Research Intranet - Research ethics and integrity

As an HDR candidate, ethical review is a key part of planning your research. It ensures your project is designed to respect and protect the people (or animals) involved, and that it meets regulatory standards.

Ethical review helps you:

• Think through risks and responsibilities before you start collecting data.
• Protect you as the researcher and participants’ privacy and wellbeing, especially when dealing with sensitive topics.
• Build trust with your research community and participants.
• Strengthen your research quality by making sure it’s fair, transparent, and beneficial.

Ethics is integral to your project and is an opportunity to ensure your research is respectful of all involved in the project.

As an HDR candidate, you’ll be listed as a student investigator on your ethics application—but a staff member must be named as the Chief Investigator (CI). This is because the CI holds overall responsibility for the ethical conduct of the project.

Here’s why this matters:

• Accountability: The CI ensures the project complies with ECU’s policies and national ethical standards, including the National Statement on Ethical Conduct in Human Research or The Australian Code for the care and use of animals for scientific purposes (2021).
• Experience and Oversight: Staff members have the experience and authority to oversee the project, manage risks, and respond to any issues that arise.
• Institutional Responsibility: Responsibility for your project is shared between you, your supervisory team and the institution.
• Support for HDR candidates: Having a staff member be the CI—usually your supervisor—ensures you have guidance throughout the ethics process and that your project is properly supported.

You’ll still be actively involved in the application and conduct of the research, but the CI has the responsibility to ensure everything is done in accordance with university and other requirements.

All research and research-related activity should be tested in the Proportional Review Checklist (PRC). By answering some brief questions about your planned activity, the PRC will determine whether the activity requires review and the most appropriate review pathway. Alternatively, your project may qualify for an ‘Out of Scope’ or ‘Exempt from Review’ notification.

Enter the ECU Research Ethics Management System and complete the Proportional Review Checklist.

Once you complete the PRC you will be notified of the appropriate review pathway for your research by email. In this email you will be provided with a link to the appropriate application form. Depending on the review pathway, this form will encompass multiple elements which require completion in plain language. Please note that for animal research projects, word forms will need to be completed and attached.

You can always access your application form through your REMS portal .

Once the application has been approved, a Microsoft Team site will be created for your project. You will be notified via email when this site has been created.

If you are an HDR candidate and working on a research project that aligns with your supervisor’s research project or another research project, to avoid duplication of ethical review, Research Services have developed a simple guide for determining how your research should be reviewed.

More information on how to submit your application can be found here and via this video.

Online videos are also available to help you to understand what is required for each section of your application.

Your human or animal research ethics application will be reviewed by one of three review committees at ECU. A preliminary review of your application will be conducted by the Research Ethics Team (RET) at which time you may be prompted for additional information or attachments. If so, you will need to upload these to your REMS application and re-submit your application.

Once ready for review, the RET will assign reviewers or add your application to the next Human Research Ethics Committee (HREC) or Animal Ethics Committee (AEC) meeting agenda (if applicable). Should your application require review by the HREC or AEC, agenda closing dates apply. When engaging in the review process, a review committee reserves the right to modify the review pathway, including escalation, to a more appropriate review level.

All lower risk research ethics applications are reviewed by your School’s Low Risk Ethics subcommittee.  Two committee members will review your application. The following videos demonstrate how the online review system works from a reviewer and researcher perspective. Please note there is no sound or voiceovers in these videos, these are visual guides only to assist with familiarity of the software. If you have any questions as you undertake or respond to an online review, please contact the Research Ethics Team.

All higher risk human and all animal ethics applications are reviewed by the relevant Committee at their monthly meetings. Meeting dates and agenda close dates are available on the research ethics website.

After the review is complete you will be advised of the outcome of the review and receive feedback that you may need to address. This could include additional information or requiring changes to your application. Please make these necessary changes in your application and then resubmit for further review.

• Researcher Information Sheet
• Reviewer Information Sheet

There aren’t fixed “steps” as such, but there are a number of elements in the application that you’ll need to address. Based on your responses in the PRC, REMS will guide you to the correct application form for your project.

These guidelines show the different elements and what the reviewers will be looking for.

You don’t need to complete the application all at once—REMS allows you to save your progress and return to it later.

Chapter 2.3 of the National Statement on Ethical Conduct of Human Research (the National Statement), Qualifying or waiving conditions for consent, provides a wealth of advice re Waiver of Consent. It is important to note that a waiver of consent does not mean that no consent is required – a waiver means that the HREC provides consent on behalf of the participant cohort that the waiver covers.

