Freedom of Information Act 2000 – Request for Information Relating to the Use of Animals in Research by AHVLA

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 by the Animal Health & Veterinary Laboratories Agency (“AHVLA”). 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 by the AHVLA in 2011?

2) By species; how many animals were bred for research purposes at AHVLA 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

AHVLA Corporate Centre (AHVLA),

Thank you for your e-mail. 

General Enquiries & Information

Your email will be forwarded to the relevant individuals for information
and/or action.

Access to Information

We are dealing with your enquiry and will respond to it as per the
timescales below.

If your enquiry is in relation to:

·       Parliamentary Questions – A response will be sent in timescale
requested.

·       Minister’s Correspondence – A response will be sent in 15 working
days unless otherwise specified.

·       Deal With Officially – Items may be forwarded to the relevant
AHVLA Office or Business Unit (within 3 days).   Where items are dealt
with by the Library and Records Management Team a response will be issued
within 15 working days.  If forwarded a response will be issued within 15
working days from receipt of the forwarded item.

·       Freedom of Information/Data Protection/Environmental Information
Requests – A response will be sent within 20 working days.

·       Complaints – A response will be sent within 15 working days.

In the event of a response not being available within the above timescale
you will be informed of this.

Regards,

Animal Health and Veterinary Laboratories Agency (AHVLA)

Corporate Office
Block C, Spur 3
Whittington Road

WORCESTER
WR5 2LQ

T: 01905 763355 
E: [1][email address]

[2]www.defra.gov.uk/ahvla

Animal Health and Veterinary Laboratories Agency (AHVLA)

This email and any attachments is intended for the named recipient only.
If you have received it in error you have no authority to use, disclose,
store or copy any of its contents and you should destroy it and inform the
sender.
Whilst this email and associated attachments will have been checked for
known viruses whilst within AHVLA systems we can accept no responsibility
once it has left our systems.
Communications on AHVLA computer systems may be monitored and/or recorded
to secure the effective operation of the system and for other lawful
purposes.

References

Visible links
1. mailto:[email address]
2. http://www.defra.gov.uk/ahvla

Enquiries AHVLA,

Ref: ATIC0048

Dear Luke Steele,

Thank you for your request for information about the use of animals in
research by AHVLA, which we received on 22nd January 2013. Your request
is being considered in respect to the access to information legislation.

As required by the legislation, we aim to answer your request within 20
working days from the date we received it. If for any reason we are
unable to meet this deadline we will keep you fully informed of the
reasons for this.

If you have any queries, please contact me.

Yours sincerely,

Cameron Smith
Assistant Librarian

Animal Health and Veterinary Laboratories Agency (AHVLA)
Library and Records Management
New Haw
Addlestone
KT15 3NB
T: 01932 357710
GTN: 3956 2710
F: 01932 357608
E: [email address]
www.defra.gov.uk/ahvla

show quoted sections

Enquiries AHVLA,

1 Attachment

Dear Luke Steele,

 

Please find attached our response to your FOI request.

 

Yours,

 

Cameron Smith
Assistant Librarian 

Animal Health and Veterinary Laboratories Agency (AHVLA)
Library and Records Management
Woodham Lane
New Haw
Addlestone 
KT15 3NB

T: 01932 357710
GTN: 3956 2710 
F: 01932 357608
E: [1][email address]
[2]www.defra.gov.uk/ahvla

 

Animal Health and Veterinary Laboratories Agency (AHVLA)

This email and any attachments is intended for the named recipient only.
If you have received it in error you have no authority to use, disclose,
store or copy any of its contents and you should destroy it and inform the
sender.
Whilst this email and associated attachments will have been checked for
known viruses whilst within AHVLA systems we can accept no responsibility
once it has left our systems.
Communications on AHVLA computer systems may be monitored and/or recorded
to secure the effective operation of the system and for other lawful
purposes.

References

Visible links
1. mailto:[email address]
2. http://www.defra.gov.uk/ahvla

AHVLA,
Library and Records Management,
Woodham Lane,
New Haw, Addlestone,
KT15 3NB

Monday 18th February 2013

Re: ATIC0048

Dear Sirs,

Many thanks for your response to my request (“The Request”), dated 18th 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(a) of Animal (Scientific Procedures) Act 1986 (“ASPA”)[1], citing the confidentiality of those contributing to the Ethical Review Committee (“ERC”) process and the data contained within Annual Statistical Returns.

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

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 AHVLA which conducts research into matters relating to aquaculture and the environment. As a government organisation, which operates as a unit of DEFRA, AHVLA 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, AHVLA 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, statistics on animal use 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.

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. [3] 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 compiliation of this data in the Statistics of Scientific Procedures on Living Animals – Great Britain report. [4]

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 and statistics on animal use.

