Applications and Approvals

1. Prepare your application in the NHMRC’s HREA portal

• What it does: The Human Research Ethics Application (HREA) is designed to help you recognise potential risks in your project and show how you plan to manage them. 
• When finished, download the HREA Output PDF. IMPORTANT NOTE: the HREA platform is not joined up to SCU platforms, clicking the 'Submit' button in the HREA does not send us an application.
• Guidance for the HREA is here

2. Assemble your supporting documents

• What they are: the accompanying materials the Committee needs to review your project (see the What to include tab, below, for the full list and templates).   Save them as upload-ready files (PDF preferred).
  

3. Submit everything in IRMA (SCU’s ethics submission system)

• What it does: manages submissions and the review workflow.
  In IRMA, create a new application and attach the HREA Output PDF and all required supporting documents, then submit.
  
• Note: Only complete applications are sent for review.
  
• Guidance for IRMA is here 

What happens next
Your submission is routed to the Human Research Ethics Committee or the Low Risk Committee, depending on the project’s level of risk

When submitting an ethics review application, please upload all relevant supporting documentation in PDF format via IRMA.

Please note: all public facing materials must display the SCU logo, a place holder for the ethics approval number (2025/XXXX), and if appropriate, contact details for the researcher/s.

1. A signed consent form is not suitable for anonymous online surveys. Instead, the Participant Information Sheet (PIS) should serve as the survey's ‘landing page’ and include a statement on implied consent. Participants should then be presented with a Yes/No checkbox to indicate their consent before proceeding to the survey. The template Consent Form includes a statement confirming participants have understood the PIS and agree to take part. For research involving the retention and reuse of physical materials (e.g. biobank samples, genomic data), separate and explicit consent must be obtained. Please update the template accordingly. 
2. Southern Cross University recommends using Qualtrics as the survey platform for all research projects involving human participants. When submitting your ethics application, you must include a live link to your survey to allow reviewers to assess the survey questions and design.If your survey includes an option for participants to provide their contact details (e.g., to receive a research summary or participate in another phase of the research), these questions must be directed to a separate Qualtrics form. Please ensure links to these additional forms are also included in your application for review.
3. If you wish to recruit staff or students from Southern Cross University to participate in a research study, you are required to seek approval for this from the relevant Associate Dean Research, Associate Dean Education, or Executive Dean of the SCU Faculty or College, or the respective Head of Work Unit. 

Visit the Resources Page for SCU forms and templates.

If your research involves human participants, you must obtain ethics approval before commencing. Human research includes any research with or about people, their data, or tissue. You need ethics approval to recruit, conduct research with participants, and you must maintain active ethics approval throughout analysis and until publication.  

Schedule your application accordingly: apply as early as possible, but only when your research is ready for review. Incomplete or tentative applications will not be reviewed. See How long will it take and Application review pathways below to plan your submission. Most applications require revisions, so allow time for resubmissions.

Please note: May and June are a peak period with exceptionally high demand. To avoid delays, we strongly recommend that you plan ahead and submit your application before or after this period.

Committee meeting dates are found on the Ethics Committee page.

It is crucial to start the ethics review process as early as possible. Plan for the review to take from two weeks to several months, depending on the complexity and risk level of your research, and the completeness of your application.  

Check the committee meeting dates and submission deadlines and see Application review pathways below to ensure you allow enough time for feedback and revisions before starting your research. 

Tips for a speedy review include:  

• Reviewers will react positively to thoughtful engagement with the ethical components of research design (see National Statement Chapter 3.1 for a ‘lifecycle of research’ approach)  
• All necessary documentation must be final versions, and any public-facing materials must be SCU-branded.  
• Attend to language – write for a lay audience, not your academic peers or your supervisor. Write your submission so reviewers can follow your decisions. Explain why you designed your project the way you did, and how you’ve taken ethical issues into account.
• Consider breaking complex research programs into their component phases – single methodology applications are easier to write and to review. 

Regardless of who drafts the application, the Chief Investigator (CI) must sign off on it. As a rule, the CI should be based in a faculty, since all research at SCU must be hosted within one. Ethics submissions reflect upon the research team’s professionalism; it's important they are well-prepared. Students should seek guidance from their supervisors during the application process. 

SCU staff or student credentials provide access to IRMA. If your SCU login details don’t work, instructions for creating an account are available in the Knowledge Base Notes. 

SCU human ethics committees only accept submissions from SCU staff and students.

According to the National Statement on Ethical Conduct in Human Research (2025):

Low risk human research describes research, including some types of clinical trials, in which the only foreseeable risk is no greater than discomfort. Discomfort is considered less serious than harm. It can involve physical or psychological impacts; for example, minor side effects of medication, discomfort related to non-invasive examinations or tests (such as measuring blood pressure), and mild anxiety associated with an interview. However, where a person’s reactions might exceed discomfort and become distress, this should be viewed as potential for harm. Any discomforts brought about by research should be effectively managed and minimised where possible. Low risk research is eligible for review by the SCU Low Risk Ethics Committee.

Higher risk human research is research in which the risk for participants or others is greater than discomfort. Research in this category carries risk of harm and therefore requires review by a Human Research Ethics Committee (HREC).

