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Ethical Review of Quality Improvement Activities in Health Services submission

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Specific Comments

The first of the principles should specifically include their data:

"all QI that is conducted with, or about people, or their data, requires ethical consideration."

Much of the QI that is conducted here includes some form of audit of medical records.

Research merit and integrity, justice, beneficence and respect

Please clarify if institutional procedures for dealing with LNR applications in an expedited manner are sufficient to meet the requirement under 2.3.5.  If not, how can the requirement for full HREC consideration be justified for an LNR application?

RESPECT - People who are the subjects in research should be actively engaged in the research process otherwise they risk being viewed as objects.  The National Statement uses the term 'participant', when people are not asked for their consent, they are not participants but become resources and are devalued accordingly.  Information collected for the purpose of QI is not always free and informed but rather if you don't sign the form, you don't get the procedure.  There needs to be some safeguards against then using this data for research purposes.

If the principle of respect refers to respect for individual autonomy, I don't see how an HREC can reach a decision that waives this requirement.  I understand that this is a practical compromise but it is inconsistent with the principle of respect for person.

Institutional responsibilities for ethical review of QI activities

The HREC responsibilities are inconsistent.  It is stated in the first principle that if the QI activity is about people (or their data) then there has to be an ethical deliberation.  It would be incongruent for this deliberation to be done by any body other than an HREC.  To then say that the HREC should only review those that are more than LNR is inconsistent.  Particularly if there is to be a waiver of consent.

Excerpts from the National Statement on Ethical Conduct in Human Research (2007)

5.1.18 - if there is a non-HREC level of review for QI, or for LNR, will the competency of these review bodies need to be assessed?  If so, how would that be done?  If not, how would the NHMRC know if they were acting in accordance with the National Statement?

General Comments


There needs to be a clear statement on what is, and what is not, QI.  Especially around the grey area of where QI ends and research begins.

Page reviewed: 17 June, 2013