Human research ethics

With the release of PRIME, all new Human Research ethics applications and any application must be submitted using the following process:

1. Complete the relevant forms:
   • Download Application Form (DOC 60KB) (mandatory for all projects)
   • Download Project Description (DOC 54KB) (mandatory for all projects, except clinical trials please use Protocol (Spirit Checklist DOC 138KB)
   • Complete Study documentation. For example, Participant information statement and consent forms, advertisements, letters of support, surveys, etc. Please refer to the templates tab for other supporting document templates)
2. Log in to  PRIME Researcher portal to create a new Human Ethics Application:
   1. Under Ethics Applications, click “+ New Human Ethics 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)

If you would like us to pre-review your application, please submit your application using the above process by the advertised pre-review cut-off dates.

To help with training and feedback please see below:

1. Training opportunities:
   • Schedule a personalised session for help with your ethics queries or with PRIME.
   • Attend our weekly drop in sessions for assistance, every Monday at 12 midday https://latrobe.zoom.us/j/84849823999
2. If you would like to book a time to discuss your needs and preferred option/s please contact the Ethics, Integrity and Biosafety Team:
   • animalethics@latrobe.edu.au
   • biosafety@latrobe.edu.au
   • humanethics@latrobe.edu.au
   • + 61 3 9479 1443

Contact the Ethics team

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

This table shows the average time to approval (calendar days) for projects submitted to each of the Human Ethics committees.

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

Human research new & deferred ethics applications - pre-review, closing and meeting dates

Human research subject to & post-approval requests:

Last meeting for 2022 is Tuesday 13 December 2022. The first meeting in 2023 will be Tuesday 16 January 2023 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

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 sub-committees
4. or wish to provide feedback

Please contact the Senior Manager Ethics, Integrity and Biosafety

T: +61 3 9479 1443

E: humanethics@latrobe.edu.au

Research Integrity

• Australian Code for the Responsible Conduct of Research 2018
• National Statement on Ethical Conduct in Human Research 2007 (Updated 2018)
• Privacy and Data Protection Act 2014 (Victoria)
• The Office of the Victorian Information Commissioner (Victoria)
• Privacy Impact Assessment Template – Office of the Victorian Information Commissioner
• Checklist for Sharing Personal Information
• Office of the Australian Information Commissioner
• Principles for accessing and using publicly funded data for health research
• Australian National Data Service (ANDS)
• Guidelines for Ethical Research in Australian Indigenous Studies
• 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
• 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
• The Australian Clinical Trials Handbook (Therapeutic Goods Administration)
• Ethical Considerations in Quality Assurance and Evaluation Activities 2014
• Child Ethics
• Victorian Health Records Act
• Principles and Guidelines for Ethical Research and Evaluation in Development

Ethical Conduct in Human Research

• National Statement on Ethical Conduct in Human Research 2007

Privacy and Data Protection

• Privacy and Data Protection Act 2014 (Victoria)
• Office of the Victorian Information Commissioner (Victoria)
• Privacy Impact Assessment Template – Office of the Victorian Information Commissioner
• Checklist for Sharing Personal Information
• Office of the Australian Information Commissioner
• Principles for accessing and using publicly funded data for health research
• Australian National Data Service (ANDS)

Aboriginal and Torres Strait Islanders: Guidelines and Protocols

• Guidelines for Ethical Research in Australian Indigenous Studies
• Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities
• Keeping Research on Track II: a Guide for Aboriginal and Torres Strait Islander Peoples About Health Research Ethics (NHMRC 2018)
• Indigenous Cultural Protocols for Producing Indigenous Australian Music, Writing, Visual Arts, Media Arts and Performing Arts (Australia Council for the Arts 2007)

Autism Spectrum Research

• Autism CRC Inclusive Research Practice Guides and Checklists for Autism Spectrum Research

Clinical Trials

• The Australian Clinical Trials Handbook (Therapeutic Goods Administration)

Quality Assurance

• Ethical Considerations in Quality Assurance and Evaluation Activities 2014

Research Involving Children

• Child Ethics

Other

• Victorian Health Records Act
• Principles and Guidelines for Ethical Research and Evaluation in Development

Both of the La Trobe University Human Research Ethics Committees (HREC) and Community of Practice Low Risk Sub-committee (COP) are seeking expressions of interest from suitably qualified people.

