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Ethical Review of Quality Improvement Activities in Health Services submission

This submission reflects the views of
Organisation Name: 
St Vincent's Health Australia
Please identify the best term to describe the Organisation: 
Health service
Personal Details
Specific Comments

In terms of general comment on the document, the Council is no doubt aware of the new National Safety and Quality Health Service Standards (NSQHSS) established by the Australian Commission for Safety and Quality in Health Care (ACSQHC) as part of the new National Accreditation Scheme (effective 1 January 2013). These standards require considerable audit activities to be undertaken by all health services as part of their accreditation processes. It is considered advantageous for the Council to link their statements about requirements for ethical review of clinical audit to this new national program and to seek guidance and clarification from the ACSQHC about the audit requirements for all health services.


In addition, the concepts of Quality Assurance and Clinical Quality Improvement are quite distinct and the document would be improved by the addition of clear definitions of these two practices to guide implementation of the process recommended.


The primary issue identified by our organisation is the ability to accurately classify Quality Improvement as distinct from low risk research. Whilst advisory documents reference the level of risk involved, this is not always appropriate to classify activities.  The current draft document risks turning many QI activities into (low risk) research.

St Vincent’s Health Australia does not agree with the statement on page 4, paragraph 2 that “there is a level of uncertainty about the appropriate levels of governance for such activity including ethical review”. Under the NSQHSS the governance for quality improvement activities is clearly enunciated and evaluated. This has been a long standing part of accreditation process in Australia and all hospitals have designated accountability for governance of quality improvement activities.


Research merit and integrity, justice, beneficence and respect

The issue of consent when undertaking Quality Improvement activities is also contentious. It is clear that public expectation requires that health services continue to monitor and improve the quality of their services and this forms part of the primary purpose for information collection, particularly in a tertiary hospital environment (in the form of patient histories etc ). It is therefore suggested that working examples specific to different environments be provided to guide the decision making process of institutions when considering ethical review of Quality Improvement activities.

St Vincent’s Health Australia strongly advocates for active participation of patients, residents and their families in healthcare processes. However it should be acknowledged that there are inherent difficulties in the stated requirement (page 5, paragraph 3, Justice) that the information emerging from the study is shared with participants, for example of quality improvement activities using a PDSA cycle which incorporate small cycles to test change and may audit a sample of de-identified medical records to evaluate process improvements


The flow chart suggests that all retrospective case note audits would need HREC approval (and a waiver) unless it can be evidenced that patient consent was obtained. It is generally accepted that QI activities are a component of the primary purpose thus HREC waiver of consent is not required. The vast majority of QI activities are based on chart reviews and consent is neither feasible nor possible.  The 2007 National Statement recommendations 5.1.18-5.1.21 should be noted. This allows institutions to adopt a simple delegated review with reporting to an HREC or a sub- committee of an HREC (with minimal paperwork). This process allows a database record of institutional QI activity and a record or demonstration of process. As well it serves the purpose of evidence of ethical review for possible subsequent publication


The flow chart describes ‘non-identifiable existing data’ and ‘other than non-identifiable existing data’. This is unclear, as the pathway above it already stipulates that this is new data that has been collected prospectively. The flow chart also suggests that the ‘QI team consider all the ethical issues and determine the level of risk’. From an operational standpoint, this should include an assessment of whether information is identified or not.


It is suggested that the outcomes at the bottom of the flow chart read “Review as QI as per institutional requirements” instead of “Review as determined by institution”.


It is suggested that the pathway which leads to ‘QI review’ mentions the requirements (if any) for consent, including how consent will be sought and at what time point this will be achieved. 

General Comments

The question of patient consent on admission for use of information regarding their care for quality improvement purposes was raised during our internal consultation process and it would be appreciated if the NHMRC provided guidance on this point in a further iteration of the document.

Page reviewed: 17 June, 2013