Human research ethics

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

1. Complete the relevant forms:
   • Download Application Form (DOC 59KB) (last updated 09.09.2020) (mandatory for all projects)
   • Download Project Description (DOC 54KB) (last updated) (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)

To help with training and feedback please see below:

1. Training opportunities:
   • Schedule a personalised session for help with your first submission through the Portal;
   • Attend PRIME daily drop in session: Occurs daily at midday https://latrobe.zoom.us/j/97343849155
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 (business days) for projects submitted to each of the Human Ethics committees.

Used when La Trobe University staff and students receive ethics approval from another NHMRC registered Human Research Ethics Committee.

• Review Externally Approved Project Guidelines
• Complete the Externally Approved Project form
• Submit all application forms, approved documents and/or letters to Human Ethics.

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

The La Trobe University Human Ethics Committee (UHEC) and College Sub-committees are seeking expressions of interest.

In accordance with the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) (the National Statement), in addition to the Chairperson, the membership of the UHEC and College sub-committees consist of the following:

1. lay people who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work;
2. person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, an allied health professional;
3. person who performs 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.

We are seeking expressions of interest for Categories 3, 4 and 5.

In this position you will be required to:

• Attend at least half of the scheduled meetings in the calendar.
• Review applications and make recommendations regarding the ethical acceptability of projects being undertaken by La Trobe University staff and students.
• Ensure that any comments submitted about a project are relevant to 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
• Light refreshments are provided at each meeting

PRIME Ethics Researcher Portal has recently been released. What this means for you is a change in the way you submit and manage your ethics requests. To help with training and feedback please see below:

1. Training opportunities:
   • Schedule a personalised session for help with your first submission through the Portal;
   • Attend PRIME daily drop in session: Occurs daily at midday https://latrobe.zoom.us/j/97343849155
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

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 63KB] (last updated 09.09.2020)
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. At the top of the screen click on “Submit to Research Office”

1. Download and complete the annual/final report [DOC 61KB] (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 an annual or final report for,
   2. At the top of the screen the “down” arrow and click “Create Annual Report” or “Create Final Report”
   3. 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 screen the “down” arrow and click “Create UAE/Safety Report”
   3. Upload completed Safety/Incident Report
   4. At the top of the screen click on “Submit to Research Office”

• The Ethics Committee and Principal Investigators should be undertaking contingency planning to address the potential impact of COVID-19 on researchers and research participants.
• Review of your current projects should be considered, and if changes are required, are done so via a modification request.
• For new projects, ensure your projects contain contingencies during COVID-19 as well as post-COVID-19.
• Contingency planning should include:
  • priority: assessment of the importance of and the risks associated with continuing the research study as designed or with necessary modifications. Responses could include continuing the research study in its present form, conducting the research in a modified form, postponing the research or closing the research.
  • participation: assessment of the ability of participants to participate in the research study in accordance with protocol requirements and consideration of alternative models for participation that would not compromise the integrity of the research study.
  • capacity: assessment of the resources available for continuing the research study, including research staff, research support staff, other support staff, space, equipment, supplies, etc. For health and medical research, a component of a capacity assessment will be consideration of the need to re-allocate research staff to clinical care and other areas of patient support.
• Contingency planning will need to be an ongoing process.

Resuming community-based research involving people

A request should be submitted to your Head of School which includes the following:

1. Completed Risk Assessment and Mitigation plan (please take note of the guidelines below);
2. Ethics Approval for any Modifications; or New Ethics Application;
3. If applicable, Complete Good Clinical Practice (GCP) training when appropriate (refer to GCP training on the Human Ethics website).

