Freedom of Information Act 2000 – Request for Information Relating to the Use of Animals in Research at NIBSC

To Whom It May Concern,

I write in accordance with the Freedom of Information Act 2000 (“The Act”) to request the disclosure of data held which concerns the use of animals in research at the National Institute for Biological Standards & Control (“NIBSC”). For the avoidance of doubt the term 'animal research' is defined as that governed by the Animal (Scientific Procedures) Act 1986 (“ASPA”).

The information I wish to request is as follows:

1) By species; how many animals were used and subsequently procured as part of research at NIBSC in 2011?

2) By species; how many animals were bred for research purposes at NIBSC in 2011? In the case of rodents, please list by genetic strain and specify for which patents are held.

3) Copies of any minutes from, or communications relating to, Ethical Review Committee (“ERC”) meetings, or boards of a similar nature for which your establishment uses a different title, for 2011.

I must stress that I am not interested in data which identifies those under the institution's employ and wholly agree for such personal information to be redacted.

As I am sure you are aware, The Act dictates that a response must be given within 20 days of receipt of this request. In the eventuality of any delay, I request that you keep me informed. If there are any matters on which you seek clarity, please do not hesitate to contact me.

Many thanks for your assistance and time spent in handling my request.

Kind Regards,

Luke Steele

Freedom Of Information, National Biological Standards Board

1 Attachment

See attached.

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Public Information Access,
Health Protection Agency,
151 Buckingham Palace Road,
London, SW1W 9SZ
Tuesday 19th February 2013

Re: Ref 13/01/21/gs/035

Dear Sirs,

Many thanks for your response to my request (“The Request”), dated 14th February 2013 and of the above reference.

I wish to take this opportunity to request an Internal Review regarding the refusal (“The Refusal”) to disclose documentation relating to The Request. The Refusal claimed exemption under S.38(1)(b), citing the safety of persons under the employ of the Health Protection Agency (“HPA”).

Summary of The Role of Ethical Review Committees

Premises conducting research on, or procedures involving, live animals are required by law to be licensed by the Home Office in accordance with ASPA. Such procedure is aimed at regulating animal welfare and ensuring that experimentation is only conducted within DSPEs, by those holding relevant project licenses.

However, responsibility is also placed on the individual DSPEs to conduct internal reviews of research through ERCs, or a similar board relevant to that institution. [1] The sole purpose of ERCs is
to peer review each research project on an individual basis and to establish if the proposed benefits to science or health outweigh any possible ethical implications. In the case of reviewing animal research, ERCs have the added onus to work within the Replacement, Refinement and Reduction (“3Rs”) policy. The latter framework seeks to establish three things - if there are methods available to avoid or replace the use of animals in the study (“Replacement”), if animal use can be minimised (“Reduction”), or if scientific procedure and husbandry techniques are available to minimise adverse effects on animal welfare (“Refinement”).

Membership of ERC panels usually consists of independent adjudicators within the establishment or department concerned, whose responsibility it is to uphold the 3Rs policy. It is also common procedure to invite representation from the facility's Named Veterinary Surgeon(s) (“NVS”) and Named Animal Care and Welfare Officer(s)(“NACWO”) to make points on any animal welfare implications associated with proposed or ongoing trials. The Personal License Holder (“PLH”) may also be invited to make comment when their proposed study is being discussed. Home Office Inspectors (“HOIs”) may also be present.

Statistics on the Use of Live Animals in Research

Premises conducting research on, or procedures involving, live animals are required by law to be licensed by the Home Office in accordance with ASPA. Such procedure is aimed at regulating animal welfare and ensuring that experimentation is only conducted within DSPEs, by those holding relevant project licenses.

On condition of research licenses being issued, Individual Project License Holders (IPLH) and DSPEs must complete Annual Statistical Returns documenting the number of animals used, their species and a vague description of the type of research undertaken.[2] These are returned to the Home Office Animals in Science Regulation Unit (“HOASRU”), allowing government monitoring of research trends and the identification of improvement under national 3Rs policy. Annually, the Home Office releases a compilation of this data in the Statistics of Scientific Procedures on Living Animals – Great Britain report. [3]

The S.38 Exemption Test

The S.38 exemption test seeks to determine if S.38 (1) Freedom of Information Act 2000 – Health & Safety - (“The Act”) can be relied upon as a valid exemption to disclosure.

