Human research ethics

Human research is conducted with/or about people, their biological materials, and/or data (information) about them. It therefore includes a broad range of activities.

In order to conduct research with or about people or their data or tissue, a project must have received prior approval from a Human Research Ethics Committee (HREC). Please contact the Ethics, Integrity and Biosafety team if you are not sure if your research requires ethics approval from the La Trobe University Human Research Ethics Committee, or for any other human ethics queries at:

  • humanethics@latrobe.edu.au
  • +61 3 9479 1443
  • Join us for weekly zoom drop-in sessions, every Monday from 12-1pm followed by a 'how to prepare an ethics application' training session from 1-2pm Link: https://latrobe.zoom.us/j/84839776836
  • schedule a personalised session for help with your ethics queries, if required

Getting your project approved

New Human Research Ethics application process

Effective 1 May 2024

NEW Human Research Ethics Applications now in use for research projects conducted by the La Trobe University Research Community.

The old forms will be accepted until 30 June 2024, you do not need to transfer existing applications in process to the new form.


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:
  3. If you are using the NHMRC Human Research Ethics Application:
    • Register for an account at https://hrea.gov.au
    • Complete your online application along with a project description (for biospecimen analysis) or the SPIRIT Statement-based project description (for Clinical Trials).
    • Prepare relevant supporting research project documentation. For example:
      • Participant Information and Consent Forms
      • Participant Invitation
      • Relevant authorisations/approval
  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/84839776836
  3. Contact us directly to discuss your needs and preferred options:

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.

Contact the Ethics team

For any questions or concerns, please contact Human Ethics or +61 3 9479 1443

Time to approval

This table shows the average time to approval (calendar days) for projects submitted to each of the Human Ethics committees during the first quarter of each of the last three years.

Committee202220232024
Human Research Ethics Committees 29.4 days / 27 projects 25.3 days / 53 projects 26.4 days / 76 projects
Low risk Ethics Advisory Panel 13.5 days / 28  projects 19.6 days / 45  projects 8.2 days / 83 projects

Meeting closing dates - Human Research Ethics

*Please note if there is a high volume of applications for any given meeting, the application may be allocated to the following meeting date.

2024 Human research new & deferred ethics applications - pre-review, closing and meeting dates
Pre-review cut-off (voluntary)Application deadlineCommittee meeting
Midday Monday, 08 January 2024Midday Friday, 12 January 2024Thursday, 1 February 2024
Midday Monday, 29 January 2024Midday Friday, 2 February 2024Thursday, 22 February 2024
Midday Monday, 12 February 2024Midday Friday, 16 February 2024Thursday, 7 March 2024
Midday Monday, 26 February 2024Midday Friday, 1 March 2024Thursday, 21 March 2024
Midday Tuesday, 12 March 2024Midday Friday, 15 March 2024Thursday, 4 April 2024
Midday Friday, 22 March 2024Midday Wednesday, 27 March 2024Thursday, 18 April 2024
Midday Monday, 8 April 2024Midday Friday, 12 April 2024Thursday, 2 May 2024
Midday Monday, 29 April 2024Midday Friday, 3 May 2024Thursday, 23 May 2024
Midday Monday, 13 May 2024Midday Friday, 17 May 2024Thursday, 6 June 2024
Midday Monday, 27 May 2024Midday Friday, 31 May 2024Thursday, 20 June 2024
Midday Friday, 7 June 2024Midday Friday, 14 June 2024Thursday, 4 July 2024
Midday Monday, 24 June 2024Midday Friday, 28 June 2024Thursday, 18 July 2024
Midday Monday, 8 July 2024Midday Friday, 12 July 2024Thursday, 1 August 2024
Midday Monday, 29 July 2024Midday Friday, 2 August 2024Thursday, 22 August 2024
Midday Monday, 12 August 2024Midday Friday, 16 August 2024Thursday, 5 September 2024
Midday Monday, 26 August 2024Midday Friday, 30 August 2024Thursday, 19 September 2024
Midday Monday, 9 September 2024Midday Friday, 13 September 2024Thursday, 3 October 2024
Midday Monday, 23 September 2024Midday Thursday, 26 September 2024Thursday, 17 October 2024
Midday Monday, 14 October 2024Midday Friday, 18 October 2024Thursday, 7 November 2024
Midday Monday, 28 October 2024Midday Friday, 1 November 2024Thursday, 21 November 2024
Midday Monday, 11 November 2024Midday Friday, 15 November 2024Thursday, 5 December 2024
Midday Monday, 25 November 2024Midday Friday, 29 November 2024Thursday, 19 December 2024
Human research subject to & post-approval requests:

The first meeting in 2024 will be Tuesday 16 January 2024 and then going forward every Tuesday.