Where a person’s reactions might exceed discomfort and become distress, this should be viewed as harm rather than discomfort.

We encourage staff and students to engage with the Ethics Office, the HREC Chair, members of the University’s HREC or LRC for advice on risk level and the appropriate pathway for ethical assessment. Visit the Training and support page to watch The Ethics Edge: Episode 7 - Assessing Risk in Research. The final determination of the risk level of a research project is delegated to the HREC Chair, who consults HREC and LRC members to achieve consensus on the decision. 

Helpful discussions about risk can be found in the National Statement on Ethical Conduct in Human Research: 

• Chapter 2.1 – Risk and Benefit: This chapter assists researchers in identifying and articulating the level of risk involved in the research, strategies for risk minimisation, justification and management, and determining the appropriate level of ethical review in relation to the identified risks,  
• Chapter 3.1 - Adopts a ‘lifecycle of research’ perspective, outlining the ethical challenges encountered at each stage of a project.
• Chapter 4.1 - This chapter discusses the recruitment of participants whose circumstances or experiences might mean that they are at increased risk from their involvement in research.

It is essential to engage with these chapters to ensure that your research aligns with the established ethical standards and that the risks are managed effectively. 

The National Statement on Ethical Conduct in Human Research (2025) puts the spotlight on a thoughtful, project-by-project risk assessment. The key question is whether your research could expose its participants to risks beyond their everyday experience of discomfort and recognising when specific characteristics or situations could heighten the risks to the people in your study. When it does, an HREC review is required.

Low Risk Review

The LRC meets fortnightly to review applications submitted in accordance with the schedule. The review response time frame is 10 working days from the submission deadline.

If you believe LRC review is appropriate for your project, you will be asked to include a brief (1-2 paras) rationale at submission. Refer to chapters 2.1 (Risk and Benefit) and 4.1 (Recruitment and involvement of research participants who may experience increased risk) of the National Statement.

Note that the LRC Chair may refer projects involving sensitive or controversial topics to the HREC for review.

High Risk Review

The HREC meets monthly to review applications submitted in accordance with the schedule. The review response time frame is 20 working days from the submission deadline. 

Minimisation of Duplication

For research led by non-SCU researchers but involving SCU staff or students as co-researchers, you will need to submit a minimisation application via IRMA. Provide the ethics approval from the host institution and all documents submitted and approved by them, including any approved changes of protocol. 

If you are transferring to SCU from another university and you want SCU to oversee your project, ensure the original HREC agrees to SCU assuming responsibility and provides correspondence to this effect. 

Collaborative research projects conducted under the auspices of SCU should display university branding on outward-facing materials to ensure visibility and transparency. If branding is not appropriate for research-related reasons, please explain this in your submission. We also expect SCU researchers to be named with their affiliation and role in the project, to reflect appropriate recognition and responsibility. 

Minimisation applications are reviewed and approved by the Human Research Ethics Chair.

See also the FAQ: How do I request a Minimisation of Duplication of ethics review

Exemption

The HREC Chair may choose to grant exemption from ethics review for low risk research that meets one or more of the conditions in section 5.1.17 of the National Statement. 

To apply for an exemption, researchers must review sections 5.1.15- 5.1.18 of the National Statement and email the following to the Ethics Office: 

• A 2-page (max) description of the activity 

• A justification letter addressing the specific criterion of the National Statement in section 5.1.17 (a)-(d), that applies, and confirming that the activity is not disqualified under section 5.1.16. 

• Any relevant project documents (eg participant documentation or gatekeeper correspondence). 

The HREC Chair will assess the application with the template, Exemption from Review Assessment , and issue a letter of approval or rejection within 10 business days.

The Ethics Office will keep records of research exempted from ethics review. Researchers must do the same. 

Researchers must keep an auditable record of any research they are undertaking that is exempted from ethics review in accordance with NS 5.1.15. This is required to ensure that there is a record of the research where no review has been conducted.

After the review, there are five possible review outcomes:

• Approve
• Approvable with minor amendments back to Chair (no submission deadline)
• Approvable with minor amendments back to Chair and Spokespeople (no submission deadline)
• Revise and resubmit to submit to the relevant committee (submission deadline applies)
• Desk reject (requires a new submission to be made)
• Rejection

LRC review

The Chief Investigator will receive an outcome notification via email two weeks after the submission closing deadline

HREC review

The Chief Investigator will be notified of the HREC review outcome via email within two weeks of the committee meeting.

The HREC and LRC and subcommittees expect any issues to be addressed within six weeks to prevent applications from lapsing. Researchers should plan accordingly to allow sufficient time for the ethics review process.

The Chief Investigator is responsible for obtaining ethics approval for all changes of protocol before they are implemented. Failure to adhere to the approved protocol constitutes a breach of ethics and may be research misconduct. It can jeopardise the researchers' legal indemnity, publication rights, and future funding opportunities.