In accordance with the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) (the National Statement), and excluding the Chair, the membership of the HRECs consist of the following categories:

1. lay people who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work;
2. people with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, an allied health professional;
3. people who perform a pastoral care role in the community;
4. lawyer, where possible who is not engaged to advise the institution; and
5. people with current human research experience that is relevant to La Trobe University.

The Human Research Ethics Committees are seeking expressions of interest for categories 2, 3, 4 and 5.

The Community of Practice Low Risk Sub-committee is currently seeking expressions of interest from category 5, La Trobe University employed members.

In these positions you will be required to:

• Attend at least half of the scheduled meetings in the calendar year.  HREC meetings are a blended model where members can attend in person or virtually via Zoom.  COP meetings are only virtual via Zoom.
• Review applications and make recommendations regarding the ethical acceptability of projects being undertaken by La Trobe University researchers and students.
• Ensure that any comments submitted about a project align with the National Statement and other relevant guidelines and regulations.
• Maintain confidentiality of the committee’s proceedings. All members are required to sign a Confidentiality Agreement prior to commencement of duties for the committee.

Benefits include:

• Continuing professional development
• The opportunity to contribute to raising the research profile of La Trobe University

1. Download and complete the annual/final report [DOC 61KB] (last updated 12.09.2022)
2. Log in to  PRIME Researcher portal to lodge an annual/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"

1. Complete the relevant Serious Safety Incident Report:
   • TEMPLATE – Safety Report (general) (DOC 54KB) (last updated 10.09.2020)
   • TEMPLATE – Safety Report for medical Devices
   • TEMPLATE – Protocol Violation Report (DOC 50KB) (last updated 10.09.2020)
2. Log in to  PRIME Researcher portal to lodge an annual/final report:
   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 Safety/Incident 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 University will continue to function under its COVID-safe plan in 2023 as this remains a Victorian Government requirement for all businesses. Safety Risk Assessments (SRAs) will be used to assess and manage COVID-19 risk but will only be needed for heightened exposure risk.  COVID-19 specific SRAs are required when research includes vulnerable groups such as:

• those who are unvaccinated and/or immunocompromised;
• situations of heightened exposure, such as working with COVID infected participants; or
• working in remote locations without access to adequate health care.

If required, please submit a completed SRA with your ethics application. Please go to COVID-Safe information and Safety Risk Assessments to determine all University requirements applicable to your research.

Health and Safety Business Partners continue to be available to provide additional guidance and practical advice, if required.

Please go to risk assessment to determine the University's current human fieldwork research safety assessment requirements that may be applicable to your research. If a fieldwork safety assessment is required, please include a copy of the completed safety assessment with your ethics application.

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 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 Ethics Committee should 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 without any signin, however your research participants will need to download the Cisco app.

To replace paper Participant Information Statement and Consent Forms with Electronic informed consent (eConsent), eConsent must provide the same information, but in an electronic format.  It is important to note that eConsent does not replace the important discussion between the participant and research team about the nature of the project and what the participant will be asked to do and why.

eConsent can be implemented by La Trobe research staff and students in the following ways (please note this advice was based on TransCelerate eConsent guidelines):

1. Use of RedCap (contact redcap-admin@latrobe.edu.au) ; AND
2. Telephone/Video Call; OR
3. Use videos and/or Audio over your PICF (see TransCelerate eConsent guidelines)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting of clinical trials that involve human participants. It is recommended that anyone involved in the conduct of research involving human participants consider completing this training. It is essential for researchers involved in clinical trials.