Closing DateMeeting Date
Midday Thursday - every weekTuesday the following week

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 57KB).
    • Prepare a copy of the approved ethics application and all support documents submitted to the external HREC, ensuring that the title of the study on the application form matches the one in the request email.
    • Prepare 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.

Complaints and feedback

For concerns about:

  1. an approved project
  2. the conduct of a researcher
  3. the conduct of the Human Research Ethics Committee (HREC) or Low Risk Ethics Adviosry Panel
  4. or wish to provide feedback

Please contact the Senior Manager Ethics, Integrity and Biosafety

T: +61 3 9479 1443

E: eib@latrobe.edu.au

Research Guidelines, Legislation and Regulations

Research Guidelines

Legislation and Regulations

Expression of interest - Human Research Ethics Committee Member

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 2023.  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 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 (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.

Members of the La Trobe University Human Ethics Committee are required to:

  • Be familiar with the National Statement on Ethical Conduct in Human Research 2023 and other guidelines and information relevant to the review of specific research proposals;
  • Attend monthly meetings of the HREC;
  • Prepare for the meetings by reading all meeting papers, including all new applications under review, paying particular attention to those assigned to you as a reviewer;
  • Consider ad hoc items such as researcher support materials upon request;
  • Attend continuing education or training programs in research ethics;
  • Promote a culture of excellence in ethical human research across the LTU community; and
  • Maintain confidentiality of the committee’s proceedings.

Induction training is provided to all new members prior to their commencement on the Committee. Though Committee members are volunteers, internal La Trobe members will receive recognition in the AWPS, external members will receive an honorarium.  The Committee is supported by the Ethics, Integrity, and Biosafety team, in the Research Office.

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 Mary Duffy, Senior Coordinator, Ethics, phone +61 39 479 1443 or email eib@latrobe.edu.au.

Modifying an approved project

Modifying an approved project

If you intend to modify your project you will be required to submit a modification request form. This can include, but is not limited to, changes to the following:

  1. Recruitment, methodology and/or funding
  2. Participant information statement and/or consent form/s (PICF)
  3. Advertisements
  4. Approval time period, i.e., if your ethics approval is due to expire and you require an extension

How do I submit a modification request?

  1. Complete Modification Form [DOC 61KB]
  2. Prepare a tracked and clean copy of all updated documents
  3. Log in to  PRIME Researcher portal to create a new modification request:
    1. To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to modify
    2. At the top of the screen the “down” arrow and click “Create Modification”
    3. Upload completed modification form and updated documentation (including tracked and clean copies)
    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

Annual Final and Safety Reports

Annual, Final reports and Clinical Trial Annual or Final Safety Report

    **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 2023.  Please select and download the appropriate form for your reporting period:

    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 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 their 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"

Incident, Safety and Breaches of GCP Reporting

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

1. Human research projects (excluding Clinical Trials)

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.

Templates

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 (Please Note: A Project Description is not required)

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]

Guidance and FAQs

Guidance

Ethics & Integrity Seminar Program

All the workshops outlined below are available as condensed versions upon request for individual schools or courses.

SEMINAR (HYBRID)

Research Ethics and Integrity

Who should attend?                                         Researchers

Facilitator                                                        Vivienne Moyle, Ethics, Integrity & Biosafety

  • 18 April – Bendigo (BE-BUS-129), 9:30 am
  • 22 July – Bundoora (BU-DMW-W112), 1:30 pm
  • 19 September – Wodonga (AW-AW-4-4211), 1 pm

Duration                                                           120 minutes

Description

Human research ethics is vital when conducting your research with people.  Unethical research may put raise risks and even jeopardise the validity of your findings. As we undertake more and more research using increasingly diverse methods including advanced technology, AI, increased collaborations, it is important to get it right the first time.​

In this seminar, you will learn the principles of ethical research, and how to manage your research in ethical and responsible ways. You will consider issues like voluntary participation and informed consent, making sure that personal information is handled safely and confidentially, and recruiting vulnerable participants in human research.; implementing the 3Rs in animal research; and considering various elements of the responsible conduct of research.

