Do I need research ethics approval if I am going to an evaluation or quality assurance activity?
It depends.
Prior to starting a research ethics application, you will need to work out whether what you will be undertaking is research or another type of activity.
In making this determination, consider;
- Will the outputs of you activity produce research data?
- Will any work from your project be published – like in a scientific journal? Or disseminated beyond the realm of its’ immediate stakeholders?
If there is a possibility of producing outputs that may be of benefit more broadly than the initial scope of the QA/evaluation, apply for research ethics approval. Apply before you commence any data collection, as approval cannot be provided retrospectively.
Yes I am doing research
Apply for research ethics approval
No
The activity I am doing is not research. If your activity differs from research, for example, quality assurance or evaluation activities, even when using research methodologies or approaches, approval from an HREC is not required.
Evaluation is a term that generally encompasses the systematic collection and analysis of information. Check with your institution about any internal approvals you may need to comply with.
An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a QA activity. Terms such as ‘peer review’, ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’ are often used interchangeably.
Irrespective of whether your activity is called research/QA/evaluation, those conducting the activity must consider whether the people involved (e.g. participants, staff or the community) will be exposed to any risk, burden, inconvenience or possible breach of their privacy.
Either way there are ethical considerations
If you are not applying for research ethics approval, you will still need to afford the same ethical considerations around privacy respect to your participants and/or data. The NHMRCs ‘Ethical Considerations in Quality Assurance and Evaluation Activities’ offers excellent guidance in how to approach your project.
Audits
At this point in time, audits are still required to go through the research ethics review process for all NT Health and Menzies School of Health Research staff/personnel.
(Application forms are available in Section 11 on the right hand bar of the page).
Do Program Evaluations Require HREC Review?
Not all program evaluations require review by the NT HREC.
Under the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2023), research is defined as:
“Investigation undertaken to gain knowledge and understanding or to train researchers.”
HREC review is required only where an activity meets the definition of research involving human participants.
Many activities described as “evaluations” are conducted to:
- assess the performance of an existing program or service
- meet contractual reporting requirements for a funding body
- inform service improvement or operational decision-making
- support future funding decisions
Where the primary purpose of an activity is program accountability, service improvement, or contractual evaluation, it may constitute service evaluation or quality improvement, rather than research.
Such activities are typically managed through the submitting organisation’s governance processes rather than HREC review.
Before submitting an application to the NT HREC, investigators should complete the Evaluation Screening Checklist to determine whether ethical review is required.
Applicants should not submit a full HREC application for program evaluations until this checklist has been completed.
If the activity does not meet the definition of research under the National Statement, a determination letter confirming that HREC review is not required may be issued.