In this section
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.
Quality assurance and evaluation usually involve minimal risk, burden or inconvenience to participants. For this reason, while some level of oversight is necessary, Human Research Ethics Committee (HREC) review processes are often not the optimal pathway for review of these activities. As per NMHRC guidance, these types of projects can undergo ethical review via an alternate pathway, or in some cases, be exempt from ethical review. As such, these applications should undergo organisational review at the department level, with the involvement of the Quality Unit where needed.
What really matters is that:
NHMRC National Statement on Ethical Conduct in Human Research (2007)(chapter 2.1), defines negligible risk as “when there is no foreseeable risk of harm or discomfort; and any
foreseeable risk is no more than inconvenience. Where the risk, even if
unlikely, is more than inconvenience, the research is not negligible risk”. For example:
The updated National
Statement 2023 refers to these projects
as ‘minimal risk’
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
The following application form and pathway has been developed to expedite the approval of negligible risk type research or provide the oversight for quality and evaluation activity as described above.
A: Negligible risk type research – to apply for HREC approval via an expedited pathway
You should not use the application form if:
In the above cases, you will need to complete a submission for research ethics approval. Please note:
From 17th February 2024, minimal risk research projects are no
longer subject to ethics review. These do not need to be
submitted via ERM, only submitted via MCC DERP which
will guide you through the documents required specific to
B: Quality Assurance activity
As long as the relevant department has the ability to assess the above issues, there is no need to seek ethical review from the relevant HREC or research office. However, in some cases the department is not capable of such a review, or the project contains sensitive issues. In this case, you should make an application for a quality assurance review to the research office. The Research Office will review and consider any ethical issues and provide Organisational Approval (i.e. an exemption of HREC approval).
From 17th February 2024, these projects need to be submitted via MCC DERP. You
will need to submit your protocol and a Head of Department declaration (which
can be completed within MCC DERP)
Please contact the REG Office for guidance if you are unsure whether this application
process best suits your study.
If your project meets the criteria for quality assurance or evaluation, please see the below checklist. The documents in this checklist must be all submitted through the ERM portal, using the Quality
Assurance (QA) VIC form. Note that the application form is now embedded within the ERM QA form. This means you do not have to fill out the application form separately to ERM .
When you submit your ERM application, please attach the below, protocol and other, supplementary project related documentation, if applicable.
Head of Department Declaration
Principal Investigator Signature
Associate Investigator Signature
One electronic copy each to ERM
Using these forms are an alternative way to obtain signatures if cannot be signed via ERM.
HoD Declaration can be completed within MCC
to MCC DERP
Other project related documentation (If applicable):
A pre-registration form is NOT required for Quality Assurance/Negligible Risk applications.
If you are unsure whether your project is QA or research please complete the
Quality Improvement or Research? Survey that has been developed as a screening tool.
Ethics approval is not required to publish the results from the QA activity. The completed
Quality Improvement or Research? Survey signed by your Head of Department should be provided to the journal as evidence of organisational approval if required.
However, 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.
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).