FAQs

All Human Ethics applications are managed in IRMA, the research management system used by Southern Cross University to manage research activities and outputs. The URL to access IRMA is https://irma.scu.edu.au 

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.

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

See ‘Add Investigators NG’ in the online manual Add Investigators NG - Research (scu.edu.au)

For access to essential templates and guides, please visit our Resources page. This page contains valuable materials designed to support your research activities and ensure compliance with our standards.

There are several options available: transfer of ethics approval from SCU to the new institution; appoint a new Chief Investigator at SCU to take over as the Chief Investigator; or, if the project is near completion, submit a final report and close the project before your departure. 
 
For more specific advice, please contact the Ethics Office at SCU or your new university. 

Contact the team by emailing human.ethics@scu.edu.au 

An HDR student is eligible to apply for ethics approval for their research project. However, the Principal 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 (see National Statement pages 7 and 8).

Activities that may not require ethics approval

Some activities use the same methodologies as research but are for a different purpose. Research is intended to create new knowledge or understanding, or train researchers how to do this. It may involve developing new ideas or using existing knowledge in new ways. 

Quality assurance, evaluation, or management improvement are mainly about checking or improving how a service or program is running, rather than producing knowledge that can be shared more widely. Contact the Ethics Office if you are unsure whether your proposed activity is research or Quality Assurance/Evaluation, and refer to Ethical Considerations in Quality Assurance and Evaluation Activities.    Quality assurance evaluation requires institutional oversight, which may be conducted at Faculty level from early 2026.

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.  

See the Exemption tab below for information about research that may not require ethics review.

Read I want to investigate aspects of SCU teaching, do I need ethics review? below for information about review of activities that may not require ethics review.

Low risk research involves only discomfort, while high risk research involves greater than discomfort.

See Applications and Approvals page: Assessing the level of risk in your research

Consult Chapters 2.1, 3.1 and 4.1 of the National Statement and engage with the Ethics Office for advice on risk level and ethical assessment pathway.

Lower risk research is reviewed by a Low Risk Committee, and research with greater than low risk is reviewed by the HREC.

Changes of protocol, Minimisations and Exemptions are reviewed by the Chair.

The Ethics Office will notify you which Committee your application has been allocated to.

Check the Low Risk Committee or HREC meeting dates for application submission closing deadlines.

Approval times vary with the level of risk and complexity of the research. Timelines 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. Some applications may be completed in as little as two weeks, while others may take several months.

As a guide, the median time to approval in 2025 is around 9 weeks for the Low Risk Committee and 10 weeks for the HREC.

The HREA assists researchers in recognising and addressing potential risks within their projects and facilitates the Ethics Office in directing each application to the appropriate review level.

Use the Help pages, in particular the How-to guide and the FAQs.

I’m having trouble accessing the HREA
It might be the browser – Chrome is preferred to Safari. Please be aware that the HREA platform is a nationally supported one. Your SCU credentials will not provide access. You must register to use it.

I hit submit in the HREA, have you got my application now?
NO! Researchers must lodge the pdf of their application to submit. This means downloading it from the HREA platform (see Section 3.1 of the HREA How-to guide) and lodging them in IRMA. You will be notified when your application is processed by the Ethics Office.

The HREA platform removes applications 90 days after submission, and after 365 days of inactivity for in-progress applications.

I am having trouble doing . . . in the HREA.
The HREA How-to guide provides invaluable assistance in creating and managing your HREA account, creating an ethics application, and submitting and revising an application. Section 3.2 details how to revise and resubmit a previously submitted application, creating a new version (retaining the same ID), while section 3.3 shows how to use an existing application as a template for a new application. 

Researchers wishing to create a new version of an active application must be aware that the HREA platform does not allow this after submission. Researchers must create a copy of their application (which results in a new application ID).

Is my omni file broken?
The omni is inaccessible to humans – researchers are advised to retain it, because it can be loaded back into the HREA platform should you want to update or copy your current project details. See the HREA FAQs section 6 for more information about .omnis.

How to create a new version of the application in the HREA website 
If you need to revise your application in the HREA you will need to create a new version, which is an exact copy of the original.