Apply for a Change of Protocol using IRMA.  (Guidance here)

Changes of protocol may include, but are not limited to:

• Adjustments to the research protocol 
• Modifications to recruitment strategies 
• Updates to participant information sheets and consent forms. 
• Revisions to letters, advertisements, questionnaires, or other documents 
• Alterations to the research team composition

When public documents such as participant information statements, consent forms, advertisements, and questionnaires are modified, amended documentation should be included with the change of protocol request. Please provide both tracked and clean copies of any revised documentation as PDF files. This ensures efficiency, transparency and adherence to ethical standards throughout the research process.

Ensure that you provide a rationale for the changes requested.

Annual progress reports

Research teams will be emailed reminders to submit the following reports via IRMA.

You must submit an annual report in IRMA, in accordance with section 5.4.8 of the National Statement, to confirm that the research remains consistent with its approved ethical framework. This includes updates on progress, data security, and adherence to approved protocols and conditions.

Reminders for overdue reports are issued at 7 and 30 days past deadline.  

Failure to respond within 60 days will result in a withdrawal of ethics approval. 

Renewal requests

You will need to apply for project renewal at least one month before the current approval expires, including reasons and a need for extension in compliance with Section 5.4.10 of the National Statement.  

If changes to the project are planned that alter its scope, amplify participant risks or necessitate additional risk mitigation, a Change of Protocol should accompany the renewal application.  

Each renewal is evaluated individually, and if approved, the team is officially informed of an additional three-year ethical endorsement. 

Final report

You should submit a final report when:  

• your research activities with participants have concluded,
• you no longer plan to contact participants for data collection or verification, and
• you have either produced the final written output (thesis, report or publication), or decided not to publish.

Monitoring/Audit

Maintain an auditable record of your entire research project. From time to time, research projects at SCU may be selected for an ethics audit. Monitoring helps ensure projects continue to meet approved ethical standards and protect participants. If your project is audited, you will be asked to provide consent documentation, recruitment materials, data protocols, and progress reports. Audits can be routine, random, or triggered by reports or concerns. Researchers are expected to cooperate fully, respond to requests promptly, and address any corrective actions identified. Keep clear records of every stage of your project – from planning and approval through to completion and dissemination, so they can be audited if required.

Southern Cross University takes all complaints seriously, whether they relate to the conduct of research or the operations of its ethics committees. All complaints are handled with sensitivity and confidentiality and may be submitted by anyone: research participants, researchers, staff, students, or members of the public.

Complaints about the ethical conduct of research

If you have concerns about how a research project is being carried out, you can raise them with the Ethics Office. 

Complaints about the conduct of the Ethics Committees  

If you have concerns about how an Ethics Committee is operating, you can raise the issue with the Office of the Senior Deputy Vice-Chancellor, if you are uncomfortable raising it directly with the Ethics Office. 

Research Integrity Complaints  

If you suspect a potential breach of the Australian Code for the Responsible Conduct of Research, 2018, you can make a complaint through the Research Integrity Database. SCU staff and students are encouraged to first seek advice from a Research Integrity Advisor in your Faculty or College. Further information on Research Integrity is on the Governance and integrity page.

Report a research related complaint here 

Adverse events are any unfavourable occurrences, outcomes or responses that affect your research participants, yourself as a researcher, or the reputation of your institution.

Examples of adverse incidents are physical harm, psychological distress, confidentiality breaches, data loss, or property damage.

A serious adverse event is one that has significant health impacts, such as death, life-threatening situations, hospitalisation or persistent/significant disability. 

All adverse events - whether serious or not, and even if they have been resolved, must be reported to the Ethics Office using the Adverse Event Form in IRMA as soon as possible.

Reporting timeframes: 

• Serious adverse events: Report within 72 hours of the event. If you are uncertain about the severity, contact the Ethics Office or call immediately for advice. 
• Other adverse events: Report promptly (within 7 days of becoming aware of the event).

• Minor/manageable events: Report through the Adverse Event Form in IRMA; if they are expected and low-impact, they may also be summarised in annual/final reports, unless part of a broader pattern.

Protocol deviations: Any changes or departures from the approved protocol that may affect participant welfare or the ethical integrity of the project must also be reported immediately.

Clinical trials of unapproved goods: Follow the TGA’s expedited reporting framework Report a problem or side effect. Therapeutic Goods Administration (TGA) and the NHMRC’s Safety monitoring and reporting in clinical trials involving therapeutic goods.

Researchers should also encourage participants to report any concerns or incidents directly to them or to the Ethics Office.

For more detailed guidance on clinical trial reporting, refer to the ICH Guideline for Good Clinical Practice.

An ethics breach is any violation of the approved ethics protocol that impacts the acceptability of your research. Ensure you report all breaches to the Ethics Office promptly via IRMA. 

Remember that breaches can include conducting unauthorised research, straying from approved protocols, and failing to comply with national ethical research guidelines. These may occur as isolated incidents or repeatedly. 

Should an ethics breach be identified, the HREC Chair has the authority to escalate the issue to the Research Integrity Office. It could lead to discussions, investigations, or resolutions, particularly if it involves infractions related to the Australian Code for the Conduct of Responsible Research. 

Consider revising your protocol as this can often remedy ethical breaches. 

Once an ethics violation is resolved, make sure it is reported back to, and acknowledged by, the Ethics Office.