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
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
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?
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
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
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
Progress so far...
•
•
•
•
•
Grant awarded
Scenarios refined
Part time Research Assistant appointed
Submitted to ethics.....
.... waiting for HREC approval
We play a TEAM SPORT…
Ongoing Collaboration in
Research, Teaching, and Engagement…
Other Medical groups
• Surgery
• ICU
• Internal Medicine
New (MCATS) Partners
Biostatistics
Research
Governance
Health
Economics
Health
Economics
Health
Informatics
Hospital administration
Allied Health Professionals
Pharmacists
Nurses
Physiotherapists
Patients…
…and Anaesthetists