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(1) The Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition (2013) (“the Code”), enacted under the Animal Research Act 1985 No 123 and the Animal Research Regulation 2010 (NSW) requires that institutions develop guidelines to ensure animal wellbeing is monitored by competent people, and that appropriate action is taken when unexpected adverse events occur. (2) These Guidelines assist (3) This guideline should be read and understood by: (4) These Guidelines are applicable to all activities involving the use of live animals that are bred, purchased, or captured by the (5) This document should be read in conjunction with: (6) In the context of this policy “acclimatisation period” means the length of time that newly received animals are given for physiological, behavioural and nutritional acclimatisation prior to their use in a (7) In the context of this policy “animal welfare check” means the daily process of BRF (8) 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). (9) 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 should be: (10) 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. (11) BRF (12) BRF (13) Chief Investigators are ultimately responsible for the monitoring of wellbeing once an animal is allocated to the project and enters the acclimatisation period, until the animal is no longer required and subsequent provisions are made. (14) During the acclimatisation period the Chief Investigator is responsible for ensuring that animals are monitored by a project team member at least twice, with the first monitoring event to occur 1-2 days post delivery to ensure that animals are appropriate for the project as per clause 2.4.15 (i) of the Code. (15) 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 project procedures. Animals without known vulnerabilities must be monitored by a project team member at least twice per week during the waiting period. Animals with known vulnerabilities may require more frequent monitoring, which will be considered by the ACEC as part of the initial project application. (16) 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 project. (17) The documentation of a monitoring strategy may involve the use of simple checklists for periods when animal 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). (18) Monitoring Checklists should be: (19) 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 should be moved to an individual Monitoring Checklist and the original Monitoring Checklist annotated to indicate that this animal is now being individually monitored. (20) The cages of animals requiring close monitoring should have a Close Monitoring Card to ensure that the need for closer monitoring is readily apparent to BRF (21) Monitoring records used by BRF (22) Investigators must use a (23) Investigators must use a Specific Monitoring Checklist(s), developed for the project and approved by the ACEC, in the following situations: (24) Records associated with the monitoring of animal wellbeing must remain with the animal/s at all times, usually in the red folder provided by the BRF. Specific monitoring records for particular animals may accompany those animals to the laboratory or other examination/ procedure area. (26) The use and effectiveness of Monitoring Checklists are reviewed during inspections of (27) Examples of Monitoring Checklists are available on the Animal Ethics website. (28) The effectiveness and relevance of monitoring checklists for specific projects must be reviewed regularly by the Investigator, with a view to improvement. (29) Consideration should be given to the use of preliminary or pilot studies to determine endpoints, particularly when the effects of the treatment are unknown. (30) Pilot studies using a small number of animals can: (31) The immediate welfare of (32) Adverse events can be a single or cumulative event, and may be unexpected or predicted. (33) Examples of adverse events are included in Table 1 and example scenarios of adverse events are available on the Animal Ethics website. (34) Unexpected adverse events have a negative impact on animal wellbeing and are: (35) Predicted adverse events are events which are adverse, but where the cause is known and the level of incidence/severity is as described in the approved project or supply unit procedures. (36) (37) A post mortem examination is required if an animal has died or has been euthanased due to its condition, and: (38) The Animal Welfare Officer must be contacted if the circumstances meet the above criteria and the Investigator proposes that a post mortem should not be conducted. The Animal Welfare Officer's decision to proceed or not conduct a post mortem remains final. (39) The ACEC requires that post mortems are conducted by a veterinarian or person approved as competent to do so by the ACEC. (40) 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. (41) Reporting adverse events involving (42) The Animal Welfare Officer must be notified of an unexpected adverse event immediately via phone or email. Where it is determined that animal health or welfare is at (43) Upon notification the Animal Welfare Officer or Ethics Officer (Animal) will promptly provide the Animal Care and Ethics Committee Chair with the details of an unexpected adverse event. In the absence of the Committee Chair, the Deputy Chair or Animal Care and Ethics Committee Executive will be informed. (44) A decision flow-chart is available on the Animal Ethics website to assist Investigators in determining the nature of the report required. (45) Submit all reports to the ACEC in accordance with Animal Ethics application procedures. (46) Adverse Event Reports must be submitted within 14 calendar days of the occurrence of the unexpected adverse event. (47) Where submissions are incomplete (e.g. post mortem results are not yet available), the completed Report must be re-submitted once results are known or the cause has been identified. (48) A Separate 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. (49) Predicted adverse events are reported in the Annual Progress Report. (50) Animal Research Monitoring and Adverse Events Guidelines
Section 1 - Purpose
Section 2 - Audience
Top of PageSection 3 - Scope
Section 4 - Related Documents
Top of PageSection 5 - Document specific definitions
Section 6 - Monitoring of Animals
BioResearch Facilities (BRF) Monitoring Responsibilities
Investigator Monitoring Responsibilities
Table 1. Summary – Investigator Responsibilities for Monitoring
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 project application.
Procedures (project has commenced)
As approved by the ACEC.
As approved by the ACEC in the project application.
Monitoring Records
Developing Monitoring Checklists
Use of Pilot Studies
Top of PageSection 7 - Adverse Events
Table 1
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
Actions Required for Adverse Events
Top of Page
Action
Details
Act Immediately:
Determine and remove obvious hazard while responding to the immediate needs of sick or at-risk animals.
Inform:
The Chief Investigator is to immediately 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 research team. Should the Animal Welfare Officer be unavailable, contact the Ethics Officer (Animal).
Inform:
The Associate Director, Research Infrastructure must be advised when an adverse event involves facilities, a disease outbreak, emergency or environmental issue.
Report:
All adverse events involving animals must be reported to the ACEC.
Section 8 - Reporting Adverse Events
Reporting Responsibilities
Table 3 – Responsibilities for Reporting Adverse Events
Situation
Responsibility
Breeding colony
Associate Director, Research Infrastructure or nominee
Stock animals prior to allocation to a project
Associate Director, Research Infrastructure or nominee
Research breeding colony
Chief Investigator or nominee
Animal supplied or allocated to a project, but experiments have not yet commenced
Chief Investigator or nominee
Animal supplied or allocated to a project, and experimental intervention has commenced
Chief Investigator or nominee
Reporting Unexpected Adverse Events
Reporting Predicted Adverse Events
Reporting Research Related Events