The requirements for submitting an exemption request to the HREC with the intent to publish a quality assurance/audit activity are provided in this guideline.

• Requesting an exemption from HREC review guideline

Exemptions may be requested from a HREC for quality initiatives (audit, quality improvement project) and research exempt from ethical review (systematic reviews, studies that use data publicly available). At a minimum the following is required for a HREC to consider the request:

• Cover letter
• Project plan (and associated documents)
• Head of Department approval

Frequently asked questions

Do I need HREC approval for my quality initiative?

Quality initiatives where there is intent to publish findings and the publication requires evidence that the quality initiative is exempt and not research may be submitted to the HREC for consideration of exemption from ethical review.

Do I need HREC approval for a case report?

Individual patient consent should be obtained for the publication of case reports; however, ethics review is not required. Case reports involving more than 2 individuals are classified as a case series and require ethics review.

Is my project research or quality?

This is a common question for locally developed projects aimed at measuring patient outcomes and the impact of models of care. Quality initiatives and research exist on a continuum of activity and sometimes expert advice is required to determine the appropriate approval pathway to follow. Key questions to ask are, What is the primary aim of my project? And how will the results be used?

If the aim of your project is to evaluate and monitor local practice and your results will be used by local staff to inform and improve health care or service delivery, then (in most cases) you are undertaking a quality initiative rather than research. Ethical principles apply to both quality initiatives and research; however, quality initiatives require institutional oversight (e.g. by a departmental director, executive director or the Safety and Quality Unit), while most research requires ethical review and site authorisation.

• Differences between quality and research

Is my research exempt from ethics review?

The National Statement on Ethical Conduct in Human Research (paragraphs 5.1.22 and 5.1.23) defines research that can be exempted from ethics review as negligible risk research that involves the use of existing collections of data or records that contain only non-identifiable data about human beings.

Following are examples of types of research exempt from ethics review:

• Systematic reviews and meta-analysis of published and non-identifiable data
• Studies that involve data available in the public domain
• Experimental or laboratory studies that do not involve data collected from or about humans or animals