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Mutual Acceptance of ethical and scientific review

Mutual Acceptance of ethical and scientific review. Clinical Trials in NSW, QLD and Victorian Public Health Organisations Version 1. 4 May 2011. Aims. Enable Public Health Organisations of participating jurisdictions to accept a single ethical review of multi-centre Clinical Trials; and

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Mutual Acceptance of ethical and scientific review

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  1. Mutual Acceptance of ethical and scientific review Clinical Trials in NSW, QLD and Victorian Public Health Organisations Version 1. 4 May 2011

  2. Aims • Enable Public Health Organisations of participating jurisdictions to accept a single ethical review of multi-centre Clinical Trials; and • Inform the ongoing development of a national system of single ethical review of multi-centre research.

  3. Outcomes • Decreased duplication of ethical review • Decreased timelines for ethics approval, thereby • Increasing access to new treatments for patients sooner, leading to improved health outcomes; and • Increasing the attractiveness of Australia as location for clinical trials; • Increased goodwill and trust between participating states, researchers and industry; and • Implementation experience to further inform development of a national system

  4. Features • Scope: clinical trials conducted in public health organisations • One ethical and scientific review (some exceptions) • Review undertaken by NHMRC certified HRECs, for clinical trials • Sites undertake site specific assessment/research governance • Studies may only commence with HREC approval and SSA authorisation

  5. Features (continued) • Each state will ensure that its NHMRC Certified HRECs are indemnified for their decisions in reviewing multi-centre clinical trials • For commercially sponsored clinical trials, the sponsor will continue to provide indemnity to the Certified HREC

  6. Exceptions • NSW • Research involving persons in custody or staff of NSW Justice Health; • Research affecting the health and wellbeing of Aboriginal people and communities; and • Research requiring access to statewide data collections • Queensland • Research studies involving access to coronial material • Victoria • Research studies involving access to coronial material; and • Research studies involving persons in custody

  7. HREC application process A researcher applies to one HREC using the relevant state processes • New South Wales • the selection of the certified HREC is at the discretion of the applicant • Queensland • the Reviewing HREC is determined by contacting the Central Co-ordinating Service (CCS) • Victoria • the Reviewing HREC is determined by contacting the Central Allocation System (CAS)

  8. HREC application process (continued) • Applications for ethical and scientific review must be completed using the Online Forms website: • National Ethics Application Form (NEAF) • For clinical trials that have a site in Victoria, the Victorian Specific Module must also be completed

  9. SSA application process • Applications for site specific assessment must be completed using the Online Forms website: • NSW SSA Form for research projects in NSW • QLD SSA Form for research projects in QLD • VIC SSA Form for research projects in VIC • A separate SSA application must be made for each site at which the research project is to be conducted

  10. Currently in development • Guidance for state legislative differences • Guidance on HREC monitoring and reporting • Communication and training strategy • Changes to the information technology platform (AU RED)

  11. Legislative differences • Developing guidance for researchers and HRECs

  12. Monitoring and reporting • Guidance being developed • Requirements will be in line with reviewing HREC and state requirements

  13. Monitoring and reporting

  14. Communication and training • Communication mechanisms • E-bulletin (April 2011) • Brochure • Information on state webites • Presentations • Training for HRECs and researchers • How mutual acceptance will work • Legislation, monitoring, IT

  15. Information management technology • Changes to AU RED • Inclusion of interstate mutual acceptance mode • Ability to link SSAs to an HREC application, across the three states

  16. When will mutual acceptance start? • Aiming for second quarter 2011 • Still to be completed • Guidance on state legislation and administrative frameworks • Information for HRECs, investigators and institutions in relation to monitoring approved research • Awareness raising strategies and training for all stakeholders • AU RED changes

  17. Further information • NSW Jo Mitchell (02) 9391 9292 • Queensland Jane Jacobs (07) 3234-0628 • Victoria Suzanne Hasthorpe (03) 9096 5912

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