Applications and Approvals

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.  

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. Tell the story of your research (don’t make reviewers guess – tell them what they need to know to be assured that the project is ethical). 
• 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. 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 log in details don’t work, email research.irma@scu.edu.au  to have an IRMA account created. 

IRMA is SCU’s system for managing research ethics applications and reviews. You need to use IRMA to submit your application and documents for both low and high risk applications.

• Guidance for IRMA is here 

High risk applications must also use the NHMRC’s HREA portal and attach the HREA Output PDF to your IRMA application. 

• Guidance for the HREA is here

According to the National Statement on Ethical Conduct in Human Research (2023):

Low risk human research is defined as research where the only foreseeable risk is no greater than discomfort, which may include minor side-effects of medication, discomforts related to measuring blood pressure, or anxiety induced by an interview. These discomforts should be effectively managed and minimised where possible. Low risk research is reviewed by the SCU Low Risk Ethics Committee.

High risk human research encompasses any study with risks beyond discomfort or those that involve a potential for harm. Such research requires review by a Human Research Ethics Committee (HREC).

The HREC must also review any research discussed in the following chapters of the National Statement:  

• Chapter 4.1: Women who are pregnant and the human fetus,
• Chapter 4.4: People highly dependent on medical care who may be unable to give consent,  
• Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness, 
• Chapter 4.6: People who may be involved in illegal activities,  
• Chapter 4.7: Aboriginal and Torres Strait Islander Peoples, and
• Chapter 4.8: People in other countries 
• Research including genomics will usually require review by an HREC, unless it does not use or generate information that can identify an individual and no linkage of data is planned.

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. 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 5.1.10 - 5.1.14 - Risk levels and corresponding review pathways: This section delves into the evaluation of risks, distinguishing between low and high levels, and outlines the appropriate procedures for each. 

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. 

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 submission.

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, 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. 

All research conducted under the auspices of SCU must display university branding.  

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

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 email the following to the Ethics Office: 

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

• A justification letter addressing each specific criterion of the National Statement in section 5.1.17 (a)-(d) 

• Any relevant project documents. 

The HREC Chair will assess the application 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. 

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

This includes: 

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.
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. 

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

Visit the Resources Page for SCU forms and templates.

After the review, there are five possible review outcomes:

• Approve
• Approvable with minor amendments back to Chair
• Approvable with minor amendments back to Chair and Spokespeople
• Revise and resubmit to submit to the relevant committee
• Desk reject (requiring 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 research from proceeding without prior approval. 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.

Annual progress reports

You are required to file a detailed annual report on IRMA, aligning with section 5.4.8 of the National Statement, to allow review of the project's ethical standing.  

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

Failure to submit after 60 days may lead to an ethics approval suspension if the research team does not respond. 

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 to verify their contributions to the research. 
• You have published your findings or completed the final write-up of your research. 

Southern Cross University takes all complaints regarding research conduct or the ethics committee's conduct seriously. Complaints can be made by anyone, including participants, researchers, staff, students, or the public, and are handled with sensitivity and confidentiality.  

If you suspect a potential breach of the Australian Code for the Responsible Conduct of Research, 2018, whether you’re an SCU student, staff member, or a person outside of the organisation, you can make a complaint using the link below. 

Before logging a complaint through the Research Integrity Database, SCU staff and students are encouraged to consult with a Research Integrity Advisor in your Faculty or College. 

Report a research related complaint here 

Complaints about the conduct of any of the SCU Ethics Committees can be addressed to the Office of the Senior Deputy Vice-Chancellor

Adverse events are any unfavourable occurrences, outcomes or responses that affect your research participants, yourself, 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 has significant health impacts including death, life-threatening situations, hospitalisation or persistent/significant disability. 

If you encounter any adverse events and serious incidents, you must report them to the Ethics Office through IRMA as soon as possible. The reporting timeframes are: 

• For serious incidents, report within 72 hours of the event. If you are not sure how serious the incident is, contact the Ethics Office or call for advice. 

• For any other incidents that may compromise the ethical integrity of your project, contact the Ethics Office or call immediately. This includes any changes or deviations from the approved protocol. 

• For clinical trials of unapproved goods, follow the TGA's expedited reporting framework: Report a problem or side effect. Therapeutic Goods Administration (TGA) and follow the NHMRC's guide to safety monitoring and reporting in clinical trials involving therapeutic goods.
• You should also encourage your research participants to report any incidents to you or the Ethics Office directly. 

For more information on how to define and manage adverse incidents in clinical trials, please refer to 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 HREC.