Guidance on the operation of the Animals (Scientific Procedures) Act 1986 Appendix J: The Ethical Review Process
THE POLICY
1. The Secretary of State requires that an ethical review process be established and maintained in each establishment designated under Section 6 or 7 of the Animals (Scientific Procedures) Act 1986. Every establishment should explain to and test with the Animals (Scientific Procedures) Inspectorate a viable process, appropriate to that establishment, before 1 April 1999. From that date, the requirement for a local ethical review process will be a standard condition for every designated user and breeding/supplying establishment.
ETHICAL REVIEW PROCESS
2. The certificate holder should ensure as wide an involvement of establishment staff as possible in a local framework acting to ensure that all use of animals in the establishment, as regulated by the Animals (Scientific Procedures) Act 1986, is carefully considered and justified; that proper account is taken of all possibilities for reduction, refinement and replacement (the 3Rs); and that high standards of accommodation and care are achieved.
AIMS
3. (1) To provide independent ethical advice to the certificate holder, particularly with respect to project licence applications and standards of animal care and welfare.
(2) To provide support to named people and advice to licensees regarding animal welfare and ethical issues arising from their work.
(3) To promote the use of ethical analysis to increase awareness of animal welfare issues and develop initiatives leading to the widest possible application of the 3Rs.
RESPONSIBILITY OF THE CERTIFICATE HOLDER
4. The certificate holder will be responsible to the Home Office for the operation of the local ethical review process and for the appointment of people to implement its procedures.
PERSONNEL
5. A Named Veterinary Surgeon and representatives from among the Named Animal Care & Welfare Officers should be involved. In user establishments, project licensees and personal licensees should also be represented. As many people as possible should be involved in the ethical review process. Where possible, the views of those who do not have responsibilities under the Act should be taken into account. One or more lay persons, independent of the establishment, should also be considered. Home Office inspectors should have the right to attend any meetings and have access to the records of the ethical review process.
OPERATION
6. These people should deliberate regularly and keep records of discussions and advice. All licensees and Named Animal Care & Welfare Officers must be informed of the ethical review process and should be encouraged to bring matters to its attention. An operating description should allow for input by colleagues and other people from outside the establishment. It should be clear how submissions can be made. The people involved should be regarded as approachable, dealing in confidence with complaints and processing all suggestions for improvement.
7. Specifically, the process should allow (where appropriate) the following:-
(1) promoting the development and uptake of reduction, replacement and refinement alternatives in animal use, where they exist, and ensuring the availability of relevant sources of information;
(2) examining proposed applications for new project licences and amendments to existing licences, with reference to the likely costs to the animals, the expected benefits of the work and how these considerations balance;
(3) providing a forum for discussion of issues relating to the use of animals and considering how staff can be kept up to date with relevant ethical advice, best practice, and relevant legislation;
(4) undertaking retrospective project reviews and continuing to apply the 3Rs to all projects, throughout their duration;
(5) considering the care and accommodation standards applied to all animals in the establishment, including breeding stock, and the humane killing of protected animals;
(6) regularly reviewing the establishment's managerial systems, procedures and protocols where these bear on the proper use of animals;
(7) advising on how all staff involved with the animals can be appropriately trained and how competence can be ensured.
8. Commonly, there should be a promotional role, seeking to educate users (in applying the 3Rs) and non-users (by explaining why and how animals are used), as appropriate. There should be some formal output from the ethical review process for staff and colleagues in the establishment, made as widely available as security and commercial/intellectual confidentiality allow.
9. Receipt of a project licence application signed by the certificate holder will be taken by the Home Office to mean that the application has been through the ethical review process for that establishment.
10. Inspectors will still be happy to discuss early ideas with prospective project licence holders and will be available for advice and clarification at any point. But an application will not be considered for formal authorisation by the Home Office until the prospective project has been considered appropriately within the ethical review process. The inspector will not negotiate with any advisory group. Local arrangements and the individual case will dictate whether amended applications must re-enter the ethical review process. It will be a matter of judgement in the particular case how best to balance the inputs of the ethical review process and the Inspectorate without duplicating effort or creating undue delay.
Home Office
1 April 1998