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Ethical Review of Quality Improvement Activities in Health Services submission

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Specific Comments

As a member of a busy Ethics Committee, I would like to express concern about some of the proposed changes. While I would agree that an Ethics oversight is desired in any QI project in which ethical risk is inherent, there is a potential for categorical responses to this proposal which would lead to some low ethical risk QI projects being deemed high risk purely on existing definitions.

Take for instance QI projects in a pathology service- say calibration of instruments with pathology samples. The use of pathology and blood specimens are currently held to have a high level of ethical implication. Which means that any such QI projects will now potentially require ethical review especially if no further efforts are made to define/ refine the current recommendations. This would lead to a large increase in number of applications with all its consequences.

This can be ameliorated in several ways:

1. Having a category of QI projects which are defined to be low/ negligible risk even with the use of human tissue or blood samples. The waive of consent would be granted under the secondary use principle of QI in health service provision/management. 

2. Having guidelines for the QI team that defines the ethical risk categories

3. Having similar guidelines for HREC Executive Officers to advise or turn around applications that do not need to be made.

It is important to note that every Low/Negligible Risk application takes up a significant amount of time as a fair amount of work is put into the application and the vetting of the documents by the HRECs/ executive officers.

Page reviewed: 17 June, 2013