(1) The (2) In accordance with the Animal Research Act 1985 No 123 (the Act) and Animal Research Regulation 2021 (NSW) (the Regulation), the (3) This Manual must be read in conjunction with the (4) This Manual applies to the breeding, holding, and use of all animals at the (5) This Manual and its associated documents are designed to ensure that animal (6) This Manual must be read and complied with by all personnel involved in (7) In the context of this Manual, the following definitions apply: (8) The (9) The ACEC Terms of Reference are outlined in the ACEC Constitution. (10) All animal (11) In accordance with the Code and the Animal Care and Ethics Committee Procedure, the content of ACEC applications and deliberations remain confidential unless required to be shared under a collaborative agreement. (12) The ACEC may identify other issues that, while outside their area of responsibility, are required to be considered by the (13) Investigators must: (14) Chief Investigators are ultimately responsible for the conduct of their animal (15) The Deputy Vice-Chancellor (Research and Innovation) is responsible for overall institutional governance for the care and use of animals. (16) To ensure the highest level of care for animals, the (17) The (18) Persons carrying out animal (19) The minimum level of competency for Investigators at the (20) Chief Investigators must ensure that all persons responsible for making observations of animals from which an intervention point or an endpoint will be determined, are trained in and competent in evaluating the normal physiology, behaviour, and body condition of the animals under observation, and the anticipated specific changes from what is considered to be normal. (21) The Senior Manager, BioResearch Services is responsible for ensuring Standard Operating Procedures are current, effective, and approved by the ACEC for: (22) The (23) BioResearch Facilities (24) The (25) The use of S4 and S8 drugs in animal (26) The use of restricted substances (Schedule 4 “S4" drugs) and drugs of addiction (Schedule 8 "S8" drugs) in animals used for (27) Additionally, the Animal Research Review Panel, the statutory body under the Animal Research Act, has issued the following policy: The use of restricted drugs and the conduct of restricted acts of veterinary science in animal research (ARRP policy 14, revised 27 February 2014). (28) Investigators and BioResearch Facilities (29) The (30) The Animal Care and Ethics Committee Procedure must be referred to when the immediate use of animals, as outlined in the Code, becomes necessary. (31) Investigators must comply with the Collaborative Research Procedure and associated documents. (32) Clause 2.1.2 of the Code requires that institutions ensure that all people involved in the care and use of animals: (33) These procedures outline how the (34) The Chief Investigator is responsible for conducting an assessment of competency for each person involved in their particular (35) In submitting an ethics application to the ACEC, the Chief Investigator will notify the ACEC whether all persons are competent for the procedures to be carried out in the (36) The Chief Investigator must notify the ACEC of any investigators who have attained competence in a particular procedure in the Annual Progress Report/Renewal application to the ACEC. (37) The ACEC may require an assessment of competency in routine or specific activities. Such an assessment will be performed by a person or group nominated by the ACEC who holds suitable qualifications against an agreed competency standard (which may be an ACEC approved SOP). (38) Table 1 outlines the competency requirements of personnel involved in animal (39) Submissions for approval from the ACEC must undergo peer review in accordance with Research Peer Review Guideline for Ethics Applications prior to submission for approval to the ACEC. (40) The Animal Ethics website “Obtaining approval for animal research” provides resources to assist with the submission process. (41) The Code, enacted under the Act and the Regulation, requires that institutions develop procedures to ensure animal wellbeing is monitored by competent people, and that appropriate action is taken when unexpected adverse events occur. (42) These procedures assist (43) If an animal (44) The ACEC requires that all animal ethics applications include information on the monitoring strategy to be used to ensure the wellbeing of animals, including the use of Monitoring