NHMRC COVID-19 guidelines for researchers

COVID-19 impacts for institutions, HRECs, researchers and sponsors.

COVID-19: Guidance on clinical trials (PDF, 140KB) for institutions, HRECs, researchers and sponsors.

Victoria University's guide to research ethics in the time of COVID-19 (PDF, 501KB).

If you intend to conduct research involving humans as participants, you must obtain ethical approval from the Victoria University Human Research Ethics Committee (VUHREC).

You must ensure that the research project adheres to all ethics principles and meets the relevant legal requirements. The VUHREC 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 Research Involving Humans.

When is Ethical Review Needed?

All Victoria University staff and students (including undergraduate and postgraduate students) who intend to conduct research involving human participants and/or their data or tissue must apply for approval from the Victoria University Human Research Ethics Committee (VUHREC) prior to commencing their research.

'Human research' has a broad definition that includes:

  • humans taking part in surveys, interviews or focus groups
  • humans undergoing psychological, physiological or medical testing or treatment
  • humans being observed by researchers
  • researchers having access to participants’ personal documents or other materials
  • the collection and use of participants’ body organs, tissues or fluids (such as skin, blood, urine, saliva, hair, bones, tumours and other biopsy specimens, or exhaled breath)
  • accessing participants’ information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database
  • accessing health informationpersonal information, and sensitive information for research purposes. 

Higher Degree by Research (HDR) projects

PhD, Professional Doctorate and Masters by Research projects should be approved by your Institute 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 Human Research Ethics Committee (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 Institute.

Please note: If your institute 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.

Human Research Ethics advice & support

If you are submitting your first application or have had a Withheld application, we recommend that you discuss your application with a Human Research Ethics Advisor before (re)submitting it to the Ethics Committee.

This discussion should include the Primary Chief Investigator (this will be the HDR supervisor in the case of a student) and associate and student investigators.

Human Research Ethics Advisors are experienced researchers in a range of disciplines and are the first point of contact for advice and assistance on human research ethics matters. Advisors are nominated for appointment by the Chair of the Human Research Ethics Committee across broad discipline areas and provide advice to academic staff and students on ethics matters.

The Advisor’s role is to offer advice in relation to the ethics process in relation to the National Statement on Ethical Conduct in Human Research and assist you to understand what is required.

The Ethics Advisor can show you where information is missing, identify aspects of your application that may raise ethical concerns, and advise you so that you can submit an application that can be reviewed and approved quickly.

As well as discussing your application with an Advisor, you can also access the Ethics Consulting Service run by the Chair of the Ethics Committee.

The Human Research Ethics Advisor can:

  • advise whether your research requires ethics review
  • conduct a pre-review of completed draft ethics applications prior to submission
  • provide general advice on Human Research Ethics processes at Victoria University
  • advise whether the design of the research is in accordance with the National Statement on Ethical Conduct in Research
  • highlight any discipline-specific ethical issues related to the proposed research activity.

A Human Research Ethics Advisor will not:

  • advise on matters other than those relating to Human Research Ethics
  • undertake any of the role of a HDR student’s supervisor
  • write the ethics application for the researcher or research student.

It is the role of the Primary Investigator on an application to contact a Human Research Ethics Advisor in your discipline area.

The Human Research Ethics Advisor will set a time or advise you how they wish to proceed. They may need to see your application and all associated supporting documentation prior to providing you advice or discussing your application.

After you have created your draft application on Quest you will be able to email a full copy of the application to yourself, with all supporting documentation.

When you create an application all supporting documentation should be attached to the online application form in PDF format. Supporting documentation may include:

  • participant information and consent forms
  • proposed questions, questionnaires and surveys
  • advertisements or recruitment leaflets, letters and emails
  • telephone scripts
  • letters of approval from organisations assisting in the research in any way
  • approval letters from other HRECs.

You may also consult one of the following staff in relation to one aspect of your supporting documentation.

