Use of Animals in Research at DSTL Porton Down

Waiting for an internal review by Defence Science and Technology Laboratory of their handling of this request.

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

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 DSTL Porton Down. 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 DSTL Porton Down in 2011?

2) By species; how many animals were bred for research purposes in 2011 at DSTL Porton Down? 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

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Classification: Unclassified

Dear Mr Steele,

 

We attach our response to your FOI request dated 21 January 2013.

 

FOI Department

 

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Friday 1st February 2013

Re: Ref FOI 803-13 AIT 22-01-2013-111914-003

Dear Sirs,

Many thanks for your partial response to my request (“The Request”), dated 1st 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 Part 3) of The Request. The Refusal claimed exemption under S.24(1) of Animal (Scientific Procedures) Act 1986 (“ASPA”) [1], citing the confidentiality of those contributing to the Ethical Review Committee (“ERC”) process.

S.24 ASPA – Introduction & Purpose Where Relevant to DSTL

S. 24 ASPA was introduced as part of ASPA in 1986, making it an offence for those under the employ of Designated Scientific Procedure Establishments (“DSPEs”) to disclose information which was contributed in confidence as part of their role.

The reasoning for the introduction of S.24 was to prevent information from falling into what could be termed as 'the wrong hands'. This has a number of interpretations, however two are particularly prominent in cases where exemption is sought:

1) Competition – Some organisations operate their businesses in a competitive nature and rely on confidentiality within their supplier and client network. It is argued that the disclosure of certain information may lead those business partners to seek contracts with other organisations of a similar business line, thus resulting in an unfair advantage for competitors. Such is the case with numerous DSPEs, such as Contract Research Organisations (“CROs”) and pharmaceutical developers.

However, this is not the case with DSTL Porton Down which conducts research into matters relating to defence technology. As a government organisation, which operates as a part of the Ministry of Defence, DSTL does not have any competitors or financial interests to protect and thus cannot seek exemption under S.24(1) ASPA in this case.

2) Protection – Animal research enterprises are more concerned about the protection of employees than other organisations. This is largely as a result of perceived threat from the extreme fringe of the animal rights movement, but this does not present an exemption from disclosure. However, what this does mean is that organisations may redact information which may lead to the identification of staff.

In relevance to The Request, DSTL Porton Down were invited to redact any information of this nature prior to disclosure. Additionally, documents which fall within the criteria of disclosure relate to the welfare of animals and not the identity of employees, sensitive buildings or other data of this nature. Consequently no exemption cannot be sought under S.24 (a) ASPA.

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. [2] 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.

The Confidentiality Test

The Confidentiality Test seeks to determine if S.24 Animal (Scientific Procedures) Act 1986 – Protection of Confidential Information - can be relied upon as a valid exemption to disclosure.

S. 24(a) ASPA 1986 states:

“A person is guilty of an offence if otherwise than for the purpose of discharging his
functions under this Act he discloses any information which has been obtained by him
in the exercise of those functions and which he knows or has reasonable grounds for
believing to have been given in confidence”

Therefore, The Confidentiality Test must determine whether person(s) under the employ of the DSPE knew, or had reasonable grounds for believing, the information concerned was given in confidence. In this case, the information to which this test is being applied is that contained within the minutes of ERC meetings.

When submitting license applications to the Home Office Animals in Science Regulation Unit (HOASRU), details of the proposed research and matters discussed by the ERC must be given so as to show compliance with 3Rs policy. When given notice ERC minutes can be inspected by the HOASRU. It can therefore be deemed that it is likely that those present at ERC proceedings are aware the information is not given in confidence due to the possibility of data being divulged to an external body.

Further, many DSPEs publish the final findings of studies in respectable academic journals. These research papers are obtainable in the public domain and detail precise information regarding experiments undertaken, listing contact information of participating researchers and the establishment at which they were conducted. Such a process invites peer review, reference and facilitates the 3Rs process in ensuring that experiments are not repeated.

