NHMRC Public Consultations

Skip Navigation and go to Content
Visit NHMRC website

Ethical Review of Quality Improvement Activities in Health Services submission

Personal Details
First Name: 
Last Name: 
Specific Comments

P 4 ‘Quality improvement (QI) is an organised process that evaluates, assesses and seeks to improve health service delivery to improve patient and population outcomes and health service efficiency. It is also known as Quality Assurance. Common QI activities include sentinel event monitoring, incident monitoring, root cause analysis, medical record review and other forms of audit as well as peer review meetings and program evaluation.’



 I find this opening paragraph problematic. It reads as if evaluation is a subset of QI when it is arguably the other way around. QI and QA are nor interchangeable either. There is a  distinction betyween the ethos of QI and the process of QA


There are numerous definitions available for these concepts and I have proved a few below.


QI definition

‘the combined and unceasing efforts of everyone—healthcare professionals, patients and their families, researchers, payers, planners and educators—to make the changes that will lead to better patient outcomes (health), better system performance (care) and better professional development’ (Batalden,  Davidoff 2007)


‘Quality improvement in public health is the use of a deliberate and defined improvement process, such as Plan-Do-Check-Act, which is focused on activities that are responsive to community needs and improving population health. It refers to a continuous and ongoing effort to achieve measurable improvements in the efficiency, effectiveness, performance, accountability, outcomes, and other indicators of quality in services or processes which achieve equity and improve the health of the community’. (cited Riley et al 2010)[i]


QA definition


Quality assurance is an organisation's guarantee that the product or service it offers meets the accepted quality standards. It is achieved by identifying what "quality" means in context; specifying methods by which its presence can be ensured; and specifying ways in which it can be measured to ensure conformance.


Evaluation definition

‘the systematic collection of information about the activities, characteristics and /or outcomes of programs to make judgements about the program, improve program effectiveness and /or inform decisions about future programming.’ (Patton 1997)


The key difference in evaluation is the judgment concept.


P 4


‘Indeed, there are not always clear ethical review pathways for such activity and the existing Human Research Ethics Committee (HREC) based review processes are often considered too onerous or time consuming in proportion to the likely risks’.




It’s not so much that HREC processes are considered too onerous, it’s more that the tools they use don’t reflect the nature of evaluation activities. Evaluation activities can be coincident with good management practices, so particularly where employees are concerned there should not be a categorical distinction between ‘business as usual’ and ‘evaluation’ activities that has ethical implications. Employees have already consented, implicitly, to being well-managed.

They are designed primarily for research activities where the investigator generally has specific research questions/ hypotheses to test, and  a clear audience for the results. By contrast evaluation activities can be iterative. They can use the mainstream research methodologies of social science but they also utilise other investigative methods  eg  discursive techniques to build an understanding of what has happened and why

The principles underpinning this document are that:

  1. all QI that is conducted with or about people requires ethical consideration;




Unit of analysis in evaluation is often not ‘humans’. While it is a human endeavour and the methodologies involve humans, evaluation is often about organisations rather than ‘humans’.

[i] Riley, William J. Moran, John W.; Corso, Liza C. MPA; Beitsch, Leslie M.; Bialek, Ronald MPP; Cofsky, Abbey,’ Defining Quality Improvement in Public Health’ Journal of Public Health Management & Practice: January/February 2010 - Volume 16 - Issue 1 - p 5–7


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

P5 Research Merit and Integrity

‘ the QI activity must have clear and achievable aims, be based on a thorough understanding of the relevant literature, use robust methods and be conducted by persons or teams with the appropriate skills, knowledge and experience.’



While this statement is laudable it does not reflect the reality of program evaluation particularly within small organisations which have neither the in house skills or time nor the resources to engage external skills to conduct evaluation. Nonetheless they are often required under the terms of service agreements and in the interests of accountability for public funds to evaluate their programs.


Institutional governance for QI

P 7 Publication

‘Evidence of ethical review and approval is often required by journal editors prior to publication. This is an attempt by journal editors to ensure that they do not publish reports of studies that do not comply with an accepted standard of ethical practice. While intent to publish the results of a QI activity does not influence the level of risk to participants, it can be a relevant’




Evaluation is only considered complete when the results are disseminated and used to inform program/ policy decisions. Sharing of knowledge is a key factor in program evaluation as it is often the way in which the evidence base built. Dilemmas arise when evaluation findings are pertinent to a wider audience and the findings are suitable for journal publication but there has been no prior ‘formal’ ethical review by an HREC. The original intent was to inform policy, program and practice NOT to publish. What is needed is an ethics process which does not hamper dissemination of relevant findings.

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

P8 NS 5.1.20


The levels of ethical review referred to in paragraph 5.1.18 may include, but need not be limited to:

(a) review or assessment at departmental level by the head of department;

(b) review or assessment by a departmental committee of peers (with or without external or independent members);




Much of the angst over ethics considerations for evaluation would be remedied if there specific guidelines/standard template for this sort of review. a nationally agreed process or tool whereby the evaluator could ‘self assess” low risk evaluation and QI activities would be useful.

Page reviewed: 17 June, 2013