| Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 | ||||
|
Chapter 5: PROJECT LICENCES
5.1 A project licence specifies a programme of work. It authorises, as part of that programme, the performance of specified regulated procedures by personal licence holders on animals of specified descriptions at a specified place [Section 5(1)]. A "programme of work", in this context, is considered to be the combination of regulated procedures and endpoints to be applied to protected animals to achieve the objectives specified in the project licence. 5.2 The licence authority links the performance of specific regulated procedures to the pursuit of defined objectives. The application of regulated procedures in pursuit of objectives beyond the scope of the programme specified in the project licence would therefore be in breach of Section 3 of the Act, even if the types of procedure involved were authorised on the relevant licences for another purpose. 5.3 A single project licence is expected to cover a coherent programme of work managed by an individual to meet a common set of well-defined objectives. A licence might therefore cover the entire medicinal drug discovery process, involving large numbers of animals of a wide range of species, numerous protocols, and a large team of personal licensees. Or, in contrast, a licence might cover the work of a single scientist, involve the investigation of one part of one system, and use a small number of animals of a single species. 5.4 The project licence:
5.5 It also specifies the designated scientific procedure establishments where the regulated work may be performed. The first named place (the primary availability) is where the majority of the work will be performed. Other scientific procedure establishments may appear as secondary availabilities. (Exceptionally, project and personal licences may stipulate places other than designated establishments - see paragraphs 2.65 and 2.66 above.) 5.6 No project licence may be in force for more than 5 years [Section 5(7)]. If work must continue beyond this time, a new licence must be obtained. Project licences originally granted for less than five years may, if the Secretary of State agrees, be extended at the request of the licence holder to five years from the original date of issue. 5.7 A project licence terminates on the death of the licence holder [Section 5(8)]. However, if the Home Office is notified of this within seven days of its coming to the attention of:
then, providing alternative arrangements are made for ensuring compliance with the terms and conditions of the licence, the Secretary of State may permit the licence to continue in force for up to 28 days from the date of notification. This can allow work in progress to be completed or new authorities sought and obtained [Section 5(8)]. 5.8 Project licence applicants should be aware that Home Office scrutiny and assessment of licence applications can take time. This is true both of applications for new programmes of work and (if continuity of authority is sought) when application is made to replace existing project licences. The total amount of time will depend on a number of factors. For example, straightforward, well-drafted applications for the continuation of an existing programme of work might be assessed more quickly. The applicant will still be expected to demonstrate that the continuation of the work is justified and that relevant developments in science and welfare have been fully considered. On the other hand, applications for complex and novel programmes of work will take much longer to assess, particularly if they need to be referred to external assessors or the Animal Procedures Committee (see paragraphs 2.93-2.99 above).
PERMISSIBLE PURPOSES 5.9 A project licence shall not be granted for any programme unless the Secretary of State is satisfied that the "experimental or other scientific purpose" for which the programme of work is to be undertaken meets one or more of the following permissible purposes [Section 5(3)]:
COST/BENEFIT ASSESSMENT 5.10 The Act requires that, as part of the consideration of whether and on what terms to grant a project licence, the Secretary of State shall weigh the likely adverse effects on the protected animals used against the benefit likely to accrue as a result of the programme of work [Section 5(4)]. 5.11 The potential benefit relates to the extent to which man, animals, plants or the environment may benefit if the project is wholly successful in meeting its declared objectives. It relates to the value that may be placed on the specific outcomes of the programme of work, rather than the importance of the general area of activity. 5.12 In assessing the likely benefit, the Secretary of State must be satisfied that the programme is scientifically valid and likely to meet the stated objectives. Appendix I provides further details.
