Human Research Ethics

Project Principal Investigators:

In submitting a project for ethics or institutional biosafety review, researchers are asked to note that the Principal Investigator on an application must be a fixed-term or ongoing La Trobe University employee or have Emeritus status conferred by Academic Board.

Projects by Student and Honorary appointees other than Emeriti must be conducted with their academic supervisor as Principal Investigator on the ethics application.

Academic supervisors must be ongoing or fixed-term university employees. This approach is consistent with the Australian Code for the Responsible Conduct of Research (2018) and the La Trobe Honorary Appointments Policy.

All new human research ethics applications must be submitted via PRIME using the following process:

1. Review the Definitions of Research to see which form aligns with your research project.  If you have any questions on which application to use, contact humanethics@latrobe.edu.au and one of the Ethics, Integrity and Biosafety team members will be happy to help you.
2. If you are using the La Trobe University Human Research Ethics Application:
   • Download and complete the La Trobe University Human Research Ethics Application Form. For assistance with the application form, please refer to the Guide to the La Trobe University Human Research Ethics Application.
   • Prepare relevant supporting research project documentation. For example
     • Participant Information and Consent Forms
     • Participant Invitation
     • Flyers/Advertisements
     • Interview/focus group outline
     • Questionnaires
     • Surveys
3. If you are using the NHMRC Human Research Ethics Application:
   • Log in as a guest or register for an account at hrea.gov.au (this will allow you to amend your application form later if required).  DO NOT  SUBMIT THE APPLICATION  THROUGH THIS PORTAL!
   • Complete your online application along with a project description (for biospecimen analysis) or a full study protocol that aligns with the SPIRIT Statement-based guidelines (for Clinical Trials).
   • Prepare relevant supporting research project documentation. For example:
     • Participant Information and Consent Forms
     • Participant Invitation
     • Relevant authorisations/approval

PLEASE NOTE: When you have completed the HREA application,  do not submit it in the HREA portal. Download a PDF copy of the completed form  and upload that along with the relevant supporting documents to PRIME.

4. Log in to PRIME Researcher portal to create a new Human Ethics Application:
   • Under Ethics Applications, click “+ New Human Ethics Application”
   • Add all researcher personnel
   • Upload all completed forms and research project documentation (as separate documents)
   • Click on “Submit to Research Office” by the relevant closing date (see Meeting Closing Dates)

Application Assistance

1. Schedule a personalised session with one of our ethics advisors for help wth your ethics or PRIME queries
2. Attend one of the weekly Ethics, Integrity and Biosafety drop-in sessions - every Monday at 12 noon via zoom:  https://latrobe.zoom.us/j/83423454099?from=addon
3. Contact us directly to discuss your needs and preferred options:
   • humanethics@latrobe.edu.au
   • + 61 3 9479 1443

Applications for Exemption from Ethics Review:

The 2023 update to the National Statement provides for institutions to determine whether a project may be exempt from requiring human research ethics approval. If you think your project may be exempt,:

1. Download the Exemption form (DOC 49KB)
2. Read the accompanying information carefully
3. Complete the form
4. Submit it via email to humanethics@latrobe.edu.au.

Your request will be considered by a member of the Ethics, Integrity and Biosafety Team and you will receive a notification if your exemption is granted or you will be advised to submit a full application to the appropriate ethics committee via the usual process.

Exemption requests may be submitted at any time and are not dependent on meeting agenda.

How to apply – research approved by an external HREC:

This process is used when La Trobe University staff and students receive ethics approval from another NHMRC registered Human Research Ethics Committee.

With the release of PRIME, all new externally approved applications must be submitted using the following process:

1. Complete the relevant forms:
   • Download the Externally Approved or Request to Transfer Application Form (DOC 58KB).
   • Provide a copy of the approved ethics application and all supporting documents submitted to the external HREC, ensuring that the title of the study on the application form matches the one in the request email.
   • Prrovide a copy of the final approval letter from the external HREC, with all conditions of approval included.
2. Log in to PRIME Researcher portal to create a new Externally Approved Application:

1. Under Ethics Applications, click “+ New Externally Approved Application”
2. Add all researcher personnel
3. Upload all completed forms and study documentation (as separate documents)
4. Click on “Submit to Research Office” by the relevant closing date (see below)

Please refer to below guidelines to help you with the preparation of the application.

