Quality improvement activities
Research
The National Statement on Ethical Conduct in Research Involving Humans (2007) defines research as systematic prospective collection of information to test an hypothesis; planned study of existing practices with a view to changing/improving practice in light of the findings in the study and/or to increase understanding; or the administration and analysis of data in response to surveys or questionnaires, interviews or opinion polling.
Is HREC review required?
The following documents can be used to determine whether a project is research or quality improvement activity, and thus if ethical review is required:
- WACHS - Research or Quality Improvement (PDF)
- NHMRC - Ethical Considerations in Quality Assurance and Evaluation Activities (2014) (PDF)
Publications
Academic journals require evidence of ethical review and approval of a QI project from a HREC, prior to publication. This process acknowledges that the project has under gone ethical review either by a full HREC or non-HREC level alternative.
At WACHS we are currently developing a process for negligible risk and/or QI projects with the intention to publish results which would mean either a QI or Safety and Quality Committee review and/or HREC exemption process, where applicable projects would undergo a non-HREC review. However, at present, no such process has been formally established, and therefore if a researcher intends on publishing findings from an audit or QI/QA project, the project must be submitted to either:
- WACHS HREC for full ethical review
- A different WA Lead HREC (or their QI Committee) for a low risk review (If involving other WA Health sites).
As per the WA Health Research Governance Policy and Procedures (2012) ethical review is required by a HREC prior to the commencement of the project as research projects must not be ethically approved by a HREC retrospectively.