FAQs

To access Human Ethics in IRMA, sign in using your Southern Cross University credentials and choose the Human Ethics tile on the Researcher Dashboard. 

If you don't see a Researcher Dashboard on login use the Navigation link at the top right of the screen to change to the NextGen view.

If your SCU log in details don't work or you don't see a Human Ethics tile, email research.irma@scu.edu.au to have an IRMA account created or modified with the following details:

• Name (first name and surname)
• Title
• Gender
• Faculty and Discipline
• Staff or student number
• ORCID (if known)
• Access required (e.g. Human Ethics) 

Detailed guidance on navigating IRMA and completing ethics coversheets is available in the IRMA navigation guide.

When your application documents are ready for review Applications and Approvals, log into IRMA and choose the Human Ethics tile and the 'add or create a new coversheet'.

For detailed instructions see the Human Ethics Knowledge Base (online manual): at How to start a new application NG - Research (scu.edu.au): 

All investigators named on the application will receive automated email from research.irma advising that their application has been assigned to be reviewed.

In IRMA choose the Human Ethics Tile and then 'Add or create a new coversheet'. Select the Annual/Completion Report or Renewal Request/Change of Protocol form.

For detailed instructions see the Human Ethics Knowledge Base (online manual): at Annual Reports, Change of Protocol, Adverse Events/Ethics Breaches NG - Research (scu.edu.au) 

Yes, instructions are in the online manual here Add Investigators NG - Research (scu.edu.au)

Yes, essential templates and guidance on applying for Human Research Ethics are on our Applications and Approvals page.

If you are leaving Southern Cross University, you must make arrangements for any approved research projects before your departure. Depending on the status of the project, you may be able to:

• transfer ethics approval from Southern Cross University to your new institution;
• appoint a new Chief Investigator at Southern Cross University to take over responsibility for the project; or
• submit a final report and close the project before your departure if the research is near completion.

For advice on the most appropriate option for your circumstances, please contact the Ethics Office or your new institution.

You can contact the Ethics Office for support by:

• Emailing the team human.ethics@scu.edu.au 
• Book a meeting with the Ethics Officer 
• Book a meeting with the Chair 

Yes, students doing Graduate Research Degrees can apply for ethics approval. However, their Supervisor must review, sign off, and approve the submission as the Chief Investigator.

Anyone conducting research with or about people, their data or their tissue must seek ethics approval before starting thei research (see National Statement pages 7 and 8).

Not all activities involving people, data or information require ethics approval.

Activities that are not human research and do not, as independent activities, require ethics review include: 

• literature review that supports the development or design of a research project
• research using aggregate data.
• research using public data (e.g. information that has been published, or information that has entered the public domain with the consent of the person(s) with whom the information is associated). (Note that the SCU Ethics Committees do not typically consider social media posts to be in the public domain. See National Statement Chapter 3.1 page 37: Secondary use of data or information.

Some activities, such as quality assurance, evaluation, audit and service improvement, use similar methods to research but have a different purpose. These activities may not require ethics approval but may still require institutional oversight.

If you are unsure whether your activity is research, quality assurance or evaluation, contact the Ethics Office for advice and refer to Ethical Considerations in Quality Assurance and Evaluation Activities.

Research that may qualify for exemption from ethics review is addressed in the Exemption tab, below.

Information about teaching and learning, quality improvement and related activities is available in I want to investigate teaching or learning at Southern Cross University, below.

The Ethics Pathway Finder can help identify the most appropriate review pathway. Final determinations rest with the relevant review body, and advice from the Ethics Office may be required in complex cases.

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

Research may be eligible for exemption from ethics review if it uses only de-identified data, anonymous surveys or observations of public behaviour, educational training activities with program-only outputs, or certain legally protected public datasets.

To apply for an exemption, researchers must carefully 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 (e.g. participant-facing documentation or data custodian correspondence).

The HREC Chair will assess the application with this 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 also 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.

Not always. Some teaching and learning activities require ethics review, while others may be quality assurance, evaluation, audit, or improvement activities that follow a different pathway.

The key question is whether the activity is human research.

If the primary purpose is to create new knowledge or understanding, or to train researchers, ethics review will usually be required.

