When is an ethical review not necessary
Exemptions from ethical review
The National Statement on Ethical Conduct in Human Research 2023 Section 5.1.17 outlines the conditions under which some research may be eligible for a grant of exemption from ethical review.
Eligibility
Some 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.
The National Statement Section 5.1.16 states that research that involves the use of personal information without consent cannot be granted an exemption from ethics review because, to conduct such research, a waiver of the requirement for consent would need to be granted by an appropriate ethics review body. Therefore, research that involves the use of data from medical records cannot be exempt from ethical review.
Submit an 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
- 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
Quality initiatives do not generally require review by a Human Research Ethics Committee (HREC).
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; 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.
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.
Eligibility
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.
Submit an 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.
Eligibility
Metro North HREC only reviews applications for Metro North HHS 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