ALTERNATIVES - REPLACEMENT, REDUCTION AND REFINEMENT 5.13 The Secretary of State may not grant a project licence [Section 5(5)] unless he is satisfied that:
5.14 The Secretary of State requires that applicants set out the measures they have taken to ensure that every reasonable effort has been made to incorporate replacement, reduction and refinement alternatives in the plan of work and protocols requested; and that named persons are consulted during the drafting of project licence applications. 5.15 Thus, the Secretary of State must be satisfied, on the basis of the experimental design and the proposed means of statistical analysis, that the programme pays due regard to using the minimum numbers of animals required to meet the objectives of the programme of work [Section 5(5)]. It is recognised, however, that the number of animals that need to be used can sometimes be reduced if additional suffering is allowed to be caused to fewer animals. The method licensed will be the one judged to cause the least suffering or distress. 5.16 The Act requires that all experiments shall be carried out under general or local anaesthesia unless the Secretary of State judges that the anaesthesia would be more traumatic to the animal than the experiment itself, or that anaesthesia is incompatible with the objective of the experiment (see paragraphs 2.109 and 2.110 above). 5.17 If necessary, procedures without anaesthesia must use analgesics and/or other appropriate means to minimise the pain, suffering, distress or harm which is caused, and to ensure that no animal is subjected to severe pain, distress or suffering. The Secretary of State will not license experiments producing serious injury or severe pain without effective anaesthesia [Section 10(2A) and Schedule 2A in Appendix A]. 5.18 The Secretary of State must be satisfied that protocols incorporate best practice and will be applied competently. Project licence applicants are required to provide a full description of the measures proposed to prevent or minimise the extent, duration and incidence of the adverse effects. These may include the specification of humane endpoints and control measures (such as inspection schedules, the criteria used to assess the adverse effects, and the means to be used to minimise them). 5.19 Humane endpoints should be set to provide for a number of eventualities: the research objectives having been achieved; the realisation that they cannot be achieved; or when welfare problems are encountered which exceed the minimum necessary to achieve the objective. 5.20 The Secretary of State will review, and may recall and revise, licence authorities should suitable replacement, reduction or refinement alternatives become available during the lifetime of a project licence.
NEUROMUSCULAR BLOCKING AGENTS 5.21 The use of neuromuscular blocking agents must be specifically authorised and will not be allowed in place of an anaesthetic [Section 17]. The Home Office has produced guidance on the use neuromuscular blocking agents (see Appendix K). Project and personal licence holders are required to comply with this guidance. CATS, DOGS, EQUIDÆ AND NON-HUMAN PRIMATES 5.22 The Secretary of State shall not grant a project licence authorising the use of cats, dogs, equidæ (horses, donkeys etc.) or non-human primates unless he is satisfied that animals of no other species are suitable for the purposes of the programme of work, or that it is not practicable to obtain animals of any other species that are suitable for those purposes [Section 5(6)].
OTHER RESTRICTIONS 5.23 The Secretary of State has decided that licences will not be issued for programmes of work involving:
PROJECT LICENCES FOR EDUCATION AND TRAINING 5.24 In considering project licence applications for education and training, the Home Office makes the following practical distinction between education and training:
5.25 Project licences will not be issued for education and training in primary or secondary schools. 5.26 Educational projects should be for the purpose of educating those who will ultimately be responsible for the design, conduct, or analysis of scientific work involving the use of living animals, and for whom an understanding of in vivo biological phenomena in protected animals is essential. The teaching objective must be specific, and not attainable by more refined methods, or means not requiring the performance of regulated procedures on living animals. It is expected that the teaching syllabus will also cover the ethics of animal use for scientific purposes. The severity limit of protocols in such projects should be either unclassified or mild (see paragraphs 5.40-5.42). 5.27 Teaching methods and materials are constantly being improved. Project licences for educational purposes, and the specific teaching objectives being pursued, should be reviewed at least annually to ensure that adequate consideration is given to identify and implement relevant replacement, reduction and refinement alternatives. 5.28 Project licences for training purposes are only issued for the training of practising surgeons in micro-vascular techniques, when applicants can demonstrate that no available alternative methods can achieve the specific training objectives. 5.29 Applications for the purposes of education and training should not be combined with applications for other permissible purposes.
SUPPLEMENTARY GUIDANCE 5.30 Supplementary guidance on certain classes of project licence applications and protocols has been prepared by the Home Office and may be obtained from the website http://www.homeoffice.gov.uk/ccpd/aps.htm. Areas include:
Protocols which are requested for these purposes and which have the potential to cause more suffering, or to use more animals, than these guidelines will only be authorised if specific justification can be shown.
5.31 The standard conditions of issue that the Secretary of State attaches to all project licence are set out in Appendix D. Additional conditions of issue may also apply.
