Human Research Ethics

Before Submission

If you intend to conduct research involving the use of humans as participants, you must obtain ethical approval from the Victoria University Human Research Ethics Committee (VUHREC) or the Low Risk Human Research Ethics Committee (LRHREC), as appropriate.

Researchers must ensure that the research project adheres to all ethics principles and meets the relevant legal requirements. The HREC must be satisfied that the research project is ethical and lawful before granting approval. Research projects must be developed in line with the National Statement on Ethical Conduct in Human Research.

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Submitting an Ethics Application

Ethics applications can be submitted online using Quest. Use your VU Staff or Student ID (eg. "e1234567") and password to login, then hover over the Ethics menu and select Applications. From here you may select any listed applications you have already created or been named on, or click on Create Application to begin a new one.

• Quest Login: https://quest.vu.edu.au/

The Quest Online Ethics Guide provides detailed technical help, tips and instructions for submitting an ethics application using Quest.

• Quest Online Ethics Guide (.pdf)

Further helpful information, including FAQs and how to get support can be found at https://research.vu.edu.au/quest.php.

Although the ethics application needs to be submitted online, you can preview the form in the document below. Please note that the questions asked in the actual form may change depending on the answers you provide. As such, this preview is only indicative:

• Online Ethics Application Form Preview V.13-07 (.pdf)

Depending on the nature of your research project, you may be required to provide an 'Information to Participants Involved in Research' form and/or a 'Consent Form for Participants Involved in Research' with your ethics application. The Office for Research has developed templates of these forms. You are required to use the templates when developing your forms as they are designed to capture all the information that needs to be provided to potential or actual participants:

• Information to Participants Involved in Research Form [Template] (.docx)
• Consent Form for Participants Involved in Research [Template] (.docx)

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Declarations

The Chief Investigator is responsible for the research project and for ensuring that all aspects of the research undertaken comply with the 'National Statement on Ethical Conduct in Human Research'. For student projects, the Chief Investigator (Primary Contact) for the application must be listed as the Supervisor, not the Student. Please note that all communications from the Ethics Secretary and HRECs will be directed to the Chief Investigator.

For Applications Using Version V.13-07

All investigators, students and other staff involved in the research project are required to provide a digital signature by logging in to Quest, accessing the application and completing the declaration table in Section 12. The application cannot be submitted until all personnel have logged in and completed this declaration.

External Investigators do not have access to Quest, therefore the Chief Investigator must supply a completed physical declaration on their behalf by following the steps below:

1. Send the person a copy of the full application form (including attachments), as well as the 'Declaration Form for External Investigators' document.
2. Once returned, attach the signed document in 'Section 11 - Required Attachments'.
3. Enter into the External Investigator's record in the declaration table and mark the checkbox to indicate that these steps have been completed, include the date you have done so.

• Declaration Form for External Investigators (.docx)

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For Applications Using Version V.12-10

All investigators, students and other staff involved in the research project are required to sign a Declaration Form. The Declaration Form must be printed, signed by all researchers, and uploaded as an attachment to your ethics application. The Chief Investigator is responsible for ensuring that all members of the research team have signed the Declaration Form.

• Declaration Form for all Investigators (.docx)

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After Submission

On submission, your ethics application will be forwarded electronically to the Ethics Secretary for review. The Ethics Secretary will check that you have completed the application correctly before determining the level of risk associated with the research project. The risk level will determine which HREC reviews your application. If the Ethics Secretary is satisfied, they will forward your application to the relevant HREC where it will undergo a formal review. You will be notified by email when your application proceeds to formal review. This email will notify you of the risk level assessment.

After your application has been reviewed, the Ethics Secretary will notify you of the feedback. There are four possible outcomes from the first stage of formal review; the application may be:

• 'Approved'. If your application is approved outright you may commence your research project.
• 'Amendments Required'. Your application has not been approved. You are required to make some revisions to your application. Once resubmitted, the application is reviewed by the Chair of the HREC.
• 'Withheld'. Your application has not been approved. You are required to make considerable revisions to your application. Once resubmitted, the application is reviewed by the entire HREC.
• 'Rejected'. Your application has not been approved and elements have been deemed to be unethical. Your research project will not receive ethical approval in its current form. You will be provided with information as to why the research protocol has been deemed unethical.

For 'Amendments Required 'and 'Withheld' applications, the specific revisions you are required to make will be communicated to you online. This is done through the 'Comments' function in Quest. Once you have revised your application accordingly, you will need to resubmit your application to the Ethics Secretary who will forward your revised application to the HREC or Chair where it will undergo a second formal review.

Your application may be approved following the second formal review, or you may be required to make some further changes. Again, if you required to make revisions this will be communicated to you online through the 'Comments' function. If your application is approved then you will be notified by email. Remember, you cannot commence your research project until you have received formal approval from the HREC.

Once your Ethics Application is formally approved, you will receive approval for a period of two (2) years.

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The Key Issues in Preparing an Application

Typically, the most important issues to consider within the Application include:

• the supporting rationale for the research;
• a detailed and clear description of all procedures/methodologies;
• evidence that the researchers have the appropriate qualifications and/or experience and skills to undertake the research;
• evidence that demonstrates that the researchers have considered the effects of participation in the research upon the participant(s);
• appropriate procedures to ensure that participants (or legal guardians) provide voluntary and informed consent and can withdraw from the study at any time;
• the likelihood and severity of risks and inconveniences posed to participants in this research – risks may involve physical, psychological, social and/or legal aspects;
• risks to the researchers or Victoria University and/or to other individuals or organisations involved in the research;
• appropriate minimisation and management of risks (potential or expected);
• a risk-benefit analysis of the research – where research poses any risks to participants, the researchers, Victoria University or other individuals/organisations involved in the research, the researchers need to demonstrate that the benefits of the research outweigh any associated risks;
• protection of participants' privacy and confidentiality – related to participant identity and the collection, storage and disposal of data; and
• that the Declaration has been completed by all investigators

The help icon, found directly next to questions within the online form and at the top of each page, will provide you with detailed advice on ethical content.

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Higher Degree by Research (HDR) projects

PhD, Professional Doctorate and Masters by Research projects should be approved by your College of enrolment through the candidature confirmation process before being submitted for ethical review. Unapproved HDR research projects may, in special cases, be reviewed by a HREC. However, researchers are required to provide good reason as to why ethical approval for the project is being sought prior to gaining candidature approval from your College. Please note that if your College requests changes to research that has already been approved by an HREC, the Chief Investigator is required to submit a request for amendment to the approving HREC.

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