved forms, and be submitted as per the instructions, provided on the RMIT website.

5.7. Reports are still required even where an approved project has not commenced or has been abandoned.

5.8. The RMIT Committee may decide not to review new applications from a Principal Investigator, whilst annual and final reports for previous projects remain outstanding.

6. Adverse events

6.1. The Animal Code requires detection, investigation and reporting of adverse events. Researchers will be aware of and accept their responsibilities under the Animal Code. These include:

6.1.1. Providing appropriate and sufficient detail about expected adverse events in ethics applications;

6.1.2. Developing, implementing and reviewing strategies to detect, avoid and minimise any pain and distress in animals;

6.1.3. Ensuring animals are monitored and assessed at all stages of the project or activity for signs of pain and distress, including deviations from normal behaviour; and

6.1.4. Prompt notification of any unexpected adverse event (see Section 7 below).

7. Unexpected adverse events

7.1. An unexpected adverse event occurs when animal welfare is or may be negatively impacted, and this was not identified or foreshadowed in the approved project or activity. Unexpected adverse incidents that will be reported include:

  • Death of an animal under anaesthesia;
  • Death of an animal during or after surgery;
  • Death of animal during or after a procedure or treatment e.g. oral gavage, intraperitoneal injection;
  • Other unexpected events detrimental to animal wellbeing (including death) before or after a procedure or treatment;
  • When there is a greater level of pain or distress than predicted in the original project;
  • When adverse events occur in a larger number of animals than predicted in the original project; or
  • An emergency situation such as a power failure, inclement weather or other factors external to a project or activity that negatively impact the welfare of animals.

7.2. Where there is any uncertainty or ambiguity as to whether an unexpected adverse event has occurred, researchers will consult the AWO for advice. The AWO will determine whether the adverse event constitutes an unexpected adverse event, in consultation with relevant parties.

7.3. Prompt action will be undertaken to alleviate pain and distress that were not anticipated in an approved project or activity, or that occur as a result of an emergency. This action takes precedence over the project or activity and may include immediate humane killing.

7.4. Investigators will report all unexpected adverse events and emergencies promptly to the RMIT Committee, using the RMIT Adverse Incident Report Form. This form will be completed and submitted by the Principal Investigator or in their absence the Delegated Researcher.

7.5. Following receipt of the completed Adverse Event Report Form, this Form will be added to the agenda for the next scheduled meeting. At this meeting this incident and any subsequent actions will be reviewed by the RMIT Committee. The RMIT Committee may require researchers to provide further information and/or carry out further actions. Where appropriate and/or as required, the RMIT Committee will notify the line manager, licence holder, and/or the Department.

8. Animal deaths

8.1. When an animal dies unexpectedly, or is humanely killed due to unforseen complications, a post-mortem (necropsy) should be performed.

8.2. The necropsy will be performed by a person competent in post mortem procedures, at RMIT this will normally be the AWO. In the event that the AWO is absent or unavailable, contact the Animal Facility Manager who will make alternative arrangements.

8.3. Where there is any uncertainty if an animal death should be reported as an unexpected adverse event, researchers will consult the AWO (see Section 7 above).

9. Monitoring approval

9.1. The RMIT Committee will monitor all approved projects and activities that involve the care and use of animals at RMIT.

9.2. The RMIT Committee will monitor the care and use of animals through inspecting animals, animal housing and the conduct of scientific procedures, and/or reviewing records and reports (including annual and final reports, review of Adverse Incident Report forms). The AWO will assist and advise.

10. Suspension and/or withdrawal of approval

10.1. The RMIT Committee may suspend or withdraw approval for any project when:

10.1.1. The welfare of animals has been compromised through practice that is inconsistent with the approved project. In this instance the Chairperson, Deputy Chairperson, and/or AWO may require that the activities (either the specific activity in question or the full project) cease immediately; or

10.1.2. An animal is being used in a manner inconsistent with the approved protocol; or

10.1.3. The approved protocol has a greater impact on animal welfare than originally understood; or

10.1.4. The researchers do not fulfil their reporting requirements; or

10.1.5. Any other instance of non-compliance with the Animal Code, which the RMIT Committee deems of sufficient nature to warrant suspension or withdrawal of approval for a project.

