Research exemptions from ethical review
The National Statement Section 5.1.17 outlines the conditions under which some research may be eligible for a grant of exemption from ethical review.
Examples of research that are considered exempt from ethical review are provided below:
- 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.
If you are unsure whether or not your research may be considered exempt from ethical review please contact the Metro North HREC with a copy of your research protocol to discuss.
Submit a research exemption from ethical review
The exemption form must be completed in Ethics Review Manager (ERM) along with the following documentation:
- Cover letter
- Project plan or research protocol
- Head of Department approval
- Fee template (for non-Metro North Health persons, a completed and signed fee template must be provided with the submission)
Quality initiatives
However, if there is intent to publish the quality initiative findings and the publication requires evidence of an exemption from ethical review granted by a HREC, an application may be submitted to the HREC for consideration.
Ethical principles apply to both quality initiatives and research. Quality initiatives require institutional oversight (e.g. by a departmental director, Executive Director or Safety and Quality), while most research requires ethical review and site authorisation. It can sometimes be difficult to determine whether a project is a quality initiative or research. Quality initiatives and research exist on a continuum of activity and sometimes expert advice is required to determine the appropriate approval pathway to follow.
Case report
A case report involves only one individual. Patient consent should be obtained for the publication of case reports; however, ethics review is not required.
Case series
Case reports involving more than 2 individuals are classified as a case series. Patient consent should be obtained for the publication of a case series, and ethical review is required.
Submit a quality exemption from ethical review
The exemption form on the Ethics Review Manager (ERM) must be completed along with the following documentation for applications seeking an exemption from ethical review.
At a minimum the following is required for a HREC to consider the request:
- Cover letter
- Quality Initiative project plan (and associated documents)
- Head of Department approval
- Fee template (for non-Metro North Health persons, a completed and signed fee template must be provided with the submission)
- Case study report Participant Information and Consent Form (case series only)
- Consent to Clinical Digital Images (case series only)
Authorised prescriber
The Authorised Prescriber scheme allows authorised medical practitioners to access and legally supply a specified ‘unapproved’ therapeutic good (or class of ‘unapproved’ therapeutic goods) to a class of patients with a particular medical condition. This will allow you to give patients with a particular medical condition, a specific or a class of unapproved therapeutic goods.
Metro North HREC only reviews applications for Metro North employees or other Queensland Heath sites who do not have a HREC.
Apply for HREC endorsement
To apply for HREC endorsement please complete the Authorised prescriber form and email to MetroNorthResearch-Ethics@health.qld.gov.au