Research modifications to accommodate COVID-19 requirements

It may be necessary to make modifications to your approved ethics application or draft ethics application to accommodate COVID-19 requirements:

• The Principal Investigators, and where appropriate industry partners, should be undertaking contingency planning to address the potential impact of COVID-19 on projects and research participants.
• Review of your current research should occur. If changes are required, please submit a modification request to the approving Ethics Committee (this may not always be La Trobe). Note: If the project is externally approved, the La Trobe Ethics Committee should be notified of the modification once approved by the external Ethics Committee.
• Please note, based on current government and/or organisational restrictions, sometimes the project may be delayed or postponed.
• To reduce the number of potential future modification requests it is recommended you outline contingency plans during COVID-19 and post COVID-19 (if applicable).
• Contingency planning outlined in modification requests and new ethics applications should include:
  • Priority: Assessment of the benefits and risks associated with continuing the research either as designed or with necessary modifications.
  • Participation: Assessment of the capability of participants to participate in the research and consideration of alternative models for participation that would not compromise the integrity of the research study.
  • Capacity: Assessment of the resources available for continuing the research during COVID19, including research staff, research support staff, other support staff, space, equipment, supplies, etc.

Contingency planning will need to be an ongoing process, that complies with evolving national and state-specific COVID-19 measures (DHHS COVID-19 website)

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)

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.

There are currently two free options provided to all La Trobe staff and students:

1. Face-to-face GCP training (currently via Zoom) - this training is delivered by Human Ethics and focuses on the application of GCP principles relevant to the research that occurs at La Trobe. Below are the upcoming dates:

Please contact Human Ethics to book into a session. Due to the interactive nature of the training there is a limit of 8 attendees per date, this will allow discussion and questions during the training. The training generally takes about 3hrs however an extra 30 minutes has been allocated to allow for discussion if needed. Please suggest a couple of dates that would suit. Note: a minimum of 3 attendees will be required for a session to run.

Note: Additional dates will be added according to need.

2. Online GCP training (provided by Genesis Research Services) - this is a self-paced online training option with a focus on the application of the GCP principles in a global setting.

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 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 valid human research ethics approval in place prior to commencement of research (National Statement, Chapters 4 and 5) and Australian state-based Human Tissue Acts).

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. A useful rule of thumb is: if the findings are only to be disseminated 'in-house' then ethics approval is probably not necessary, but if they are to be presented to wider audiences via conferences, seminars or journals then ethics approval is almost certainly needed.

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.

La Trobe has streamlined its processes to use the same application form, project description, templates and closing dates for all projects, regardless of level of risk. This reduces paperwork in the event that your project risk level is re-classified and ensures your project is reviewed via the fastest routes to receive ethics approval. There are provisions within the National Statement (Chapter 4 and 5) that allow negligible and low risk research to be reviewed and approval by a body other than the Humans Research Ethics Committee. At La Trobe, both the negligible and low risk applications are reviewed by one of the College based Low-Risk Sub-Committees.

Risk is determined by reviewing the potential harm and the steps you have put in place to reduce its impact and ensure safety (we call this risk mitigation strategies) to the following people:

1. Participants (e.g. risk of study procedures such as ionizing radiation, bio specimen collection, drugs/devices, psychological risk, cultural risks);
2. Researchers (e.g. safety to researchers such as wearing personal protective wear, 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 should be outlined in the project description and can be gauged by taking into account (National Statement, Chapter 2.1):

• the kinds of harm, discomfort or inconvenience that may occur;
• the likelihood of these occurring; and
• the severity of any harm that may occur and your risk mitigation strategies to reduce the risk

The expression 'low risk research' describes research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk.

The expression 'negligible risk research' describes research in which the only foreseeable risk is of harm or discomfort; and any foreseeable is no more than inconvenience.

Both negligible and low risk human ethics applications can be reviewed by the relevant College Low Risk Human Research Ethics Committee. The information provided in your application form and project description is used to judge the level of risk. Please Human Ethics if you would like advice regarding your project's level of risk.

Above low risk human ethics applications, that is, research in which the risk for participants is more serious than discomfort, must be reviewed by the University Human Research Ethics Committee.

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.