ANIMAL RESEARCHACT ……. 20 YEARS ON

thethe journey journey begins…..begins…..

19781978 - Australian Veterinary Assoc receives Australian Veterinary Assoc receives brief from NSW governmentbrief from NSW government

* Separate legislation* Separate legislation

* Comprehensive review of * Comprehensive review of existing existing legislationlegislation

* Ontario legislation as model* Ontario legislation as model

* Extensive consultation* Extensive consultation

19831983 - AVA submits proposal to governmentAVA submits proposal to government

19851985 - - Animal Research Act passedAnimal Research Act passed

Animal Research Act 1885Animal Research Act 1885An Act to protect the welfare of animals used An Act to protect the welfare of animals used

in connection with animal researchin connection with animal research..

Guiding principleGuiding principle – to create legislation which takes to create legislation which takes into account the rights of opposing groups to hold into account the rights of opposing groups to hold and express differing views and which attempts to and express differing views and which attempts to address and recognise issues on which opinions address and recognise issues on which opinions differ in such a way as to bring a degree of differ in such a way as to bring a degree of acceptance from all concernedacceptance from all concerned.

Enforced self-regulation Enforced self-regulation Public participation in the decision-making processPublic participation in the decision-making process

Key Elements …..Key Elements ….. Focus on ‘duty of care’Focus on ‘duty of care’ Central role for ACECCentral role for ACEC

– approve and monitor all animal useapprove and monitor all animal use– power to direct appropriate treatmentpower to direct appropriate treatment

External membership of ACECExternal membership of ACEC ARRP overview of activitiesARRP overview of activities

– animal welfare organsationsanimal welfare organsations– reports to Minister/Parliamentreports to Minister/Parliament

Linked to Code of PracticeLinked to Code of Practice Separate legislation /enforced self-regulationSeparate legislation /enforced self-regulation

AVA ProposalAVA ProposalBackground:Background: Recognise need to use animals for scientific Recognise need to use animals for scientific

purposes but to do so is a privilege.purposes but to do so is a privilege. Recognise community concernsRecognise community concerns International recognition of ethical responsibilitiesInternational recognition of ethical responsibilities Dual needs - scientific & socialDual needs - scientific & social Legislation to define minimum standardsLegislation to define minimum standards Responsibility of institutions and investigatorsResponsibility of institutions and investigators

AVA Proposal…..AVA Proposal…..

The proper management of animals The proper management of animals used for scientific purposes is used for scientific purposes is essential for their welfare and the essential for their welfare and the validity of research data.validity of research data.

Issues considered in development of Issues considered in development of legislation -legislation - NSW Submission SSCAWNSW Submission SSCAW

• Changing community attitudes Changing community attitudes • Importance of human/animal bondImportance of human/animal bond• Moral standing of animals ?Moral standing of animals ?

– relevant differences ?relevant differences ?– setting limits and on what grounds?setting limits and on what grounds?

• Australian COP - already contained essential elements Australian COP - already contained essential elements of legislationof legislation

• Public perception of science Public perception of science • Public participation > undue controlsPublic participation > undue controls

Legislative framework ….Legislative framework ….1. Providing a balance between accountability 1. Providing a balance between accountability

for both the decision to use animals for for both the decision to use animals for scientific purposes and the conduct of those scientific purposes and the conduct of those activities and the value of freedom of activities and the value of freedom of scientific enquiry.scientific enquiry.

2.2. Judgements need to reflect a balanced view Judgements need to reflect a balanced view especially where lack of community especially where lack of community consensus.consensus.

The Animal Research Act ….The Animal Research Act ….• Style and purpose of Act reflects changing Style and purpose of Act reflects changing

community attitudescommunity attitudes• Mechanisms to ensure responsibility & Mechanisms to ensure responsibility &

accountabilityaccountability• Goal to extend legislation to promote 3RsGoal to extend legislation to promote 3Rs• External monitor of institutional activitiesExternal monitor of institutional activities• Public particpation at both levels of accountabilityPublic particpation at both levels of accountability• Code of Practice - principles to guide conductCode of Practice - principles to guide conduct

Role of ACECRole of ACEC• Major social benefit by bringing together people of Major social benefit by bringing together people of

differing viewsdiffering views• Serve to amplify awareness of scientistsServe to amplify awareness of scientists• Improved review - focus on animal concernsImproved review - focus on animal concerns• Seek reconciliation of human needs and animal interestsSeek reconciliation of human needs and animal interests• Pivotal role for lay/non-scientific members Pivotal role for lay/non-scientific members • Knowledge basis for judgement also essentialKnowledge basis for judgement also essential• Acknowledged critics of processAcknowledged critics of process

InstitutionalInstitutional committeescommittees will be effective will be effective by bringing considered, collective by bringing considered, collective judgement to the decision to use judgement to the decision to use animals for research and by the close animals for research and by the close supervision they can bring to the supervision they can bring to the conduct of such research … they must conduct of such research … they must be informed of issues, aware of be informed of issues, aware of community and scientific sensitivities community and scientific sensitivities and committed to the resolution of and committed to the resolution of conflicts.conflicts.