All requests for a waiver of consent must be submitted to the Human Research Ethics Committee (HREC) for full review and approval. To help the HREC assess your request, you’ll need to address all the items listed in section 2.3.10 (a–i) of the National Statement. These items are also available in REMS under Element 3.

If the HREC needs more information, they’ll request it—and because waivers can only be approved during a formal meeting, any extra details you provide will be reviewed in session.

In brief (list not exhaustive), before deciding to approve a waiver, an HREC must be satisfied that, among other matters listed in 2.3.10:

• involvement in the research carries no more than low risk to participants
• the benefits from the research justify any risks of harm associated with not seeking consent
• it is impracticable to obtain consent (e.g. due to the quantity, age or accessibility of records)
• there is no known or likely reason for thinking that participants would not have consented if they had been asked

If the HREC is not satisfied that all requirements as outlined in 2.3.10 are met, they will not approve the waiver.

All research projects are approved for a specified period of time – from the date of approval until the date of completion provided in the ethics application.

Ethics approval covers both the collection and use/analysis of data, information and/or samples.

If an extension of the approval period is required, an amendment must be submitted via REMS before the original approval expires.

To submit an extension of ethics approval, please complete the following:

Visit your REMS Portal and click on the file  icon for your project; on the home page tick the relevant box.  See the Managing Research in REMS fact sheet for further information.

For managing an approved animal ethics application please see the Managing your approved animal research ethics application web page.

It is important to note that while there are no limitations on extensions in the human space, the AEC will only grant one one-year extension to approved projects.

The Ethics Committees understand that research designs do change, particularly for long-term projects.

For human research, any changes to your project must be reviewed and approved by the Ethics Committee. This includes, but is not limited to, updates to:

• Recruitment materials (e.g. advertisements, invitation letters)
• Participant documents (e.g. questionnaires, information sheets, consent forms)
• Research personnel
• Methodologies
• Research questions

If your amendment changes the risk level of your project or introduces overseas recruitment or Aboriginal and/or Torres Strait Islander recruitment, it must be reviewed by the HREC.

All ethics committees can request further information for amendments if it is required for their review.

To request an amendment please complete the following:

Visit your REMS Portal and click on the file icon for your project; on the home page tick the relevant box.  See the Managing Research in REMS fact sheet for further information.

For managing an approved animal ethics application, please see the Managing your approved animal research ethics application web page. It is important to note that all amendments to approved applications will require review and approval by the AEC.

All amendments to approved applications, must be reviewed and approved before implementation in the project.

If you need to extend the approval period for your project, please see the response to Question 8 above.

If the ethics approval for your research project has expired, you will need to submit a new ethics application.

See the Managing Research in REMS fact sheet for further information.

Yes. Consent is required for the use of all (social media) data, even if it is publicly available online. Consent cannot be assumed; it needs to be actively given. Where consent cannot be obtained by individuals, as is usually the case, a researcher must seek a waiver of consent which will be reviewed and approved by the HREC.

Therefore, please complete the PRC and submit your research ethics application via REMS; the rationale for a waiver of consent should be clearly outlined in element 3 of your ethics application in the consent section and as described in question 5.  Ensure you complete and submit your application by agenda close for the next HREC meeting.

A comprehensive discussion about the levels of risk is available in the National Statement on Ethical Conduct of Human Research (the National Statement). Please refer to Chapter 2.1: Risk and Benefit.

A risk is a potential for harm or discomfort to the participants.

It involves:

• the likelihood that a harm or discomfort will occur
• the severity or magnitude of the harm or discomfort, including their consequences.

The National Statement provides the following table about the levels of risk.

While no list of harms can be exhaustive, one helpful classification from the National Statement identifies the following types of potential harms in or from research:

• physical harm: including injury, illness, pain or death
• psychological harm: including feelings of worthlessness, distress, guilt, anger, fear or anxiety related, for example, to disclosure of sensitive information, an experience of re-traumatisation, or learning about a genetic possibility of developing an untreatable disease
• devaluation of personal worth: including being humiliated, manipulated or in other ways treated disrespectfully or unjustly
• cultural harm: including misunderstanding, misrepresenting or misappropriating cultural beliefs, customs or practices
• social harm: including damage to social networks or relationships with others;
• discrimination in access to benefits, services, employment or insurance; social
• stigmatisation; and unauthorised disclosure of personal information
• economic harm: including the imposition of direct or indirect costs on participants
• legal harm: including discovery and prosecution of criminal conduct.

If you are an enrolled student or staff member of ECU, once your project has received ethical  approval, your research is automatically covered by insurance. The RET notifies the insurer of all approved research projects at ECU.

