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Ethical Review of Quality Improvement Activities in Health Services submission

ID: 
16
This submission reflects the views of
Organisation Name: 
Faculty of Health Sciences, Australian Catholic University
Please identify the best term to describe the Organisation: 
Educational institution – tertiary
Personal Details
Specific Comments
Comments: 
Institutional responsibilities for ethical review of QI activities

We welcome the endorsement a separate body undertaking review of need for ethical approval for low-risk studies.  We consider that such bodies should be registered with an appropriate HREC to ensure that members of these bodies are familiar with the National Statement.  Inaddition, the remit of such bodies should be limited to the determination of whether HREC review is necessary ie determination whether an application is indeed low risk.

Flowchart

Examples should be provided to support the flow chart on page 9.  The use of routinelycollected hospital administrative data for quality improvement could be interpreted as requiring HREC approval (by virtue of using existing data for a purpose other than that informing their collection). We would suggest that the use of such existing data for QI should be deemed low risk.  At present it would only be low risk if new data were to be analysed and not existing data sets.  Most quality improvement initiatives would entail the use of existing health service data as quality outcomes such as hospital acquired infection or length of stay are embedded in these data.  The financial impost associated with HREC consideration of initiatives using these data act as a barrier to the sensible use of  health service routine information systems.

Page reviewed: 17 June, 2013