Human research ethics application process

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.

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.

To login to Quest:

1. Go to http://quest.vu.edu.au
2. Current VU staff and students: Click the 'VU LOGIN' button. Then login at the standard VU Login screen.
3. All other persons: Beneath heading 'External login', use supplied credentials to login.

NOTE: 'External login' does not work for current VU staff and students. See step 2.

Can't access Quest? Log a job:

• navigate to https://vusupporthub.vu.edu.au/
• scroll down and select the 'Research' tile
• choose 'Submit a new ticket' and then 'Quest Application'
• enter 'Service' and 'Details of Request'
• click the 'Review & Submit' button.

Some useful resources include:

• Ethics Quick Start Guide - outlines the basic steps in creating an application and how to respond to comments.  
• Quest Online Human Ethics Guide (PDF, 771.94 KB) - comprehensive document useful to refer to when developing your application.
• Quest Help & Frequently Asked Questions page.

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:

• Conducting research with the Department of Education
• Melbourne Archdiocese Catholic Schools (MACS)
• Departments of Defence and Veterans’ Affairs Human Research Ethics Committee
• Research involving Aboriginal & Torres Strait Islander Peoples
• Human research with young people (PDF, 160.25 KB)

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.

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.

Gift Vouchers are an acceptable form of reimbursement for adult participants. If, as a researcher, you choose to offer gift vouchers, participants will need to be notified via the Information to Participants Form/s and Consent Form/s by inclusion of a clear statement that if the participant chooses to accept a gift voucher, VU will record their names for financial auditing purposes.

Please note:

• cash payments by the university will only be provided as a gift card
• physical cash payments or bank transfers are not approved methods of payment to participants
• gift cards can only be ordered through Procurement using the Gift Card Request Form.

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;

• Information to participants form (DOCX, 127.52 KB)
• Consent form (DOCX, 129.66 KB)
• Understanding consent in human research (PDF, 178.35 KB)

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.

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

Additional risks to consider:

• legal risks
• risks to the researcher
• risks to data integrity, such as bot interference with survey data

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 (PDF, 347.75 KB) 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:

• Information to participants form (DOCX, 127.52 KB)
• Consent form (DOCX, 129.66 KB)
• Understanding consent in human research (PDF, 178.35 KB)

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.