Learning outcomes

  • Identify and evaluate key principles of ethical research found in the National Statement on Ethical Conduct of Human Research​, the Australian Code for the Responsible Conduct of Research, and the Australian code for the care and use of animals for scientific purposes.
  • Identify potential ethical issues relating to attendee’s own research​.
  • Understand the process for applying for ethical review and maintaining ethical approval at La Trobe University​

SEMINAR (HYBRID)

Supervision: Human Research Ethics

Who should attend?                                         Supervisors

Facilitator                                                        Vivienne Moyle, Ethics, Integrity & Biosafety

  • 25 June – Bundoora (BU – DMC-C101), 11 am
  • 15 October – Bendigo (BE-CSC-109), 10 am

Duration                                                           60 minutes

Description

Helping to guide students and candidates through the Human research ethics process is vital to their success.  Understanding your role as supervisor and principal investigator in the gaining and maintaining of their ethics approval is a key part of that process.

Learning outcomes

  • Understand the student requirements for gaining and maintaining human research ethics approval.
  • Understand the dual role of supervisor and principal investigator.
  • Consider the risk levels appropriate to student research.
  • Understand timing implications and other factors on student ethics applications.
  • Identify potential ethical issues relating to student human research ethics applications.

SEMINAR (HYBRID)

Social Media Research and Human Research Ethics

Who should attend?                                         Researchers

Facilitator                                                        Mary Duffy, Ethics, Integrity & Biosafety

  • 11 November – Bundoora (BU – DMC-C101), 10 am

Duration                                                           90 minutes

Description

Social media research refers to research undertaken on social or professional networking platforms such as Facebook, Twitter, TikTok and LinkedIn where the aim of the site for the public is to build communities or networks and/or comment on local/national/world events rather than to be a platform for digital data like ABS Statistics. Prior to the mid-2000s, the ethical understanding was that information on the internet was public and researchers did not require ethics approval to conduct research with public information. However, while social media research is relatively new, principles about publicly available information contained in the National Statement on Ethical Conduct in Human Research 2023 still apply to research undertaken on social media platforms.

Learning outcomes

In this webinar, we will explore how to apply the principles of the National Statement to Social Media research, including how to:

  • Understand how risk, consent, confidentiality, and recruitment are understood within the social media research context.
  • Understand the relationship between social media users and their data.
  • Apply the principles in the National Statement to social media research.

SEMINAR (HYBRID)

Risk and Mitigation: A Human Research Ethics Seminar   *** NEW DATE ***

Who should attend?                                         Researchers

Facilitator                                                        Mary Duffy, Ethics, Integrity & Biosafety

  • 28 May – Bundoora (BU – DMC-C101), 2 pm

Duration                                                           90 minutes

Description

Research involving human participants always involves some level of risk to research participants, to us as researchers and/or to the public. A key element of ethical research practice involves identifying and managing the risks our research may pose to ourselves and others. Failing to get this right can result in anything from unnecessary inconvenience to participants, reputational damage, litigation or, in some cases, serious injury.

Learning outcomes

In this seminar, we will explore risk in human research and how we need to respond to it. It will help you:

  • Understand how risk is understood within the human research context.
  • Understand the relationship between risk and benefit.
  • Identify, minimise, and manage risks in your own research.

SEMINAR (HYBRID)

Privacy and Confidentiality: A Human Research Ethics Seminar

Who should attend?                                         Researchers

Facilitator                                                        Vivienne Moyle, Ethics, Integrity & Biosafety

  • 12 June 2024 – Bundoora (BU-DMC-C101), 10 am

Duration                                                           90 minutes

Description

When we collect personal information from research participants, we have a legal obligation to protect their privacy. As researchers, we also have a moral obligation to respect participants by designing research that appropriately maintains confidentiality. This seminar will explore these obligations and the practical steps we need to take to fulfill them.

Learning outcomes

  • Understand regulatory frameworks concerning privacy.
  • Understand the practical measures necessary to protect the privacy of research participants.
  • Understand the ethical importance of confidentiality.
  • Identify and manage limitations to confidentiality.

