Human research ethics

REMINDER:  Effective 1 July 2024

The new Human Research Ethics Applications will be mandatory for most projects conducted by the La Trobe University Research Community.

Clinical Trials/Interventional and Human Biospecimen analysis research are the exception, they will require the NHMRC Human Research Ethics Application.

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:
   • 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:
   • 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.

Contact the Ethics team

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

How long will the governance and ethics review process take?

The National Statement provides a risk profile for human research and LTU provides pathways for review or request for exemption based on this profile:

"Low risk research describes research, including some types of clinical trials, in which the only foreseeable risk is no greater than discomfort. Accordingly, research in which the risk for participants or others is greater than discomfort is not low risk research. Research in this category is considered higher risk research and carries risk of harm. Higher risk research requires review by an HREC."

Ethics review at La Trobe University (LTU) is managed by the Ethics, Integrity and Biosafety (EIB) Team.  The review is a two-stage process. The governance review is done by a member of the EIB and is typically started within three business days of application submission. This review serves to confirm that you have answered the necessary questions, provided the required documentation, and the application is ready for ethics review.

After completion of the governance review, the ethics review is done by either the LTU Human Research Ethics Committee (HREC)or the Low-risk Ethics Advisory Panel (LEAP).  The LEAP conducts rolling reviews so meeting and submission dates do not apply.

It is the Principal Investigator’s responsibility to allow enough time for the review process. Applications should be submitted early if there are other relevant deadlines such as grant submissions, project start dates, etc. Applications are reviewed in the order received.

We recommend you start your application eight (8) weeks in advance of your anticipated start date. While it is unlikely it will take this long, it ensures you allow enough time for the required steps in the review process including:

• governance review and relevant discussions and any necessary revisions; and
• ethics review and any relevant discussions and any necessary revisions

Factors that may have an impact on the turnaround times for review include:

• the completeness and quality of the project application;
• review category, e.g., low risk versus greater than low risk review;
• number of project applications currently under active review by the Coordinator, LEAP or HREC
• response time by the researcher to provide requested information; and
• potential wait for external documents or letters of permission for related items.

If you have any questions as you prepare you application, please email humanethics@latrobe.edu.au and someone will be in touch within two (2) business days.

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.

*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

Human research subject to & post-approval requests:

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

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.

• Review Externally Approved Project Guidelines

Complaints about a La Trobe University Research Project

Any interested person may make a complaint about the conduct of a research project. Such a complaint will be made in writing and submitted electronically via email.  A Complaints Form is available. The complaint should be forwarded to the attention of the Senior Manager, Ethics, Integrity and Biosafety, via Ethics, Integrity and Biosafety at eib@latrobe.edu.au. An acknowledgement of the complaint will be sent by a member of the Ethics, Integrity and Biosafety Team within two (2) business days of receipt of the complaint.

The Senior Manager, Ethics, Integrity and Biosafety, will review the complaint to determine if there is an apparent ongoing impact to a participant’s, animal’s welfare, or immediate risk to the environment (depending on the type of complaint received) that extends beyond those described in the approved ethics submission. If that is determined to be the case, the Senior Manager, Ethics, Integrity and Biosafety, will notify the Executive Director of the Research Office and subsequently advise the Principal Investigator to cease research activities until a review has been undertaken.

Where the complaint relates to activities that would normally require Ethics Committee or Review Body approval, the complaint will be considered by the Senior Manager, Ethics, Integrity and Biosafety, or nominee, and the Chair of the relevant Ethics Committee or Review Body, who will determine the level of investigation required in accordance with the relevant ethical guidelines.  Where further investigation is called for, the Ethics, Integrity and Biosafety Team will undertake a full risk-based monitoring investigation and prepare a report for the relevant Ethics Committee or Review Body. The report will detail the investigation and any findings and recommendations for further action.

The Ethics Committee or Review Body decides on any required actions and informs the relevant parties. These actions may include but are not limited to:

• a caution
• increased reporting requirements and/or monitoring by the Ethics, Integrity and Biosafety
• the requirement for amendments to the project
• suspension of ethical approval
• withdrawal of ethical approval.

