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title: "Clinical audit and quality improvement"
canonical: "https://research.refined.site/space/Research/48332933/Clinical%20audit%20and%20quality%20improvement"
format: markdown
---
It is not easy to provide a clear definition between activities that are research and activities that are classed as quality improvement, clinical audit and related activity. For example, a programme evaluation can be considered a quality improvement activity, unless the programme *"was not originally designed based on robust evidence"*, in which case it may be considered research. Regardless of how a study is categorised and whether it falls formally within the scope of the [Health & Disability Ethics Committees](https://ethics.health.govt.nz/home), staff involved in activities that share features of research should follow the [National Ethical Standards for Health & Disability Research and Quality Improvement](https://neac.health.govt.nz/draft-national-ethical-standards-health-and-disability-research-consultation-document) (NEAC Standards).

The [NEAC Standards](https://neac.health.govt.nz/publications-and-resources/neac-publications/national-ethical-standards-health-and-disability) acknowledge that quality improvement, clinical audit and related activity have a lower risk profile than most research, and that healthcare organisations have obligations to conduct these activities as part of providing high quality health care. However, these organisations remain accountable for the ethical conduct of those activities and must ensure there is appropriate ethical oversight for activities in relation to their risk. To this end, these activities are required to complete a Te Whatu Ora -Waitematā [approval process](http://staffnet/kc/locality/locality-process.asp). The relevant manager and clinical director (or clinical lead/professional lead/governance group) must authorise the activity to ensure it is a question worth answering and that the design is sufficiently robust and methodologically sound to enable the question to be answered.

Preliminary ethical review or advice can be sought from the Research & Knowledge Centre (R&KC) and where uncertainty prevails then a formal opinion from an HDEC can be sought. If formal ethical review is required, this can be sought from a Health & Disability Ethics Committee. R&KC can assist with this.

#### Resources

[Clinical audit protocol template](http://staffnet/kc/resources/WDHB-Protocol-template-Clinical-Audit.docx)

[Locality application form](http://staffnet/kc/locality/Waitemata-Locality-Application.pdf)

[Quality & Risk team Staffnet site](https://waitematadhb.hanz.health.nz/Pages/Quality%20and%20Risk/Audits.aspx)