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Ethical Review of Quality Improvement Activities in Health Services submission

This submission reflects the views of
Organisation Name: 
NSW Ministry of Health - Central Office
Please identify the best term to describe the Organisation: 
Government department – State / Territory
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Specific Comments

The introduction to the paper sets out the broad outline quality improvement, however this introduction acts as a definition for quality improvement which is too wide and captures service improvement functions which are inherent management responsibilities.


Institutional governance for QI

It needs to be recognised that NSW, and no doubt other Australian jurisdictions, has in recent years implemented sophisticated and comprehensive systems for quality improvement, such as the Incident Information Management System, Reportable Incident Briefs, Root Cause Analysis, which have been developed with extensive stakeholder and public consultation resulting in comprehensive legislation and policies. As part of the development of these schemes, careful consideration has been given to the competing ethical issues. It would be preferable for the statement to recognise such processes should fall outside these HREC review proposals, given the work already done, the potential for confusion and delay in progressing incident investigations through an additional or HREC process.

 Further, it needs to be acknowledged that legislation exists sanctioning use or disclosure of information without consent or further ethical consultation as part of a QI policy process (for example Health Administration Act 1982 and Human Tissue Act 1983). The statement should be clear that the requirements for HREC approval do not cut across or override existing legislative permissions.


In relation to the flow-chart, it appears that there is a distinction in the review process for negligible risk QI activities that use non-identifiable existing data (obtained with consent), as opposed to non-identifiable new data (obtained with consent). Following the flow chart, a negligible risk project using non-identifiable existing data (obtained with consent) is exempt from review, whereas a negligible risk project using new non-identifiable data (obtained with consent) requires review as determined by the institution.

Provided that consent is received for the collection of the data at the time of its collection, the ethical difference between using existing data and new data is unclear. Should negligible risk QI undertaken with consent actually require a different level of review depending on whether the data is new or existing? The relevant issues are consent, the level of risk, burden to the participant, and the other principles outlined in the NS. NSW MoH is aware that the flowchart reflects an interpretation of NS paragraph 5.1.22(b); however, perhaps that paragraph requires re-consideration.

QI and the National Statement on Ethical Conduct in Human Research (2007)

Requiring an HREC review for all QI activities above what is considered to be low or negligible risk is an additional layer of approval processes will cause unnecessarily delays across the health system. For example, over 600 wards and units participate in the nursing and midwifery Essentials of Care (EoC) program, which is largely a QI project. It would be particularly onerous if a significant portion of EoC projects required an HREC review. It is recommended that the statement include a more restricted definition of QI activities which would require an HREC review.

One Local Health District (LHD) has advised the MoH of its concerns in relation to the National Statement. The LHD noted the requirement for HRECs to waive the need for consent conflicts with the Human Tissue Act 1983 which allows non-consented use of small samples of tissues and bodily fluids for laboratory and hospital quality improvement programs.

General Comments

The proposed use of the NHRMC National Statement on Ethical Conduct in Research Involving Humans (2007) will assist in the standardisation of the governance and ethical review of quality improvement (QI) activities and increase awareness of the importance of the ethical implications of QI. This is to be encouraged.

NSW Ministry of Health (MoH) has developed its own practice guide in the form of a Guideline (GL2007_020) in order to provide advice to Public Health Organisations on QI and ethics review. We note that much of the material in the NHMRC consultation draft (consultation draft) is in alignment with the NSW Ministry approach.

NSW MoH has also identified that the obligation to perform an ethical review of QI activities should not create an unnecessary obstacle and therefore discourage the practice of QI and has recommended “a routine and simple review process to identify ethical risks” (GL2007_020, p1).

From practical experience, we would note that most health services have established their own Quality Improvement Departments/Units who routinely advise on QI activities, and in many cases, this already includes assisting in an assessment of the ethical aspects of those activities. In many of these facilities, there is a close relationship between the administrative personnel of the Quality Improvement Unit and those of the Human Research Ethics Committee (HREC) who, between them, can assist a researcher / applicant in assessing a particular activity’s risk level and other ethical aspects and advise whether it needs to go through an informal QI process or a more formal HREC review.

Encouraging a routine and simple process such as this is essential for the proper ethical review of QI activities as well as full research projects (regardless of the quality/research distinction). The review by an HREC in order to identify and assess the ethical issues for many QI activities is not only onerous and time-consuming for those conducting QI activities; it also unnecessarily consumes the time of the committee who should be using their limited time to review projects that contain greater than low risk.

NSW MoH supports the principles, outlined in the consultation draft, that:

(1)    all QI that is conducted with or about people requires ethical consideration; and

(2)    the National Statement on Ethical Conduct in Human Research (National Statement) provides a basis for ethical review of QI.

NSW MoH also supports amending the National Statement in accordance with the proposed wording set out on p8 of the consultation draft; that is, to add specific references to “QI” to those sections of the National Statement dealing with ‘Research involving no more than low risk’ and ‘Research that can be exempted from review’.

Page reviewed: 17 June, 2013