Researchers can undertake online GCP training that meets the minimum requirements for ICH GCP E6 R2 and is recognised by TransCelerate Biopharma Inc. via the following options:

1. The Australian Clinical Trials Education Centre (A-CTEC, formally V-CTEC) offers a free 'Trials Essentials for Investigators' online course that meets the minimum requirements for ICH GCP E6 R2 training and is recognised by TransCelerate Biopharma Inc.  You will need to register as a La Trobe University staff or student member to complete this self-paced comprehensive 5 module introductory course.  A certificate will be issued following satisfactory completion. More details can be found at A-CTEC: Comprehensive Course Packages (myopenlms.net)
2. NIDA Clinical Trials Network offers a free online GCP course conducted by the NIDA Clinical Trials Network (part of the National Institutes of Health in the US) that is TransCelerate Biopharma Inc. recognised. This is a 12 module self-paced course that should take 6 hours to complete.  Upon receiving at least 80% pass rate for all the exams a certificate of completion can be obtained.  Please use the link above to access the course.
3. The Global Health Network ICH Good Clinical Practice E6 (R2) * Global Health Training Centre (tghn.org) offers free online ICH GCP E6 R2 training for site investigators that is TransCelerate Biopharma Inc. recognised.  This training will take up to 1 hour to complete and you will need to register beforehand.  A pass rate of 80% in the online exam is required to successfully complete the course and request the free certificate of completion.
4. Genesis Research Services (https://genesisresearchservices.com/product/good-clinical-practice-ich-gcp-course/). The online GCP training is a self-placed online training option with a focus on the application of the GCP principles in a global setting. It takes approximately 2-4 hours to complete with a $10 fee now applicable.

GCP Refresher

If a refresher course is required once GCP certification has expired, as a partner organisation through Monash Partners and Melbourne Academic Centre for Health the Australian Health Research Alliance (AHRA) offers a TransCelerate recognised   GCP Refresher course at a reduced rate of $40 for member organisations.

Additional V-CTEC opportunities

The Victorian Clinical Trials Education Centre (V-CTEC) hosts a suite of evidence-based, interactive clinical trials education opportunities. It is highly recommended for all La Trobe staff and students, is free of charge and includes:

• Research competency training for investigators, study coordinators and research nurses
• Courses:
  • introduction to clinical trials
  • managing clinical trials
  • running clinical trials
  • regulatory environment and requirements
  • ethics and governance
  • safety monitoring and report
  • protocol compliance and breaches
• Live webinar series and workshops

HREC Guidance - Participant Reimbursement [DOC 42KB]

NHMRC - Payment of participants in research [PDF 217 KB]

All La Trobe staff and research students who conduct research projects will require human research ethics approval 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).

Types of activities that may not require ethics approval

Conducting quality assurance (QA) and evaluation activities does not required 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 (e.g. to improve the quality of a teaching program or instructional method) is a QA activity. Evaluation is used to make judgements, usually about the effectiveness, efficiency and/or appropriateness of an activity. In cases where a QA or evaluation activity forms part of or transforms into research, a human research ethics approval must be acquired.

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.
• Inconvenience is where the only foreseeable risk is one of inconvenience, such as completing a non-identifiable online survey where no sensitive or personal questions are asked.

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 negligible low risk, the other for above low risks 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 judged by the Human Research Ethics Office, alongside the Chair of the committee, 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 and Negligible Risk Research - Review by SHE or ASSC Low Risk Human Research Ethics Sub-Committee
• Pathway 2: Above Low Risk Research - research by a Human Research Ethics Committee

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 be that revisions are needed. the clos starts again when the PI submits their response to the letter of outcome.

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 they 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 NH&MRC-registered HRECs and their delegated negligible and/or low-risk review bodies. This means that La Trobe staff and students undertaking research do not need to seek ethical review by the La Trobe HRECs or its Low Risk Sub-Committees if their project has been approved by another NH&MRC-registered HREC or their delegated negligible and/or low-risk review bodies. However, to maintain insurance coverage, any projects involving La Trobe staff and research students must be registered via the externally approved projects pathway.

In some cases, you may need to seek multiple approvals from HRECs. An example includes conducting research in Schools in Victoria and New South Wales. Ethics approval must be given by the Department of Education in each state, and depending on the state, sometimes they will ask La Trobe to issue approval first. For these instances please contact Human Ethics or call +61 3 9479 1443 to discuss.

La Trobe HREC and its Low Risk Sub-Committees do not provide retrospective approval for any research conducted without ethics approval or under an expired ethics project.

The HREC and its Low Risk Sub-Committees 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 requestioned 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.
• 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) may be considered by the HREC/Sub-Committee on the condition that appropriate reason or justification is provided. The approving HREC/Sub-Committee may be 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.