Justice CommitteeWritten evidence from Understanding Animal Research

Executive Summary

1. Animal research is vitally important to the development of new treatments for a range of serious conditions from cancer and heart disease to neurological conditions such as Parkinson’s disease, Alzheimer’s disease, spinal injury etc. However, it is controversial and while most of the public are supportive, it can provoke strong feelings among those who oppose it. Most of those opposed to animal research engage in passionate debate and sometimes employ radical propaganda, but campaign within the law. However, a small minority of radical animal rights extremists are prepared to use intimidation or outright violence to further their cause. This has ranged from threats to arson attacks and letter bombs.1

2. The extremist tactic of targeting organisations involved in animal research by attacking the individuals that work for them or the companies that supply them, dates from the mid-90s. The threat to medical research became so serious that 10 years later the UK government developed a strategy and drew up specific laws to crack down on extremist activity against animal research. Freedom of Information requests have been used as a tactic by animal rights groups across the world to obtain information about animal research.

3. The Home Office regulates animal research by issuing licences. A project licence contains significant detail on intellectual property, information about the individual scientists conducting the research and the location of the establishments where animal research is conducted. It was never intended to be placed in the public domain. Obtaining copies of project licences is a key target for those who oppose animal research.

4. We believe that more information about animal research should proactively be made available to the public, while safeguarding information which could be used by extremists to target individuals and institutions.

Recommendations

5. We recommend that the following information should be exempt from the Freedom of Information Act and that this should apply to all public bodies:

the names and addresses of individuals and establishments involved in animal research, to help protect them from the possibility of attack by extremists; and

information provided to the Home Office in confidence for the purposes of applying for a Project Licence.

6. We also propose that the Home Office should more closely define which sections of the Project Licence application form will contain confidential information and hence be excluded from publication through Freedom of Information requests. This advice will also clearly define the information which may be placed in the public domain.

About Understanding Animal Research

7. Understanding Animal Research is a membership organisation with over 110 member organisations and many more individual supporters. Organisational members are drawn from various sectors including academic, pharmaceutical, charities, research funders, professional and learned societies, and trades unions.

8. We aim to achieve broad understanding and acceptance of the humane use of animals in biomedical research in the UK, to advance science and medicine. The information provided by Understanding Animal Research is based on thorough research and understanding of the facts, historical and scientific.

9. Understanding Animal Research seeks to engage with and inform many sectors to bring about its vision. Key stakeholders include members of the public, the media, policy makers, schools and the scientific research community.

Introduction

10. We wish to address the specific application of the Freedom of Information Act (FOIA) to animal research conducted in UK Universities and other public bodies. We are concerned that FOIA may be used by animal rights extremists to obtain information which can be used to target individuals and institutions involved in animal research. We also have concerns about the release of intellectual property, which we know other respondents are addressing. In this response, we will deal principally with the safety concerns.

Regulation of Animal Research

11. There have been special controls on the use of laboratory animals in the UK since 1876. These were revised and extended in 1986 as the Animals (Scientific Procedures) Act (ASPA). This law safeguards laboratory animal welfare while allowing important medical research to continue. These controls are widely regarded as the tightest in the world.

12. Central to ASPA is a cost-benefit assessment which must be applied before any research project involving animals can go ahead. Thus the potential costs, in terms of animal suffering, must be weighed against the potential benefits of the research.

13. Three separate types of licence are required for animal research or testing. The Act says that animal procedures can only:

take place in research institutes or companies which have appropriate animal accommodation and veterinary facilities, and have been granted a certificate of designation;

be part of an approved research or testing programme which has been given a project licence; and

be carried out by people with sufficient training, skills and experience as shown in their personal licence.

14. The project licence is a detailed document often running to hundreds of pages. It outlines a plan of work covering up to six years from the time of writing. The information required in a project licence application enables the Home Office to decide whether to grant a project licence. It will usually contain significant amounts of detail on intellectual property, information about the individual scientists conducting the research and the location of the establishments where animal research is conducted. It was never intended to be placed in the public domain.

15. In practice, a number of options included in the project licence may never be used. This is because it is difficult to reliably predict the detailed operation of the project several years ahead. For example, the early outcomes of the project will affect plans for later stages; and the publication of relevant or overlapping results by other research groups can occur at any time and affect the planned project. The licence often contains options that depend on the progress of the programme of work, and the researcher will choose which options to use as the research programme builds. Therefore a significant but unpredictable proportion of what is in the application will never happen under that licence.

16. There is currently a process whereby applications for Project Licences are first discussed in Ethical Review Process meetings. This process ultimately concerns the securing of maximum welfare standards while achieving optimal scientific outcomes in medical research using animals. The free and frank exchange of ideas will be undermined if the full minutes of these meetings are published following FOI requests and the members of the committee could be targeted if their identities were known.