PROJECT LICENCE HOLDERS 5.32 An applicant for a project licence undertakes to assume overall responsibility for compliance with the conditions of issue of the licence and for the proper conduct of the programme of work specified in the licence [Section 5(2)]. This includes the direction, training, management and supervision of the personal licensees working on the project [Section 22(2)]. In particular, the project licence holder must ensure that:
5.33 The mandatory training requirements for project licence applicants are set out at Appendix F. 5.34 Project licence holders must ensure that procedures are only performed at the places specified in the licence. These are the 'primary availability' (see paragraph 5.5 above) and, where programmes of work are carried out at several sites, approved 'secondary availabilities' or exceptionally (see paragraphs 2.65 and 2.66 above) places other than designated establishments [Sections 6(1) and 6(2)]. 5.35 All applications for project licences, and amendments to existing licences, must complete the local ethical review process at the establishment(s) where the programme of work will be conducted, before they are sent to the Home Office for formal assessment (see paragraphs 4.13-4.17 above and Appendix J). Applicants should make full use of advice and support available in the establishment and must consult the Named Veterinary Surgeon and the Named Animal Care & Welfare Officer. Inspectors can offer preliminary advice on the structure and content of applications, but they will not offer advice in parallel with, or that is likely to compromise, the work of the ethical review process.
DEPUTY PROJECT LICENCE HOLDERS 5.36 Only one person may hold each project licence. Joint applications are not acceptable under the terms of the Act. 5.37 A project licence holder may, however, have one or more named deputies to whom some authority may be delegated, with the approval of the Secretary of State. Deputies may be of particular value where:
5.38 Deputies must be in a position to exercise control over the programme of work under the delegated authority of the project licence holder. A deputy project licence holder will normally hold a personal licence and, whilst not mandatory, completion of training module 5 is strongly recommended (see Annex to Appendix F). 5.39 Project licence holders remain responsible and accountable to the Home Office for the proper discharge of their responsibilities, and for the performance and conduct of their deputies.
PROTOCOL SEVERITY LIMITS 5.40 The severity limit for each protocol is determined by the upper limit of the expected adverse effects that may be encountered by a protected animal, taking into account the measures specified in the licence for avoiding and controlling adverse effects. It represents the worst potential outcome for any animal subjected to the protocol, even if it may only be experienced by a small number of the animals to be used. 5.41 In assessing the severity limit of a protocol, account should be taken of the effect of all the procedures (whether regulated or not) applied to each animal or group of animals; the nature and extent of the likely adverse effects; the action taken to mitigate these effects; and the humane endpoints to be applied. 5.42 The severity limits of the protocols in the licence are categorised as follows.
The Secretary of State will not license any procedure likely to cause severe pain or distress that cannot be alleviated [Section 10(2A)].
THE SEVERITY CONDITION 5.43 Licence holders are required by conditions in both project and personal licences to minimise any pain, suffering, distress or lasting harm. They should approach the limit of severity which has been authorised only when absolutely necessary to meet the specified objective [Sections 10(2) and 5(5)]. 5.44 If it seems likely that the severity limit of a procedure has or may be exceeded, the project licence holder, or deputy project licence holder, must contact the Home Office. Provided the project licence holder can show sufficient justification, the Secretary of State may temporarily authorise a higher severity limit for a period of up to 14 days to allow the balance of likely benefit and likely cost to be reviewed and amendment to the project licence to be considered. 5.45 The project licence condition will be regarded as breached if the Home Office is not notified promptly by the project licence holder (or deputy) when a protected animal has, as the result of the regulated procedures performed, suffered (or is likely to suffer) more than is authorised by the severity limit. It will also be regarded as breached if the endpoints applied resulted in more suffering than was necessary to achieve the specific objectives. 5.46 The condition may be considered to have not been breached if the suffering arose for an unforeseeable, extraneous reason (that is, a problem unrelated to the regulated procedures), providing adequate and effective steps have been taken promptly to alleviate the suffering.
THE OVERALL SEVERITY BAND OF A PROJECT 5.47 The assessment of the overall severity of a project will reflect the cumulative effect of each procedure. This assessment is used by the Secretary of State to weigh the likely adverse effects on all the animals to be used against the benefits likely to accrue, as required by Section 5(4) of the Act. 5.48 The assessment of the severity band for the project as a whole reflects the number of animals used on each protocol and the actual suffering likely to be caused as a result. It is based on the overall level of cumulative suffering to be experienced by each animal, not just the single worst possible case. It takes into account the proportion of animals expected to reach the severity limit of the protocol and the duration of the exposure to that severity limit, the nature and intensity of the adverse effects, and the actions to be taken to relieve the suffering. 5.49 The assessments of severity (of individual protocols or the project as a whole) should be reviewed and revised as necessary during the lifetime of a project.