If the primary purpose is to monitor, evaluate or improve a service, program, course or teaching practice, the activity may instead be considered quality assurance, evaluation or audit.

Some quality assurance and evaluation activities still require ethics review or other institutional oversight, particularly where they involve privacy concerns, innovative interventions, comparison of groups, secondary use of data, or activities involving vulnerable groups.

If you are unsure which pathway applies, use the NEW Ethics Pathway Finder or contact the Ethics Office for advice.

Research is generally considered Lower Risk where the only foreseeable risk to participants is discomfort. Where participation may result in distress or other forms of harm, the research should generally be regarded as Higher Risk.

To help determine the level of risk in your research, consult Chapters 2.1, 3.1 and 4.1 of the National Statement, read Assessing the level of risk in your research and engage with the Ethics Office for advice on appropriate risk level and ethical review pathway.

Human research that is Lower Risk is reviewed through the rolling review process by a Lower Risk Panel. Research that is greater than Lower Risk is reviewed by the Human Research Ethics Committee (HREC).

Applications for Exemption from Ethics Review, Minimisation of Duplication of Ethics Review, and Changes of Protocol are assessed by the HREC Chair.

The Ethics Pathway Finder can help identify whether ethics review is required and, if so, which review pathway is likely to apply. Final determinations rest with the relevant review body, and advice from the Ethics Office may be required in complex cases.

HREC reviewers will use this review template.

LRC reviewers will use this review template

Here's an Example of what a review of a well-prepared Lower Risk project will look like

The Privacy Act is most likely to affect research where you propose to use existing personal (i.e. identifying) information in your research without obtaining explicit consent from the individuals concerned for the use of their information in your research.

This commonly occurs where:

the information identifies, or could reasonably re-identify, an individual;
the information was originally collected for a different purpose (for example, healthcare, service delivery or course administration); and
the information is being used for research without obtaining participants' consent for that research use.

Researchers proposing to use existing personal or health information should consider whether the Privacy Act 1988, the Australian Privacy Principles, and the National Statement's requirements for a Waiver of Consent apply to their project.

For a preliminary assessment, try the Privacy Legislation Checker. Researchers should also refer to the discussion on our Policies and Legislation Page, Legislation | Navigating Privacy Legislation.

See the 'What to include' in the Applications and Approvals section of our website.

Researchers must complete the Human Research Ethics Application (HREA) in the NHMRC's HREA platform, then download the application documents and submit them through IRMA. Completing an application on the HREA platform does not submit it to Southern Cross University.

HREA accounts are separate from Southern Cross University accounts. Your SCU credentials do not work on their site, and you must register for the HREA separately. For help using the HREA, including revising applications and saving .omni files, see the HREA help guides, especially the How-to guide and the FAQs.

SCU notes on navigating and troubleshooting the HREA system are found on our Applications and Approvals page.

Within three days of submission, the Ethics Office will advise the review pathway allocated to your application and the expected timeframes for review.

Applications may be reviewed through a rolling review process or considered by the Human Research Ethics Committee (HREC), depending on the level of risk and review requirements.

As a guide, the median time from submission to approval in 2026 is 5–6 weeks. 

Approval times are strongly influenced by how quickly researchers respond to feedback and requests for clarification; prompt responses make a significant difference to the overall time to approval. The Ethics Office now undertakes administrative screening of all new applications to ensure they are ready for ethics review. With timely responses from research teams, applicants can generally expect to receive the outcome of the initial review process within 3 weeks of submission.

See the Ethics Committees webpage for more details on the review process.

If your project has already been approved by another Human Research Ethics Committee (HREC), Institutional Review Board (IRB) or equivalent ethics review body, Southern Cross University staff and students should submit a Minimisation of Duplication of Ethics Review application through IRMA so that the approval can be registered with the University.

To apply:

• Start a new application in IRMA.
• Select "Minimisation Duplication of Ethical Review V3" from the coversheet/form type drop-down menu.
• Upload all application, approval and supporting documents from the external review process, including any correspondence that resulted in amendments to the project.

Further information is available on the Applications and Approvals page: Application review pathways 

Informed consent is a central tenet of ethical research. However, there are circumstances where it is not possible or practicable to obtain consent from the individuals whose information will be used. In these situations, researchers may apply for a Waiver of Consent so that an ethics committee can determine whether the research may proceed without participants' explicit consent.

