AWERB Minutes February 2020

 National Institute for Biological Standards and Control

 Animal Welfare and Ethics Review Body

 Minutes of a meeting held on Tuesday 19 February, 2020 at 2:00 pm

2.      Minutes of meeting held on 19 December 2019

Made available for reference and no comments received. Approved Minutes will be signed by the Director.

3.      Matters arising from 19 December 2019 Minutes – see Action Log

(a)   Action 19-32. Director has approved that funds will be available from Corporate Affairs budget to includeAPSA E&L; tour of facilities; RSPCA forum. CLOSED

All other open Actions were closed; the 2019 log will be archived once the above are closed; new log for 2020 will be created. Action 19-44, Secretariat

(b)   Action 19-45 ToR – on Agenda

(c)   Action 19-47 HOLC to contact PPL Holders to (i) collate data for PPL amendment; (ii) submit end of term review and (iii) RA. CLOSED

(d)   Action 19-48 SMT/AWERB member will add full item to next SMT at which they are present, adding the ‘What to expect from AWERB’ document for information. Action, SMT member

(e)   Action 19-49, Chair discussed with PPL Holder who clarified that the purpose had been a bridging exercise from one species to another; oversight of NHP work in absence of former Vaccine Trials Ctte (VTC) has been replaced by pre-study meetings; PPL Holder will write text to AWERB to address the points; main focus resident macaques: discussions are raised with HO, NACWO, PPL holder and NVS but this would not be part of the pre-study meeting.

Agreed to include the resident NHP in the NACWO report on an alternate AWERB meeting basis or as required; review of other resident animals in the PEL reports are to include anticipated usage, stock size and issues (births, deaths, rehoming); available stock; funding; usage flow; to assist in production and welfare; formal update every 6 months (3 meetings). This was seen as a positive addition in support of 3Rs work and the Concordat; funding bodies also appreciate such information. Action 20-01 NACWO, HOLC, add these as standing items to Agenda

(f)    Action 19-50 HOLC, document is near completion; final comments to go to HOLC within 14 days.

4.      Mid-term review PPL

ThePPL holder deputy highlighted the key elements of the licence. A good range of questions from across the committee. There was some unexplained mortality; some moderate severity were exceeded; tumour biology and growth can be unpredictable, and cells can be mobile after injection. These events had been reported to the HO. The NVS was confident that all avenues had been explored to improve the studies regards welfare.

5.      End of PPL Retrospective Assessment

The PPL holder gave an overview of progress against the activities. There have been published papers and some currently under review. Usage was lower than anticipated owing to the ability to analyse samples archived from each study rather than undertake new studies. Some of the studies were not required, owing to advances in the scientific field thereby further reducing animal usage. PPL holder to finalise document and return to HOLC for submission to HO. Action 20-02 PPL Holder

With regard to the process, the group agreed that a Retrospective Assessment requirement upon expiry of a PPL, replaces the need for the PPL Holder to also submit an end-of-term review to AWERB.

6.      Updated Terms of Reference (ToR) feedback

ToR were circulated for comment. These are based on key requirements for AWERBs from ASPA. The ‘what to expect from AWERB’ is referenced.

The term of membership was agreed as: ‘for review after 3 years’ rather than state 2 × 3-year terms; the possibility of development posts was discussed and will be discussed at a later meeting; the terms for office of the Chair will remain unchanged.

Further comments are invited and the final version will be confirmed by email. Action 20-03, Secretariat, All. 

7.      PEL Holders update (BSD, NACWOs, NTCO, NIO & HOLC)

HOLC met with Director in December 2019.

Staffing level: a 3-year apprentice has been approved; awaiting HEO recruitment; BSD Head to be advertised. It has been a challenging year but comment from PPL Holder that the communications have remained very good, and this has been appreciated; BSD staff acknowledged that especially senior staff have had additional responsibilities and added workload. Thanks have been relayed to previous NVS Deputy for their input, since their departure from RVC team that supports NIBSC. 

8.      NVS Reports

SAHF – some growths in immunodeficient mice have been noted and need to better understand why these might occur.

PF – CHIKV (Study III) ended 19.2.20; a couple of transponders stopped working occasionally; following discussion with the PPL holder, the transponders were reinserted and they worked well thereafter. This was well planned and recognised that all involved will need to discuss ahead of next study to understand which ones to use. There was intense procedural work on the animals and small volumes; always very conservative on blood volume per kilo body weight but this depends on body profile of the animal e,g, juvenile versus larger adult with more adipose tissue – the team considered these factors when increasing the blood volume to achieve the study aims. This will need to be considered for the subsequent study which will also use smaller weight animals. BSD staff responded very well to the required activities.

9.      Openness

FOI request had been received from Animal Justice Project requesting Minutes from AWERB meetings. HOLC is coordinating the response to this annual request; the Minutes are available. Action 20-04, HOLC 

1.   3Rs / welfare initiatives

No updates 

1.   Updated ‘What to expect …’ document

This is now completed. 

2.   AOB 

(i)    MHRA Lay member commented that they had attended Lay Members’ Forum; their feedback highlighted how they saw that the activities of this AWERB are achieving a very good standard in how the group operates including facility tours, rehoming activities, and discussion on NTS. For the latter, these are felt by lay members to be more technical than is necessary and lay members should have review capacity; however the NTS is auto-generated and HOLC will ask HO how this issue can be addressed. Action 20-05, HOLC

(j)    AGM. Proposed for late June. Potential topics for presentation to come to Chair. Action 20-06, All

 The meeting concluded at 16:15 pm.

 END

 These Minutes have been viewed and approved by the Establishment Licence Holder (Director of NIBSC). 

Date: 11^th June 2021