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Survey of approval processes for HRECs at University of Melbourne affiliated hospitals (The SHREC Study) Professor David Story MBBS, MD, BMedSci, FANZCA Professor and Chair of Anaesthesia Head of Anaesthesia, Perioperative and Pain Medicine Unit (APPMU) Melbourne Medical School

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Some medical perceptions After that Ethics experience I will never do research again Anaesthetist, personal communication Because of Ethics who wants to do research? Neurosurgeon, personal communication That #%&**!! Ethics committee Story, 2004

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The challenge 14 hospitals affiliated with the Faculty of Medicine, Dentistry, and Health Sciences Research strategy: Greater research collaboration More multicentre research Different HRECs = different requirements = barrier to research?

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What is happening out there? Differences and similarities between the HRECs are currently unclear Joint project between OREI and APPMU Survey each HREC about their processes for different types of research, 5 sample scenarios to examine different HREC approaches

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Increasing difficulty 1.Retrospective audit of the rates of Staphylococcus aureus bacteraemia at a hospital from 2003 to 2013 2.Prospective observational study of intravenous fluid use during elective hip and knee replacements 3.Phase IV randomised trial investigating the association of intra-operative intravenous fluids with post-operative serum electrolytes in elective total hip or knee replacement 4.Phase II randomised trial of post-operative high-powered magnets for disease recurrence in glioblastoma 5.International, multicentre study investigating molecular markers in women with grade 3 breast cancer

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Importance The benefits of this study are anticipated to be: Identify similarities and differences between HRECs, Opportunity to share ideas around HREC approaches Assist governance support MCATS Foundation for future collaboration between University affiliated hospital HRECs, and OREI to further unify processes, and assess site specific concerns, while optimising ethics and integrity. Collaborate with other streamlining initiatives eg: Victorian Consultative Council for Clinical Trial Research Publication in an appropriate peer reviewed journal

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Progress so far... Grant awarded Scenarios refined Part time Research Assistant appointed Submitted to ethics......... waiting for HREC approval

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Ongoing Collaboration in Research, Teaching, and Engagement We play a TEAM SPORT

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Other Medical groups Surgery ICU Internal Medicine

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New (MCATS) Partners Health Informatics Research Governance Biostatistics Health Economics

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Hospital administration

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Allied Health Professionals Nurses Physiotherapists Pharmacists

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Patients

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and Anaesthetists