Is It Really Just QI? When Audit and Improvement Activities Need Ethics Review

Quality improvement (QI) and Audit activities are essential to a functioning health system. They allow services to reflect, adapt, and improve, often quickly and pragmatically.

They are also one of the most misunderstood areas of research ethics.

In Aotearoa, guidance from the National Ethics Advisory Committee at Chapter 18 of their standards makes an important distinction:

Not all QI requires ethics review.

But some of it absolutely does.

What counts as QI or audit?

At its core, QI and Audit activities are about improving local practice.

This typically includes:

• Auditing performance against an existing standard

• Testing small-scale changes within a service, organisation, business or locality

• Monitoring outcomes to guide internal decision-making

  
  

These activities are generally low risk, embedded in routine care and focused on local benefit.

In these cases, formal ethics committee review may not be required. We say may, because sometimes it still does – depending on locality, governance or internal policy.

Where things start to shift

QI/Audit becomes ethically more complex when the intent changes.

Warning signs include:

• The project is designed to produce generalisable findings 

• There is a clear intention to publish or present externally 

• The activity introduces changes beyond usual care 

• Participants experience additional burden or altered treatment 

  
  

At this point, the activity begins to look less like QI — and more like research.

The publication myth

A common belief is:

“If we decide to publish later, we can deal with ethics then.”

This is not how ethical review works.

Ethics approval is based on the design and intent of the activity at the time it is conducted, not what happens after.

If a project is structured in a way that generates generalisable knowledge, it should be treated accordingly from the outset.

“It’s just an audit” = a risky assumption

Labelling something as audit does not exempt it from ethical scrutiny. Consider:

• Are you comparing groups or introducing change?

• Are you collecting data beyond routine requirements?

• Could this influence patient care or outcomes?

• Would participants reasonably expect to be part of this activity?

  
  

If the answer to any of these raises concern, it is worth pausing.

A practical way to think about it

Rather than asking “Is this QI or research?”

A more useful question is: “What is the primary purpose of this activity?”

• If the goal is local improvement, with minimal risk, it is more likely to be quality improvement activities

• If the goal is new, transferable knowledge, bingo – it’s likely research

  
  

The difficulty is that many projects sit somewhere in between.

Why this matters

Misclassifying research as QI can expose participants to unreviewed risk, undermine trust in health services and create issues when findings are disseminated. Indeed, some publishers are moving towards a model which requires ethics approval even for this type of activity (for example, the New Zealand Medical Journal).

Equally, over-regulating genuine QI can:

• Slow down meaningful improvement

• Create unnecessary barriers

  
  

The goal is not to label everything as research, but to ensure the right level of oversight is applied.

Final thoughts

QI and audit are not outside ethics. They sit alongside it. And in some cases, they cross directly into it.

The responsibility lies in recognising when that line has been crossed, and acting accordingly.

If you’re unsure where your project sits, early advice can prevent issues later. These decisions are rarely clear-cut, but they should always be intentional.