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Streamlining Multi-Centre Clinical Trials Ethical Review in Public Health Orgs

This document outlines the mutual acceptance of ethical and scientific review processes for multi-centre clinical trials in public health organizations across NSW, QLD, and Victoria. The aim is to reduce duplication, expedite ethics approval timelines, enhance patient access to new treatments, and boost Australia's clinical trials appeal. The features include single review by NHMRC-certified HRECs, site-specific assessments, and specific exceptions in each state. Researchers follow state-specific HREC application processes and online forms for ethical and scientific reviews. Monitoring, communication, and training strategies ensure effective implementation. For more information, contact the relevant state representatives provided.

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Streamlining Multi-Centre Clinical Trials Ethical Review in Public Health Orgs

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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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