Checklist(s). (45) The ACEC expects that a monitoring strategy will be developed to ensure that abnormalities are detected and acted upon before they result in significant pain, distress, or the death of an animal. The frequency of observations must be: (46) All monitoring of animals must be conducted in accordance with the strategy approved by the ACEC. ACEC approval is required for any changes to an approved monitoring strategy and must be obtained before implementing any changes. (47) BioResearch Facilities (48) BioResearch Facilities (49) Chief Investigators are ultimately responsible for the monitoring of animal’s wellbeing once it is allocated to the (50) During the acclimatisation period the Chief Investigator is responsible for ensuring that the animals are monitored by a (51) If approved by the ACEC, animals are considered to be in a waiting period after the acclimatisation period has ended and prior to commencement of the (52) Table 2 provides a summary of Investigator responsibilities for monitoring animals. (53) The Code requires records of the monitoring of animals to be maintained. Standard ACEC approval requires that monitoring records begin at the time that an animal is allocated to an approved (54) The documentation of a monitoring strategy may involve the use of simple checklists for periods when an animal’s welfare is less likely to be impacted (e.g. during the acclimatisation period), and more detailed checklists for periods when an animal’s welfare is more likely to be impacted (e.g. following an intervention). (55) Monitoring checklists must be: (56) Animals may be monitored individually or in a group. If group monitoring is used and a problem is identified with an individual animal, the monitoring of that animal must be moved to an individual Monitoring Checklist and the original Monitoring Checklist annotated to indicate that this animal is now being individually monitored. (57) For animals requiring close monitoring, the cages must have a Close Monitoring Card to ensure that the need for closer monitoring is readily apparent to BioResearch Facilities (58) Monitoring of animals by BioResearch Facilities (59) Investigators must use a (60) Investigators must use a Specific Monitoring Checklist(s), developed for the (61) Records associated with the monitoring of an animal’s wellbeing must remain with the animal at all times (usually in the red folder provided by BioResearch Facilities). Specific monitoring records for particular animals may accompany those animals to the laboratory or other examination/ procedure area/s. (62) Monitoring records must: (63) The use and effectiveness of Monitoring Checklists will be reviewed during inspections of (64) Examples of Monitoring Checklists are available on the Animal Ethics website. (65) The effectiveness and relevance of monitoring checklists for specific (66) Consideration must be given to the use of preliminary or pilot studies to determine endpoints, particularly when the effects of the treatment are unknown. (67) Pilot studies using a small number of animals can: (68) The immediate welfare of (69) Adverse events can be a single or cumulative event and may be unexpected or predicted. (70) Examples of adverse events are included in Table 3 and example scenarios of adverse events are available on the Animal Ethics website. (71) Unexpected adverse events are those that have a negative impact on animal wellbeing and: (72) Predicted adverse events are those events which are adverse, but where the cause is known and the level of incidence/severity is as described in the approved (73) (74) A post-mortem examination is required if an animal has died or has been euthanased due to its condition, and the: (75) If circumstances in Clause (74) are met, the Animal Welfare Officer must be contacted to determine whether a post-mortem is required. The Animal Welfare Officer’s decision to proceed with a post-mortem is final. (76) The ACEC requires that post-mortems are conducted by a Veterinarian or person approved as competent to do so by the ACEC. (77) Where the gross examination does not reveal the cause of death, further pathological testing should be undertaken to maximise the chance of determining the cause of the unexpected adverse event. (78) Table 4 outlines the actions required for adverse events. (79) Reporting adverse events involving (80) The Animal Welfare Officer, or Ethics Officer (Animal) must be notified of an unexpected adverse event promptly via