Animals (Scientific Procedures) Act 1986: Ethical Review Process
It has been a requirement set out as a standard condition since 1999 that each establishment designated under Section 6 or 7 of the Animals (Scientific Procedures) Act 1986 (“the Act”) has an Ethical Review Process. These requirements were updated by a Supplementary Note issued by the Chief Inspector in December 2000. Appendix J to the Guidance of the Operation of the Act refers to the Ethical Review Process and can be found as Appendix 1 to this document.
B. Ethical Review Process
1. In the Ethical Review Process 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 Act 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.
2. The process adopted by the University will be informed by, and meet the requirements identified in Appendix J.
3. The Ethical Review Committee
The Committee will have the following membership:
The Certificate Holder (Chair)
The Named Veterinary Surgeon (NVS)
The Named Animal Care and Welfare Officer(s) (NACWO)
At least one or up to two Project Licence Holders
A senior member of Technical Staff
At least one or up to two Personal Licence Holders
Up to 3 Co-opted members who do not hold a licence under the Act
A Lay member who has an interest in animal welfare and / or ethics
Any person who is co-opted shall serve as a member of the Committee for an initial term of three years, and may be re-appointed to serve one further term of 3 years
The Committee shall be quorate if at least one Project Licence Holder (if no-one with active Project Licence is available they may be substituted by someone who has held a Project Licence within the last five years or someone who is currently applying for a Project Licence), one Personal Licence Holder, one NACWO, the Certificate Holder and the NVS are present or have been included in any decision.
4. The membership of the Committee includes those with defined responsibilities and obligations specified in the Certificate of Designation. The interest of experienced project and personal licence holders covering research and education and training are represented. The co-opted members will have an interest in animal welfare and / or ethics but they will not be engaged in work under the Act. The Home Officer Inspector shall also have the right to attend any meeting of the Committee.
5. The work of the Committee will be guided by the three aims of the ethical review process identified by the Secretary of State, namely:
To provide independent ethical advice to the Certificate Holder, particularly with respect to project licence applications and standards of animal care and welfare.
To provide support to named people and advice to licensees regarding animal welfare and ethical issues arising from their work.
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.
These aims will be achieved by the Committee performing the three main functions of the ethical review process (as set out in sections 6 – 8 below).
6. Approval of Applications for Project Licences and Amendments
6.1 The Committee will consider and approve all applications for project licences before they are signed by the Certificate Holder and submitted to the Home Office. Draft project licences should be sent to the Committee Secretary for distribution.
6.2 Applicants must comply with all requirements of the Act and also with the University’s policies on working with animals and on the prevention of illegal procedures. Applicants must consult and seek advice from existing experienced project licence holders, the Named Animal Care and Welfare Officer and the Named Veterinary Surgeon before submission of their applications.
6.3 To prevent undue delay in the consideration of applications, where scheduled meetings of the Committee are more than six weeks away, draft project licences shall be circulated by post or electronically with a request for feedback to be made within two weeks.
6.4 Applications may be signed by the Certificate Holder once favourable responses have been received from members of the Committee. Members unable to give unqualified approval may request that minor points are taken up with the applicant and clarified or amended as appropriate, or request that the application be deferred until the full meeting of the Committee. If such minor points cannot be resolved with the applicant consideration will be deferred until the next Committee meetings, with the applicant invited to attend.
6.5 Among the criteria used by the Committee to assess applications will be the following derived from the 3Rs:
Is it clear that there are no valid alternatives to the use of animals in the work proposed?
Is the number of animals which it is proposed to use appropriate – i.e. large enough to produce a satisfactory valid result and not larger?
What is the balance between the cost to the animals involved and the likely benefits to be gained by the research?
Irrespective of the latter, are there ways in which the procedures could be refined to reduce the cost to animals without affecting the scientific validity of the project?
When applications for new licences for continuing work are considered the Committee will specifically review whether proposed numbers of animals involved are reduced and techniques are refined.