1. Log into HREA website (hrea.gov.au) (use your HREA login, not your SCU login)  
2. Under the ‘Top 5 in progress applications’ click ‘View all’ to list all applications and then follow one of the following options:
   1. If your application is listed and the status is marked as ‘in progress’: 
      click on the application title
   2. If your application is listed and the status is marked as ‘complete’: 
      click the application identifier
      select ‘new version’
      in the pop-up box select ‘new version’ 
      rename (for clarity) and click ‘new version’
      click on the application title
   3. If your application is not listed:
      click upload application (top right)
      navigate to the relevant .omni file on your computer and double click
      click ‘new application’ in the pop-up window
      add an application title 
      click save 
      click on the application title
3. edit answers in the form if required by navigating the tabs on the left
4. In the ‘upload’ tab (on the left side)
   1. Delete old versions of documents that have changed—press the red delete button
   2. upload new versions of documents—click ‘add another’
   3. leave documents that have not changed
5. click through the next two sections (HREC and Declaration)
6. click the green ‘Generate HREA document’ button
7. from the pop-up window, download and save all available files including:
   1. ‘All application forms and attachments’ (.zip)
   2. ‘Tracked changes’ (.docx) (if available)
   3. ‘HREA file able to be re-uploaded at a later time’ (.omni)  (DO NOT try to open this file –it is an HREA specific data file—simply save it in your ethics files)
8. Submit the revised pdf in clean and tracked changes formats into IRMA. 

Report it to the Ethics Office through IRMA as soon as possible. 

Violations of the approved ethics protocol impacting the acceptability of your research. Report all breaches promptly via IRMA.

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

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

See Training and Support page, The Ethics Edge Episode 4: What is a gatekeeper letter?

Gatekeeper approval is permission from an authorised person or structure within an organisation — such as a Head of School, CEO, club secretary, or Facebook group admin — to contact their members or use their recruitment channels for your study. 

If your research project already has ethics approval, you don’t usually need another ethics review from an external organisation to recruit their members. However, you do need their permission to approach people or distribute materials through their channels. This permission, often called gatekeeper approval or organisational support, is a governance or logistical requirement, not an ethics review.

Gatekeeper approval can be obtained before applying for ethics approval or at the same time. If you already have support, you may include this in your ethics application as evidence of access to your participant pool, otherwise provide draft correspondence for review. 

Processes differ between organisations, so contact them early to confirm what’s required and whom to approach. 

Important: You may speak with gatekeepers before ethics approval is granted, but you must not begin recruiting participants until ethics approval is in place. That means you must not: 

• Identify individuals as potential participants
• Make contact with potential participants (including advertising)
• Screen or excluding individuals
• Prepare to seek consent 

A brief letter or email of permission is usually sufficient for ethics documentation, but we have a template you can adapt.

If your project has ethics approval, you do not typically need additional ethics approval from Southern Cross University (SCU) to recruit SCU staff or students. However, you must obtain institutional support (sometimes referred to as gatekeeper approval) to access recruitment channels or dissemination mechanisms at SCU. 

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

Each Faculty or Work Unit will consider requests on a case-by-case basis. Be sure to seek approval before circulating any recruitment materials, either digitally or on campus.  

The National Statement (Chapter 5.5) encourages the minimisation of any unnecessary duplication of ethics review both within and across research sectors. This extends to research that will be conducted in more than one Australian jurisdiction or across international boundaries. If you already have ethics approval for your project from another HREC, IRB or equivalent ethics review process, SCU staff and students  are encouraged to register their approval with us by submitting a Minimisation via IRMA.   

Guidance for starting a new application is here: How to start a new application NG - Research When asked for the coversheet/form type in the dropdown, choose ‘Minimisation Duplication of Ethical Review V3’

Submit ALL application and approval documents from the external HREC into IRMA (include any correspondence you had with them that lead to small changes in the project proposal).

Also see the Applications and Approvals page: Application review pathways.

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 (e.g. participant documentation or gatekeeper 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 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

Competent data management is central to the ethical conduct of research. Please consult the Research Data Management pages for guidance and the Australian Research Data Commons (ARDC) Good Data Practices | ARDC page  

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

A conflict of interest arises when personal, financial, or professional interests have the potential to influence, or appear to influence, the way research is conducted. This can involve individuals or institutions and may relate to personal, familial, or organisational benefits. 

Competing interests are not limited to financial matters — they include any interest that could unduly affect research decisions or outcomes. Even the perception that a conflict is not properly managed can damage trust in the research and the institution. 

COIs and perceived COIs must be acknowledged and disclosed. Where possible they should be managed. This might include arranging for a third party to conduct recruitment, assigning an independent person to oversee parts of the project, or separating data collection from data analysis. 

Refer to the Conflict of Interests Relating to Research - Procedures.

Informed consent is a central tenet of ethical research. Occasionally, obtaining consent is not possible.  

Typically, researchers need to apply for a Waiver of Consent when they are proposing to analyse an extant dataset of 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 is required for any dataset where consent has not been given, regardless of whether it contains identifying details about individuals.

Approval must be granted by the 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 detailed in the National Statement Chapter 2.3.10. Researchers seeking a waiver of consent must demonstrate that the research meets all nine criteria listed. 

For a discussion about the use of waiver of consent watch this HREC Conference presentation from Nik Zeps Navigating the pitfalls of using a waiver of the requirement for consent: practical approaches based on real world applications (Nov 2022, 20 mins).

HREC reviewers will use this review template.