phone or email. Animal Research Authority Specific Monitoring Sheets should be followed for specific guidance regarding timelines and actions. Where it is determined that animal health or welfare is at (81) Upon notification the Animal Welfare Officer or Ethics Officer (Animal) will promptly provide the ACEC Chair with the details of an unexpected adverse event. In the absence of the Committee Chair, the Deputy Chair or ACEC Executive will be informed. (82) All reports must be submitted to the ACEC in accordance with Animal Ethics application procedures. Table 5 outlines the reporting responsibilities for adverse events. (83) Adverse Event Reports must be submitted within 14 calendar days of the occurrence of the unexpected adverse event. (84) Where submissions are incomplete (e.g. post mortem results are not yet available), the completed Adverse Event Report must be re-submitted once results are known or the cause has been identified. (85) A Variation Application is not required where the adverse event consequently requires currently approved studies to be repeated, and this is detailed in the Adverse Event Report. Studies must not be repeated until the ACEC has approved the Adverse Event Report and an amended Animal Research Authority has been issued. (86) Predicted adverse events are reported in the Annual Progress Report. (87) (88) Researchers can use S4 drugs (“restricted substances”) for animals in approved (89) Researchers can use S8 drugs (“drugs of addiction”) for animals in approved (90) Please refer to the Animal Care and Ethics Committee Procedure. (91) The (92) The Animal Research Regulatory Manual
Section 1 - Introduction
Legislation
University Policies and Guidelines
External Resources:
Top of PageSection 2 - Scope
Section 3 - Intent
Section 4 - Audience
Section 5 - Document Specific Definitions
Top of PageSection 6 - Animal Research Policy
Part A - The Animal Care and Ethics Committee
Part B - Investigators
Chief Investigators
Part C - The Care and Use of Animals
Accountability and Responsibility
Competency of People Involved in Animal Care and Use
Animal Care, Animal Husbandry and Breeding and Holding Facilities
Monitoring and Adverse Events
The Use of S4 and S8 Drugs
(28) Replaced Animal Care Staff with BioResearch Facilities StaffQuarantining and handling animals that pose risk to other animals and humans
The Immediate Use of Animals
Part D - Collaborative Animal Research
Section 7 - Animal Research Procedures
Part E - Animal Research Competency Procedures
Intent
Assessing Competency
Assessment of competency must occur prior to completion of an ethics application that lists investigators for a particular project. Standard Operating Procedures (SOP), approved by the ACEC, must be used to determine competency in a particular procedure where an SOP for that procedure exists.Competency Requirements
Table 1. Competency Requirements
Role
Competency Requirements
Animal based researchers, Investigators, and Teachers
Chief Investigators
Senior Manager, BioResearch Services
BioResearch Facilities
The Code (clause 2.4.2), requires that, within the scope of their responsibilities, animal carers and veterinary staff must ensure that their duties are performed competently.
Veterinary
The Code (clause 2.4.2), requires that, within the scope of their responsibilities, animal carers and veterinary staff must ensure that their duties are performed competently.
Animal Welfare Officer
Animal Care and Ethics Committee (ACEC)
Part F - Submission, Receipt and Processing of Applications to the ACEC
Part G - Animal Research Monitoring and Adverse Events Procedures
Purpose
Monitoring of Animals
BioResearch Facilities Staff Monitoring Responsibilities
Reference clause in (47) updated from 7 to 7.c.Investigator Monitoring Responsibilities
Table 2. Summary – Investigator Responsibilities for Monitoring Animals in Holding
Period
Period Duration
Monitoring Frequency
Acclimatisation
5-7 days unless approved otherwise by the ACEC.
At least twice during the period with the first monitoring event at least 1-2 days post-delivery.
Waiting period for animals without known vulnerabilities.
As approved by the ACEC.
At least twice per week.
Waiting period for animals with known vulnerabilities.
As approved by the ACEC.
As approved by the ACEC in the research project application.
Procedures (
As approved by the ACEC.
Monitoring Records
Pre and Post Delivery Monitoring of Central Animal House Animals Sheet – NOT USED, clause updated.
