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Managing a Project
This page outlines how to conduct and manage a project using animals from receipt of Animal Ethics Committee (AEC) approval to submission of the Final Report.
Notice of Approval
Your project can only commence once you receive formal notice in writing from the AEC, which will be sent to the Principal Investigator (PI) and any Supervisor (in the case where the PI is a student). This means that no animals can be ordered, housed, held, captured or used in any way until receipt of this notice of approval.
Once you receive this notice it is the responsibility of the PI to inform other participants of the approval and provide all other participants with a copy of the approved AEC protocol and notice of approval. This includes the manager of any facility that will be used in the project (see below).
The PI must ensure that all participants are aware of their roles and responsibilities, understand the project and are capable of carrying out their roles.
The following documentation and records must be maintained by staff working on the project and made avialable to the AEC, the Animal Welfare Officer or any auditors if requested.
The PI or delegate must maintain the following records:
- Copies of approved protocols
- Copies of amendments to the protocol
- Notices of approval
- A running record of animal usage for each species/strain, breed, life stage corresponding to the approved Animal Use Spreadsheet and Notice of Approval
- Records of adverse events
- Copies of Unexpected Adverse Event Reports anf their outcomes
- Copies of Annual Progress Reports
- Copies of Final Reports
These can be in electronic or hard copy form.
Signage and documentation requirements at animal holding site
The following details need to be recorded on each enclosure/cage/tank or on a centrally located facility plan of groups of enclosures/cages/tanks:
- AEC approval number
- Enclosure/cage/tank ID
- Species/strain/line of animal
- Individual animal IDs (if applicable/practical)
- Number of animals in each enclosure/cage/tank
- DOB/age (if applicable)
- Details of breeding (if breeding)
This could be done in a number of ways:
- Card attached to each housing unit
- Plan/diagram of the area showing each unit and above information written onto it e.g whiteboard
- Any other way that suits the species, enclosure and environmental conditions
The information needs to be written in a way that it will not degrade or easily rub off and that it is protected from environmental conditions.
Documentation to be Maintained at the Research Site or Facility
The following records to be kept in the room or facility where the animals are housed and they need to be available to staff, the AWO or the AEC at any time:
- Animal care staff records of attendance, details of husbandry duties performed at each attendance (water or food provided, cages/tanks cleaned or changed and how many), details of animal movements, any issues or abnormalities found, maintenance issues,
- Researcher’s animal monitoring records (as approved by the AEC), dates of attendance, details of any adverse events, sickness injuries, procedures done, drugs administered, UAEs
- Animal numbers in each room/area/enclosure
- Species housed
- AEC approval letter
- AEC approved protocol and any approved amendments
- Total number of animals in each room/area (there needs to be a regular animal audit carried out so that at any time, it can be determined roughly how many are in each cage/room/facility and so whether an animal is missing)
- Emergency procedures
- Emergency contacts and staff contact details
- Breeding records
- Health records
- Pest control records (if applicable)
These records could be kept in a variety of ways or forms including:
- Checklists and paper record sheets
- Activity diaries
Monitoring records should, preferably, be kept in a form that is unalterable, especially those detailing the attendance of staff and activities carried out.
Electronic records are acceptable as long as there is a way to ensure there is some way that anyone could easily check the records to determine the status of the animals. For example, anyone should be able to log onto the computer and have access to the records, including any inspector or auditor.
Animal monitoring records should be available at all times in the animal facility unless they need to be removed for short periods to transfer information to lab books or other systems.
Developing a Monitoring Plan
The monitoring plan must be sufficient to detect likely abnormalities or changes in health, wellbeing or behaviour.
In developing a monitoring plan for a project, the following should be taken into account:
- Animal details i.e. species, strain, phenotype, sex and age.
- Project details i.e. types of procedures, level of impact at each stage, housing type and stocking rate/density.
- Available resources i.e. remote monitoring systems and telemetry, anaesthetic monitors and handling equipment.
- The levels and frequency of monitoring required and whether different monitoring regimens are required at different stages or for different procedures. E.g. acclimation, pre-research, post-surgical monitoring, anaesthetic monitoring, monitoring of new strains of GM animals.
- The personnel who will be carrying out the monitoring, whether they are competent or may require training and supervision in order to reach an acceptable level of competence.
- Scientific endpoints: the monitoring plan should take into account the earliest time when the animals can be removed from the project.
- Predetermined humane endpoints.
- Previous experience, pilot studies and literature reviews should be used to determine likely effects of the research and assist in the development of monitoring plans.
A monitoring plan should contain the following details:
Level of monitoring - will the animals be cage checked, picked up, or receive a physical examination or other more intensive assessment?
Monitoring criteria - what will be monitored, and these should be based on the following indicators of animal health and wellbeing:
- Behaviour including food and water consumption, defaecation and urination and response to stimuli, including their interaction with other animals;
- Body weight and/or an assessment of body condition
- Physical appearance and
- Physiological/clinical parameters
- There should be a mix of objective and subjective criteria
Frequency of monitoring - how often the monitoring will take place.
- Frequent enough that the onset of any adverse events will be detected as soon as possible after they begin so that distress, pain or discomfort can be minimised.
- Should be increased around times of increased risk or stress.
- When animals have experienced an adverse event and are under treatment from the designated veterinarian, the frequency of monitoring may be decided by this veterinarian for a period of time.
