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Ethical Review of Quality Improvement Activities in Health Services submission

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This submission takes a devil’s advocate approach as I am not persuaded that the vast bulk of QI/QA/ audit/patient safety activities require any form of prospective review by either a HREC or any other institutional review process.  Other than the risk of breach of privacy, I agree with the draft NHMRC document where it states that “QI activities are often of low or negligible risk”.  I challenge the authors of the draft document to provide published evidence of any significant harm arising from QI activities. If the only significant risk of QI relates to breach of privacy, existing privacy guidelines are adequate to inform clinicians of their responsibilities.

Incorporating QI activities formally within the National Statement was inappropriate and represents a form of “ethics creep”. The “ongoing concerns about this issue” as mentioned in the covering letter over the signature of Dr Sandra Hacker are a reflection of the error that was made in that incorporation. Attempting now to give additional advice as to how to use the National Statement will not correct that error. AHEC has as a result got itself into a bind – as evidenced by the bolded statement in Dr Hacker’s letter: “It is important to recognise that the aim of the document is not to constrain quality improvement activities but to develop them in an ethical context”. The process established under the National Statement, and reinforced by this new document, is highly likely (if heeded) to constrain such activities.

The extension of the four “core values” of the National Statement  applying to research (research merit and integrity, justice, respect and beneficence) to QI activities as provided in the draft document seems very forced and generally inappropriate. By attempting to apply them, AHEC has effectively redefined QI as research.  Just because QI activities might have their own “ethical issues” does not constitute an automatic need for independent ethical oversight of such activities. No attempt seems to have been made to identify ethical principles or issues specific to QI.

Most clinicians I have questioned since the release of the 2003 NHMRC document entitled “When does quality assurance in health care require independent ethical review” were unaware of its existence. I suggest that they are also likely to be unaware of, or ignore, any new advice given by the NHMRC on this topic. If clinicians do heed the advice, the amount of useful QI activities undertaken may well decline. This would be to the detriment of the modern focus on patient safety.

I suggest instead that all that is needed is for institutions to regularly remind clinicians planning QI activities to ask themselves whether what they are planning might actually be a research study rather than a QI activity. If a clinician is in doubt, then that is the point at which advice from a HREC would be appropriate. (Reinstatement of the 2003 document might also help in this regard). Governance of QI activities might best involve regular retrospective selected or random review of QI activities so that an institution can assure itself that its staff is indeed behaving appropriately.

Another way of looking at the ethics creep involved via this new document is to be reminded that the concept of prospective independent ethical review of medical research arose initially because of the gross harms perpetrated by Nazi doctors. Such review remains needed because some research is indeed potentially very harmful and researchers are not always able to consider their research proposals from the viewpoint of the participant. To apply the principles developed for the review of medical research over the last 50 years to very low or negligible risk QI activities is wasteful of resources and may inhibit useful activities. There are many actions taken every day by clinicians in routine patient care that carry significant risks that far and away exceed those of QI and audit. If clinicians can be trusted to be professional and ethical in such daily routine activities (without ethics committee review of the activities) then surely it would be wise to trust them to behave professionally and ethically when engaging in routine QI activities.

Finally, a considerable amount of audit is conducted in private medical practice. Indeed regular self-audit is a component of the Royal Australasian College of Surgeons’ continuing professional development requirements. Is AHEC suggesting that the national statement on research now applies to these activities?

Dr Kerry J Breen AM, MBBS, MD, FRACP

[Personal information removed by ONHMRC]


Page reviewed: 17 June, 2013