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Legislation:

Research Ethics & Compliance Dr Simon Barrett Manager, Research Ethics & Compliance Monash Research Office. Legislation:. Prevention of Cruelty to Animals Act 1986 NHMRC Act 1992 ARC Act 2001 Prohibition of Human Cloning Act 2002 Research Involving Human Embryo Act 2002

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Legislation:

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  1. Research Ethics & ComplianceDr Simon BarrettManager,Research Ethics & ComplianceMonash Research Office

  2. Legislation: • Prevention of Cruelty to Animals Act 1986 • NHMRC Act 1992 • ARC Act 2001 • Prohibition of Human Cloning Act 2002 • Research Involving Human Embryo Act 2002 • Gene Technology Act 2000 • Quarantine Act 1908 • National Health Security Act 2007 • Privacy Act 2000

  3. Codes of Practice • NHMRC & ARC • Australian Code for the Responsible Conduct of Research • Australian Code of Practice for the Care and Use of Animals for Scientific Purpose • The National Statement on Ethical Conduct in Human Research • Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research ………………………………………….And many more

  4. Review Processes • Monash University Human Research Ethics Committee • Animal Ethics Committees (10 x local) • Monash University Institutional Biosafety Committee

  5. What is Human Research? • Taking part in surveys, interviews or focus groups • Undergoing psychological, physiological or medical testing or treatment • Being observed by researchers • Researchers having access to personal documents or other materials • Collecting organs, tissues, fluids or exhaled breath • Access to information (individually identifiable, re-identifiable or non-identifiable) as part of an existing published or unpublished source or database

  6. Risk and Benefit • benefits justify the risks • level of ethical review should reflect the level of risk

  7. Consent • Participation is voluntary • Consent must be informed • Sufficient information to understand the purpose, demands, risks and potential benefits.

  8. Animal Ethics Review: • All Monash scientific activities (teaching or research) using animals requires approval from a Monash AEC before work can commence.

  9. Animal Welfare General Principles: • Justification • Responsibilities • Replacement • Reduction • Refinement

  10. Applications: • Applications are made to local AEC • Must be reviewed by full committee in “face to face” meeting. • Application usually require amendments • Often approved once amendments are received by secretary and reviewed by chair.

  11. Gene Technology (GT) Act, 2000 • Introduces a national scheme for the regulation of GMOs in Australia • Protect the health and safety of Australians and the environment • Identify and manage the risks posed by or as a result of gene technology

  12. Requirements of the GT Act • Organisations undertaking dealings are “Accredited” • Dealings are classified based on their level of risk • Exempt • Notifiable Low Risk Dealings • Licensed (non-intentional release & intentional release) • Facilities for certain “Dealings” are “Certified”

  13. Funding Bodies • Requirement of clearances • Funds aren’t released until clearance approvals have been sited. • Code for the Responsible Conduct of Research • “Compliance with the code is a prerequisite for the receipt of NHMRC and ARC funding”

  14. What you need to know.That…… • Approvals for you work are in place • You names are added to any existing or new approvals • Be familiar with the content of the approved application • Be familiar with any conditions of approval…..and comply with them

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