- Since body weight and changes in body weight or condition are major indicators of pain and distress, animals should be weighed or assessed for loss of condition regularly. In projects where pain or distress is expected then this should occur weekly.
Duration of monitoring - animals may have different monitoring requirements depending on what they have experienced.
- Monitoring must start during the acclimation period to allow baseline data to be collected so that changes can be assessed at later stages.
- Animals must be monitored for the duration of their stay in the facility, or in field research the duration of their use or time in captivity.
- If a higher level and/or frequency of monitoring are required over a period of increased stress or risk, it must continue until the animal is assessed to have returned to an acceptable state of wellbeing.
Records and documentation
Each animal must have its own monitoring record showing that all the necessary criteria have been assessed at each of the monitoring timepoints.
Separate monitoring sheets must be developed for monitoring during anaesthesia and procedures and these must be kept in the animal facilities.
For all animals the details of any experimental procedure and the date on which they took place must be written on each cage card.
Investigators should keep additional records that show when an animal requires treatment such as analgesia or other medications as a result of adverse events.
The cages or pens of animals requiring extra monitoring, treatments or medication must be appropriately flagged to indicate the requirement for extra care.
Monitoring records for all living animals must remain in the animal facilities up to the time the animals leave or are killed. After this, the records can be removed and archived.
After the completion of a project, monitoring records must be retained in line with the University’s record retention requirements for laboratory books.
Unexpected Adverse Event Reporting (within 48 hours of occurrence)
An unexpected adverse event is any adverse event that was not foreshadowed in the approved project or activity.
Unexpected Adverse Events must be handled according to the Unexpected Adverse Events Procedures.
An unexpected adverse event may result from different causes, including but not limited to:
- death of an animal, or group of animals, that was not expected
- adverse effects following a procedure or treatment that were not expected
- adverse effects in a larger number of animals than predicted during the planning of the project or activity, based on the number of animals actually used, not the number approved for the study
- a greater level of pain or distress than was predicted during the planning of the project or activity
- power failures, inclement weather, emergency situations or other factors external to the project or activity that have a negative impact on the welfare of the animals
- effects that indicate the model or experimental design is not proceeding in a way to give meaningful results and to continue would mean that animals may be wasted
If you are working in the field, or unable to provide a full report within 48 hours, send an email or contact the Animal Welfare Officer by phone, then provide the report at a later date.
Failure to report an Unexpected Adverse Event is a breach of the Code and can result in disciplinary action including withdrawl of AEC approval.
Annual Progress Report
Regardless of the duration of approval of a project, the AEC must receive an Annual Progress Report for the period between the 1st January and 31st December of each year.
The report is due every year by the 1st March, and is to be completed on the AEC Project Report Form.
The AEC will review the report and decide whether to:
- Allow the project to continue
- Suspend the approval for the project
- Withdraw approval for the project
Failure to submit the Annual Progress Report by the due date may result in automatic suspension of the project approval, until the report is received, or withdrawal of approval.
On the completion of the project, a Final Report must be submitted to the AEC.
Failure to sub,to a final report may result oin suspension of approvals for other projects being carried out by the same investigators and/or refusal to issue approvals for new projects.
Inspections and surprise inspections
The AEC and Animal Welfare Officer monitor animal welfare and compliance across the university and all research/teaching and animal holding sites in the following ways:
- Annual Scheduled Inspections - are conducted for all facilities and animal holding sites
- Photographs and Video - May be requested for field sites and fieldwork
- Surprise Inspections - unannounced inspections of facilities, holding or fieldwork either carried out routinely or in response to a complaint or concern that has been raised
Note: All animal holding sites must be inspected and approved by the AEC before they can be used for animal holding or research/teaching.
The AEC must be consulted from the planning stages for any new facilities or renovations of existing facilities.
What is non-compliance?
Non-compliance occurs when one of the following happens:
- There is a breach of the legislation such as carrying out a project without AEC approval
- Using more animals than approved
- Changing aspects of the project without approval
- Starting before receiving approvals in writing, or continuing to carry out research after the approval has ended
- You breach the requirements of the Code such as not monitoring animals as outlined in the application, failing to euthanise an animal once it reaches an endpoint, not administering pain relief to animals in pain, failing to submit an adverse event report in the appropriate time (or at all), failing to submit an annual progress report or final report for a project
- Animal cruelty, neglect, providing false or misleading information to inspectors, the AEC, the AWO or their delegates, modifying or changing documentation to hide actions or problems, using inappropriate methods of euthanasia, carrying out painful procedures without adequate anaesthesia, carrying out procedures on animals that are illegal under other Acts of parliament
If a non-compliance comes to the attention of the AEC, it will be thoroughly investigated according to established procedures and according to procedural fairness an natural justice. If it is proven that non-compliance has occurred the AEC will make a decision on what action needs to be taken, but this could include:
- Suspension or withdrawal of an ethics approval (or several)
- Suspension or withdrawal of approval for a person to carry out scientific work on animals
- Official reprimand or the issue of a warning to personnel
- Referral to the university for research or staff misconduct
- Termination of employment
- Withdrawal of funding and may affect ability to secure future funding
- Withdrawal of publications, including higher degree theses
- The university may lose funding and may affect its ability for future funding
- The university may lose its Animal Research Registration
Self-reporting Inadvertent Non-compliance
What do you do if you think you may have inadvertently done something that could constitute non-compliance?
Notify the AEC as soon as possible. Self-reporting inadvertent instances are generally seen more favourably by the AEC, than cases uncovered by other means.