Name & contact details Expertise Assistance available
Professor Max de Courten
+61 3 9919 2208
[email protected]
Expertise in chronic disease prevention, management of clinical trials, community health programs and health education.
  • Management of clinical trials
  • Research methodology
  • Quantitative and qualitative analysis
Professor Rob Aughey
+61 3 9919 6329
[email protected]
Expertise in the design, monitoring and interpretation of training and training load in athletes built over two decades as an applied sport scientist and coach, Institute for Health and Sport.
  • Management of clinical trials
  • Research methodology
  • Quantitative analysis
  • Analysis of training design
Professor Todor Vasiljevic
+61 3 9919 8062
[email protected]
Expertise with biology and biotechnology.
  • Management of food science trials
  • Development of sensory trials
  • Creating sensory questionnaires
Dr Catherine Lou
+61 3 9919 1354
[email protected]
Research expertise in supply chain management, operations management, value chain analysis and sustainable industries.
  • Conducting business research
  • Statistical analysis
  • Quantitative analysis
  • Development of questionnaires and focus groups
Associate Professor Darryl Coulthard
+61 3 9919 1899
[email protected]
Research expertise in law and justice.
  • Conducting research in law
  • Conducting research in other countries legal systems
Dr Elmira Jamei
+61 3 9919 5847
[email protected]
Research expertise in sustainable built environment, Net Zero Buildings and Construction, Energy benchmarking, Indoor thermal comfort, Climate and water sensitive urban design, Urban heat island, adaptation and mitigation strategies, Outdoor thermal comfort, Active transportation for Healthy Communities.
  • Statistical analysis
  • Quantitative analysis
Dr Ehsan Yaghoubi
+61 3 9919 4804
[email protected]
Expertise in the areas of geotechnical and pavement engineering (civil engineering).
  • Conducting research in engineering
Dr Alison Baker
+61 3 9919 4868
[email protected]
Research expertise in community and liberation psychology, community-based participatory research, youth identities, intercultural relations, activism.
  • Researching with young people
  • Participatory research methodology
Emeritus Professor Tarquam McKenna
+61 3 9919 2065
[email protected]
Expertise in Aboriginal and Torres Strait Islander research, arts education, research in allied professional health, gender and arts-based research
  • Qualitative research
  • Psychotherapy
Dr Matt Lee
+61 3 9919 4008
[email protected]
Expertise in exercise physiology. Research experience in managing human trials involving exercise prescription and training, nutrition interventions, invasive tissue sampling (e.g. blood, muscle), and body composition analyses (i.e. DXA scans).
  • Management of clinical trials
  • Research methodology
  • Quantitative analysis
  • Conducting research involving ionising radiation (e.g. DXA scans)
  • Psychotherapy
Dr Efrat Eilam
+61 403282249
[email protected]
Research in science and climate change education.

Qualitative and quantitative methodologies, as applied to educational research.

Dr Thu-Huong Nguyen
+61 3 9919 1268
[email protected]
Research in International marketing, tourism and travel behaviour.

Qualitative and quantitative methodologies.

 

Submitting a new ethics application

The Quest Online Human Ethics Application Form is part of a comprehensive research management system used to administer and support research activity at Victoria University.

Go to http://quest.vu.edu.au  and log in using your VU Staff or Student ID (eg. "e5123456") and password.

Some useful resources include:

Your ethics application should include a strong rationale for the research. There should be a detailed and clear description of all procedures/methodologies. Evidence must be included to demonstrate that the researchers have the appropriate qualifications and/or experience and skills to undertake the research.

The application should include evidence that demonstrates that the researchers have considered the effects of participation in the research upon the participant(s). There should be appropriate procedures to ensure that participants (or legal guardians) provide voluntary and informed consent and can withdraw from the study at any time.

It is important that you assess the likelihood and severity of risks and inconveniences posed to participants in this research - risks may involve:

  • physical
  • psychological
  • social
  • and/or legal aspects.

These risks, along with risks to the researchers or Victoria University and/or to other individuals or organisations involved in the research, should be included in the application no matter how small or unlikely.

The application should clearly demonstrate how the research team will ensure the protection of participants' privacy and confidentiality - related to participant identity and the collection, storage and disposal of data.

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

  • Include all relevant information. The reviewers will not presume information – your application is a document that should have clarity for any reader. 
  • Write for your audience.  All documentation should avoid jargon, where specific terminology is needed it should be clearly defined.  Members of the committee and research participants must all be able to understand what they read with clarity.
  • Use references to the literature to back up your claims, justifications and choice of research methods.
  • Applications can evolve over time as they are developed.  At the point of submission, every aspect of the application should be in alignment, from the number of participants to be recruited to the title of the application and attachments.
  • Consider if there are other aspects such as legal issues or additional clearances you may need to consider and address.
  • Consider the practical aspects of your project on a step-by-step basis to ensure you have addressed and considered all relevant issues.

