National Institute for Biological Standards and Control
Animal Welfare and Ethics Review Body
Minutes of a meeting held on Tuesday 18 August 2020 at 2:00 pm
REDACTEDr (BSD Head; NACWO)REDACTED(Lay)REDACTED(PPL Holder)REDACTED (primary NVS)REDACTED (NTCO)REDACTED (Scientist)REDACTED (NACWO)REDACTEDt (NIO)REDACTED (Scientist)
REDACTEDt (HOLC)REDACTED (Chair)REDACTED (NACWO)REDACTED (Stats)REDACTED (Secretariat, PPL Holder)REDACTED(Lay)
REDACTED (NACWO)In attendance:
REDACTED Item 4REDACTED Item 5
Made available for reference.
Draft Minutes were updated thus:
(a) Comment was added to Item 5 to reflect the group agreed that an End-of-Term review will be replaced by the Retrospective Assessment document when deemed necessary by the Home Office.
(b) Two typographical errors corrected.
Approved Minutes will be signed by the Director.
Matters arising from 19 February 2020 Minutes – see Action Log
3 (a) to (f):
(a) 19-44: 2020 log initiated – action closed
(b) 19-45: ToR, no further comments were received by Secretariat; Chair noted that terms of appointments are not clarified and will send comment to Secretariat; then ToR can be considered as complete and reviewed at suitable point.
(c) 19-47: Closed
(d) 19-48: Carried forward: Secretariat will ask for the ‘what to expect from AWERB’ document to be shared at the next SMT meeting for information.
(e) 20-01: Closed – NACWOs will incorporate items in to the PELH update at the periodicity agreed
(f) 19-50: Closed.
20-02: document finalised and submitted to HO. Closed.
20-03: see 3b – 19-45 above, awaiting comments from Chair
20-04: redacted AWERB minutes, once agreed and signed by the Director, will be made available via our open access website. Closed.
20-05: New ASPeL is undergoing continuous development and feedback has been shared. Closed.
20-06: Cancelling AGM for 2020 – this will be scheduled for when a face to face meeting is possible. An email joint from Chair and PELH to be sent to all staff to say we recognise value in having the AGM but currently not possible – the value in having this is fully recognised so will postpone the face to face meeting. Action 20-07: (Incoming) Chair and PELH
Retrospective assessment of PPL 70/8506
The PPL Holder presented an oral update against the report. Highlights:
- End of a 5-year license for using SIV models for development and evaluation of HIV/AIDS vaccine strategies; practically not done a lot of work on PPL because of lack of resource for HIV as it has been diverted to emerging viruses; scientific interest remains;
- Mostly normal bleeders but number of animals on site was relatively low; reflects a level of re-use. Numbers on the form match the HO submissions;
- Not clear on best way forward: have experienced and well-adapted animals for donation of normal blood, or to have more animals used;
- Much of the work towards 3Rs has been achieved over a longer period of time and is reflected as ‘business as usual’ in a PPL such as this – this would be different for a newer study.
o Q: requested clarification on the form for the species used and not used. A: agreed
o Q: suggested incorporating all species authorised under PPL even if not used. A: agreed
o Q: does this have any impact on whether we should be maintaining animals on site as normal bleeders. A: there had been one discussion with HOI on having a licence to support any NHP project; could be value in other areas of Institute for reactivity to e.g. pandemics.
- Post discussion (in absence of PPL holder) – request short paper to SMT to detail what is needed for normal bleeders on a licence or a separate one? There are benefits to having easy access to the NHP on site – as they age are they still relevant for blood use. NVS – there might be many reasons for why having the animals is of benefit e.g. the repurposing of the animals assigned to CHIKV has allowed them to be moved to the SARS-2 PPL.
- Action 20-08: PPL holder and HOLC to update RA and submit to HO.
Mid-term review PPL PE12BE3A7
- Predicted and actual numbers differed
o Some assays have not been used at all
o Kendrick test – has had 5 assays for contract and for WHO but introduced the refinement to this test and it’s now more reproducible and so 36 mice reduced to 20 / group. Just over 50% of the numbers at outset of licence now needed – does require specific mice and some supply issues e.g. sometimes older than requested; can take time to produce the numbers
- Acellular pertussis – no batches have been received for testing – may change after Transition Period
- An in vitro assay has been introduced for the MenB assay so numbers are lower than initially estimated
- Diptheria antitoxin – some more animals needed increased testing likely due to stockpiling of antitoxin
- BCG seed lot testing - test has been removed from OCABR guidelines so won’t be used again
- A number of refinements further to those above, including: histamine test was removed; single use needles; tunnel handling of mice reduces stress; antipyretics in drinking water; housing etc
- NIBSC has led on the removal of a lot of these tests and refinements, and have offered assistance elsewhere e.g. EDQM; presentations have been made by BSD; Concordat group is aware of the refinements and replacements made – ask for liaison with Comms in that group for potential stories; Action 20-09:NACWO representative on Concordatgroup to propose comms piece
- AWERB thanked the presenter for the good work that has gone under the PPL to address the 3Rs, especially the replacement by in vitro tests.