17. A key part of the application is the inclusion of a project abstract. The project abstract is designed to be published on the Home Office website and is written using lay terms. It summarises the information in the project licence without containing the personal information or information about the location of the work. This is part of the move towards greater openness and is an expectation of all project licences.

Safeguarding Information

18. It has been a tenet of both the existing Animals (Scientific Procedures) Act 1986 (ASPA) and the European Directive 2010/63/EU, which is in the process of being transposed into UK legislation, that certain information must be safeguarded because of the possibility of extremist attacks and to prevent the loss of intellectual property. This is worded in different ways in different regulations but essentially the advice is the same.

19. The Guidance on the Operation of ASPA2 explains that the purpose of Section 24 of the Act, which makes it an offence for those with responsibilities under ASPA to disclose information given in confidence, is to safeguard:

“the names and addresses of individuals and establishments, to help protect them from the possibility of attack by extremists”; and

“detailed information that must be provided in licence applications (so that the cost/benefit assessment can be carried out and the scope for using alternatives reviewed) which might be commercially sensitive or intellectually valuable”.

20. The European Directive 2010/63/EU3 states that published information “should not violate proprietary rights or expose confidential information” and that “published details should not breach the anonymity of the users”.

The Threat from Extremists

21. There is evidence that the international threat to animal research from extremists is again growing, and collaboration between UK and international animal rights groups is also increasing. The protection of individuals and organisations involved in animal research, both entirely within the UK and as part of international collaborations, is still important and remains part of the purpose of current legislation regulating animal research.

22. The threat from animal rights extremism in the UK has diminished since 2005 but has not gone away entirely. In the past year there has been one arson attack in the UK4 and a number of arson attacks throughout Europe5 aimed at the employees of organisations involved in animal research. There is growing evidence that European animal rights groups are exchanging information with each other and working together.

23. In the USA, animal rights groups have also resorted to illegal acts and have been targeting both university staff and individual students. They have published names, addresses and contact details of individuals with the clear implication that these people should be targeted by extremists. One group, Negotiation is Over (NIO) has even resorted to targeting the children and grandchildren of researchers and has also offered rewards for information about individual students studying on courses involving animal research. This organisation is using US freedom of information laws to gain the information they need to intimidate researchers. There is growing evidence that UK based animal rights groups have developed links with NIO and that the groups are sharing information.

Case Study

24. In 2008, Newcastle University received an FOI request for project licences relating to specific projects in a particularly sensitive area: the use of non-human primates in research. The request was initially refused using three exemptions: health and safety (endangering the safety of an individual), commercial interests and prohibitions on disclosure. The prohibition on disclosure related to the licences having been issued by the Home Office under ASPA. This was accepted by the Information Commissioner when Newcastle’s original decision was challenged, but over-ruled by the Information Tribunal on appeal in 2011. Newcastle University has now released the information under FOI. In addition to the risk which the university believes this poses to individual members of staff, this decision also places staff at risk of prosecution for disclosing the information because in this instance FOI is in conflict with ASPA Section 24.

25. This decision by the Information Tribunal has led to similar requests being received by a number of other Universities and public bodies.

Balancing Freedom of Information and Protection of Researchers

26. There is a need to balance the public interest in how and why UK research involving animals is undertaken, against the protection of researchers from the possibility of attack by extremists. It is clearly not in the public interest to identify institutions or individuals when the sharing of this information results in putting them at risk of intimidation or harassment. Intimidation and harassment from animal rights extremists could lead to added fear among institutions, avoidance of controversial research, decreased openness and driving such work to less regulated countries.

27. The main aim of animal rights groups is to try to prevent animal research from taking place. Information on projects that are either in progress or have not yet been undertaken is therefore likely to be a focus for protest or illegal activity. Experience shows that details of completed work can safely be placed in the public domain.

28. All parties are agreed that it is desirable to have more openness and transparency about the use of animals in research. Some years ago, Understanding Animal Research published a researcher’s guide to communicating about animal research6 in an attempt to encourage more openness, and has an active “openness” programme working with the academic sector. The programme and the guide encourage universities, as a first step, to publish material about their animal research on their websites. Many universities have published their policies about animal research and some go much further.7 This proactive openness provides important information about animal research undertaken by a University while protecting information which could be used by extremists.

Conclusions

29. Scientists and other staff working in animal research institutions must be protected from harassment, intimidation or worse. The work that they conduct is vitally important to the development of new treatments for a range of serious conditions from cancer and heart disease to neurological conditions such as Parkinson’s disease, Alzheimer’s disease, spinal injury etc.

