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Ethical Review of Quality Improvement Activities in Health Services submission

This submission reflects the views of
Organisation Name: 
University of Canberra
Please identify the best term to describe the Organisation: 
Educational institution – tertiary
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General Comments

Dear Sir / Madam,

Re: Comments on NHMRC public consultation draft: Ethical Review of Quality Improvement Activities in Health Services

The Human Research Ethics Committee (the Committee) of the University of Canberra wishes to thank the National Health and Medical Research Council for the invitation to make the following comments in relation to the public consultation regarding the Ethical Review of Quality Improvement Activities in Health Services.

The Committee is constituted in accordance with the National Statement on Ethical Conduct in Human Research. 


The National Statement (NS) has 2 components:

a) principles of ethical research

b) how these principles are applied in research involving humans.

The consultation draft takes the principles and some aspects of their application from the NS and applies them to the grey area between research and professional practice - the field of quality improvement (QI).

Issue 1: The conception of QI

The draft does not recognise that the quality field is large and well-established with a comprehensive vocabulary (including Quality Management and Continuous Quality Improvement, Quality Control, Quality Audit, etc.) and international standards, including the ISO9000 series, that provide a clear articulation of the field.

For example, the consultation draft equates quality assurance (QA) with QI. However, there are significant differences:

  • QA is an ongoing governance system that aims at ensuring that the processes and outcomes of operational human-technical systems meet a set of quality criteria. A QA system collects data on the operational system and reports it.
  • QI is a project that an organisation undertakes to change an operational system, or a QA system, so that quality criteria can be seen to be better met. QI typically collects data from the processes and products of an operational system and from that implements evidence-based decisions about process change.

The consultation draft makes a reference to one of many quality processes, the 'PDSA' method. However, it appears that 'QI' only refers to the 'S' (study) part of that method. The consultation draft would be improved by using standards-based terminology and being clear about what activity it is referring to and better covering the quality methodologies.

Issue 2: 'QI' as research

The consultation draft argues that QI projects are usually not seen as 'research'. If 'research' produces public knowledge (new theory, etc) and QI produces change in a specific organisation's operations then QI is not research. It is true that the principles in the NS can be applied to many kinds of human activity, not just research, but is it the role of the NHMRC to engage with non-research activity?

The consultation draft focuses mainly on the use of data in QI. This data is usually controlled by the operational systems (e.g. security and levels of access) under the Privacy Act and often consent for its use has been explicitly given (e.g. "your call may be recorded and used for quality control and training"). It is confidential. Where there is doubt, perhaps operational systems need to be changed to seek permission to use data or samples for QI at time of collection.

Issue3: QI in non-research health services

A significant part of the health-service sector involves organisations that have no research links and are not associated with any Human Research Ethics Committee (aged care facilities, etc.). It is not clear whether the consultation draft is proposing to cover such organisations, or how.

Issue 4: QI in non-health services domains

QI projects are undertaken in all domains where there is professional practice - education, business, government. While the NHMRC is specifically interested in health, the NS is used to inform research project design across all domains where humans participate in research. Likewise, the Human Research Ethics Committee assesses research proposals across all domains.

Presumably the proposed method of ethics review of QI projects would be applied across all domains, not just 'health services'. For example, a university interested in a QI project to improve its education should consider ethical aspects of the project design and should have formal oversight. This project would be submitted to a Human Research Ethics Committee. Perhaps organisational change processes should likewise have ethical review. There is a scope issue here.


The consultation draft seems to have issues of definition and scope.

'Action research' is a recognised research method in many domains that seems to cover QI activity. Perhaps QI and other similar projects can be encouraged to be framed as action research and be brought into the normal Human Research Ethics Committee processes. An enlarged consultative role for the Human Research Ethics Committee would be valuable in this instance, as it would for other researchers in doubt about the need for Human Research Ethics clearance.

Page reviewed: 17 June, 2013