The Project Summary must clearly and simply in plain language, (avoiding technical terminology and jargon), provide an overview of your project stating:

  • the aims of the project
  • research design
  • who the participants will be
  • and how the project will be analysed.

The Ethics Committee aims to weigh the potential benefits of the proposed research against the burden placed on participants. Have you identified a gap in existing research, which demonstrates a need to undertake further primary research?

In Section 4 of the application you will provide further detail of the aims, background and rational for the project, including outlining the methodology and procedures.

The Investigators are comprised of the group of people who are accountable for the conduct of the project. The Primary Chief Investigator will be the main contact for the application, and in the case of a research student, this will be their supervisor.  All other Chief and Associate Investigators should be included in the Investigator Section. 

All members of the investigation team need to include information on their relevant experience in the field and knowledge/experience of the research methods that will be used.

Student investigator details are requested separately and specific information is requested in relation to their supervision support in the application.

Other individuals and organisations involved such as technicians or research assistants who perform other tasks within the project will be listed separately.

The nature of the project relates to unique elements of your project that impact risks and special ethical and legal considerations.

This section includes questions about the following topics;

  • what type of project it is, (pilot study, part of a larger study, quality assurance or evaluation, clinical trial or intervention)
  • the target population (e.g., Aboriginal and Torres Strait Islander People, young people under 18 years of age, people highly dependent on medical care, etc.)
  • how intrusive the project is (e.g., will the research cause discomfort, collect potentially sensitive data or collect information that may relate to illegal activities)

Please note: Your responses to the questions asked in the actual form may expand the application to include supplementary pages depending on the answers you provide.

The methodology section should include a detailed and clear description of all procedures/methodology.

The project description provides the committee and ethics reviewers with information on the context, and the scientific and academic backgrounds to your application.  In association with the rest of the application, your project description should provide the committee with insight into how you are addressing any ethical issues that might arise in your research. 

Your project description should be written in plain English, using non-technical terminology. It should be easy for reviewers with non-technical backgrounds to understand. 

In this section you will also be asked to describe:

  • the kind of data you are collecting
  • who will be collecting the data
  • who will access the data
  • and how will the data be analysed. 

Participant selection outlines the characteristics of each group that you intend to recruit. Here you will outline:

  • your inclusion and exclusion criteria
  • the expected number
  • and age range of the participants.

Some resources may help you if you are undertaking research with particular participant populations:

Further information regarding research with a variety of participant populations can be found on our website, Human Research at VU.

Recruitment of participants

When considering recruitment of participants please consider:

  • Who will be recruiting the participants – will it be members of the research team or will there be others involved?
  • How will participants be approached and informed about the research?
  • How will the potential participants notify the investigators of their interest in participating?
  • Will potential participants be given time to consider and discuss their involvement in the study?
  • How will you obtain informed consent from participants? You will need to outline your process in a step-by-step manner.

Recruitment strategies in human research

Competing interests & reimbursement

Competing interests include dual relationships or conflicts of interest that may exist between a researcher and potential or actual participants. Please consider dependent relationships – and address them (student/lecturer, health practitioner/patient)

Any reimbursement/incentive must be approved in your ethics application. You can be reimbursed for:

  • travel
  • accommodation
  • parking
  • time
  • and inconvenience.

The key principle is that remuneration should not be disproportionate to the time involved and should not encourage people to take risks.

Payment of participants in research: information for researchers, HRECs and other ethics review bodies (NHMRC)

Informed consent

Recruitment of research participants involves seeking their consent regarding their participation in a research project.

The National statement on Ethical Conduct in Human Research states that the consent of participants must be both voluntary and informed. When recruiting participants, their informed consent must be sought in relation to their participation in the research.

Consent may involve Information to Participants' forms and Consent forms, however in some cases oral consent may be appropriate. In the case of online surveys, consent is implied; consent is considered to have been given if the participant chooses to complete and submit the survey which would have essential information about the project included on the first page.

You must use the following pre-approved templates when preparing your Information to Participants and Consent forms;

Waiver of consent

Research may involve access to and use of data or information that was originally generated or collected for previous research or for non-research purposes. The main ethical issue arising from this use is the scope of consent provided, or alternatively, the impracticability of obtaining consent.