Typically, researchers need to apply for a Waiver of Consent when they are proposing to analyse an extant dataset containing people's information that was collected for purposes other than research. In these cases, the individuals whose data is being used will not have provided consent for it to be used in research, so an ethics committee must determine whether it is appropriate to allow the research to proceed without participants' explicit consent.

A Waiver of Consent is generally required whenever consent has not been obtained for the proposed research use of the information, regardless of whether the dataset contains identifying information. The exception is research using non-identifiable data that has been exempted from ethics review, where the exemption decision takes precedence.

Most waivers relate to lower-risk secondary use of information and can be reviewed through a non-HREC pathway.

Approval must be granted by the Human Research Ethics Committee (HREC) where the dataset contains identifiable information and either the research is medical in nature or the dataset includes health information.

The conditions for granting a waiver are set out in Chapter 2.3.10 of the National Statement. Researchers seeking a Waiver of Consent must demonstrate that the research satisfies all nine criteria.

For a practical discussion of Waivers of Consent, see Nik Zeps' HREC Conference presentation Navigating the pitfalls of using a waiver of the requirement for consent: practical approaches based on real world applications (Nov 2022, 20 mins).

Gatekeeper approval is permission from an authorised person or body within an organisation, such as a Head of School, Chief Executive Officer, club secretary or Facebook group administrator, to access potential participants or use organisational recruitment channels for your research.

If your project already has ethics approval, you do not usually need a separate ethics review from an external organisation to recruit its members. However, you may need gatekeeper approval to distribute recruitment materials or access participant groups through that organisation's communication channels.

Gatekeeper approval is primarily an access and governance matter between the researcher and the organisation. It is no longer routinely required as part of an ethics application.

Gatekeeper approval can be obtained before applying for ethics approval or at the same time. If gatekeeper support has already been obtained, it may be included in the ethics application as evidence of access to the participant population. If support has not yet been obtained, the recruitment strategy should explain whether gatekeeper approval is required, who will provide it, and how it will be sought.

Researchers may discuss a proposed project with gatekeepers before ethics approval is granted. However, recruitment must not begin until ethics approval is in place. This means researchers must not:

• identify individuals as potential participants;
• contact potential participants, including through advertising;
• screen or exclude individuals; or
• seek consent.

A brief letter or email is usually sufficient evidence of gatekeeper approval. Researchers may also use the University's gatekeeper correspondence templates.

See The Ethics Edge Episode 4: What is a gatekeeper letter? for further guidance. 

To recruit Southern Cross University students or staff, you must obtain institutional support from the relevant area before distributing recruitment materials or accessing University recruitment channels.

Ethics approval and institutional support are different things. If your project already has ethics approval, you do not usually need additional ethics approval from Southern Cross University to recruit SCU staff or students. However, you must obtain institutional support (sometimes called gatekeeper approval) before accessing SCU recruitment channels or distributing recruitment materials within the University.

Requests for institutional support should be directed to:

• Taught students: Associate Dean (Education)
• Graduate Research students: Associate Dean (Research)
• Faculty or College staff: Executive Dean
• Staff in non-Faculty units: relevant Head of Work Unit

Requests are considered on a case-by-case basis. Institutional support should be obtained before circulating recruitment materials, whether electronically or in hard copy on campus.

If you use a prize draw as a research incentive, you are responsible for ensuring that the draw complies with any applicable state legislation and regulatory requirements. Ethics approval does not replace these obligations.

This information is provided as general guidance only; if you are unsure about your obligations, you should check the current state legislation or seek appropriate advice.

Across both Queensland and New South Wales, this generally means:

• Entry must be free, with no cost or purchase required beyond participation in the research.
• Clear terms and conditions must be provided to participants before they enter.
• The draw mechanism must be transparent, including how and when the winner will be chosen.
• An impartial or random selection process should be used to determine the winner.
• Winners must be notified in line with the stated terms and conditions.

In New South Wales, prize draws of this kind are often referred to as “trade promotion lotteries”, even when used in research settings.

Bots and Incentives

Offering incentives in online research can increase the risk of bots and non-genuine responses, which may swamp your data with poor-quality or fake entries. Consider using safeguards like screening questions and CAPTCHA and be transparent about data quality measures to help protect your research.

