AWERB Minutes February 2021

National Institute for Biological Standards and Control 

Animal Welfare and Ethical Review Body 

Minutes of a Special meeting held on Thursday 25 February, 2021 at 12:00 pm via MS Teams

2.      Introduction by chair

The special meeting of AWERB was called to discuss what advice, guidelines and/or processes AWERB should have in place for NIBSC scientist who are taking part in collaborative projects that involve animal studies and animal derived materials taking place outside of the UK, in order to ensure that the procedures undertaken on the animals are ethical justified and/or align with the ethical standards for animal work in the UK.

The question came up after one NIBSC scientist contacted the HOLC to ask for advice in connection with a collaborative study for which the animal work will be performed in Russia and for which mice will undergo retro-orbital blood sampling.

The following questions were put for discussion:

1.       Should we have guidelines for scientists for addressing the ethical dilemma and for mitigating the reputational risk associated with such collaborative studies?
2.       If yes, what should these guidelines say?
3.        How should AWERB approach this subject?

3.      Open discussion

(a)   Scientist: NIBSC scientists should ensure that there is an ethical review process in place in the country in which the animal study is performed and that an ethical review has taken place for the planned animal study. In addition, NIBSC scientists should inform collaborators on best practices within the UK.

(b)   Lay Member: The ethical dilemma and the reputational risk for NIBSC are more severe in cases in which material from the animal study is received and investigated at NIBSC. NIBSC scientists should be able to justify their involvement in studies that do not meet the ethical standards applied in the UK.

(c)   NVS: In addition to collaborating on animal studies taking place outside of the UK where ethical standards may be lower, considerations regarding ethical standards also apply to materials derived from animals such as for example blood products, foetal calf serum and certain antibodies. NIBSC scientist should consider where the material that they purchase comes from and how it is produced. Are there alternatives to these materials from more ethical sources available? Detailed records for and ethical sourcing of materials are particularly important in cases, where the material is to be used for later distribution in reference reagents.

If NIBSC is named on publications the ethical implications of the animal work and sources for animal materials become very important, especially if NIBSC scientists are leading the studies.

Following a clear legal framework is particularly important in studies that involve NHP. In the UK, special HO approval must be sought for work with wild animals/monkeys.

If NIBSC is the lead, what is the reason for the animal work being performed outside of the UK? Is this justifiable?

Ethical considerations should not only apply to regulated procedures, but also to the killing of the animals. How animals are monitored and treated should adverse effects occur should also be considered, along with the sharing of protocols / standard operating procedures.

AWERB should try to increase the awareness of researchers within NIBSC regarding how materials are ethically sourced.

(d)   Lay Member: If a study does not meet the ethical standards in place in the UK and if the study is not crucial, NIBSC scientist should take the moral high ground and should withdraw their involvement.

NIBSC should ask collaborators to fulfil the ethical requirements and should suggest alternative procedures where suitable. If the collaborator does not agree to this, the NIBSC scientist should make a decision on whether to participate at all. NIBSC should not be named as a participant on the publication resulting from a study that doesn’t meet the ethical standards of the UK.

(e)   NACWO: Rather than just suggesting alternatives, NIBSC should offer training for alternative methods. If a procedure is not permitted in the UK, NIBSC should not be involved in studies performing these procedures abroad.

(f)    Scientist: It may also be important to consider who is funding the collaborative studies in question and what is the position of these funders towards animal studies.

We maybe should consider reviewing all collaborative animal work performed by NIBSC scientists outside of the UK at AWERB. A review could take place at pre-grant level if the collaborative work is part of a grant application.

(g)   HOLC: It may be a good idea to first assess the scale of the issue? How many collaborative studies in which animal work is performed outside NIBSC / outside the UK are NIBSC scientist involved with?

It also may be worth investigating how other AWERB committees are dealing with this and should be used as an opportunity to promote best practices.

(h)   Scientist: Maybe in addition to contacting other AWERB groups, we could contact NC3Rs to get advice from them and see how funders are approaching the issue.

(i)    Lay Member: In order to establish the scale of the issue within NIBSC, we should design a questionnaire for internal use at NIBSC (consider easy tick-box questions). How many NIBSC scientists are involved in animal work performed outside of the UK?

Once the scale of the issue within NIBSC has been established, an internal procedure could be established that allows AWERB to interact with NIBSC scientist considering participation in collaborative work involving animal studies performed outside of the UK.

(j)    Chair: The chair asked for volunteers to design a suitable questionnaire for inhouse use to investigate the scale of the issue. – Three volunteers came forward.

It may be a good idea to include this topic in the next general AWERB meeting held at NIBSC in order to engage NIBSC scientists.

4.      Action(s) to take forward

4.1.    Chair will distribute the minutes of the meeting among AWERB members for further input.

4.2.    Chair will liaise with volunteers in order to draft a questionnaire for internal use for investigating the scale of the issue. The draft questionnaire will be shared with the other AWERB members for further comments before being distributed within NIBSC.

4.3.    Chair will contact the scientist who brought the issue to the attention of AWERB and will thank him for seeking AWERB input on the topic.

4.4.    Chair will look into whether the AWERB hub can be used to learn how other AWERB committees / institutions deal with this issue.

4.5.    BSD head will look into other networks to find out how other institutions deal with this issue.

The meeting concluded at 12.58 pm.

 END

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

Signature: REDACTED

Date: 11^th June 2021