S. 38(1) provides that:

“Information is exempt information if its disclosure on this Act would, or would be likely too:

(a) Endanger the physical or mental health of any individual, or
(b) Endanger the safety of any individual”

In this case, it can be deemed that the term 'endanger' can be interpreted in the same way as 'prejudice' in other exemptions in the Act. The Tribunal in the case of Hogan v Information Commissioner explained that the application of the prejudice test involved a number of steps:

“[F]irst there is a need to identify the applicable interest(s) within the relevant exemption...second, the nature of the 'prejudice' being claimed must be
considered...a third step for the decision maker concerns the likelihood of occurrence of prejudice” [4]

The HPA has applied section 38(1)(b) to the information in respect of all of the questions within the request. Section 38(1)(b) provides that information is exempt if disclosure would, or would be likely to, endanger the safety of any individual. The HPA argues that this is the appropriate part of the exemption to apply because disclosure would, in its opinion, be likely to lead to the organisation being targeted by animal rights extremists, which would endanger the safety of the institution's staff and other individuals associated with the institution.

In the Hogan case the Tribunal commented that “an evidential burden rests with the decision-maker to e able to show that some casual relationship exists between the potential disclosure and the prejudice”.

What now must be considered is whether, in the circumstances of this case, a link can be made between disclosure of the particular information requested and the possibility of the threat posed by animal rights extremists would increase.

For this to be established, it must be taken into account that HPA have admitted to holding the data concerned and thus in effect publicly confirmed their engagement in animal research. Irrespective of the number of animals used, the species on which licensed procedures were undertaken and the level of internal breeding taking place, the matter remains that it is now public knowledge that HPA engage in animal testing. This, in the eyes of those from whom the authority seek protection, is a 'legitimate reason' in itself to target the organisation as any animal use is wrong, regardless of the scale on which animals are used. Consequently, any potential threat level will not be altered by disclosure.

Additionally, the data contained within annual returns and, with redaction, the minutes of Ethical Review Committee meetings would not identify those under the employ of HPA, thus all risk would be removed.

Further, research carried out by HPA's academics is routinely published in scientific journals. Whilst such information may not be intended for the public at large it is nevertheless publicly available. Indeed, it is possible to find a number of publications on the pubmed and Google Scholar websites wich show the authority is involved in research involving animals:

1) Permissable Variation in the 3' Non-Coding Region of the Haemagglutinin Genome Segment of the H5N1 Candidate Influenza Vaccine Cirus NIBRG-14 – Plos One [5]

2) Charicterisation of MHC haplotypes in a breeding colony of Indonesian cynomolgus macaques reveals a high level of diversity – Immunogenetics [6]

3) Charicterisation of Mhc class I and class II DRB polymorphism in red-bellied tamarins (Saguinus labiatus) – Immunogenetics [7]

4) Diversity of TRIM5α and TRIMCyp sequences in cynomolgus macaques from different geographical origins – Immunogenetics [8]

5) Phrenic nerve-hemidiaphragm as a highly sensitive replacement assay for determination of functional botulinum toxin antibodies – Toxicon [9]

Given that such information also includes the names of academics involved, it is difficult to see what further prejudice would be caused by the disclosure of this more general information on the number of animals used in research carried out by the authority, the number of animals bred and the redacted content of Ethical Review Committee meetings.

It must now be considered the likelihood that disclosure of the information in the request and the redaction of personal data would endanger the safety of any individual if it were disclosed. It must be considered that the term 'endanger' should be interpreted in the same way as the term 'prejudice' in other exemptions in the Act. In this case, HPA has indicated that the exemption is engaged because disclosure would be likely to endanger the safety of individuals. When discussing the prejudice test the Information Tribunal in John Connor Press Associates Limited v The Information Commissioner confirmed that “the chances of prejudice being suffered should be more than a hypothetical possibility; there must have been a real and significant risk”. [10] This in turn follows the judgement of Mr Justice Munby in R (on the application of Lord) v Secretary of State for the Home Office. In that case, the view was expressed that:

“Likely connotes a degree of probability that there is a very significant and weighty chance of prejudice to the identified public interests. The degree of risk must be such that there 'may very well' be prejudice to those interests, even if the risk falls short of being more probable than not.”

In light of this the view is taken that in order for the exemption to be engaged on a “would be likely to endanger” basis the risk of endangerment need not be more likely than not, but must be substantially more than remote. It must now be considered whether disclosure would be likely to endanger any individuals involved in animal research at the HPA, including its staff.