ACQUISITION, USE AND DISPOSAL OF ANIMALS 5.50 The Act places restrictions on the acquisition and use in regulated procedures of certain types of animal. These are described in Chapter 8, along with aspects concerning disposal of animals at the conclusion of a series of regulated procedures. RELEASE TO THE WILD IN THE COURSE OF A PROTOCOL 5.51 The release of an animal to the wild in the course of a protocol requires the prior consent of the Home Office [Section 10(3B)]. 5.52 The Secretary of State must be satisfied that the maximum possible care has been taken to safeguard the well being of such an animal [Section 10(3C)]. Those applying for such authorities must demonstrate that the animal is fit to be set free and that it will be at no biological disadvantage as a result of the procedures performed or of its time in captivity. They must also satisfy the Secretary of State that the release of the animal poses no danger to public health or the environment and ensure that the requirements of other relevant legislation have been identified and met. 5.53 The Secretary of State may require that the project licence holder obtains certificates of fitness for release, signed by a veterinary surgeon or other suitably qualified person (see paragraphs 8.29 and 8.31-8.34). 5.54 The Secretary of State will not authorise the release of animals to the wild in the course of protocols being applied for the purposes of education and training.
USE OF PROTECTED ANIMALS 5.55 The 'use' of a protected animal on a protocol extends from the time the animal is issued from stock and the protocol begins, until the observations or the collection of data (or other product) are complete or the animal is killed. 5.56 Where there is a need to obtain blood samples from an animal that has received a specific pre-treatment, the use of the animal encompasses both the dosing and sampling. Similarly, in the case of a protocol for polyclonal antibody production, use on a single protocol spans the pre-immunisation bleed, the immunisation (and re-immunising) and the blood harvesting.
CONTINUED USE 5.57 If, after a protocol authorised by a project licence has been completed, the same animal is being used in a second or subsequent protocol as a matter of scientific necessity, and a naive animal would not suffice, then this constitutes 'continued use'. 5.58 A common example is the production of genetically modified or surgically prepared animals on one protocol and their subsequent use in separate protocols requiring animals of that description. Similarly, the transfer of protected animals from a protocol on an expiring project licence to its equivalent on a new project licence providing continuity of authority is also considered to be continued use. 5.59 All continued use of protected animals, whether on a protocol on the same or another project licence, requires the consent of the Secretary of State and must be specifically authorised [Sections 14(3) and 14(4)].
RE-USE OF PROTECTED ANIMALS 5.60 After a series of regulated procedures for a specific purpose authorised by a project licence has been completed, if an animal is used in a second or subsequent protocol and a naive animal would have sufficed, then this represents 're-use'. Section 14 of the Act establishes the framework under which the Secretary of State may consider requests to re-use animals that have completed a series of regulated procedures for a particular purpose. 5.61 For example, if repeated samples of normal blood are to be taken from an animal to prepare blood products, and each sample could equally well come from a naive animal, this would constitute re-use. 5.62 All re-use of protected animals, undergoing the protocol again (or a different protocol, whether or not it is authorised in the same licence), requires the consent of the Secretary of State and must be specifically authorised [Sections 14(3) and 14(4)]. 5.63 The Secretary of State's consent for re-use is generally conditional upon the animal having suffered no significant adverse effects as a consequence of the first use, and its not having been subjected to any intervention which compromises its suitability as a subject for the second or subsequent protocol. Authority to re-use any animal that has experienced significant adverse effects in its previous use is unlikely to be granted. 5.64 The Secretary of State may not authorise the use of any animal more than once in a procedure entailing severe pain or distress [Section 14(1)]. 5.65 The Act places additional restraints on the powers of the Secretary of State to authorise a protected animal's use for any further regulated procedures [Section 14(2)] where it has been:
5.66 In this context, the Secretary of State may only give his consent for re-use:
5.67 Project licence holders must maintain full, accurate, contemporary records of the regulated procedures carried out under the authority of the project licence. The records shall be in a form acceptable to the Home Office and shall be made available to the Home Office on request. 5.68 The records should include the following information:
ANNUAL STATISTICAL RETURN OF PROCEDURES 5.69 Section 21(7) of the Act requires that information on animal use under the Act be published each year. This is achieved through the "Statistics of Scientific Procedures on Living Animals". 5.70 The data contained in this report are collated from details that project licence holders must supply concerning the procedures started during each year. This information must be provided to the Home Office by 31 January each year, on the "return of procedures" form that is provided. Code lists and explanatory notes are issued annually by the Home Office. Whilst project licence holders can delegate the completion of the form, they retain responsibility for submitting a timely and accurate return. Failure to submit the required data by the specified date, or the provision of inaccurate data, may result in revocation of the licence, subject to the right to make representations. 5.71 If the project licence expires or is revoked during the year, the return must be made within 28 days of the date of revocation or expiry. 5.72 The Government is also required under the terms of the European Directive and Council of Europe Convention ETS 123 to report specific information on animal use. This information is extracted from the statistical returns made by licensees. It differs from that published in the UK because the 1986 Act regulates some procedures not covered by the Directive or Convention, or not regulated in other European countries. An example is the production and breeding of genetically modified animals.
