What is the difference between quality assurance, evaluation and research?

Quality assurance, evaluation and research can exist on a continuum. Your project might begin as one type of activity and evolve into another type of activity over time. For this reason, the boundaries between quality assurance, evaluation and research can be fluid.

This is a topic endlessly debated, and sometimes hard to determine as they both sit on the same continuum. They often use the same methods (e.g. similar design, surveys, interviews, data analysis) and the same ethical principles apply. The difference between the two is around the intent of the work. Is the project working towards:

• discovering what is the right way of doing something? (Research)
  OR
• evaluating/improving practice to ensure it is the done the right/best way? (Quality)

Research is trying to discover what is the right way of doing things, hence we are potentially putting participants at risk, for an unknown benefit. This is not the case for Quality projects, so these do not require Research Ethics review. 

Quality work can be published, however your choice of journal may be limited if the project is reviewed under a QA framework or if the journal disagrees with the determination that the work is QA.

What really matters is that: 

• participants in quality assurance and evaluation projects are afforded appropriate protections and respect 
• quality assurance and evaluation is undertaken to generate outcomes that are used to assess and/or improve service provision
• those who undertake quality assurance and evaluation adhere to relevant ethical principles and state, territory and Commonwealth legislation
• organisations provide guidance and oversight to ensure activities are conducted ethically, including a pathway to address concerns. 
  

Definitions

Minimal Risk

The NHMRC National Statement on Ethical Conduct in Human Research (2025)(chapter 2.1), provides guidance on risk as minimal risk is defined as “no foreseeable risk of harm or discomfort; potential for minor burden and inconvenience”. For example:

• use of existing de-identified clinical data with no foreseeable risk to the participants
• use of existing research data for which consent has been provided for the secondary use, or
• project using surveys or basic short interviews that do no present risk of distress (this will depend on how the specific questions impact the specific participants)

  
  

Quality Assurance

The NHMRC: Ethical Considerations in Quality Assurance and Evaluation Activities (2014),state that these studies’ “primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation.” Furthermore, evaluation is a term that generally encompasses the systematic collection and analysis of information to make judgements, usually about the effectiveness, efficiency and/or appropriateness of an activity for example

• clinical audits
• quality improvement activity, or
• health service delivery evaluation

Application pathways 

Quality assurance and minimal risk type research – 

These will all need to be submitted through MCC DERP and can be signed off by your head of department. When you log into DERP you will be able to complete a guided risk assessment. This approval can only be provided for campus based projects and cannot be extended to other sites.  

Below is an example of a protocol template that can be used, however your Head of Department may prefer a different format, please ensure that the protocol includes enough guidance so that the protocol can be followed and repeated. 

Protocol template QA minimal risk protocol template

Determinations around whether work is QA or research is the responsibility of the applicant. If you wish to publish your quality work you will need to be able to justify to journals that the work is quality and not research. Research ethics approval cannot be provided retrospectively if the journal does not agree that the work is quality. Quality projects do not receive research ethics approval. Your QA project will be reviewed by your HoD and you will receive a confirmation of approval once they have signed off on your project.

Please speak to your Head of Department or supervisor for guidance if you are unsure whether this application process best suits your study.

FAQs

Do I need to do a pre-registration form?

A pre-registration form is NOT required for Quality Assurance or Minimal Risk applications.  

Can I amend a Quality or Minimal Risk application?

Yes to can.  Research ethics and governance are currently in the process of developing a form for amendments to QA and minimal risk projects. Currently and amendments can be emailed to rch.ethics@rch.org.au with the HoD CC'd in advising of the change and providing updated documents. the email must state that the change has been endorsed and approved by the HoD. REG will then attach this to the MCC application. REG do not need to be informed of administrative amendments to minimal risk or QA projects. 

Quality Assurance or Research?

If you are unsure whether your project is QA or research please speak to your head of department or supervisor and consider the intent of the work in accordance with the above advice. 

Even if my project is quality assurance or improvement, I want to publish my results so I need ethics approval. 

Ethics approval is not required to publish the results from the QA activity. Quality work can be published, however your choice of journal may be limited if the project is reviewed under a QA framework or if the journal disagrees with the determination that the work is QA.

If  the primary purpose is to publish your findings, then you should reconsider whether the project is actually research. In many cases publishable findings are new generalizable knowledge, and therefore research. Retrospective research ethics approval cannot be granted. 

Collection, Use and Disclosure of Health Information 

Identifiable (including potentially identifiable) health information cannot be transferred outside of the RCH without consent from participants e.g. must remain within the RCH server, cannot be transferred onto RedCap or other MCRI/UoM applications. This is a requirement of the Health Records Act (Vic) 2001 and the Privacy Act (1998).