LRC reviewers will use this review template

As set out in Australia’s privacy legislation, health information is a subset of sensitive information which is, in turn, a subset of personal information.  

If your research involves collecting or working with sensitive material, you have greater responsibility to protect the participants whose sensitive material you are using. Read the Australian Research Data Commons (ARDC) advice on dealing with sensitive data.  

Personal information is defined in the Privacy Act 1988 as information or an opinion about an identified individual, or an individual who is reasonably identifiable: 

• Whether the information or opinion is true or not; and
• Whether the information or opinion is recorded in a material form or not. 

Sensitive information is defined in the Privacy Act 1988 as: 

• Personal information that includes information or an opinion about an individual’s:
  • racial or ethnic origin; or
  • political opinions; or
  • membership of a political association; or
  • religious beliefs or affiliations; or
  • philosophical beliefs; or
  • membership of a professional or trade association; or
  • membership of a trade union; or
  • sexual orientation or practices; or
  • criminal record; that is also personal information; or
  • health information about an individual; or
• genetic information about an individual that is not otherwise health information; or
• biometric information that is to be used for the purpose of automated biometric verification or biometric identification; or
• biometric templates 

Health information is defined in the Privacy Act 1988 as: 

• information or an opinion about:
  • the health, including an illness, disability or injury, (at any time) of an individual; or
  • an individual’s expressed wishes about the future provision of health services to the individual; or
  • a health service provided, or to be provided, to an individual; that is also personal information;
• other personal information collected to provide, or in providing, a health service to an individual;
• other personal information collected in connection with the donation, or intended donation, by an individual of his or her body parts, organs or body substances;
• genetic information about an individual in a form that is, or could be, predictive of the health of the individual or a genetic relative of the individual. 

(Adapted from the HREA Information Page) 

This is a developing area. Researchers applying for ethics approval must comply with the Generative Artificial Intelligence (GenAI) Use Policy.  Ethics review at SCU will follow the Guide for assessing research involving Artificial Intelligence, Machine Learning and Large Language Model Technology (collectively “AI”)  

In ethics applications:

If AI tools such as large language models are used to prepare or draft parts of the application (for example, rephrasing text or summarising background literature), this must be disclosed in the submission. Applicants remain responsible for ensuring accuracy, completeness, and alignment with the National Statement and institutional requirements.

In research design and conduct:

If AI tools will be used in the project itself (e.g. transcription, coding, analysis, data handling), applicants should describe this clearly in the project description or protocol. This allows the Committee to consider any implications for data security, integrity, or participant risk.

To use AI appropriately in research and applications, applicants should:

• Disclose when AI tools have been used.
• Verify factual claims and references against primary sources.
• Edit with judgment, applying discipline-specific knowledge and ethical sensitivity.
• Accept responsibility: the final submission and project outputs must reflect the researcher’s considered work, not unexamined machine output.

AI can support drafting and analysis, but responsibility for accuracy, integrity, and ethical soundness always rests with the researcher.

Please see GenAI in Research at SCU and the Library guide on GenAI.

Committees like to see detail in your dissemination plan about how you will make your findings available to participants and stakeholders, either through publishing, community outreach or personal feedback to participants who express their interest.

Where publication is unlikely, a common approach is to include a link to a separate survey at the end of anonymous data collection for participants who would like feedback. Interested participants use this link to provide contact details, which must be stored securely and kept separate from survey results. The Participant Information Sheet (PIS) should clearly explain this process.

For a lighter-touch approach, student researchers could also consider informal ways of sharing results, for example, posting a short summary on a community or organisational noticeboard, contributing to a departmental newsletter or intranet, or preparing a brief poster or summary that can be circulated among colleagues and stakeholders.

If your data could be traced back to the individual who provided it, then it is re/identifiable.  

The identifiability of information is a characteristic that exists on a continuum. This continuum is affected by contextual factors, such as who has access to the information and other potentially related information, and by technical factors that have the potential to convert information that has been collected, used or stored in a form that is intended to protect the anonymity of individuals into information that can identify individuals. Additionally, contextual and technical factors can have a compound effect and can increase the likelihood of re-identifiability and the risk of negative consequences from this in ways that are difficult to fully anticipate and that may increase over time. [Copied from NS Chapter 3.1: Identifiability of information] 

Refer to the Australian Research Data Commons (ARDC) page on Identifiable Data   

Evidence-based Improvement, Innovation, Evaluation & Audit Activities

SCU values contributions to evidence-supported change, including SoLT investigations. (See also The_Belmont_Report_and_Innovative_Practice)

There are a couple of considerations when deciding if human research ethics review is required:

1. Are you conducting research with people, their data or tissue?

If yes, then you’ll need Human Research Ethics review.

Some activities use the same methodologies as research but are for a different purpose. Research is intended to create new knowledge or understanding, or train researchers how to do this. It may involve developing new ideas or using existing knowledge in new ways.