6.6 Project licence applications approved by correspondence will be reported to the next meeting of the Committee.
6.7 Amendments to current project licences must be approved by the Certificate Holder before submission to the Home Office. If, after consulting the NACWO, the NVS, an experienced project licence holder and an experienced personal licence holder, the Certificate Holder is advised that the amendments are either trivial or advantageous to the animals then he/she shall have the authority to approve them and report them to the next Committee meeting. If issues of substance are raised then all members of the Committee shall be consulted by correspondence, and if necessary consideration deferred until the next meeting. All amendments approved by the Certificate Holder shall be reported to the next Committee meeting.
6.8 Applications for secondary availability of project licences in the University’s designated premises shall be treated as new applications.
6.9 Amendments to project licence applications and alternations to them made by the Home Office shall be reported to the Committee.
7. Facilities, Management and Staff: Advice, Support and Guidance
7.1 The designated animal facilities are located within the College of Environmental Sciences and Engineering. The Certificate Holder has both duties and responsibilities under the Act and delegated management responsibilities for the provision of appropriate animal facilities and for the staff using them. The Committee will be concerned to ensure that high standards of care and accommodation are practised in the animal facilities and that appropriate managerial systems are in place to ensure compliance with the Act. The Certificate Holder will also be responsible for advising the University’s Estates & Facilities Department on requirements of maintenance and improvements to the facilities.
7.2 Members of the Committee will visit the animal facilities on an annual basis. Before the visit a brief report will be prepared describing the available facilities, the number of animals cared for by species and procedures, the numbers of staff involved and their qualifications and the managerial arrangements. The Committee will receive annual information about project and personal licence holders, technical staff, and others concerned with animal care, including training and staff development undertaken. The Committee will review this information and will advise on how all staff involved with the animals can be appropriately trained and how competence can be ensured. The Committee will also ensure that suitable resources are in place to facilitate this.
7.3 The Committee will offer advice on any ethical matter relating to the use of animals under the Act within the University, and will receive and respond to expressions of concern (in confidence if necessary). In particular members of staff considering undertaking work with animals of a controversial nature will be advised to contact the Committee at an early stage.
7.4 The Committee will consider in the light of its developing experience what steps it can take to advance best practice in the use of animals and to promote reduction, replacement and refinement alternatives in animal use.
8. Review of Current Projects
8.1 The Committee will conduct reviews of current projects at appropriate intervals, (initially annually as the number of projects is small). Project licence holders will be required to submit a short written report, covering inter alia:
Progress to date: whether the results are as anticipated; if amendments are necessary;
Any adverse effects of procedures and corrective action;
Information of number of animals used and scope for reduction in numbers and refinement of techniques.
9. Records and Dissemination of Information
9.1 The Certificate Holder shall be responsible for the keeping of adequate records of the ethical review process, including minutes of meetings which shall be circulated to members and the Home Office Inspector.
9.2 The Certificate Holder shall be responsible for the preparation of an annual report of the work of the Committee. This will be circulated to the Committee for approval and subsequently to project licence holders and to the University Ethics Committee. The existence and purpose of the Ethical Review Committee shall be made known within the University through appropriate means and the annual report shall not be unreasonably withheld from any member of the University seeking information. Submissions relating to the work of the Committee and to the operation of the Act from other University Committees, individual members of the University, or organisations and individuals external to the University may be made via the Secretary to the Committee and shall be considered by the Committee.
9.3 The Committee will also receive regular information on ethical review, the 3Rs, best practice in animal welfare and other relevant matters distributed by the Home Office, the National Centre for the Replacement, refinement and Reduction of Animals in Research and animal welfare and other interested organisations.
9.4 The Secretary of the Committee shall be responsible, on behalf of the Certificate Holder, for maintaining a central register of all persons within the University trained to carry out Schedule 1 procedures
Approved by the University Council 27th March 2009. Version 1
Minor amendments approved by the Chair of the Ethical Review Committee and the Home Office, August 2011