The licence holder must give any necessary assistance to inspectors carrying out visits by virtue of section 18(2A)(b) and to experts of the European Commission carrying out duties under Article 35 of the Animals Directive.
What does this mean in practice?
If an inspector from ASRU or a European Commission expert visits the facility to check how animals are being used and cared for in research facilities, the licence holder must help them with whatever they need to do their job. This could include giving them access to the site, showing them documents, or answering their questions.
It’s about making sure inspections and checks can be carried out properly and openly.
How do I comply with PIL Standard Condition 21?
As a holder of a PIL, it is essential to be prepared for both scheduled and unannounced visits. During these visits, ASRU inspectors or their representatives may request to observe you as you carry out your research or animal care activities, including during planned surgeries. This enables them to understand the culture of care in the establishment and evaluate its systems, education, training, supervision, and overall values.
You may also be selected to contribute to a full systems audit, where a number of individuals, including PIL holders, are interviewed on how the establishment and licence holders manage compliance with the conditions of their licences.
By understanding the various conditions and their interactions with the project and establishment licence requirements, you will empower yourself to effectively demonstrate your compliance with ASPA and ensure high standards of animal welfare while achieving your research objectives.
Engaging in ongoing professional development through modules like these is essential for enhancing your understanding and management of your licence conditions. This preparation will equip you not only for audits but also for interviews and discussions with inspectors and key personnel in your establishment.
What resources are available to support me?
Most establishments provide support for individuals who feel anxious about the interview process. The key is to be confident in your work and open about your activities.
ASRU has produced a Guide on the Audit Process and a Table of Evidence for Assessment of Compliance against ASPA and licence conditions that ASRU inspectors use during audits.
- Full system audit process (PDF, 221KB, 12 pages)
- Evidence for assessment of compliance against ASPA and licence conditions (PDF, 298KB, 33 pages)
The licence holder shall ensure that suitable arrangements exist for the care and welfare of animals during any period when the personal licence holder is not in attendance.
Examples of documentary evidence
Standard Operating Procedure for handover.
Examples of additional evidence
Interviews with NACWOs, animal care staff, and PIL holders to confirm handover procedure.
The licence holder shall maintain a record of all animals on which procedures have been carried out, including details of supervision and declarations of competence by the project licence holder as appropriate. This record shall be retained for at least five years and shall, on request, be submitted to the Secretary of State or made available to an Inspector.
Examples of documentary evidence
Standard Operating Procedures for recording procedures and records demonstrating the recording of procedures.
Examples of additional evidence
Interviews with PIL holders to confirm records are being accurately kept.
“Traditionally, during an inspector’s visit, it was not unusual to find the animal facility completely deserted, as research staff often felt apprehensive about performing their duties in the presence of an inspector. This tends to no longer be the case, with most research staff on ASRU visit days much more confident to talk to an inspector and explain their role in the care or research they are carrying out. The inspectors are just people; they care about the roles we play in animal research, and being confident to show and demonstrate how your establishment functions and supports your work is integral to the audit process.“
What happens if I don’t comply with PIL Standard Condition 21?
If you are chosen to speak with inspectors during an audit but refuse or deny them the opportunity to observe your work, it will likely raise suspicions and signal that you may be concealing something.
During audits, inspectors frequently browse the ASPeL system and randomly select the names of people they’d like to meet with. Even those individuals who are absent due to leave are expected to schedule follow-up meetings with the inspectors upon their return to work.
How does ASRU assess compliance with PIL Standard Condition 21?
Institutions must maintain a record of any breaches of conditions, including instances where a licence holder does not participate during inspections or visits.
During an audit, the Establishment Licence holder will discuss the management of breaches with inspectors to ensure that appropriate actions are taken when a breach occurs. This dialogue is essential for confirming that the institution effectively addresses any compliance issues.
How do I know if I am complying with PIL Standard Condition 21?
Being open and actively engaged with inspectors during their inspections, audits, and visits is crucial. This commitment to transparency also extends to all forms of communication, including reports, incident notifications, and PPL SC18 submissions.