10.2. Where the RMIT Committee has suspended or withdrawn approval for a project, the Chairperson will notify the line manager of the Principal Investigator and licence holder, and may also notify the Department and other parties as appropriate and/or as required.

10.3. In reviewing cases of non-compliance or situations in which animal welfare has been compromised, the RMIT Committee will refer the matter to the institution (the Designated Person at RMIT), or the Department as appropriate, for consideration. Where required, the RMIT Committee will refer a matter to the institution (the Designated Person at RMIT) for consideration in line with the Research misconduct process.

11. Standard operating procedures

11.1. As set out in the Animal Code, the RMIT Committee can establish approved Standard Operating Procedures (SOPs) relating to the care and use of animals.

11.2. The RMIT Committee will review SOPs every three years.

11.3. Researchers are encouraged to reference approved SOPs in ethics approval applications to help standardise the application. SOPs should only be used where appropriate.

11.4. Approved SOPs are available online for all RMIT researchers and Committee members.

12. Facilities

12.1. The RMIT Committee will inspect and approve all animal facilities used for research and teaching purposes at RMIT at least annually, to ensure compliance with the relevant regulatory requirements. The Department will also inspect these animal facilities, as required.

12.2. The licence holder will register any RMIT facilities in Victoria with the Department.

12.3. Should additional facilities be required for use in animal research, researchers will contact the Secretary who will provide advice and liaise with the Department to register these facilities for use.

13. Complaints

13.1. Complaints concerning animal research:

13.1.1. Staff, students, members of the public, or any other concerned persons may make a complaint concerning animal research or teaching at RMIT.

13.1.2. These complaints will be forwarded to the Secretary and the Research Office will respond, as appropriate.

13.2. Complaints concerning the care and use of animals at an RMIT facility:

13.2.1. Staff, students, members of the public, or any other concerned persons may make these complaints.

13.2.2. Where there is apparent ongoing animal welfare impacts that extend beyond those described in the application, the institution may require that researchers cease activities and the AEC may suspend or withdraw approval.

13.2.3. These complaints will be forwarded to the Secretary who will notify the Research Office, the AWO and the Chairperson. The Research Office will acknowledge receipt of the complaint, and take one or more of the following steps:

     13.2.3.1. Where the complaint relates to activities that would normally require RMIT Committee ethics approval, refer the complaint to the RMIT Committee to investigate in accordance with the Animal Code;

     13.2.3.2. Where the complaint raises the possibility of research misconduct, or a breach that is not related to ethics approval, refer the complaint to the Designated Person who will handle the complaint in line with the Research misconduct process;

     13.2.3.3. Where the complaint alleges misconduct that is not research related, refer it onto the appropriate institutional process;

     13.2.3.4. Dismiss the complaint and provide reasons for the dismissal.

13.2.4. The Research Office will update the complainant and other relevant parties, including the Department, as appropriate and in a timely manner.

13.3. Complaints regarding ethical decisions made by the RMIT Committee:

13.3.1. The RMIT Committee is the ultimate decision making authority regarding the ethical acceptability of an activity, in line with the Animal Code. Therefore, any decisions regarding the ethics of animal research made by the RMIT Committee cannot be overridden.

13.4. Complaints regarding the operation of the RMIT Committee:

13.4.1. Make the complaint in writing to the Director, Research Integrity, Governance and Systems, who will notify the RMIT Committee and the Research Office.

13.4.2. Where communication between the RMIT Committee and the complainant cannot resolve the complaint, the RMIT Committee will form a Subcommittee to investigate the facts of the complaint, write a report, and formulate a response.

13.4.3. Where the Subcommittee cannot resolve the complaint, a person external to the RMIT Committee (the RMIT Designated Person or nominee) will review the operational process followed by the RMIT Committee, and report findings and recommendations to the complainant, the Research Office and the RMIT Committee. The RMIT Committee will consider the findings and recommendations of this review, in line with the Animal Code.

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