Privacy concerns arise when the proposed access to or use of the data or information does not match the expectations of the individuals from whom this data or information was obtained or to whom it relates.

Recruiting participants via social media

A standard Human Research Ethics application needs to be submitted. In most cases this will include a request for a waiver of consent as part of the application in a statement attached in lieu of the Information to Participants’ form.

Writing an application for Waiver of Consent

There are three main areas of risk to participants to be considered when you are developing an ethics application:

  • physical risks
  • social risks
  • psychological risks.

In each of these cases you need to consider if there are high and/or low probability risks; how will they be mitigated and how would these risks be managed if any adverse event was to occur?

You will need to outline how data related to the research will be stored for the duration of the project and beyond. Maintaining comprehensive data, materials and records for each research project or activity is essential to the integrity of research, and is a requirement under the Australian Code for the Responsible Conduct of Research.

All research data, materials and records must be safely and securely stored during each project. Data, materials and records must be kept for a defined retention period beyond the completion of the project. This is to ensure that outcomes can be validated and justified.

The R: drive (research data storage) has been established for the safe storage and retention of digital data, files and records. All VU researchers and research students have free access to the R: drive.

R: drive folders are automatically backed-up and password protected. They are accessible from any VU computer or from off campus (via VPN), and allow files/records to be shared within your project or with supervisors.

The Research Data Management Planning (RDMP) form includes an application page for a new R: drive folder. These should be submitted to [email protected].

The minimum retention period is normally five (5) years. Please see VU's Research Data Management Procedure which describes the University's processes in relation to the management of Research Data at VU, from initial research conceptualisation through to research project conclusion.

Only at the expiration of the retention period should the data and materials be re-evaluated and considered for further retention at VU or elsewhere.

Here you will outline how you intend to disseminate and publish your research, including conference presentations, reports to organisations and publication in journals.

When submitting to journals may require the inclusion of raw data. It is recommended that you allow for this possibility in your ethics application.

This section of the application allows for the inclusion of any other relevant information that the research team may consider relevant.

Your application should include all relevant attachments from the following:

  • Interview question guides
  • Questionnaire content
  • Information to Participant and Consent Forms
  • Diagrams where relevant of processes or equipment
  • Timelines for longer intervention projects
  • References
  • Text of emails to be used for recruitment
  • Recruitment flyers

Supplementary forms will only be visible in your form if you have identified:

  • certain aspects to your project (e.g., clinical trial)
  • target populations as outlined in the National Statement, (e.g. Aboriginal and Torres Strait Islander People, People under 18 years of age, People highly dependent on medical care)
  • participants or members of the research team based outside of Australia
  • or if the project is considered intrusive or may collect potentially sensitive information.

You must use the following pre-approved templates when preparing your Information to Participants and Consent forms:

Only the Primary Chief Investigator can finalise and submit a Human Research Ethics Application. They will be the primary contact.

In the case of a Higher Degree Student, their supervisor will be the Primary Chief Investigator for their project.

The Primary 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 Primary 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.

All investigators, students and other staff involved in the research project are required to provide a digital signature by:

  1. logging in to Quest
  2. accessing the application
  3. 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 Primary Chief Investigator must supply a completed physical declaration on their behalf.

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 level of review is appropriate for your application.

If the Ethics Secretary is satisfied, they will forward your application to 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.

If an application is assigned to low risk review, it will pass through a continuous low risk panel process, initially assigned being assigned to two reviewers and then the Chair of the Ethics Committee before the reviewed application is returned to the researchers. Please allow three to five weeks' turnaround for these applications. If amendments are required, once the researcher has resubmitted the amended application, these are normally processed within a week.

If an application is assigned for high risk review, it will be considered by the Victoria University Human Research Ethics Committee with feedback being provided to researchers within five to ten working days of the meeting.  Meetings are held eleven months of the year and submission dates are three weeks prior to the meeting to allow for a pre-review process.

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:

  • '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 VUHREC sub-committee.
  • '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 VUHREC.
  • '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 VUHREC 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 are 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 VUHREC.

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

Contact us

For help and further information regarding ethical conduct and completing your application, contact the Secretary for the Human Research Ethics Committee.

Phone: +61 3 9919 4461 | +61 3 9919 4781

Email: [email protected]