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

Non-research activities exempt from ethics review include quality assurance activities and the publication of case reports. Quality assurance activities where there is intent to publish findings may be submitted to the HREC Chairperson for exemption of ethics review. Individual patient consent should be obtained for the publication of case reports; however, ethics review is not required (HREC Chairperson advice can be sought, if required). Case reports involving more than 2 individuals are classified as a case series and require ethics review.

• Differences between Quality Assurance and Research

Steps to submitting a Quality Assurance/ Audit Activity request:

• Submit the waiver of Human Research Ethics Committee review for a Quality Assurance / Audit activity via the ERM Applications system.
• Checklist for Quality Assurance / Audit activity submission.