University research ethics approval
All human research at Australian universities must be approved by a Human Research Ethics Committee (HREC) constituted under the National Statement on Ethical Conduct in Human Research 2007 (updated 2018). This checklist guides university legal and research offices through the ethics approval process, from risk classification to post-approval monitoring.
This is a 12-step checklist for obtaining human research ethics approval at an Australian university. It covers the National Statement on Ethical Conduct in Human Research, HREC application requirements, and ongoing compliance obligations.
The checklist
Classify the research risk level
Determine whether the research is negligible risk, low risk, or greater than low risk under the National Statement to identify the correct review pathway.
Identify the correct review body
Confirm whether the application goes to the full HREC, a low-risk sub-committee, or qualifies for expedited review based on the risk classification.
Prepare participant information and consent forms
Draft participant information sheets and consent forms that meet National Statement requirements for voluntary, informed consent.
Address vulnerable populations requirements
If the research involves children, Aboriginal and Torres Strait Islander peoples, or other vulnerable groups, address the specific additional requirements in the National Statement.
Complete data management and privacy assessment
Document data collection, storage, access, retention, and destruction plans, confirming compliance with the Privacy Act 1988 (Cth) and institutional data management policies.
Prepare risk mitigation strategies
Document strategies to minimise risks to participants including physical, psychological, social, and economic harms identified in the project.
Obtain institutional authorisations
Secure any required approvals from department heads, research offices, or external organisations where research will be conducted.
Submit the HREC application
Complete and submit the ethics application form through the institutional portal with all supporting documents, protocols, and survey instruments.
Respond to HREC conditions
Address any conditions, modifications, or requests for clarification from the HREC within the specified response period.
Confirm reciprocal ethics arrangements
If multi-site research, confirm whether the lead HREC model under the National Mutual Acceptance scheme applies or if separate approvals are required.
Set up annual reporting and amendments process
Establish a system for annual progress reports, amendment requests, and adverse event reporting to the approving HREC.
Plan for ethics approval expiry
Note the approval period (typically five years maximum) and schedule renewal applications well before expiry to avoid interruptions to data collection.
When this checklist applies
Use when planning any university research project involving human participants, personal data, or biological samples requiring HREC approval.
Common pitfalls
- Incorrect risk classification leading to the wrong review pathway
- Consent forms using overly technical language not accessible to participants
- Failing to address specific requirements for Aboriginal and Torres Strait Islander research
- Data management plans that do not address long-term storage and destruction
- Not submitting annual progress reports, causing ethics approval to lapse
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General guidance for university research ethics approval. Verify against the current National Statement and institutional HREC policies.
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