Guidance on research data management is available through Southern Cross University's Research Data Management pages and the Australian Research Data Commons (ARDC) Good Data Practices resource.

Competent data management is central to the ethical conduct of research.

See Policies and Legislation - Southern Cross University Legislation | NSW State Records Retention Periods for Research data

Data is identifiable if a person can be identified from the information directly or indirectly. As a rule of thumb, if you or someone else could reasonably work out who provided the information, the data should be treated as identifiable or potentially re-identifiable.

Identifiability exists on a spectrum. Some information clearly identifies a person (for example, a name, student number or email address). Other information may not identify a person on its own but could do so when combined with other information, particularly in small or specialised groups.

Whether data is identifiable depends not only on the data itself, but also on who has access to it, what other information is available, and whether there is a reasonable possibility that individuals could be re-identified.

For examples and further guidance, see the Australian Research Data Commons (ARDC) page on Identifiable Data and Chapter 3.1: Identifiability of information in the National Statement.

Personal information, sensitive information and health information are defined terms under Australia's privacy legislation. These definitions are used when assessing privacy risks, data management arrangements and ethics review requirements.

If your research involves personal, sensitive or health information, you are responsible for ensuring that the information is collected, used, stored and disclosed appropriately. Research involving sensitive or health information generally requires greater protections than research involving personal information alone.

Personal information identifies, or could reasonably identify, an individual. Sensitive information is a subset of personal information that attracts additional privacy protections. Health information is a subset of sensitive information.

Examples of personal information include names, email addresses, student numbers, photographs, or any combination of information that could reasonably identify an individual.

Examples of sensitive information include racial or ethnic origin, religious beliefs, political opinions, sexual orientation, criminal history, genetic information, biometric information, and health information.

Examples of health information include information about a person's physical or mental health, disability, injury, healthcare, treatment, or genetic information that may predict health outcomes.

For further guidance, see the ARDC resource on Sensitive Data and the Privacy Act 1988.

A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes

• Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioural treatments, dietary interventions, and process-of-care changes).
• Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events

Consult resources on these pages:

• Research Compass guidance on Clinical Trials
• Australian Clinical Trials;
• Clinical trials | Therapeutic Goods Administration (TGA) for trials involving the supply or use of therapeutic goods.

Researchers conducting clinical trials should provide PIS/CF forms that comply with content requirements as outlined in the Guideline for Good Clinical Practice: Informed Consent of Trial Subjects[/Participants].  Consider adapting the CT:IQ InFORMED Project template and user guide for your project; use SCU badging.

NEW: Clinical Trial Decision tool to help researchers and administrators identify whether a proposed project is likely to be considered a clinical trial and whether therapeutic goods regulatory considerations may apply.

Southern Cross University recommends using Qualtrics as the survey platform for all research projects involving human participants. REDCap is also supported and is particularly suited to clinical and health research, longitudinal studies, and projects requiring structured database management alongside survey functionality.

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 project design 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 survey form. Please ensure links to these additional forms are also included in your application for review.

Any adverse event that affects, or may affect, participant welfare, safety, rights, wellbeing, or the conduct of the research should be reported to the Ethics Office as soon as possible.

Submit an Adverse Event/Ethics Breach Report through IRMA. Link the report to the relevant approved protocol and provide details of the event and any actions taken in response.

An ethics breach occurs when approved research is conducted in a way that differs from the approved protocol or ethics conditions. Examples may include using unapproved recruitment materials, enrolling participants who do not meet the approved eligibility criteria, failing to obtain consent as approved, or a loss, disclosure or misuse of research data.

All ethics breaches must be reported promptly through IRMA using the Adverse Event/Ethics Breach Report coversheet. Link the report to the relevant approved protocol and provide details of the incident and any actions taken in response.

A conflict of interest (COI) arises when personal, financial or professional interests have the potential to influence, or appear to influence, the conduct of research. Conflicts may involve individuals or institutions and can include personal, family, financial or organisational interests.

Competing interests are not limited to financial matters. They include any interest that could affect, or be perceived to affect, research decisions, conduct or outcomes.

Researchers must disclose actual, potential and perceived conflicts of interest, even where they do not believe an actual conflict exists. Where possible, steps should be taken to manage these interests.