An activity where the primary purpose is to monitor or improve the quality of a service delivered by an individual or an organisation is a QA activity.

If you are not conducting research:

2. What kind of Institutional Oversight do you need, and who can supply it?

Even if you consider that your activity is Not Research, you may find that it meets triggers for ethics review (See 2e of Ethical Considerations in Quality Assurance and Evaluation Activities);

• Where the activity potentially infringes the privacy or professional reputation of participants, providers or organisations.
• Secondary use of data - using data or analysis from QA or evaluation activities for another purpose.
• Gathering information about the participant beyond that which is collected routinely. Information may include biospecimens or additional investigations.
• Testing of non-standard (innovative) protocols or equipment.
• Comparison of cohorts.
• Randomisation or the use of control groups or placebos.
• Targeted analysis of data involving minority/vulnerable groups whose data is to be separated out of that data collected or analysed as part of the main QA/evaluation activity

3. Even if it does not trigger the requirement for ethics review, some institutional oversight may be required. Section 2 of Ethical Considerations in Quality Assurance and Evaluation Activities states:

In many situations, oversight of the activity is required, but ethical review is not necessary. These include situations where:

• The data being collected and analysed is coincidental to standard operating procedures with standard equipment and/or protocols;
• The data is being collected and analysed expressly for the purpose of maintaining standards or identifying areas for improvement in the environment from which the data was obtained;
• The data being collected and analysed is not linked to individuals; and
• None of the triggers for consideration of ethical review (listed below at point (e)) are present.

We anticipate that by Q2 2026 the university will have formal review process in place for activities that do not require ethics approval. In the absence of that, you may apply to the Low Risk Ethics Committee.

Other activities on the cusp between Human Research and Quality Assessment may be eligible for an exemption (see Can I apply for an exemption? for details)

Incorporating sex, gender, variations of sex characteristics (VSC), and sexual orientation in research is essential for producing high-quality, ethical, and inclusive research. These factors can influence health outcomes, social experiences, and access to services, yet they are often underrepresented or poorly accounted for in study design and reporting. 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 require researchers to demonstrate how they have considered these dimensions.

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)

Disclaimer: Nothing in this section may be relied upon as legal advice. These comments are intended to explain how the Privacy Act applies to research generally; researchers must ascertain the status of their own research proposals with respect to Privacy legislation.

Research at SCU that intends to access and utilise existing data that is:

• personal (e. information that could identify an individual), and
• originally compiled for a different purpose (g., provision of a health service or course administration), and
• is to be used in research without obtaining individual consent from the individuals whose data is being used,

is subject to The Privacy Act 1988 (Cth).

The Australian Privacy Principles (APP) especially APP 6, pertaining to the use or disclosure of personal information, are the most accessible way to understand how the act applies to research.

Medical research (including epidemiological studies) or research that uses health information:

Section 16(B) of the Privacy Act allows the use or disclosure of personal information without consent where a permitted health situation exists – one of which is conducting research or the compilation or analysis of statistics, relevant to public health or public safety. Illustrative examples of the phrase ‘relevant to public health or public safety’ include research relating to communicable diseases, cancer, heart disease, mental health, injury control and prevention, diabetes and the prevention of childhood diseases (see Office of the Australian Information Commissioner – OAIC – Privacy Guidance on Research for information about Health Research).

Guidelines approved under S95 and S95(A) of the Privacy Act 1988 set out the requirements for assessing whether disclosure of such information to researchers can be approved.

• Guidelines under Section 95 of the Privacy Act 1988, sets out procedures that HRECs and researchers must follow when personal information is disclosed from a Commonwealth agency for medical research purposes.
• Guidelines under Section 95A of the Privacy Act 1988, provides a framework for HRECs to assess proposals to handle health information held by organisations for health research (without individuals' consent). They ensure that the public interest in the research activities substantially outweighs the public interest in the protection of privacy. Flowchart determining whether the s95A guidelines apply

If research requires the use or disclosure of other kinds of identifiable information without individual consent, the exceptions that allow its use or disclosure for a secondary purpose are more restrictive. In the context of research, information held about individuals can be shared where:

• individuals have consented to a secondary use or disclosure (e., research), or
• individuals would reasonably expect their information to be used or disclosed, and
  • only where the secondary use is related to the primary purpose, or
  • in the case of sensitive information, only where the secondary use is directly related to the primary purpose (see APP 6).

If individual consent is not sought for the use of data in research, researchers must request a waiver of the usual requirements for consent (see National Statement 2.3 – especially the criteria listed at 2.3.10). Note that NS 2.3.10 i) states that the waiver must not be prohibited by State, federal, or international law.

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.

If you include a prize draw in your research, you must comply with the relevant state requirements. 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.

Please note that ethics approval does not replace or override state regulatory requirements for prize draws.

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.