Applying for ethics approval
To ensure your research project is ethically appropriate, you are required to submit an ethics application to a Human Research Ethics Committee (HREC). The HREC will review the research/scientific methods, ethical standards, safety and welfare of research participants.
Ethics approval from a Queensland Health HREC
For research conducted at Queensland Health and at Victorian and Mater Health facilities, you have to complete the ethics and governance applications online at Ethical Review Manager (ERM). If applying to a Queensland Health HREC, all research ethics applications must be made using the Human Research Ethics Application (HREA) form. In addition, all post-approval amendments and reports are to be created and submitted in ERM.
Help and resources for ERM
Ethics review pathways
Two pathways exist for ethical review: low or negligible risk review and greater than low risk review.
Low or negligible risk review
- ‘Low risk’ is where the only foreseeable risk is one of discomfort such as measuring blood pressure or interview-induced anxiety. ‘Negligible risk’ is where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience (S2.1.6 National Statement on Ethical Conduct in Human Research 2018).
- A sub-committee of the HREC reviews low or negligible risk applications out of session.
Greater than low risk review
- Is warranted where the risk, even if unlikely, is more serious than discomfort (S2.1.6 National Statement on Ethical Conduct in Human Research 2018).
- Greater than low risk ethics applications are reviewed by the full HREC. Applications must be submitted by close of business on the closing date prior to the HREC meeting. Refer to the reviewing Queensland Health HREC for application closing dates, meeting dates and site requirements.
Submitting an ethics application
This is a guideline for the ethics application process.
It is recommended that all researchers contact the HREC before submitting their application to discuss submission requirements. Most Queensland Health HRECs provide a checklist for researchers to ensure submission requirements have been met.
Step 1: Prepare your research proposal
Before submitting and ethics application, you are required to prepare a research proposal to plan your research project.
Step 2: Obtain other required and supporting documents
Following completion of your research proposal, you should obtain other required and supporting documents.
Step 3: Complete and submit a Human Research Ethics Application (HREA)
The HREA is completed and submitted in Ethical Review Manager (ERM).
Find out more information about Obtaining ethics approval from a Queensland Health HREC (DOC, 251.5 KB)
Publishing clinical case reports
The publication of clinical case reports and quality assurance activities are examples of non-research activities exempt from ethics review. However, case reports involving more than 2 individuals are classified as a case series and require ethics review.
In addition to obtaining patient consent for the publication of a case report, researchers are required to submit a request for an exemption from HREC review.
Exemption application process:
- Complete the QLD Exemption form in Ethical Review Manager (ERM).
- Upload all supporting documentation to the exemption form, sign the application and select submit.
- Exemption applications are reviewed by the HREC chairperson out of session.
A site-specific assessment (SSA) application is NOT required for non-research activities or exempt research (unless otherwise specified by the Pathology Queensland Research Office).