30. UK and European legislation recognises the threat from extremists and attempts to build safeguards into the legislation to mitigate the threat. At the same time, legislation recognises that there may be important intellectual property and commercial interests associated with the research undertaken by these scientists. ASPA legislation contains a specific section to protect the confidentiality of the detailed information required to assess whether a project licence should be granted. This information includes personal information about the applicant, information about the location of animal research facilities and intellectual property. Section 24 of ASPA was designed to protect this information from publication.

31. However, the Freedom of Information Act makes it possible to obtain the same information from other public bodies that ASPA Section 24 was designed to keep confidential. Release of this information may result in extremist targeting of individuals and institutions.

January 2012

APPENDIX

Project Licence

The Project Licence is a detailed form often running to hundreds of pages. It outlines a variety of information and is a plan of work covering up to six years from the time of writing. The current project licence application contains seven distinct sections:

A.PROJECT LICENCE HOLDER.

B.PLACE(S).

C.SCIENTIFIC BACKGROUND.

D.PLAN OF WORK.

E.PROTOCOLS.

F.DECLARATIONS.

G.PROJECT ABSTRACT.

Section A—Project Licence Holder

Personal information about the person applying for the licence who has overall responsibility for the programme of work. This includes name, address, date of birth, knowledge, skills and experience, etc.

Section B—Place

Details of where the animal procedures will be conducted.

Section C—Scientific background

Contains the scientific justification for the project. It includes an assessment weighing up the possible adverse effects on the animals to be used in the programme against the potential benefit resulting from the work specified in the licence. This is supported by a number of published and/or unpublished references.

There is considerable intellectual property in this section of the licence. There is also much information that is personal to the applicant (eg references to published and unpublished work) that would lead to ready identification.

Section D—Plan of work

The plan of work outlines how the objectives of the research will be achieved.

It also describes how the programme of work cannot be achieved satisfactorily by any other practicable method not entailing the use of animals. It details how the proposed procedures use the minimum number of animals; involve animals with the lowest degree of neurophysiological sensitivity; cause the least pain, suffering, distress or lasting harm: and are most likely to produce satisfactory results.

If the work is to include cats, dogs, primates and equidae, the researcher must justify the use of these species. Similarly, if it involves endangered species or animals taken from the wild, a similar justification must be given.

Section E—Protocols

In this section, the researcher describes the procedures which will be applied to the animal(s) over the period covered by the licence, possible adverse effects of each procedure and how these adverse effects will be managed if they occur. In practice, the adverse effects may be extremely unlikely but the protocol must demonstrate that researchers are prepared for any eventuality, no matter how unlikely, and know how to deal with it.

The protocols section may run to dozens of separate protocols, especially if the licence covers a programme of work over several years. This section may be 100 pages in length or longer, and forms an important part of the intellectual property of the researcher.

In practice, a number of protocols may never be used. This is because it is difficult to reliably predict the detailed operation of the project several years ahead. For example, the early outcomes of the project will affect plans for later stages; and the publication of relevant or overlapping results by other research groups can occur at any time and affect the planned project. The licence often contains options that depend on the progress of the programme of work, and the researcher will choose which options to use as the research programme builds. Therefore a significant but unpredictable proportion of what is in the application will never happen under that licence. This is reflected in the Home Office’s annual statistics in which some Project Licence holders make zero returns. If published in full, the protocols would not give an accurate picture of the research programme.

The protocols which are not actually used in the programme may form an important part of the intellectual property of the researcher and can be used in later research programmes.

Section F—Declarations

This is signed by various members of the research team to declare that the information in the application is accurate, etc.

Section G—Project abstract

The project abstract is designed to be published on the Home Office website and is written using lay terms. It summarises the information in the project licence without containing the personal information or information about the location of the work. The Home Office guidance says that it should “Use lay terms and avoid confidential material or anything that would identify you or your place of work”. This is part of the move towards greater openness and is an expectation of all project licences. This is the only part of the project licence that is intended for public dissemination.

1 http://www.understandinganimalresearch.org.uk/policy_issues/animal_rights_extremism

2 http://tna.europarchive.org/20100413151426/http://www.archive.official-documents.co.uk/document/hoc/321/321.htm

3 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:En:PDF

4 http://www.thisislincolnshire.co.uk/Animal-rights-group-bomb-attack-Lincolnshire-farm/story-12927259-detail/story.html

5 References available on request.

6 http://www.understandinganimalresearch.org.uk/resources/document_library/download_document/?document_id=16

7 Two current examples of good practice are:
http://www.ox.ac.uk/animal_research/index.html
http://www.nottingham.ac.uk/animalresearch/index.aspx

Prepared 25th July 2012