Transparency data

PLA subgroup: terms of reference

Updated 17 April 2024

1. Purpose

1.1. To provide timely and independent scientific scrutiny of project license applications referred to it by the Home Office’s Animals in Science Regulation Unit (ASRU).

2. Governance

2.1. The PLA subgroup is a standing subgroup of the ASC and is chaired by the ASC Chair, or their nominated deputy. All members of the ASC are privy to the applications under review and are able to set questions to seek clarification from the applicant around technical or ethical issues. Technical issues might include further details of the procedures proposed, and ethical issues might include further discussion of ethical arguments made. The PLA subgroup acts under delegated authority on behalf of the ASC in the decision-making process. The outcomes of reviews and any recommendations made are reported to the ASC at its quarterly meetings.

3. Licences referred for review

3.1. Under the Animals (Scientific Procedures) Act 1986 [A(SP)A] (section 9(1)), the Secretary of State will refer certain project licence applications to the ASC for advice, as appropriate, on applications involving:

• the use of wild-caught non-human primates
• the use of cats, dogs, equidae or non-human primates in severe procedures
• use of endangered species
• projects with major animal welfare or ethical implications
• projects involving the use of admixed embryos as advised in the Guidance on the use of Human Material in Animals
• projects of any kind raising novel or contentious issues or giving rise to serious societal concerns

3.2. In addition the Inspectorate can request advice (formal or informal) from the PLA subgroup in relation to general emerging issues in the licensing process. Emerging issues will also be discussed with the whole ASC as necessary.

3.3. The PLA subgroup can also review a selection of licences already awarded in a specific research area and/or a random selection of licences awarded within a certain timeframe, to provide context for their considerations of licences under 3.1 or to make any general observations which they consider appropriate.

4. Membership

4.1. The PLA subgroup is chaired by the Chair of the ASC. There is no standing membership of the PLA subgroup; all members of the ASC will be invited to attend each meeting.

4.2. The attendees of the subgroup will be reviewed by the Chair and Secretariat and supplemented if necessary, depending on the availability of the members, additional expertise required, and where conflicts of interest prevent participation of a member.

5. Duration

5.1. The PLA subgroup is an ASC standing group. Meetings are convened as appropriate to ensure the expeditious review of applications within the legal timeframe of 55 days following the submission to ASRU of a ‘correct and complete’ application.

6. Meetings and working methods

6.1. All licence applications to be considered by the subgroup will be circulated to the full ASC membership prior to the subgroup meeting to allow for any issues of concern to be raised.

6.2. Questions raised by ASC members will be compiled by the Secretariat and sent to the applicant to enable them to prepare responses prior to attending the PLA subgroup meeting. Where a large number of points have been raised, it is the responsibility of the subgroup Chair to prioritise these.

6.3. The quorum for meetings of the PLA subgroup shall be four persons, with at least two lay members and two non-lay members, including the Chair. In this context, the term ‘lay’ is defined as members of the Committee who are not directly involved in research using animals.

6.4. In addition to PLA subgroup members, the assigned Inspector from ASRU, and other ASRU representatives as necessary, may attend the projects licence application panel meeting to provide relevant information as requested by the Chair of the PLA subgroup.

6.5. The Project Licence Applicant will be provided with the opportunity to present to the PLA subgroup prior to discussion of the concerns raised. Following the discussion, the PLA subgroup will reach an agreement as to whether they will recommend that the project licence should be granted, granted subject to amendments or rejected. In licences considered under 3.2 and 3.3 above, attendance of the Project Licence Applicant will not be required unless specifically invited.

6.6. Decisions on licence applications will be considered and recommended by the panel attendees and the Secretary of State will be informed of the range of views provided. Any abstentions from the agreement of the subgroup will also be indicated to the Minister in the letter containing the PLA subgroup’s recommendations.

7. Declaration of interest

7.1. In line with the ASC Code of Practice, Subgroup members will be reminded at the beginning of each meeting to make a declaration of interest where that interest relates specifically to an issue under discussion. Following any declaration, the Subgroup Chair will make a judgement as to whether the member should withdraw from the discussion.

8. Confidentiality

8.1. PLA subgroup members will not misuse information gained in the course of their public service for personal gain or for political purpose, nor must they disclose any information which is confidential in nature or which is provided in confidence without authority. This duty continues to apply after any member has left the Committee.

8.2. Protecting health and safety is a particular concern for people and establishments involved in animal research and confidentiality remains obligatory for people or place names. The Government also reaffirms its legal responsibility towards safeguarding confidentiality of information that constitutes intellectual property, whilst supporting a more open and transparent environment surrounding the use of animals in scientific research and increasing public understanding of the use of animals where no alternative exists. A(SP)A clause (section 24) imposes a very broad duty of confidentiality on everyone working under the Act. Section 24 denotes that the Home Office cannot release any information received in confidence under ASPA, even when the provider has no objection to its disclosure. This also applies to ASC members and particularly in respect of matters relating to licences and applications for licences.

9. Secretariat

9.1. The Secretariat will coordinate availability, forward licence applications, arrange meetings as required and collate comments/issues.

9.2. Recommendations made by the subgroup will be drafted by the Secretariat, reviewed by the subgroup and ratified by the Chair before being forwarded to ASRU’s Head of Policy. It is the responsibility of the Head of Policy to seek agreement from the Secretary of State and to ensure that a process is implemented to ensure appropriate and timely feedback to the ASC. It would be unusual for this feedback to be delayed beyond the time the Project Licence Applicant received a final decision on their application.

Date: 16 April 2024