REQUESTS FOR AMENDMENTS 5.73 As work proceeds and the programme of work evolves, the project licence may need to be amended. This is necessary when:
5.74 Requests for amendments should complete the relevant stages of the local ethical review process before being sent to the Home Office for formal consideration. 5.75 As with applications for new licences, inspectors appointed under Section 18 of the Act will advise the Secretary of State on whether and on what terms the amended authorities should be granted. Requests for amendments may be referred to external assessors or the Animal Procedures Committee (see paragraphs 2.93-2.99 above). 5.76 Licence amendments do not take effect until the revised authorities have been issued by the Home Office. Project licensees must not anticipate revised authorities: they should await receipt of the amended licence documents; make sure they and the relevant personal licence holders are familiar with the terms and conditions of the amended authorities; and supply a copy of the revised authorities to the certificate holder. (When a project licence allows work at a 'secondary availability' - see paragraph 5.5 above - the licensee must copy these authorities to the second certificate holder before procedures are carried out.)
5.77 If it appears to be urgently necessary for the welfare of any protected animal, the Secretary of State may suspend the licence. If a project licence is suspended, all procedures being carried out under the authority of that licence must stop immediately. Similar considerations apply in relation to the certificate of designation (see paragraph 4.72 above) and personal licences (see paragraph 6.36; also paragraphs 2.69 and 2.70 above).
VARIATION AND REVOCATION 5.78 Project licence authorities expire on the date shown on the licence document, at which time the licence will be revoked. 5.79 Subject to due process, the Secretary of State can revoke or vary project licences at other times:
5.80 Project licences are issued to individuals. If a project licence holder wishes to relinquish responsibility for the programme of work, or is no longer able to ensure compliance with terms and conditions of the licence, a fresh application for a project licence must be made by a new applicant if the programme of work is to continue. 5.81 In exceptional cases, where:
a licence based upon the earlier authorities may be issued to the new applicant with the same expiry date, licence number, and conditions of issue as the original licence. 5.82 The certificate holder for a designated place specified on the licence can also request that authority to work at that establishment be revoked. If it is the 'primary availability' which is to be revoked (see paragraph 5.5 above), this will effectively revoke the licence unless a new primary availability is approved by the Home Office within 28 days. 5.83 Section 12 of the Act gives the right to make representations when the Secretary of State intends to vary or revoke a licence other than at the request of the holder. This is set out in Appendix H. 5.84 It is recognised that programmes of work may continue for longer than the maximum 5-year span of a project licence. The Home Office serves project licence holders with reminders of the expiry dates of licences in order to allow sufficient time for new authorities to be negotiated, where necessary. Authority may be considered, on request, for the transfer of animals part-way through protocols to the equivalent protocol on the replacement licence. (This is classed as continued use - see paragraphs 5.57-5.59 above.) 5.85 When a protocol has been started but not completed before a project licence expires, and no new authority allowing the continued use of the protected animals on another protocol is in place, then:
5.86 In the latter case, and in accordance with the conditions of the certificate of designation, the animal must be placed under the supervision of the veterinary surgeon. The Named Animal Care & Welfare Officer must ensure that it is provided with care and accommodation. No further regulated procedure may be applied to the animal without the express permission of the Secretary of State. Such animals may only be removed from the designated place when a veterinary surgeon or other suitably qualified person certifies that they will not suffer if they cease to be kept at a designated establishment [Section 10(6D)].
| ||||