As note above, the HPA have been invited to redact all information regarding the identity of staff and anything additionally deemed to be of a sensitive nature. This, therefore, removes all potential for further prejudice.

In a similar case – Information Officer v Keele University [Ref: FS50303734; March 2011] – the ICO ruled in favour of limited disclosure of statistics relating to the number of animals used in research. It was deemed that no increase in threat to the public authority would occur as a result of disclosure of similar statistical data, as a consequence of it being public knowledge that the said institution conducts animal research. Additional indication was given that “Public authorities are not entitled to rely on general arguments concerning the public interest maintaining the exemption”.

The Public Interest Test

The Public Interest seeks to establish if information sought falls within the remit of public concern.

Information contained within ERC minutes sought through The Request concern this subject. As already stated, the primary role of the ERC committee is to implement the 3Rs and raise important questions surrounding this policy. It is certainly in the public interest to see that such a process is being undertaken to the highest standards possible and invite constrictive critique in order to facilitate improvement, should it be needed.

In addition, HPA is operated on government funding and consequently all animal studies are paid for through tax-payers monies. It is therefore of high interest to show that animal welfare is stringently being upheld within public institutions where experimentation is taking place.

Consideration must also be taken as to how others within the research sector respond to requests for data under Freedom of Information legislation. It can be determined that S.38(1)(a) was not deemed relevant to numerous high-profile public institutions when faced with similar requests, with full disclosure of ERC minutes was provided subject to redaction. [11] [12] [13]

Consequently, it is a fair statement to make that the disclosure of ERC minutes meets the requirements of The Public Interest Test.

Conclusion

The above evidence clearly shows S.38(1)(a) Freedom of Information Act 2000 does not provide a valid exemption from disclosure in this case.

The S.38 Exemption Test indicates, through historical evidence obtained from previous rulings, that no additional threat or prejudice is incurred as a consequence of disclosure.

The Public Interest Test also leans towards disclosure. It is imperative that government funded organisations, particularly those who conduct licensed procedures, are open in their conduct. This allows external constructive critique to ensure policies such as the 3Rs are met and that the highest standards of animal welfare are upheld. It must also be taken into consideration that other public institutions have published their retrospective ERC minutes.

In conclusion, I request that the above matters are taken into consideration and an Internal Review is conducted regarding disclosure.

I await your response.

Yours Sincerely,

Luke Steele

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Sources:

[1] University of Oxford – Committee on Animal Care and Ethical Review :- http://www.admin.ox.ac.uk/statutes/regul...

[2] User Guide to Home Office Statistics of Scientific Procedures on Living Animals (Home Office; July 2012) - http://www.homeoffice.gov.uk/publication...

[3] Statistics of Scientific Procedures on Living Animals – Great Britain (Home Office; July 2012) :- http://www.homeoffice.gov.uk/publication...

[4] Hogan v Information Comissioner and Oxford City Council [EA/2005/26] and [EA/2005/30], paras. 28 - 34

[5] Plos One (2011) :- http://www.plosone.org/article/info%3Ado...

[6] Immunogenetics (February 2012; Vol. 64, Issue 2, Pages 123 - 129) :- http://link.springer.com/article/10.1007...

[7] Immunogenetics (October 2011; Vol. 63, Issue 10, pp 619-626) :-
http://link.springer.com/article/10.1007...

[8] Immunogenetics (April 2012; Vol. 64, Issue 4, pp 267-278) :- http://link.springer.com/article/10.1007...

[9] Toxicon (June 2011; Vol. 57, Issues 7-8, Pages 1008 - 1016) :- http://www.sciencedirect.com/science/art...

[10] John Connor Press Associates Limited v The Information Commissioner [EA/2005/005], para. 15.

[11] University of York – Vivisection statistics and committee meetings (July 2009) :-
http://www.whatdotheyknow.com/request/vi...

[12] University of Newcastle – Vivisection statistics and committee meetings (July 2009) :-
http://www.whatdotheyknow.com/request/vi...

[13] University of Leeds – Vivisection statistics and committee meetings (June 2009) :-
http://www.whatdotheyknow.com/request/vi...

Freedom Of Information, National Biological Standards Board

Dear Mr Steele

The Health Protection Agency acknowledges your request for an internal review. You will receive a response within 20 working days.

Kind regards

Freedom of Information Officer

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Freedom Of Information, National Biological Standards Board

1 Attachment

Please find attached the Health Protection Agency's response to your request for an internal review.

The references for the original cases were 033 and 034, not 034 and 035.

Freedom of Information Officer

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