| Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 | ||||
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Chapter 3: ROLES AND RESPONSIBILITIES
3.1 The effective implementation of the Act depends on all those with responsibilities under this legislation properly understanding and discharging their duties. 3.2 This chapter presents a brief overview of those roles and responsibilities. Chapters 4-6 give more details. Appendix G describes the roles of civil servants and the Animal Procedures Committee.
GENERAL POINTS 3.3 The Act exercises control at three levels: certificates of designation, project licences and personal licences. These provide the only direct lines of accountability to the Home Office. Licences and certificates under the Act are issued to individuals. It is therefore, the individual (not the organisation) who is responsible and accountable to the Home Office for ensuring compliance with the terms and conditions of the licence or certificate. 3.4 Failure to comply with these terms and conditions may result in the variation, suspension, or revocation of the licence or certificate, and could result in prosecution. Failures by project licence holders could expose the certificate holder to censure. Failures by personal licensees could reflect on both the project licence holder and the certificate holder. 3.5 The Act makes limited provision for authorities to be delegated, but responsibility and accountability to the Home Office for compliance with the terms of conditions of the relevant licence or certificate are retained by the licence or certificate holder. Thus, Named Animal Care & Welfare Officers (NACWOs) and Named Veterinary Surgeons are accountable to the certificate holder and, in some circumstances, to their professional bodies. A deputy project licence holder is accountable to the project licence holder. Figure 1 illustrates the key relationships.
CERTIFICATE HOLDERS 3.6 Chapter 4 sets out information about certificate holders and their responsibilities. Certificates of designation are issued to persons occupying positions of authority at designated establishments. Certificate holders must be visible to, and approachable by, those who work with animals at the designated establishment. Communication with those holding responsibilities under the Act and co-ordination of their activities are key functions for the certificate holder. 3.7 Certificate holders are required to maintain management systems that make all reasonable efforts to prevent the performance of unauthorised procedures. They must implement and maintain local ethical review processes acceptable to the Secretary of State (see paragraphs 4.13-4.17 and Appendix J). 3.8 The certificate holder is accountable to the Home Office for the performance and conduct of Named Veterinary Surgeons and Named Animal Care & Welfare Officers. These nominees are not directly accountable to the Home Office (though they may be as licence holders). Certificate holders must ensure that those named in the certificate understand their responsibilities, are properly trained and resourced, are seen to have senior management's support, and function effectively.
FIGURE 1: KEY RELATIONSHIPS
Note: the advisory roles have been simplified in this diagram.
NAMED PERSONS 3.9 Named Animal Care & Welfare Officers and Named Veterinary Surgeons are actively involved, on a day to day basis, in safeguarding the welfare of the protected animals bred, kept and used at designated establishments. 3.10 They need to be entrusted with the necessary management authorities and their advice on the welfare of animals should be sought and taken by project and personal licence holders, of whatever seniority, both at the planning stage and whilst work is in progress. 3.11 To discharge their responsibilities, Named Veterinary Surgeons and NACWOs should have access to licences and other relevant documentation relating to the production, care and use of animals within the designated establishment. They should play a central role in the local ethical review process.
PROJECT LICENCE HOLDERS 3.12 Project licence holders are responsible for the proper design and conduct of programmes of work. They must ensure that they are kept informed about progress being made and problems being encountered whilst licensed work is in progress; and that there is compliance with the authorities, severity limits and conditions of issue on the relevant project licence. They must ensure that personal licensees working under their control are aware of the nature and limitations of the project licence authorities, are adequately supervised and trained; and that the regulated procedures are competently performed in accordance with the project licence authorities. Further details are at Chapter 5. 3.13 The Secretary of State requires that the project licence applicant seeks advice from the appropriate Named Veterinary Surgeon and Named Animal Care & Welfare Officer during preparation of the application. The licence holder should continue to liaise with them as work progresses. These named persons can provide invaluable advice on the care and welfare of animals. 3.14 Local ethical review processes provide project licence applicants and holders with additional opportunities and resources to improve their proposals and methodology. (Other purposes of the ethical review process are described at paragraphs 4.13-4.17.)
PERSONAL LICENCE HOLDERS 3.15 Chapter 6 addresses personal licences. Personal licence holders assume primary responsibility for the welfare of animals on which they perform regulated procedures. They are accountable to the Home Office for compliance with the terms and conditions of issue on their personal licence. They must ensure that they understand, and abide by, these authorities. 3.16 It is essential that personal licence holders also understand the tasks delegated to them by project licence holders and the authorities granted by the project licence, including the endpoints to be implemented.
CONFLICTS OF INTEREST 3.17 The Act makes provision for a number of individuals to assume responsibility for different aspects of the well-being of protected animals at designated establishments: certificate holders, project licence holders, personal licence holders, Named Animal Care & Welfare Officers, and Named Veterinary Surgeons. 3.18 The contractual relationships between, and other responsibilities of, these individuals can create conflicts of interest. There may also be occasions when one individual legitimately fulfils more than one of these of roles. For example, in most cases, project licence holders will hold, or will have held, a personal licence. For these reasons, the Secretary of State normally requires that, for any group of protected animals, at least three individuals should fill these five roles. 3.19 When a Named Veterinary Surgeon or Named Animal Care & Welfare Officer has (under any other of the statutory roles) a substantial interest in the scientific outcome of a programme of work, alternative provision should be made for the veterinary or welfare oversight of the animals in question.
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