Ethics in Animal Research at CSU Peter Chenoweth Presiding Officer, CSU ACEC
Animal Research in NSW is Governed by: • NSW Animal Research Act (1985) • Animal Research Regulation 2005 • Animal Research Review Panel (ARRP) (self-regulatory process under the Act. • NH&MRC Code of Practice for the Care and Use of Animals for Scientific Purposes “The Code” • http://www.health.gov.au/nhmrc/research/awc/cop.pdf (Covers all research and teaching using non-human vertebrate animals & is periodically revised)
Animal Research Act The objective of the Animal Research Act 1985 is to protect the welfare of animals used in connection with research by requiring persons or organisations carrying out animal research or supplying animals for research to be authorised under this Act and by regulating the carrying out of animal research and the supply of animals for research by those persons or organisations. Authorisations under this Act may be granted only for recognised research purposes. Recognised research purposes include purposes involving the use of animals for research, teaching, testing and the production of biological products.
Animal ethics committees Animal Ethics Committees (AECs) govern the use of animals in research, teaching and product testing. Their role is to advise and monitor the use and supply of animals for these purposes. The role of AECs is to: • review, discuss, approve, reject or revoke approval for proposals to perform animal research or teaching • document their consideration of proposals • have guidelines on procedures for animal research or teaching • inspect animals and facilities used in research or teaching
Individual Researchers Responsibilities • Good research and good ethics go together • Investigators have direct and ultimate responsibility for all matters relating to their research • MUST obtain written approval before commencing each project • MUST comply with directions of the Ethics Committee • MUST comply with the Code of Practice • Failure to comply can lead to suspension, fines or imprisonment
Principles for Animal Welfare • the rat’s point of view • the three R’s • Reduction • Minimum number of animals necessary to ensure scientific and statistical validity (statistical tests used for this), not to increase suffering of any individual animal • No repetition of experiments (unless essential) • In teaching, minimum number to meet educational objectives
Principles for Animal Welfare • Replacement • Techniques that can totally or partially replace use of animals should be used where possible • Refinement • Ensure the correct animals are used for the project • Minimise impact on animals – anaesthesia, analgesia etc • Wildlife not to be taken from natural habitat unless captive bred are unavailable • Death as an end point is not usually acceptable • Minimise duration
Methodologies banned or not usually accepted • Draize Test (used since 1944, now rarely used if at all) – application of irritants to rabbit cornea (as in cosmetics) • LD 50 – amount of a chemical that is required to kill 50% of test animals (eg mice) within a specified time period, in one dose (eg Parathion – 3mg/kg, pyrethrins – 200mg/kg) • Requires ministerial approval in NSW
Principles for Animal Welfare Cont. • Experimental Design • are animals necessary • are there alternatives • are the right number of animals being used • statistical tests to estimate numbers based on expected variances • are the animals the right kind of animals (SPF?), monogastric cf. ruminant
Principles for Animal Welfare Cont. • Housing and Husbandry • are they adequate to meet the animals biological and social needs? • are they being held for too long a period?
Principles for Animal Welfare Cont. • Anaesthesia and Analgesia during surgery • Post-operative monitoring • analgesia • health status and checklist • monitoring regularity
Principles for Animal Welfare Cont • Euthanasia techniques • Record keeping for scientific purposes and accountability • Detailed, current and comprehensive
CSU Animal Care and Ethics Committee - Membership • Presiding Officer • Category A - Veterinarians (2) • Category B - Researchers (2) • Category C - Animal Welfare Groups (2) • Category D - Independent (2) • Quorum (at least one from each category)
Main Activities of ACEC • Approval of individual projects • Approvals normally unanimous • Approvals annual • Proceedings confidential
ACEC Project Approvals • Applications are submitted to Executive Officer • Monthly meeting (submit 2 weeks prior) • Attention to • justifications • ethical issues • techniques • methods (including group sizes)
ACEC Project Approvals • Applications are then: • Approved*. • Approval with stipulations* • Rejected. NB - * Phone contact during meeting!
Site Inspections • All holding and research facilities are inspected annually • New facilities inspected before use (eg preclinical building) • ACEC must be involved in development or renovation of facilities • Written reports are prepared by the ACEC • Head of School is advised of any action to be taken
Changes to Approvals • Procedures must not be changed without written approval by ACEC • Requests to change procedures must be made in writing (providing reasons)
Issues • Confidentiality • Commercial in confidence • Protection of committee members • Antivivisection
Tips for Survival & Equanimity • Address appropriate sections on submission form • Use website resources - SOPs • Read approval letter carefully (annual review needed even with 3 year approval) • Write in common-sense terms for lay-people • Don’t assume committee members have your background or perspectives • If in doubt, seek advice (e.g. EO or PO) beforehand • Be in phone/mobile contact during the meeting
DON’T Conduct animal work (teaching or research) without ACEC approval