In the case of DSTL Porton Down, numerous study papers have been published which fall within the time scope of this request and were all discussed by ERCs:

1) Development of an acute model of inhalational melioidosis in the common marmoset (Callithrix jacchus) – International Journal of Experimental Pathology [3]

2) Post-exposure therapy of inhalational anthrax in the common marmoset – International Journal of Antimicrobial Agents [4]

3) The Utility of Human Plasma-Derived Butyrylcholinesterase (huBuChE) as a Therapeutic Measure in the Absence of Pre-Treatment or Conventional Post-Poisoning Therapies Against Nerve Agent – DTIC [5]

4) Post-exposure therapy with human butyrylcholinesterase following percutaneous VX challenge in guinea pigs – Clinical Toxicology [6]

5) The developmental impact of prenatal stress, prenatal dexamethasone and postnatal social stress on physiology, behaviour and neuroanatomy of primate offspring: studies in rhesus macaque and common marmoset – Psycho-pharmacology [7]

It must be considered that the cited study papers, which are limited to five randomly selected and published in the time scale of The Request, were authored by researchers with the consent of DSTL Porton Down. Inference can therefore be drawn that those contributing to the ERC process are aware that information is not given in confidence and details of experiments conducted by the DSPE can be published in the public domain following their conclusion.

Using The Confidentiality Test conclusive indication can be given that persons presenting information before the ERC are reasonably aware that this is not given in absolute confidence. As a consequence, disclosure is not exempt under S24(a) ASPA.

The Public Interest Test

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

Over recent months, DSTL's use of animals in research has been the subject of widespread journalistic coverage. [8] [9] Consequently, many questions have been raised by the media regarding a reported rise in designated procedures being conducted in the field of defence research.

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, as part of the Ministry of Defence, DSTL 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.24(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. [10][11][12]

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.24(a) Animal (Scientific Procedures) Act 1986 does not provide a valid exemption from disclosure in this case.

Firstly, DSTL Porton Down does not fall within the scope of protection for which S.24 was introduced – not only does the facility not have competing organisations, and therefore cannot hold information sensitive in relation to remaining competitive as part of an industry, but also that the disclosure of information sought will not fuel any adverse consequences where employees are concerned.

In addition, The Confidentiality Test leans towards disclosure. Employees cannot have reasonably thought information was, or was likely to have been, given in confidence when detailed study papers are published in the public domain following study conclusion. Secondly, the content of ERC minutes are available for inspection by external bodies, such as the Home Office Animals in Science Regulation Unit, upon application for experimental licenses.

The Public Interest Test also leans towards disclosure. Firstly, there conclusive evidence showing an interest in animal procedures conducted by DSTL Porton Down. Further 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

___________________

Sources:

[1] Section 24 – Animal (Scientific Procedures) Act 1986 :-
http://www.legislation.gov.uk/ukpga/1986...

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

[3] International Journal of Experimental Pathology (November 2011; Vol. 94, Issue 1, 74) :- http://onlinelibrary.wiley.com/doi/10.11...

[4] International Journal of Antimicrobial Agents (July 2011; Vol. 38, Issue 1, Pages 60-64) :- http://www.sciencedirect.com/science/art...

[5] DTIC (September 2011; ADA553097) :-
http://oai.dtic.mil/oai/oai?verb=getReco...

[6] Clinical Toxicology (April-May 2011; Vol. 49, No. 4, Pages 287 - 297) :- http://informahealthcare.com/doi/abs/10....

[7] Psycho-pharmacology (March 2011; Vol. 214, Issue 1, Pages 33 - 53) :- http://link.springer.com/article/10.1007...

[8] The Telegraph - Rise in Animal Experiments at Defence Laboratory (18 December 2012) :- http://www.telegraph.co.uk/science/97533...

[9] Huffington Post – 'Cruel' Animal Testing on Monkeys and Pigs By MoD at Porton Down 'On The Rise' (18 December 2012) :-
www.huffingtonpost.co.uk/2012/12/18/anim...

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

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

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

CIO-FOI-IR (MULTIUSER),

Dear Mr Steele,

Acknowledgement of Request for a Freedom of Information Act (FOIA)
Internal Review

I acknowledge your email received here on 5 February 2013 in which you
requested an internal review of your request for information under the
FOIA, dealt with by DSTL, our reference 22-01-2013-111914-003.

The Department's target for completing internal reviews is 20 working
days and we therefore aim to complete the review and respond to you by 5
March 2013. While we are working hard to achieve this, in the interests
of providing you with a realistic indication of when you should expect a
response, I should advise that the majority are currently taking between
20 and 40 working days to complete.

The review will involve a full, independent reconsideration of the
handling of the case as well as the final decision.

Regards,
Ms Usha Sondhi
------------------------------------------------------------------------
Ms Usha Sondhi | CIO-SPP-IR Comp2 | 01.N.16 MOD Main Building |
Whitehall | London SW1A 2HB

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