Management strategies may include using an independent person to conduct recruitment, oversee parts of the project, or separate data collection from data analysis.

Refer to the Conflict of Interests Relating to Research Procedures for further guidance

Information on Research Integrity can be found on our Research Governance and Integrity page.

All researcher development programs and workshops available to academic staff and Graduate Research (HDR) students are accessible on the Research Compass calendar. Access the Research Compass - Home page to find out about upcoming opportunities. 

Your dissemination plan should explain how research findings will be shared with participants, stakeholders and other relevant audiences. This may include publication, community outreach, presentations, reports, or providing feedback to participants who express an interest in receiving results.

Researchers should consider how participants who are interested in the outcomes of the study can be informed of the findings. Where publication is unlikely, a common approach in anonymous surveys is to provide a separate link where interested participants can submit contact details to receive a summary of the results. Contact details should be stored securely and separately from research data, and this process should be explained in the Participant Information Sheet.

For student projects and smaller studies, dissemination may also involve less formal approaches, such as sharing a summary through a community or organisational noticeboard, departmental newsletter, intranet article, poster, or summary report provided to participants and stakeholders.

Southern Cross University assesses research involving Generative AI in accordance with the NHMRC's Guide for assessing research involving Artificial Intelligence, Machine Learning and Large Language Model Technology. As this is a rapidly evolving area, institutional processes and expectations may continue to develop in line with national guidance.

A key consideration during ethics review is whether AI is being used routinely as an assistive tool or is being deliberately deployed in a way that may influence participants, data collection, analysis, interpretation or research outcomes.

Routine use includes AI used in a standard assistive capacity embedded in approved University systems, such as drafting support, spelling and grammar assistance, transcription, formatting, translation, and similar administrative tasks. 

Deliberate or interventionist use occurs where AI may influence participants, research procedures, data collection, analysis, interpretation, decision-making or research outcomes. Examples include using AI to interact with participants, generate interview questions or survey content, make decisions about participant eligibility, analyse data in a way that influences findings, personalise interventions, or generate outputs that form part of the research itself. These uses should be clearly described in the ethics application and will be considered during ethics review.

If Generative AI has been used to prepare any part of an ethics application, this should be disclosed in the submission. Researchers remain responsible for the accuracy, completeness and integrity of all information provided.

If Generative AI will be used in a non-routine manner as part of the research itself, this should be clearly described in the application.

Researchers should:

• Disclose when Generative AI tools have been used.
• Verify factual claims and references against primary sources.
• Apply academic and professional judgement when using Generative AI.
• Remain accountable for all submitted materials and research outputs.

Further guidance is available through the Southern Cross University Generative Artificial Intelligence (GenAI) Use Policy, GenAI in Research at SCU, the Library guide on GenAI and AI and research - Australia's Artificial Intelligence Ethics Framework.

Usually, yes. Sex, gender, variations of sex characteristics (VSC) and sexual orientation can influence health outcomes, social experiences, access to services and research findings. However, these factors have often been overlooked, underrepresented or poorly accounted for in research design, analysis and reporting.

Researchers should consider whether these factors are relevant to their research question, participant population, study design, analysis and reporting, and be able to explain their decisions.

Considering them helps:

Ensure relevance and equity: Research that reflects the diversity of the population avoids biased outcomes and better serves all communities.
Improve scientific validity: Ignoring sex and gender variables can lead to incomplete or misleading findings.
Meet ethical obligations: Researchers have a responsibility to respect and protect the dignity of participants, including those with diverse sex, gender, and sexuality characteristics.
Align with best practice and policy: Major funding bodies and institutions increasingly expect researchers to consider sex, gender, variations of sex characteristics and sexual orientation throughout the research lifecycle and to explain the decisions they make.

Ultimately, thoughtful inclusion supports more accurate, respectful, and socially responsible research.

Please refer to Statement on Sex, Gender, Variations of Sex Characteristics and Sexual Orientation in Health and Medical Research | NHMRC

Apply the SAGER Guidelines in research design, study implementation and scientific reporting, as well as in general science communication

Other resources:

The Centre for Sex & Gender Equity in Health and Medicine

Nature Podcast: Talking about sex and gender doesn’t need to be toxic (58:39 mins)