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The Use of Animals in Scientific Research - Legal Controls and Applying for a Licence . Legislation. Cruelty to Animals Act 1876 European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 Signed on 5th November 2002
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The Use of Animals in Scientific Research - Legal Controls and Applying for a Licence
Legislation • Cruelty to Animals Act 1876 • European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 • Signed on 5th November 2002 • Transposes European Directive 86/609/EEC and revokes S.I. No. 17 of 1994 • Animal Remedies Regulations, 1996 - Department of Agriculture and Food • European Dimension - Directorate General (DG)XI and DG3/E
Objective Proposed Protocol Names of other researchers involved Sources of Funding Experience and Education Experimental Procedure Certified as being essential 3 R’s Reduction Refinement Replacement Nominated person within each registered facility Licensing System
Licensing System • Applications submitted are further examined by the Chief Medical Officer in the Department of Health and Children or the Deputy Director of the Central Veterinary Research Laboratory of the Department of Agriculture and Food.
Certificates • Licence alone • Under anaesthesia • Sacrificed if pain is likely to continue • Certificates A, B, C, D, E, EE, F and G • Granted by 2 qualified persons under Act • Minister may disallow if concern with animal welfare or revoke at anytime
Application Form • 7 pages - typed • Protocol included • Sections requiring particular attention • Section D - General Description and Objectives of Experiments • Section E - List of Procedures, Frequency and Duration • All details on both Application Form and Certificates
Signatures • Head of relevant discipline in the University or research establishment - page 6 • “Competent person” in user establishment - page 7 • Statutory signatures of two professors from relevant discipline - page 7 • Applicants signature - pages 1 & 8 • Signatures on Certificates • N.B. - where necessary dated
Animal Welfare • Choice of Species/Experiment • Minimum number • Lowest degree of neurophysical sensitivity • Least pain, suffering or physical harm • Most likely to provide satisfactory results • Nominated Competent Person • Ethics and/or scientific committee
Registration of Premises / Source of Animals • Registered as a “user establishment” by Department of Health and Children • Animals sourced from registered breeding and supplying establishments • Purpose bred: • Mouse, Rat, Guinea Pig, Hamster, Rabbit, Non - Human Primate, Dog, Cat and Quail
Statistical Information • Records - Veterinary inspector may call to premises at any time • Directive requires member states to collect and as far as possible make publicly available statistical information on use of animals in experiments • Agreed EU Format
Statistical Information • Statistical Returns form • 10 Tables • Tables 1(a), 1(b), 1(c) and Table 2 must be completed by all licensees • Further tables if necessary • Fill in actual numbers of animals • Group returns • Licence is granted that a return is submitted to the Minister “at such time or times as he may require, in such form and containing such particulars as he may direct.
Alternatives to Animal Experiments • European Centre for the Validation of Alternative Methods (ECVAM) • Cosmetic Testing:It is the practice in Ireland not to licence any experimental activity using live animals • Procedures currently under review at European Level • LD50& LC50 • In Vivo monoclonal antibody production • Use of Primates - it is the practice in Ireland to prohibit the use of Primates as experimental animals
Freedom of Information Act, 1997 • Release of Information • Each application examined on its own merits • Personal Information - Confidential