Review externally approved project guidelines

Complaints about La Trobe University Research Projects

Anyone interested in voicing a concern or lodging a complaint regarding the conduct of a human research project, including clinical trials, is encouraged to do so in writing by emailing eib@latrobe.edu.au. A Complaints Form is available to facilitate this process. The complaint will be forwarded to the Senior Manager of Ethics, Integrity, and Biosafety (Senior Manager) and other relevant individuals upon submission. You can expect an acknowledgment of your complaint within two (2) business days from a member of the Ethics, Integrity, and Biosafety Team (EIB).

Complaints about the Ethics Review Process

According to Chapter 5.6 of the National Statement, researchers have the right to express concerns regarding the ethical review process; however, they cannot appeal a final decision that results in the rejection of an ethics application If you have a concern regarding the human research ethics review process please do so in writing by emailing eib@latrobe.edu.au in the first instance. Acknowledgement of receipt will be provided within two (2) business days.

Research Guidelines

• National Statement on Ethical Conduct in Human Research 2025
• Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities
• Keeping research on track II: A companion document to Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders
• Australian Code for the Responsible Conduct of Research 2018
• Principles for accessing and using publicly funded data for health research
• AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research
• Guide to Applying the AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research

Legislation and Regulations

• Privacy and Data Protection Act 2014 (Victoria)
• Victorian Health Records Act
• Victoria Guardianship and Administration Act 2019
• Privacy Act 1988 (C'th)

The La Trobe University Human Research Ethics Committee (HREC) reviews ethics applications associated with research projects from all disciplines in the University in accordance with the National Statement on Ethical Conduct in Human Research 2025.  The HREC promotes and ensures ethically good human research, reviews the conduct of human research, identifies risks, and deliberates about ethical issues related to human research.

We are currently seeking expressions of interest for the following categories of membership:

• Category B: A person who brings a broader community or consumer perspective;
• Category C: A person with knowledge of, and current experience in, the professional care or treatment of people; for example, a nurse, counsellor or allied health professional;
• Category D: A person who performs a pastoral care role in a community including, but not limited to, an Aboriginal and/or Torres Strait Islander elder or community leader, a chaplain or a minister of religion or other religious leader; and
• Category F (particularly Humanities and Social Science, Education, Allied Health, Human Services and Sport, Business): A person or people with current research experience that is relevant to research proposals to be considered at the meetings they attend.

How to Express an Interest

Expressions of Interest can be submitted to the Chair of the Human Research Ethics Committee, at eib@latrobe.edu.au. Expressions of Interest should include a brief statement outlining your interest in joining the Committee and a biography or an abridged resume.

If you would like further information about this position, please do not hesitate to contact Leanne Clinch, Senior Coordinator, Ethics, phone +61 39 479 1443 or email eib@latrobe.edu.au.

**NOTE: If your project has expired you will not be able to upload your progress report in PRIME, please email your completed report form to humanethics@latrobe.edu.au. A Research Ethics Advisor will upload it and mark your milestone as complete on your behalf.**

The La Trobe University Progress Report Forms have changed to meet requirements of the National Statement on Ethical Conduct in Human Research 2025.  Please select and download the appropriate form for your reporting period:

• Human Research Ethics Annual Progress Report Form [DOC 78KB] (due on the anniversary date of your ethics approval)
• Human Research Ethics Final Report Form [76KB] (due within 3 months of the project finishing)

Please contact humanethics@latrobe.edu.au if you have any questions or come to the Ethics, Integrity and Biosafety weekly zoom drop-in session for assistance.

For Externally Approved Ethics Applications, please note you are not required to complete the La Trobe Annual and Final Report forms. Please upload a copy of the annual and /or final report submitted to the approving HREC with evidence of their acceptance of the report. Please contact humanethics@latrobe.edu.au if you have any queries about this.

For all Clinical Trials download and complete the Clinical Trial Annual Progress Safety Final Report [DOC 55KB]

La Trobe University’s Human Research Ethics Committees have the discretion to request more frequent reporting of clinical trials.

If La Trobe is not the lead HREC, please submit your Annual Progress Report and Annual Safety Report as per the approving HREC's requirements and provide a copy of the approved report to La Trobe via humanethics@latrobe.edu.au

3. Log in to PRIME Researcher portal to lodge an annual of final report:

1. To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to submit an annual or final report for
2. At the top of the ethics record, click the “down” blue arrow drop down menu and click “Create Annual Report” or “Create Final Report”
3. Click the 'post approval documents' tab and upload completed annual/final report form
4. At the top of the screen click on  "Submit to Research Office"

La Trobe University's Incident and Safety monitoring reporting requirements:

1. Human research projects (excluding Clinical Trials)

• To report an incident, please complete and submit the Human Research Adverse Event Form [DOC 53KB]

2. Clinical Trials

The NHMRC’s Safety monitoring and reporting in clinical trials involving therapeutic goods (2016) sets out the requirements for the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials.

