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Ethical Review of Quality Improvement Activities in Health Services submission

This submission reflects the views of
Organisation Name: 
Australasian College for Emergency Medicine
Please identify the best term to describe the Organisation: 
Medical college
Personal Details
Specific Comments
General Comments

Submission to the National Health and Medical Research Council:

November 2012




The Australasian College for Emergency Medicine (ACEM) welcomes the opportunity to review and provide comment on the Public Consultation Draft, Using the National Statement: Ethical Review of Quality Improvement Activities in Health Services, prepared by National Health and Medical Research Council (NHMRC).


ACEM is a not-for-profit organisation responsible for the training of emergency physicians, and for the advancement of professional standards in emergency medicine, in Australia and New Zealand. ACEM, as the peak professional organisation for emergency medicine in Australasia, has a vital interest in improving the quality of emergency care provided to the community and supports appropriate, workable process for ethical review of quality improvement activities in health services.


ACEM is supportive of the general principles described in the Consultation Draft, as ethical implications are not often recognised explicitly in quality improvement activities, unless the results are intended for publication in peer-reviewed literature. However, ACEM would like to highlight some issues in the Consultation Draft that warrant further consideration:


  • In other comparative countries audits and some low risk observational studies are not required to undergo review by Human Research Ethics Committees (HREC). For example, in New Zealand this applies if audit or quality assurance study data is disseminated within the organisation that collected original data, however, should the audit outcomes be more widely disseminated (e.g. published) then there is a process of determining risk. If the audit study is deemed to be very low risk, ethical review is waived by the New Zealand Health and Disability Ethics Committees (at the Chair’s discretion). For low risk studies an expedited Ethics Committee review is obtained and for higher risk activities a full Ethics Committee review is required.


  • The Consultation Draft and the flowchart (on page 9 of the document) do not adequately define the intentions or requirements for ‘consent’ in terms of previously collected data. If the NHMRC means implied consent, in that the data was collected in the context of a healthcare-client interaction, then that is understandable and reasonable. However, if it is intended to mean written consent for existing data to be used subsequently, then all retrospective audits will need HREC review. This would be a very onerous process to implement. This also makes the process unrealistic and unworkable in its current form.


  • The Consultation Draft also does not explicitly state the ethical obligations of national health quality agencies (e.g. Australian Council on Healthcare Standards, The Health Roundtable, Health Quality and Safety Commission, etc) and whether these organisations should be subject to the same obligations as individual departments or institutions (e.g. hospitals) with respect to the collection and dissemination of information related to quality improvement activities in health services.


ACEM believes that a quality culture is fundamental to the provision of the highest standard of care in Australasian emergency departments (EDs)[1], therefore ACEM advocates that the final NHMRC document supports and facilitates quality improvement processes. To this end, as quality improvement activities are routine practice in Australian and New Zealand EDs, requiring HREC review for every quality improvement proposal would be onerous and run counter to promoting a quality culture, particularly as most activities would be regarded as low risk. A practical approach would be to establish standing guidelines for HREC review of quality improvement activities by exception only. This would be facilitated by providing definitions and some benchmarking examples on what is regarded to be ‘low risk/negligible risk’ and ‘more than low risk’ quality improvement activities, thereby clarifying the NHMRC document intentions and ensure consistency in implementation. This would be especially relevant where institutions wish to conduct multi-site audits, as it would be undesirable to have a situation whereby some sites require a HREC review and other sites do not, for the same quality improvement activity.


ACEM also recommends that if patient data is de-identified and only reported in aggregated analyses then the requirement to obtain written consent, as well as the need for ethical review, should be waived for ‘low risk/negligible risk’ quality improvement activities when using existing or new data.



Thank you for the opportunity to provide a submission on the Public Consultation Draft, Using the National Statement: Ethical Review of Quality Improvement Activities in Health Services. If you require any clarification or further information, please do not hesitate to contact the ACEM Director of Policy and Research, [Personal information removed by ONHMRC].



                        Yours sincerely,

















[1] Australasian College for Emergency Medicine POLICY ON A QUALITY FRAMEWORK FOR EMERGENCY DEPARTMENTS http://www.acem.org.au/media/P28_v03_Quality_Framework_for_EDs.pdf

Page reviewed: 17 June, 2013