Developing Monitoring Checklists
Use of Pilot Studies
Adverse Events
Table 3. Adverse Event Examples
Animal related events
Environmental/husbandry-related events
(potential effect on animal welfare)
Death
Air-conditioning problems
Sickness
Lighting problems
Pain
Access to food/water affected in
some manner
Distress
Flooding of cage
Injury
Emergency situation
Abnormal behaviour
Power failure
Unexpected Adverse Events
Predicted Adverse Events
Research Related Events
Post Mortem Examinations
Table 4. Actions Required for Adverse Events
Action
Details
Timeframe
Responsibility
Act Immediately:
Determine and remove any obvious hazards while responding to the immediate needs of sick or at-
Immediate
Researcher / Chief Investigator / BioResearch Facilities
Inform:
The Chief Investigator is to promptly contact the Animal Welfare Officer following an unexpected adverse event. If the Chief Investigator is unavailable, the Animal Welfare Officer may be contacted by another member of the
Follow Animal Research Authority Specific Monitoring Sheets for specific guidance regarding timelines and actions.
Chief Investigator or Researcher
Inform:
The Senior Manager, BioResearch Services must be advised when an adverse event involves facilities, a disease outbreak, emergency, or environmental issue.
Promptly
Researcher / Chief Investigator / BioResearch Facilities
Report:
All adverse events involving animals must be reported to the ACEC by email or phone.
Within 48 hours
Animal Welfare Officer / Ethics Officer (Animal)
Report:
All unexpected adverse events involving animals must be reported to the ACEC via the Adverse Event Report.
Within 14 days.
Chief Investigator
Report:
All expected adverse events involving animals must be reported to the ACEC via the Annual Progress Report.
Annually.
Chief Investigator
Reporting Adverse Events
Reporting Responsibilities
Table 5. Responsibilities for Reporting Adverse Events
Adverse Event Situation
Responsibility for Reporting
Breeding colony
Chief Investigator or their nominee
Stock animals prior to allocation to a project
Chief Investigator or their nominee
Research breeding colony
Chief Investigator or their nominee
Animal supplied or allocated to a
Chief Investigator or their nominee
Animal supplied or allocated to a
Chief Investigator or their nominee
Reporting Unexpected Adverse Events
Reporting Predicted Adverse Events
Reporting Research Related Events
Part H - S4 and S8 Drug Use Procedures
S4 Drugs
S8 Drugs
Top of Page
Section 8 - Complaints and Non-Compliance
Section 9 - External review
View Current
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(26) and (27) brought up to policy area from old guideline/procedure area below.
Previously “completion” rather than “submission”.
All persons listed on animal research projects will:
In accordance with the Code (clause 2.4.5), Chief Investigators must:
In accordance with the Code (clause 2.5.14), the Senior Manager, BioResearch Services is responsible for the overall management of research animal breeding and holding facilities at the University , and is appointed on the basis of appropriate animal care or veterinary qualifications, or experience.
The Senior Manager, BioResearch Services will ensure that:
The Senior Manager, BioResearch Services is responsible for providing details of the training and experience of BioResearch Facilities staff to the ACEC, and for giving information about how inexperienced staff will be supervised until they are considered competent for the procedures they perform in the following circumstances:
The University supports BioResearch Facilities staff in gaining formal animal care qualifications and accepts, as evidence of competency, completion of a suitable competency-based animal care course.
The Animal Welfare Officer (AWO):
The Animal Welfare Officer is expected to comply with the requirement for demonstrated continuing professional education to maintain registration.
Where the composition of the ACEC meets the requirements of the Code, the ACEC is considered competent in undertaking ethical reviews and providing fair, consistent, and timely review of applications and reports related to the care and use of animals.
The University provides an induction for new ACEC members which includes legislative and committee documentation; makes available appropriate periodicals via the University Library access; and will endeavor to support the attendance of ACEC members at appropriate seminars, conferences, and workshops.
Updated ASU to Bioresearch.
Daily unless approved otherwise by the ACEC
(27) Animal Services Unit (ASU) staff required to take any special responsibilities for monitoring animals in addition to routine husbandry must become part of the research team. ASU staff details must be included on the Animal Research Authority for the project, via the New Project Application or a via a Variation Application. The addition of ASU staff to the project will need to be approved by the Chief Investigator of the project and the Director, Research Facilities, and agreed to by the ASU staff member/s involved.