The Clinical Trial Safety Reporting Flowchart and Glossary of Terms has been developed as a valuable tool to assist you in determining which report is required, to whom it should be reported and the timelines for doing so.

• To report a safety issue (e.g. serious adverse event/reaction/effect or significant safety issue), complete and submit the Safety Report - Clinical Trial v3 [DOC 70KB].   Please note: You are no longer required to individually report Adverse Events as they occur if not serious (i.e. non-serious incidents that are not related to the trial) to the HREC.  Please retain adequate records and include these Adverse Events in your Annual Safety Report to La Trobe University.
• To report a Serious or Suspected or Non-Serious Breach as a requirement of ICH E6 (R2) Good Clinical Practice or the clinical trial protocol, complete and submit the Breach of Good Clinical Practice Protocol Report - Clinical Trial v3 [DOC 56KB]

3. Log in to PRIME Researcher portal to lodge an Incident/Safety/Breach of GCP Reports:

1. To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to submit a Safety Report/Incident,
2. At the top of the ethics record click the “down” arrow and click “Create UAE/Safety Report”.
3. Upload completed Report.
4. In the progress bar at the top of the page, select "Review by Research Office" and then click "Mark as Current Status" to the right.

The following templates can be used as a guide for your PICFs which combine Participant Information Statement, Consent and Withdrawal of Consent Forms:

Human Research (excluding Clinical Trials):

Template PICF - General [DOC 63KB]

Template PICF - Online Survey [DOC 59KB]

Template PICF - Parent/Guardian [DOC 64KB]

Clinical Trials:

Template Clinical Trial Protocol - Spirit Checklist [DOC 138KB]

Template PICF - Clinical Trials [DOC 67KB]

Template PICF - Clinical Trials Parent/Guardian [DOC 68KB]

CTN Request Form (TGA) [DOC 47KB]

CTRA Request Form [DOC 36KB]

Ethics & Integrity Seminar Program

Education Program – 2026

The EIB team is currently revising the content of our education program.

Updated schedules will be posted here soon!

The Ethics, Integrity and Biosafety Team has prepared some supplementary guidance materials on topics of interest to researchers that may assist in the preparation of human research ethics applications.

• Participant Information and Consent Form Guidelines
• Social Media in Human Research
• Research with Legal Implications
• Overseas Research
• Data Types and Identifiability
• Honours and Human Research
• Advertising Materials in Human Research

External guidance on topical areas of interest are also available:

• Ethical Considerations in Quality Assurance and Evaluation Activities
• Payment of participants in research: information for researchers, HRECs and other ethics review bodies
• Ethical Research Involving Children
• Indigenous Cultural Protocols for Producing Indigenous Australian Music, Writing, Visual Arts, Media Arts and Performing Arts (Australia Council for the Arts 2007)
• Autism CRC Inclusive Research Practice Guides and Checklists for Autism Spectrum Research
• Principles and Guidelines for Ethical Research and Evaluation in Development

Do I need human research ethics approval?

All La Trobe staff and research students who conduct research projects will require human research ethics approval (or an exemption) if they intend to conduct research or research activities involving the following:

• engagement with human participants;
• collection and/or use of previously collected human biological material (e.g. obtained from person including tissue, blood, urine, sputum and any derivative from these including cell lines. This does not include non-human biological material such as micro-organisms that live on or in a person;
• artefacts or archival material;

Irrespective of the level of risk of the activity, researchers must have human research ethics approval in place prior to commencement of research
(National Statement, Chapters 4 and 5).

Type of activities that may not require ethics approval

Conducting quality assurance (QA) and evaluation activities does not require human research ethics approval even when such activities may utilise research methodologies. An activity where the primary purposes is to monitor or improve the quality of service delivered by an individual or an organisation is considered a QA activity. Evaluation is used to make judgements, usually about the effectiveness, efficiency and/or appropriateness of an activity. More information is available in the supplementary guidance document available above.

Regardless of whether an activity is research, QA or evaluation, all participants involved in the activity should receive optimal care and any potential risks, burden, inconvenience or possible breach of their privacy must be carefully considered and addressed.