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 AHVLA, numerous study papers have been published which fall within the scope of this request and were all discussed by ERCs:

1) Heart rate variability analysis in sheep affected by transmissible spongiform encephalopathies – BMC Research Notes [5]

2) Immune Responses to the Enduring Hypoxic Response Antigen Rv0188 Are Preferentially Detected by Mycobacterium bovis Infected Cattle with Low Pathology – Plos [6]

3) Cytokine responses of Holstein and Sahiwal zebu derived monocytes after microbacterial infection – Tropical Animal Health and Production [7]

4) Isolation of Prion with BSE Properties from Farmed Goat – Emerging Infectious Diseases [8]

5) Use of Murine Bioassay to Resolve Ovine Transmissible Spongiform Encephalopathy Cases Showing a Bovine Spongiform Encephalopathy Molecular Profile – Brain Pathology [9]

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
AHVLA. 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.

Further, as cited in the previous section IPLHs and DSPEs submit Annual Statistical Returns to the Home Office each annum. These are in turn compiled and published in the public domain. Given that this is a mandatory obligation under condition of project licenses being issued, it can reasonably be argued that both an IPLH and DSPE are aware that the information is not being submitted in confidence.

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. Additionally, it can be deemed that persons submitting Annual Statistical Returns are aware that this is not given in absolute confidence.

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, as part of the DEFRA, AHVLA 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, AHVLA 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. 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.

Further, it is common knowledge that data included in Annual Statistical Returns is compiled and published annually. It cannot reasonably be said that persons involved in this process were unaware of this and thus disclosure would not conflict with S.24(a) ASPA.

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

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

[5] BMC Research Notes (2011; 4:539) :- http://www.biomedcentral.com/content/pdf...

[6] Plos (2011) :- http://www.biomedcentral.com/content/pdf...

[7] Tropical Animal Health and Production (March 2012; Vol. 44, Issue 3, Pages 651 - 655) :-
http://link.springer.com/article/10.1007...

[8] Emerging Infectious Diseases (December 2011; 17(12): 2253-2261) :- http://www.sciencedirect.com/science/art...

[9] Brain Pathology (October 2011; Vol. 22, Issue 3, Pages 265 - 279) :- http://onlinelibrary.wiley.com/doi/10.11...

[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...

AHVLA Corporate Centre (AHVLA),

Thank you for your e-mail. 

General Enquiries & Information

Your email will be forwarded to the relevant individuals for information
and/or action.

Access to Information

We are dealing with your enquiry and will respond to it as per the
timescales below.

If your enquiry is in relation to:

·       Parliamentary Questions – A response will be sent in timescale
requested.

·       Minister’s Correspondence – A response will be sent in 15 working
days unless otherwise specified.

·       Deal With Officially – Items may be forwarded to the relevant
AHVLA Office or Business Unit (within 3 days).   Where items are dealt
with by the Library and Records Management Team a response will be issued
within 15 working days.  If forwarded a response will be issued within 15
working days from receipt of the forwarded item.

·       Freedom of Information/Data Protection/Environmental Information
Requests – A response will be sent within 20 working days.

·       Complaints – A response will be sent within 15 working days.

In the event of a response not being available within the above timescale
you will be informed of this.

Regards,

Animal Health and Veterinary Laboratories Agency (AHVLA)

Corporate Office
Block C, Spur 3
Whittington Road

WORCESTER
WR5 2LQ

T: 01905 763355 
E: [1][email address]

[2]www.defra.gov.uk/ahvla

Animal Health and Veterinary Laboratories Agency (AHVLA)

This email and any attachments is intended for the named recipient only.
If you have received it in error you have no authority to use, disclose,
store or copy any of its contents and you should destroy it and inform the
sender.
Whilst this email and associated attachments will have been checked for
known viruses whilst within AHVLA systems we can accept no responsibility
once it has left our systems.
Communications on AHVLA computer systems may be monitored and/or recorded
to secure the effective operation of the system and for other lawful
purposes.

References

Visible links
1. mailto:[email address]
2. http://www.defra.gov.uk/ahvla

Cotterill, Chris (AHVLA),

1 Attachment

Please see the attached response letter containing the Internal Review of
this case.

<<Steele Int Rev Response Letter.docx>>

Chris Cotterill
Privacy/Data Sharing Manager IMT

Animal Health and Veterinary Laboratories Agency

Block C

Whittington Road

Worcester  WR5 2LQ

E     [email address]

Animal Health and Veterinary Laboratories Agency (AHVLA)

This email and any attachments is intended for the named recipient only.
If you have received it in error you have no authority to use, disclose,
store or copy any of its contents and you should destroy it and inform the
sender.
Whilst this email and associated attachments will have been checked for
known viruses whilst within AHVLA systems we can accept no responsibility
once it has left our systems.
Communications on AHVLA computer systems may be monitored and/or recorded
to secure the effective operation of the system and for other lawful
purposes.

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