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Ethical Review of Quality Improvement Activities in Health Services submission

Personal Details
First Name: 
Last Name: 
Specific Comments

This section includes a definition of QI with reference to PDSA cycle, which provides a useful starting point. What I feel is missing from this section is the idea that QI and research are activities that fall across a continuum with a “grey” area where it is often difficult to define whether an activity is QI or research – hence the need for a statement with clear guidelines and processes to follow. The concept of a continuum was highlighted in the 2003 document  “When does quality assurance in health care require independent ethical review?” I feel it would be useful to make mention of this continuum here. For example, this spectrum may be conceptualised along the following lines:

  1. QI – no departure from routine clinical care, no capture of additional information and aimed at service improvement (e.g. traditional Morbidity & Mortality meetings, sentinel event/incident monitoring)
  2. QI research – an increasing area of activity, with methodological similarities to research and often involving capture of information beyond routine care (e.g. before and after methodology, staff surveys etc), which are primarily aimed at service improvement, but may also be of interest to other facilities via publication
  3. Research – methodology aimed at obtaining new information and dissemination beyond the facility level.

It may be useful to include in the “principles underpinning this document” section a third principle stating that national/state legislation needs to be followed in terms of use of data. For example, the Hospital and Health Boards Act 2011 (Qld) provides legislation regarding use of confidential information and the Public Health Act 2005 (Qld) provides legislation regarding release of confidential information for research purposes where individual consent has not been obtained.

Research merit and integrity, justice, beneficence and respect


There is mention of the need for an “ethically defensible plan”. It would be good to provide guidance on what is meant by this. In some instances, an ethically appropriate plan may need to be determined with senior executives after a QI activity identifies an issue that may be of importance to the care of an individual or their family, i.e. a plan, apart from an escalation pathway, may not be able to be determined in advance. 


In addition to individual risks to be considered, resource implications and impact on staff when undertaking QI activities also need to be considered. This risk:benefit analysis is an important governance component.


The section on consent does not provide guidance on instances when QI activities may be undertaken without consent, e.g. Queensland state legislation (Hospital and Health Boards Act 2011) allows for disclosure of confidential information “to another designated person for evaluation, management, monitoring or planning health services” (s150).

Senior executive responsibilities

Under dot point one, I suggest inclusion of complies “with relevant legislation”

Maintaining a register of all QI activities may not be feasible or appropriate for senior executives in the institution. For example, there may be activities undertaken at a team or unit level, which are informal or embedded into routine activity, that only require oversight by unit line mangers. If different levels of oversight are appropriate, it would be helpful to have guidance on when a QI activity requires entry on an institutional register.

Dot point 2: “processes in place for ethical review” may be better worded as “ethical/governance review” as there may be broader considerations (e.g. resources involved and how and where the information will be disseminated).

Institutional responsibilities for ethical review of QI activities

Dot point 2 under “Department responsibilities” may be better worded as “ethical/governance review” (as per comment above).



It would be useful to provide guidance on the timing of when HREC (or other) review/approval should occur, as there may be instances where a QI activity has been conducted and only latter is deemed suitable/appropriate for wider dissemination. Maybe a principle here should be to seek HREC Chair (or other appropriate) advice as soon as there is a consideration that the QI activity is suitable for publication.  There is also the issue of whether a HREC can provide approval for an activity that has already been conducted and how this should be dealt with from a QI perspective. Guidance on instances where it may be appropriate to seek a waiver of HREC review, e.g. from a HREC Chair , and thus satisfy journal requirements that an appropriate level of review has occurred  would be helpful. 


My comments are as follows:

  1. The definition of new data is not clear: is this data that will be collected in the future (but is routinely collected) or data that is not routinely collected?
  2. Pathway from “Has consent been obtained for the collection and use of data?” and “No”: there may be instances appropriate under state legislation for the use of confidential information for QI activities (e.g. s150 of the Health and Hospital Boards Act 2011 Qld), which do not require HREC review.
  3. The definition of who the “QI team” constitutes is not clear: is this the individual/team undertaking the QI activity or an institutional representative (e.g. a Director of a Department or a hospital committee)?
  4. Reference to sections of the National Statement may be useful at various points in the flowchart, e.g. low/negligible risk (NS 2.1), review as determined by the institution (NS 5.1.20), exempt from review (NS 5.1.22). 
General Comments

This is a much needed guidance document for persons undertaking QI activities (e.g. health practitioners), those providing guidance on ethical review (e.g. research governance officers and HREC administrators) and those providing governance (e.g. hospital managers).

Page reviewed: 17 June, 2013