What are the review pathways for negligible risk, low risk and above low risk human research?

In accordance with the National Statement (sections 5.1.18 - 5.1.21), La Trobe has established two review pathways, one for low risk, the other for above low risk research. Closing dates, applications forms, project documentation (e.g. advertisement, Participant Information & Consent forms, study tools) and level of detail remain the same. The only difference between the pathways is the committee who reviews the application. At the time of submission, you may indicate the pathway you think is most appropriate, however, the level of risk will be reviewed by the Ethics, Integrity and Biosafety Team, and downgraded/upgraded as deemed appropriate in accordance with the National Statement. At all stages, we will communicate with you, which committee will be reviewing your application and the date you can expect to hear an outcome.

The pathways and committees review are as follows:

• Pathway 1: Low Risk Research - Review by the Low-risk Ethics Advisory Panel
• Pathway 2: Above Low Risk Research - research by a Human Research Ethics Committee

There is also an exemption pathway available for research that meets the relevant criteria.

When can I commence my research?

You cannot commence your project (i.e. recruitment and data collection) until you have received written approval from the Human Research Ethics Committee (HREC) or the Low-risk Ethics Advisory Panel.

Consultation and literature reviews to determine the scope and design of your project may occur prior to applying for ethics approval.

If your project requires approval from another jurisdiction (e.g. hospital, school, Department of Defence, etc) please following the information under 'I have received ethics approval from another external organisation do I still need La Trobe ethics approval?'.

I have received ethics approval from an external organisation. Do I still need La Trobe ethics approval?

La Trobe has adopted the recommendation of the National Statement (Chapter 5.3) to minimise the duplication of ethical review and therefore recognises approval issued by other NHMRC-registered HRECs and their delegated low-risk review body. This means that La Trobe staff and students undertaking research do not need to seek ethical review by the La Trobe HREC or its Low-risk Ethics Advisory Panel if their project has been approved by another NHMRC-registered HREC or their delegated low-risk review body. However, to ensure appropriate governance and insurance coverage, any projects involving La Trobe staff and research students must be registered via the externally approved projects pathway.  If you plan to conduct your research in the Prison system, ethics approval will be required from the Justice Department's HREC and once obtained submitted through the externally approved projects pathway at La Trobe University.

In some cases, you may need to seek multiple approvals from HRECs. An example includes conducting research in Schools in Victoria, where ethics approval must be granted by RISEC or by the Department of Education in other states. Often this can be done in parallel but enquire first whether La Trobe HREC approval is required prior to submitting an application.

Can I receive retrospective approval?

La Trobe HRECs and the Low-risk Ethics Advisory Panel do not provide retrospective approval for any research conducted without ethics approval or under an expired ethics project.

What is the approval period?

The HRECs and the Low-risk Ethics Advisory Panel can provide approval for up to five years.

Can I extend my approval period?

The Principal Investigator can apply for an extension before the end date of an approved project. A project modification form must be completed to request an extension of ethics approval. Please note that:

• Requests for extension can only be granted during the approval period for which the project already has approval.
• Retrospective extensions will not be granted.
• The modification request must remain within the scope of work of the original approved research project.

Extension up to 12 months

A 12-month extension submitted on a modification request form can be granted to complete recruitment and data collection. Please note that:

• Additional extensions cannot be requested once an extension has been approved.  A new application will need to be submitted.
• Projects with a high number of modifications submitted during the initial approval period may be advised to provide a new application.
• Requests for extensions can only be granted if all annual reporting and approval conditions have been met.

Extensions exceeding 12 months

In general, extension for periods of longer than 12 months should be submitted as a new application. Special circumstances (e.g. project paused due to unforeseen reasons, such as the COVID-19 pandemic) may be considered by the HREC or LEAP on the condition that appropriate justification is provided. The approving Committee may grant a 3-month extension to allow the researcher additional time to generate a new application for ethical review.

What online collaboration tools can I use for human research?

The advice from La Trobe Information Services is that Zoom can be used for non-confidential matters (including research). However, anything that is highly confidential should be conducted via Microsoft Teams. Tips on how to increase security using Zoom can be found at on the La Trobe Information Services website.

To use Microsoft Teams the recipient must have an Office 365 account (this account doesn’t have to be a La Trobe Office 365 account for it to work). This means some research participants won’t be able to log in via Teams if they do not have a 365 account. The Human Research Ethics Committee will take this into consideration in addition to the highly confidential nature of the research interview when reviewing projects.