Mid-term review PPL P4F343A03
- PPL passed to current holder as previous owner left Institute; required significant training updates to cover all relevant species
- Some protocols have not been used because of changes to resources in the Division and re-prioritised work programmes; some protocols have not required specific assays e.g. in the pre-pandemic flu area; some lower usage reflects that the high containment laboratory was unavailable for the work for a period of time – this is expected to resume towards the end of the year.
- An amendment was made to increase the number of rats on the licence from 2000 to 6000 over the full 5-year term of the licence (confirmed after the meeting and added to Minutes). This reflects advances in novel polio vaccine development progressing to the requirement to test for immunogenicity and antigenicity; Sabin inactivated polio vaccine development has increased globally – NIBSC is responsible for developing a suitable batch release test and in testing pilot lots from new manufacturers using the rat immunogenicity test; work on non-polio enteroviruses towards standards and inactivated vaccines has led to an increased need to assess their potency.
- Adverse event in rabbits was assessed, protocol and materials reviewed; eliminated problem with inoculum; reviewed use of adjuvant and sought external opinion on its use; amended PPL to allow for greater number of inoculation sites, improved needle usage. Noted good communication with BSD helped – this was appreciated by the PPL holder and the scientists
- Numbers used in remaining protocols are as anticipated at this stage of the PPL lifespan.
PEL Holders update (BSD, NACWOs, NTCO, NIO & HOLC)
– Due to pandemic working conditions, instead of quarterly report, this is a 6-monthly report. This was agreed with Director.
– There was quick PPL creation and turnaround for the SARS-2 PPL – submitted to AWERB in April, submitted to HO in May and approved 2/6/20
– Staffing – HOI noted the current interim position at head of BSD; BSD Head stated a number of posts not yet being filled; an internal appointment was successful – but means a post needs to be back-filled; 12 month maternity cover – recently offered to a candidate; some recruitment issues, including an advertised post being withdrawn; slower than expected responses from the Recruitment team; some involving change of staff; limited time of senior BSD staff to deal with the administration involved. BSD is still working in teams for business continuity owing to the pandemic – impacts more on the senior team, who are helping with general husbandry too; confident that animal welfare issues are prioritised – they are matching work flow with resources; staff are working longer hours; this needs to be flagged again with SMT – there is no room for staff absence; need to address the capacity for not only the future needs but also the current situation. Staff are emotionally committed to the welfare of the animals meaning that they frequently go above and beyond – and a lot of this falls on the senior members of BSD; needs recognition that this is not a new situation but has been a long-term issue. Suggestion that Head BSD compiles hours worked and issues; NVS recognises the ‘compassion fatigue’.
– AWERB agree that the impact on staff needs to be addressed.
– Came up at Risk Review meeting with HOI
Action 20-10:BSD Head: situation to be escalated to SMT via Head of ABS
NVS now 1/week visit – under pandemic was reduced to essentials
Generally, no issues. The issue with the rabbits was raised under Item 6; training for COVID-related projects has been ongoing; it is busy in the unit – monitoring the animals, including the primates, surgeries for animal implants on COVID studies etc. Supports Item 7 action point.
Deferred to next meeting
3Rs / welfare initiatives
i. Statistics – Statistician will be running courses – will include the power calculation; comment that the licensing training does have some statistics e.g. power calculations – recent trainee will forward to Statistician for information; the form was requested since there is significant impact on estimation of numbers and needing reassurance that numbers have been given due consideration. NACWOs ask the scientists in pre-study meeting to check statistical input has been sought. Action 20-11:Scientist to forward training materials to Statistician
ii. Current Chair handing over to new Chair (also, until recently, a PPL holder). The PELH has confirmed the appointment. The AWERB extended its thanks to the out-going Chair for coordinating the group very effectively over a number of years, and welcomed the incoming Chair.
iii. There will be a need for an additional PPL holder on the group since the Secretariat is the only one currently. Action 20-12:(Incoming) Chair to consider future membership
iv. Request for the out-going Chair to compile a report with key successes during tenure but also any unresolved issues – this should include the staffing issues in BSD, particularly in light of working conditions under the pandemic. Action 20-13:(Out-going) Chair
The meeting concluded at 16:20 pm.
These Minutes have been viewed and approved by the Establishment Licence Holder (Director of NIBSC).
Date: 11th June 2021