Senate Select Committee on Animal Welfare Senate Select Committee on Animal Welfare Report on Animal Experimentation 1989Report on Animal Experimentation 1989

• Supported separate legislation based on duty of Supported separate legislation based on duty of care and respect for animalscare and respect for animals

• Supported model of enforced self-regulationSupported model of enforced self-regulation• Supported primacy of responsibility of investigatorsSupported primacy of responsibility of investigators• Noted benefits of accreditation vs licensing Noted benefits of accreditation vs licensing • Cautioned the need to balance between self-Cautioned the need to balance between self-

regulation by institution and government controls.regulation by institution and government controls.

Ethics committees are the lynch pin in Ethics committees are the lynch pin in the system of responsibilty and the system of responsibilty and accountability. accountability.

It is the collective wisdom of a It is the collective wisdom of a committee, with each member bringing committee, with each member bringing his or her own expertise to bear on the his or her own expertise to bear on the matter together with other members, matter together with other members, that enables a collective judgement to that enables a collective judgement to be made.be made.

Foundations of Foundations of LegislationLegislation

Duty of care core valueDuty of care core value Primacy of responsibility of Primacy of responsibility of

investigatorinvestigator Pivotal role for institutional ACECPivotal role for institutional ACEC Participation of wider communityParticipation of wider community Institutions < > governmentInstitutions < > government

19861986 - Animal Research Review Panel AppointedAnimal Research Review Panel Appointed

- Code of Practice- Code of Practice

- Accreditation process- Accreditation process

19891989 - Act amended LD 50 & Draize tests - Act amended LD 50 & Draize tests

19901990 - Regulations proclaimed - Regulations proclaimed

19911991 - Act introduced - Act introduced

19921992 - Site Visit program - Site Visit program

Code of PracticeCode of Practice• Incorporation of a code of practice into a Incorporation of a code of practice into a

legislative framework based on principles legislative framework based on principles of good conduct rather than prescription of good conduct rather than prescription of practices most effective way of of practices most effective way of promoting good practice and the 3Rspromoting good practice and the 3Rs

• Guidelines should clearly lay down Guidelines should clearly lay down general principles and criteria by which general principles and criteria by which practices and procedures can be judged.practices and procedures can be judged.

Aims to • emphasise responsibilities, emphasise responsibilities,

• ensure animal welfare is ensure animal welfare is always an essential factor, always an essential factor,

• ensure animal use is valid, ensure animal use is valid,

• minimise numbers minimise numbers

• limit pain and distress limit pain and distress

• promote replacement.promote replacement.

1990

Australian Code of Australian Code of PracticePractice

## Self regulatory systemSelf regulatory system Responsibility & Accountability

## Ethical issuesEthical issues Framework for Review

## Good Scientific Practice < > Animal Good Scientific Practice < > Animal WelfareWelfare

# # Principles of PracticePrinciples of Practice Evidenced-based

Accreditation….Accreditation….In keeping with the notion of promotion of good In keeping with the notion of promotion of good practice - it incorporates peer review and mandates practice - it incorporates peer review and mandates critical and informed review and appraisal. critical and informed review and appraisal.

To be effective the agency responsible must have To be effective the agency responsible must have sufficient knowledge to evaluate practices and sufficient knowledge to evaluate practices and procedures and be able to reflect in its judgement a procedures and be able to reflect in its judgement a balanced community view.balanced community view.

Assessment by a panel of persons , including Assessment by a panel of persons , including community representatives, should achieve this.community representatives, should achieve this.