However, If you are conducting a Clinical Research Trial (CRT), specific insurance cover is required. The RET will organize this on your behalf.  CRTs do need specific insurance prior to the clinical trial commencing.

For more information or queries regarding ECU Insurance, please contact insurance@ecu.edu.au or the Research Ethics Team.

See also the Clinical Trials Governance Review web page.

For research where ECU is the only institution involved (i.e. no other Australian or international institution, agency or organisation is involved), but data are being collected from people in other countries, the review should be conducted by the ECU Human Research Ethics Committee (HREC).  The normal application process should be followed.

Where the research is being led by another institution, ECU will provide reciprocal approval when the lead organisation’s ethical review is consistent with the principles of the National Statement.

Also see this additional information.

ALL research at ECU needs to be tested in the Proportional Review Checklist to determine if it requires ethical review. Activities which do not require review will be sent an exemption or out of scope notification.

Types of research that may be exempt from ethics approval include

• use of existing data
• a focus on archival research
• is a quality assurance or audit
• features a creative or journalistic output

If, based on your responses in the PRC, your research meets the criteria in the ‘Exemption Test’ or 'Out-of-Scope Test', you will receive an email with a link to a short application form. This form includes questions about the project as well as the data management plan. Upon submission of the application, you will receive an automated notification via email notifying you that, based on your responses, your activity is deemed exempt.  The Research Ethics Team (RET), on behalf of the Human Research Ethics Committee (HREC), regularly audits exempt applications and may request additional information if needed.

If your application is in the wrong pathway and actually requires ethical review, the RET will guide you through the correct process to ensure your project meets the necessary requirements.

This will depend on the consent attached to the data and if it was collected for research purposes.

Your best approach will be to test your project through the Proportional Review Checklist which will indicate if ethics review is required.

You can also reach out to the Research Ethics Team for advice.

Before your research project is approved, you will need to complete a Data Management Plan (DMP) as part of your ethics application. In the DMP you detail where your data will be stored.

All digital and non-digital research data must be stored in a safe and secure technical or physical environment.

Digital storage. ECU provides centrally provisioned research data storage space to ensure that data is classified, labelled and managed appropriately. All research project information and collected or generated data should be stored in the centrally provisioned site, which will be available to members of the project team. This SharePoint site is provided to all team members when the project receives ethics approval.

Non-digital storage. It is important non-digital data is protected and kept as safe and secure as is practicable during research. Ideally, this means storing physical records in a secure, locked location on ECU premises, boxed and clearly labelled with the unique research number.  The Information Management and Archive Services can assist researchers with providing labelled boxes.

For further information see this guide.

It’s important to clearly explain to participants what will happen to the data you collect from them. This information should be included in your participant information letter and must align with the data storage outlined in your DMP.

Being transparent about data use helps build trust and ensures your research meets ethical and legal standards.

Yes, you do.

ECU provides reciprocal ethics approval for research projects that have already been reviewed and approved by another institution's ethics committee. This could be another Australian university, or a hospital, for example.

The process is described below:

• When completing the Proportional Review Checklist (PRC), and if you already have ethics approval from an external ethics committee, you should answer ‘yes’ to the question about prior review.
• You’ll then be directed to a shorter application form in REMS via email link.
• You must attach both the original approved ethics application and the approval letter to your REMS application. These documents must have been reviewed and issued by same ethics review committee.
• Once submitted, the Research Ethics Team (RET) will process your application and forward it to the HREC Executive for review.
• The HREC Executive has 7 days to complete their review and may request additional information if needed. Approval will be issued if appropriate.
• If the HREC Executive decides that reciprocal approval is not suitable, and full ethical review is required, you’ll be advised of the next steps.

ECU provides reciprocal ethics approval for research projects that have already been reviewed and approved by another institution's ethics committee (see question 16 for further details). This could be another Australian university, or a hospital, for example.

The visiting researcher would work with their ECU collaborator to apply for reciprocal approval through REMS. This is an abbreviated review and requires the letter of approval and original ethics application from the other institution’s Ethics Committee to be submitted.

The HREC Executive will review the documentation from the previous ethical review and ensure it aligns with ECU's requirements.  This process acknowledges that the research has already been vetted for ethical considerations by another reputable institution.

If you are both a staff member and a student, it’s important to consider any potential conflicts of interest in your research. You may have access to certain information in your staff role that you should not access/use in your student role. Using this information could unintentionally breach the Privacy Act 1988.

Acknowledging and managing this conflict is a key part of your ethics application. If you’re unsure how to navigate this, you can contact the Research Ethics Team (RET) at research.ethics@ecu.edu.au for guidance.