National Institute for Biological Standards and Control
Animal Welfare and Ethics Review Body
Minutes of a meeting held on Tuesday 15 December at 2:00 pm
REDACTED(BSD Head; NACWO)REDACTED (Lay)REDACTED (Chair)REDACTED (primary NVS)REDACTED (NACWO)REDACTED (Scientist)REDACTED (NTCO, NACWO)REDACTED (NIO)REDACTED (Scientist)
REDACTED (HOLC)REDACTED (Stats)REDACTED (Secretariat, PPL Holder)REDACTED (Lay)
In attendance:REDACTED Item 4REDACTED Item 5REDACTEDItem 6
Made available for reference and confirmed as accurate. Action 20-14: Chair to organise for approved Minutes from August to be signed by the Director.
20-07: Chair to contact REDACTED (Interim Head of ABS) to discuss AWERB workshop on BSD workload / priorisation of research projects
20-12: Chair to draft e-mail for recruitment of new members to the AWERB committee; draft to be circulated and discussed among AWERB Committee members
20-14: (Incoming) Chair to provide a summary of meeting with Director (REDACTED) and a copy of the presentation to SMT to AWERB. Carried over
20-16: HOLC to include comments from additional staff member in lessons learned document; Chair to forward and discuss the final document with the PELH
The PPL Holder presented an oral update against the report. Highlights:
– Tg mouse inoculation work – the training element which is a technically complex method to ensure the assay is valid
– The PPL has been renewed previously; it is essential for the polio eradication initiative
– The establishment is the only one able to do the training
– The method is critical for application to new vaccines; the institute has to train and monitor performance for others – internal and external to the institution, plus batch release for vaccines through the Establishment.
– For 3Rs – this will be discussed in the training workshop to be held at the Institute in 2021. The method has been optimised over the years so it may not be possible to further reduce the numbers but the topic will be raised since it is an important question
– The training is monitored to ensure the best operators are taken forward to complete the training to minimise the number of animals used
– Excess animals from breeding are used in the training, rather than breeding/purchasing for the training specifically.
– In the follow-on licence – the methodology will stay the same and the number of animals may stay the same should the BSD trained staff levels stay the same. BSD Head indicated that one new person will be trained but the numbers are already captured in those in the PPL. Not really possible to reduce the numbers much further though some consideration can be given to the number used in the proficiency (ink) tests.
– Long-term, there is a plan to validate an in vitro molecular test that in the future could reduce the numbers of animals needed. A 4-year externally funded grant allows for expansion of this work.
– Lay member indicated that this is an excellent example of the work to look forward to reducing numbers further and the development of animal-free assays for the future.
– Comment that the report was well written.
- The protocols have not all been used since there have been no external requests for product testing
- Protocol 5 was not used as heavily as planned when the PPL was written as the focus became the challenge model
- Protocol 6 is most used – the TB challenge. Numbers are broadly as expected. COVID pandemic and lab shutdowns (H&S; maintenance) have hampered the experimental progress. Did see some unexpected weight loss in animals with clinical isolates – introduced daily weigh-in to minimise risk of exceeding acceptable weight loss; appears to be specific with the high dose
- Protocol 7: malaria challenge. Fewer animals used mainly because there was some issue with supply of the malaria mosquitoes; in the future will use the mosquitoes from the humanised mouse work but the numbers still likely to be low to the end of the PPL.
- Protocol 8: couldn’t proceed as planned so fewer animals used – will require the malaria challenge model before the co-infection can progress.
- The lack of use of the 4 protocols – use is typically low since established BCG vaccines do not need this test set – they are more for novel vaccine development.
- Agreed that there is no requirement to amend the numbers on the PPL
– The Institute licence. Immunodeficient animals to look at therapeutics e.g the malaria model to date. The procedure is refined periodically.
– Protocol 1 – engraftment – main use to date: mature white blood cells; can get some GVHD; use of stem cells also included. Takes longer for engraftment. A different strain of mouse can be used which might engrafts better
– Protocol 2 – more complex model bone marrow, liver, thymus (BLT) – surgical model. Not used this to date.
– Can be transferred to one of 8 protocols to follow up the model eg biotherapeutics; a new protocol was added recently.
– This was a new type of PPL where it is institute-wide and each person has a different project driver; seems to be working well. A group meeting is held to talk through data, protocols, for refinement. Challenging for BSD since protocols are complex and animals need a lot of checks.
– From BSD point of view, there are often short term changes which can be challenging to manage regards staffing. More training planned for the new year and need to manage the general workload across the facility.
– Staff are getting more information on the protocols with added experience which should help more with the planning on BSD side.
– PPL Holder thanked for the good interaction with NVS and BSD team
Deferred to next meeting
– Staff are busy especially with COVID work but working hard to keep standards high.
– Hamsters – some unexpected events; loss of 1 animals; looked at issues since also seen in stock animals not on study; NACWO didn’t find any information from wider network because not many people using this species. Older males used and may be more sensitive to anaesthesia; but decision that gas anaesthesia was acceptable; HO informed and know the causes being investigated. No issues since gas being used.
– Looking at alternatives to housing the TgB21 colony – can be quite aggressive; NACWO looking at possible changes
– Knowledge and practices at biocontainment without compromising welfare – member of staff (REDACTED) gave good talk and shared experience to show what can be done.
– PF: 4 normal bleededs (2 x rhesus, 2 x cynomolgus) – one of the cynos was seeming unwell – some weakness. But suspected some metabolic issues – gastrointestinal disease or possibly kidney disease; within a month the animal was losing weight and euthanased. Left a singly-housed male – managed this by keeping him in a room where femailes are housed but kept separate. PPL Holder (for NHP work) looking to see if a use for the male. Meantime vascetomised the male and so should be able to be co-housed with the females so gives an alternative to housing separate from the femailes.
– Implantation of transponders to tamarins – generally has gone very well. One issue with an animal who didn’t respond well and decision to terminate. However, nothing unusual showed on post mortem but could have been stress-induced. Lot of good experience with these transponders now.
Lay Member had an interview with the web redesigners. Mentioned it was time to be more open and to give good examples and indicate the worthwhile efforts that the Institute has made. Not certain that the group understood the topic and the need to be more open about the work.
Number of actions from recent Concordat meeting – might be useful to have another presentation from NC3Rs.
Propotional campaign for animal ‘postcards’ which are anonymous.
Five surplus female rats: requesting rehoming under policy. One BSD member interested to rehome the group of 5. Action: All, to email Chair with decision by Friday 18 December.
12.1 quinquennial review is planned for January 2021. There is a focus on the scientific rationale for the in vivo work however, the review will also capture the 3Rs and welfare elements – it is anticipated that BSD staff will be contributing to the talks etc,
12.2 Lay member achnowledged the input from the teams and the hard work.
The meeting concluded at 16:00 pm.
These Minutes have been viewed and approved by the Establishment Licence Holder (Director of NIBSC).
Date: 11th June 2021