Where the investigation finds that the complaint involves a breach of the relevant ethical guidelines, legislation or policy, the Senior Manager, Ethics, Integrity and Biosafety, will work with the relevant Ethics Committee or Review Body and/or School/Centre to avoid a recurrence.

Where the review or investigation finds that the breach of the relevant ethical guidelines may also represent a breach of the Australian Code or research misconduct, the Senior Manager, Ethics, Integrity and Biosafety, will refer it to the La Trobe University Designated Officer who will handle it in line with the La Trobe Research Misconduct Procedure.

Where the review or investigation determines the complaint to be unfounded or unsupported, the Senior Manager, Ethics, Integrity and Biosafety, will dismiss the complaint and the reason/s for dismissal will be provided to the complainant and to the committee.

Where the review or investigation finds that the complaint should be dealt with under other institutional provisions, the Senior Manager, Ethics, Integrity and Biosafety, will refer it on as appropriate.

The relevant Ethics, Integrity and Biosafety Secretariat will inform the researcher(s) in writing, of the result of and any actions arising out of the investigation, within five (5) business days.

The complainant will be advised by the relevant Committee Secretariat in writing of the outcome of the investigation of the complaint.

It is the responsibility of the Secretariat to update the records and the database of research proposals accordingly.

A summary of complaints will be included on the Ethics, Integrity and Biosafety regular report to the Research Graduate School Committee.

All Complaints will be recorded in the Ethics, Integrity and Biosafety Complaints Register.

Complaints will remain confidential.

Review Body Conduct Complaints

Where a complaint cannot be readily resolved by communication between the complainant and the Ethics Committee or Review Body, a complaint may be submitted to the Senior Manager, Ethics, Integrity and Biosafety, in writing via eib@latrobe.edu.au using the Ethics Integrity and Biosafety Complaints Form.

Following receipt of a complaint the Senior Manager or their nominee will seek further information from the relevant Ethics Committee or Review Body Chair; Ethics, Integrity and Biosafety Research Staff; or other relevant La Trobe staff or students as necessary to establish the veracity of the complaint, and whether any La Trobe University policies or procedures have been compromised.

The Senior Manager, Ethics, Integrity and Biosafety, or nominee will provide a report to the relevant Ethics Committee or Review Body and the complainant on the outcome of the investigation of the complaint and include a recommendation for any further actions.

The ultimate decision regarding the ethical acceptability of an activity lies with the relevant ethics committee and must not be overridden.

A summary of complaints will be included in the regular Ethics, Integrity and Biosafety report to the Research Graduate School Committee.

All Complaints will be recorded in the Ethics, Integrity and Biosafety Complaints Register.

Complaints will remain confidential.

For queries about this process, contact the Senior Manager Ethics, Integrity and Biosafety:

T: +61 3 9479 1443

E: eib@latrobe.edu.au

Research Guidelines

• National Statement on Ethical Conduct in Human Research 2023
• 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 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.

**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:

• 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 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"

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.

NEW DATES ADDED

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

• 22 July – Online, 1:30 pm
• 19 September – Online, 1 pm

Duration                                                           90  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

• 15 October – Online, 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 – Online, 10 am

Duration                                                           60 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

• 3 September  – Online, 2 pm

Duration                                                           60 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

• 19 November – Online, 2 pm

Duration                                                           60 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

• 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.

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.

• 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

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.

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 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.

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:

• 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.

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.

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:

• United Nations Security Council (UNSC) sanction regimes
• Australian autonomous sanctions in please for fieldwork location
• See in-country approval for conducting fieldwork before making and confirming travel arrangements (National Statement, Chapter 4.8)
• Additional documentation for in-country ethics approval can be found at Research for Development Impact Network. Please note some countries (e.g. Indonesia) have additional requirements before non-nationals can enter the country to undertake research. Evidence of such approval is required with your application before your application can be fully approved.

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.

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.

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

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.