Survey of approval processes for HRECs at University of Melbourne affiliated hospitals (The SHREC Study)

Professor David StoryMBBS, 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

Ongoing Collaboration in Research, Teaching, and Engagement…

We play a TEAM SPORT…

Other Medical groups

• Surgery• ICU• Internal Medicine

New (MCATS) Partners

Health InformaticsResearch

Governance

Biostatistics Health EconomicsHealth Economics

Hospital administration

Allied Health Professionals

Nurses

Physiotherapists

Pharmacists

Patients…

…and Anaesthetists