SEMINAR (HYBRID)

Authorship: A Research Integrity Seminar

Who should attend?                                         Researchers

Facilitator                                                        Valentina Bulatovic, Ethics, Integrity & Biosafety

  • 16 April 2024 – Bundoora (BU-DMC-C101), 10 am
  • 6 August 2024 – Bundoora (BU-DMW-W112), 1 pm

Duration                                                           90 minutes

Description

Authorship must not be attributed when an individual has not made a significant intellectual or scholarly contribution to a research output and, as a rule, all those who have made a significant intellectual or scholarly contribution should be named as authors.  Institutional policies should clarify the circumstances in which these contributions should be included and how inclusion of such contributions should be handled and require that all named authors must have confidence in the integrity and accuracy of these contributions.

Learning outcomes

  • Understand what is meant by authorship and significant contribution.
  • Understand how to ensure appropriate and fair attribution of authorship.
  • Understand acknowledgements and accountability in research outputs.

Supplementary Guidance for Researchers

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 applicaitons.

External guidance on topical areas of interest are also available:

Zoom, MS Teams, WebEx for 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.

Cisco Webex is also another secure option. This can be used by people external to La Trobe University without any sign in, however, your research participants will need to download the Cisco app.

FAQs

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 activites 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 wehere the primary purposes is to monitor or improve the quality of service delivered by an individual or an organistation is considered a QA activity. Evaluation is used to make judgements, usually about the effectiveness, efficiency and/or appropriateness of an activieity. 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.

If you are unsure whether or not ethics approval is needed, please contact Human Ethics.

How to determine the level of risk in my research project?

How to determine risk?

Risk is determined by reviewing the potential for harm and the steps you have put in place to mitigate its impact, ensuring the safety of:

  1. Participants (e.g. risk of study procedures such as ionizing radiation, biospecimen collection, drugs/devices, psychological risk, cultural risks);
  2. Researchers (e.g. safety to researchers such as wearing personal protective wear, vicarious trauma and safety when conducting research activities at home or in public spaces) and;
  3. University (e.g. financial and reputational)

The level of risk of a research project and the risk mitigation strategies should be outlined in the project description using the guidance provided in the (National Statement, Chapter 2.1).  Please consider the kinds of harm, discomfort or inconvenience that may occur, the likelihood of them occurring, and the severity and consequences of them.

  • Harms can be:
    • physical, such as pain or injury.
    • psychological, like distress.  Distress can be defined as something that endures great mental or physical suffering, like extreme anxiety, sadness, pain or being in danger.  Research that seeks sensitive or embarrassing personal information such as recalling domestic or sexual abuse, or suicidal thoughts have the potential to trigger distress.
    • social such as damage to social networks or relationships.
    • economic such as direct or indirect costs for participants.
    • legal such as the discovery and prosecution of criminal conduct.
    • reputational harms are factors that change a participant's reputation.
  • Discomfort is physical and/or psychological and is the negative accompaniment or effect of research, less serious than harm that involves the body and/or mind, such as anxiety induced by interview/survey questions.

The information provided in your application form and project description is used to assess the level of risk and will ultimately determine which Committee reviews your project.

  • Above low risk research:  Research that has the foreseeable risk of harm like distress is considered 'above low risk' and needs to be reviewed by one of the University's Human Research Ethics Committees.
  • Low risk research:  Research where the only foreseeable risk is one of discomfort or inconvenience is considered ' low risk' and will be reviewed by the Community of Practice Low Risk Human Research Ethics Committee.

Please contact the Human Ethics team if you need further advice assessing your project's level of risk.

What are the review pathways for negligible risk, low risk and abow 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 review the application. At time of submission, you can indicate which 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:

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

How long do I have to wait to receive ethics approval?

We will aim for all projects to obtain ethics approval within 30 business days of the closing date. Business days are calculated as the number of days between the advertised closing date to the day the Principal Investigator (PI) is sent the letter detailing the outcome of the ethics review. The outcome may involve clarification sought and/or required revisions and the clock commences again once the PI submits their response addressing the committee review outcomes.

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 should 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?'.

If your project involves overseas fieldwork, researchers must obtain ethics from La Trobe University and demonstrate that they comply with any of the following:

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.  Please contact Human Ethics or call +61 3 9479 1443 to discuss.

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.

If you need any assistance, please contact Human Ethics.

If you have any additional questions please contact Human Ethics or call +61 3 9479 1443