Scope of activities Scope of activities todaytoday

• 103 accredited institutions103 accredited institutions

• 24 licensed animal suppliers24 licensed animal suppliers

• 75 accredited schools75 accredited schools

• 2,315, 328 animals (2004)2,315, 328 animals (2004)

• monitored by AECs and ARRPmonitored by AECs and ARRP

Outcomes …..Outcomes ….. Robust processesRobust processes

– AECsAECs– ARRPARRP– Public involvementPublic involvement– AccountabilityAccountability

Identify animal welfare benefitsIdentify animal welfare benefits– 3Rs3Rs– High standards of careHigh standards of care

ARRP Annual ReportsARRP Annual Reports• Produced annually since 1987Produced annually since 1987• Documents administrative arrangementsDocuments administrative arrangements• Panel Membership , meetings, attendance, site visits, Panel Membership , meetings, attendance, site visits,

subcommittee activitiessubcommittee activities• Issues arising from site inspections and other ARRP activities Issues arising from site inspections and other ARRP activities

and remedial actionsand remedial actions• Statistics on animal use (since 1992)Statistics on animal use (since 1992)• Policies and guidelinesPolicies and guidelines• Initiatives to achieve 3RsInitiatives to achieve 3Rs

ReplacementReplacement• Use of models, videos, interactive programs, Use of models, videos, interactive programs,

abattoir specimens in teachingabattoir specimens in teaching• Extensive use of Extensive use of in vitroin vitro systems before systems before

progress or animal studiesprogress or animal studies• In vitroIn vitro production of monoclonal antibodies production of monoclonal antibodies• Development of Development of in vitroin vitro methods to replace methods to replace

animals animals • Habitat assessment prior to trappingHabitat assessment prior to trapping

ReductionReduction• Statistical assessmentStatistical assessment• Trials follow GLP or GCP - data qualityTrials follow GLP or GCP - data quality• Review of breeding protocols - overbreedingReview of breeding protocols - overbreeding• New analysis methods -dec. tissue sampleNew analysis methods -dec. tissue sample• Sharing tissuesSharing tissues• Wildlife studies - number of ways to dec samples Wildlife studies - number of ways to dec samples

reportedreported• Collaborative projects eg antibody productionCollaborative projects eg antibody production

RefinementRefinement• Use of chicken eggs to produce PABsUse of chicken eggs to produce PABs• Setting early endpointsSetting early endpoints• Group housing / companionsGroup housing / companions• Environmental enrichmentEnvironmental enrichment• Education programsEducation programs• Pain management esp. analgesics, monitoringPain management esp. analgesics, monitoring• Baited hair tube traps/pitfalls modifiedBaited hair tube traps/pitfalls modified• Alternative methods for identificationAlternative methods for identification

Strategic Plan -Goals The principles, processes and responsibilities of the Code The principles, processes and responsibilities of the Code

are actively embracedare actively embraced

All use of animals consistent with the Code & ActAll use of animals consistent with the Code & Act

Procedures regularly reviewed and refined to minimise Procedures regularly reviewed and refined to minimise numbers and reduce impactnumbers and reduce impact

Pain & distress promptly recognised & relievedPain & distress promptly recognised & relieved

High standards of housing and careHigh standards of housing and care

Access to information about animal useAccess to information about animal use

Support for AEC Support for AEC ProcessProcess

Site inspection reports - detail, analysis, Site inspection reports - detail, analysis, supportive evidencesupportive evidence

Development of Policies (17) and Guidelines Development of Policies (17) and Guidelines (21)(21)

Meetings for AEC members Meetings for AEC members Meetings - special issuesMeetings - special issues Model Protocol FormModel Protocol Form Animal Ethics InfolinkAnimal Ethics Infolink

International Developments

• Ethical principlesEthical principles• Criteria to assess animal welfare Criteria to assess animal welfare

outcomesoutcomes• Evidence-based guidelines to Evidence-based guidelines to

inform processinform process

• Harmonisation of guidelinesHarmonisation of guidelines

Commitment to and engagement with process by all Commitment to and engagement with process by all involvedinvolved

Acceptance of diversity of viewsAcceptance of diversity of views

Good communicationGood communication

Focus on core issuesFocus on core issues

On-going review and promotion of animal welfare On-going review and promotion of animal welfare standardsstandards

Education and evidence-based practice underpinEducation and evidence-based practice underpin actionsactions

Ongoing ChallengesOngoing Challenges Identifying barriers to participation & Identifying barriers to participation &

developing strategies to responddeveloping strategies to respond Development, implementation and Development, implementation and

promotion of the 3Rspromotion of the 3Rs Effective pain managementEffective pain management Housing and care - species needsHousing and care - species needs Supporting evidence-based practiceSupporting evidence-based practice

Responsibility....Responsibility.... Individual Individual

InstitutionInstitution

RelationshipsRelationships

Individual Individual < >< > AE Committee AE Committee

Individual Individual < >< > Institution Institution

Institution Institution < >< > Community Community

AcknowledgmentsAcknowledgments Members of Animal Ethics Members of Animal Ethics

CommitteesCommittees

Members of ARRPMembers of ARRP

Researchers , TeachersResearchers , Teachers

Animal TechniciansAnimal Technicians

Animal Welfare UnitAnimal Welfare Unit

thethe journey journey continuescontinues