What does this mean in practice?
You should understand exactly what you are authorised to do under both your Personal Licence and the Project Licence you are working under.
Before carrying out any procedure, you should review the relevant Project Licence and confirm:
- The authorised species
- The aims, purpose, and objectives of the project
- The approved protocol steps
- Expected adverse effects, including expected incidence rates and humane endpoints
- Any special conditions attached to the licence
Special conditions may include:
- Limits on the number of animals used
- Reporting requirements for adverse effects
- Monitoring of mortality rates within specific protocols
In some cases, you may also need to confirm whether the project involves additional licence conditions:
- Notification of POLEs
- Retrospective assessment
- Use of neuromuscular blocking agents
- Animals taken from the wild
- Export or transfer of animals
You should also check your own Personal Licence authority to ensure you are authorised for:
- The species involved
- The procedures you intend to perform
You should never assume that a procedure is authorised simply because it is routinely performed within the establishment or by other colleagues.
How do I comply with PIL Standard Condition 19?
There are several tools and resources available to help you confirm both your own licence authorities and the authorities granted under the Project Licences you work under.
ASPeL should always be treated as the live and authoritative version of:
- Your Personal Licence (PIL)
- The Project Licence (PPL)
- Approved protocol authorities
In many UK establishments, Experimental Plans also play an important role in supporting compliance with this Standard Condition.
Experimental Plans act as practical reference documents for technical and research staff and support quick, informed decision-making, particularly when monitoring animals for adverse effects or managing procedures.
Experimental Plans should typically include:
- Details of the approved protocol
(for example chemicals, drugs, concentrations, routes, and volumes) - Expected adverse effects
- Welfare interventions
- Humane endpoints
- Individuals authorised to work under the study plan
- Relevant Personal Licence holders and delegated non-licensed staff
Experimental Plans also provide several additional benefits, including:
- A secondary compliance check by individuals such as the NACWO, Veterinary team, or senior technical staff
- Additional oversight where interpretation of licence authority may be complex
- Confirmation that the Project Licence Holder is aware of planned work
- Improved coordination of support, husbandry, and welfare monitoring
- Better preparation for anticipated animal welfare needs
These systems provide an important safety net, recognising that mistakes or misunderstandings can occur and that additional review can help maintain both compliance and animal welfare.
What resources are available to support me?
The Project Licence Holder (PPLh), Experimental Plans, and Named Persons all play an important role in supporting compliance with licence authorities and helping ensure appropriate management of experimental animals.
These individuals are there to support you and will often be familiar with the protocols, expected adverse effects, and practical considerations associated with the work, particularly for newer or less experienced Personal Licence holders.
In many cases, it is beneficial to discuss your planned work with the Named Persons before submitting an Experimental Plan. These conversations can help identify additional welfare, procedural, or compliance considerations that may not be immediately obvious to newer members of a research team.
One of the best ways to maintain compliance with this Standard Condition is to ensure your Experimental Plan is clear, accurate, and detailed.
You should include as much relevant information as possible about the procedures the animals will undergo, including:
- Administration routes
- Volumes and dosing frequencies
- Compounds and concentrations
- Planned procedure dates where appropriate
- Housing or husbandry requirements before and after procedures
Providing this level of detail helps everyone involved in the care and management of the animals understand the expected animal experience and identify the adverse effects, welfare concerns, and monitoring requirements associated with the authorised protocols.
What happens if I don’t comply with PIL Standard Condition 19?
Failure to comply with this Standard Condition is taken seriously, as it may result in procedures being carried out without the appropriate legal authority.
This could lead to:
- Non-compliance with the Animals (Scientific Procedures) Act 1986 (ASPA)
- Immediate suspension of work under the Project Licence
- Investigation by the Home Office Inspectorate (ASRU)
- Amendment, suspension, or revocation of your Personal Licence (PIL)
- Impact on the Project Licence Holder (PPLh) and the wider establishment
- Potential animal welfare concerns, particularly where procedures exceed authorised severity limits or animals are not monitored appropriately
In practice, common risks include:
- Performing procedures not authorised under your Personal Licence authority
- Working under a protocol you do not fully understand
- Failing to recognise or apply humane endpoints correctly
- Misinterpreting expected adverse effects or welfare controls
Even unintentional errors can have serious welfare and compliance consequences. Taking the time to confirm licence authority, understand the protocol, and seek clarification where needed is therefore essential.
How does ASRU assess compliance with PIL Standard Condition 19?
ASRU assesses compliance with PIL Standard Condition 19 by reviewing how establishments and Personal Licence holders ensure that appropriate licence authorities are in place before regulated procedures are performed.
During an inspection, ASRU may review Standard Operating Procedures and local systems designed to prevent unauthorised procedures. Inspectors may also examine documentary evidence showing how licence authorities, protocol approvals, and procedural permissions are checked and reviewed before work begins.
Compliance may additionally be assessed through discussions with the Establishment Licence Holder (PELh), Named Persons, animal care staff, Personal Licence holders, and Project Licence Holders (PPLhs) to confirm that effective processes are in place to prevent work being carried out outside authorised licence conditions.
ASRU may also assess whether Personal Licence holders understand the limits of their own licence authority, the relevant Project Licence authorities, and any conditions attached to those licences before performing regulated procedures.
How do I know if I am complying with PIL Standard Condition 19?
How do I know I’m fulfilling this Standard Condition?
You can be confident that you are fulfilling this Standard Condition if you can clearly demonstrate the following:
You understand your Personal Licence authority
- You know which species and procedures your Personal Licence (PIL) authorises you to perform
- You understand any limitations or restrictions attached to your licence
You understand the Project Licence
- You have reviewed the relevant protocol(s) within ASPeL
- You are familiar with:
- Expected adverse effects
- Humane endpoints
- Severity classifications
- Any special or additional licence conditions
You are working to an approved plan
- An Experimental Plan is in place where required
- The plan has been reviewed by appropriate individuals, such as the NACWO, NVS, technical staff, or Project Licence Holder
- The Experimental Plan accurately reflects the authorised protocol and expected animal experience
You seek support when needed
- You have discussed the work with appropriate individuals, including:
- The Project Licence Holder (PPLh)
- Named Persons such as the NACWO, NVS, or NTCO
- You have clarified anything you are unsure about before beginning work
You understand the animal experience
You are able to explain:
- What procedures the animal will undergo
- What adverse effects may occur
- What welfare interventions or actions may be required in response
A useful sense-check is to ask yourself:
“Could I confidently explain this procedure, its limits, and its welfare considerations to someone else?”
If the answer is yes, you are likely fulfilling this Standard Condition.