Human research ethics
Human research is conducted with/or about people, their biological materials, and/or data (information) about them. It therefore includes a broad range of activities such as:
- Taking part in surveys, interviews, and/or focus groups
- Undergoing psychological, physiological, medical testing and/or treatment
- Being observed by researchers
- Researchers accessing participants’ personal documents and/or other materials
- The collection and use of participants’ biological materials (body organs, tissues, fluids and/or exhaled breath)
- Access to participants’ information as part of an existing published or unpublished source/database
In order to conduct research with or about people a project must have received prior approval from a Human Research Ethics Committee (HREC). Please contact the Ethics, Integrity and Biosafety team if you are not sure if your research requires ethics approval from the La Trobe University Human Research Ethics Committee.
How to apply - research greater than low risk
- Review relevant guidance in the National Statement of Ethical Conduct in Human Research (2007) - updated 2018
- Complete Online Application Form
- Upload attachments (e.g. Data Management Plan, letters of support, advertisements, Participant information statement and consent forms, surveys etc..) via the online portal
- Select University Human Ethics Committee (UHEC) as reviewing committee in Research Master
- Need access? Contact researchmasteradmin@latrobe.edu.au
- Attach completed External Investigator Declaration for each external investigator
- Need help? email humanethics@latrobe.edu.au
- Submit to a review round by one of the deadlines below:
| Application deadline | Committee meeting |
|---|---|
| Tuesday 22 January 2019 | Thursday 07 February 2019 |
| Tuesday 19 February 2019 | Thursday 07 March 2019 |
| Tuesday 19 March 2019 | Thursday 04 April 2019 |
| Tuesday 16 April 2019 | Thursday 02 May 2019 |
| Tuesday 21 May 2019 | Thursday 06 June 2019 |
| Tuesday 18 June 2019 | Thursday 04 July 2019 |
| Tuesday 16 July 2019 | Thursday 01 August 2019 |
| Tuesday 20 August 2019 | Thursday 05 September 2019 |
| Tuesday 17 September 2019 | Thursday 03 October 2019 |
| Tuesday 22 October 2019 | Thursday 07 November 2019 |
| Tuesday 21 November 2019 | Thursday 05 December 2019 |
How to apply - low and negligible risk research
- Review relevant guidance in the National Statement of Ethical Conduct in Human Research (2007) - updated 2018
- Complete Online Application Form
- Upload attachments (e.g. Data Management Plan, letters of support, advertisements, PICFs, surveys etc..) via the online portal
- Select SHE or ASSC College Sub-Committee as reviewing committee
- Need access? Contact researchmasteradmin@latrobe.edu.au
- Attach completed External Investigator Declaration for each external investigator
- Need help? email humanethics@latrobe.edu.au
- Submit to a review round by one of the deadlines below:
Application Deadline | Committee Meeting |
|---|---|
Thursday 11 April 2019 | Monday 6 May 2019 |
Thursday 2 May 2019 | Monday 20 May 2019 |
Thursday 16 May 2019 | Monday 3 June 2019 |
Thursday 30 May 2019 | Monday 17 June 2019 |
Thursday 13 June 2019 | Monday 1 July 2019 |
Thursday 27 June 2019 | Monday 15 July 2019 |
Thursday 11 July 2019 | Monday 29 July 2019 |
Thursday 25 July 2019 | Monday 12 August 2019 |
Thursday 8 August 2019 | Monday 26 August 2019 |
Thursday 22 August 2019 | Monday 9 September 2019 |
How to apply - research approved by an external HREC
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 humanethics@latrobe.edu.au
Modifying an approved project
If you intend to modify your project you will be required to submit a modification request form. This can include, but is not limited to, changes to the following:
- Recruitment, methodology and/or funding
- Participant information statement and/or consent form/s (PICF)
- Advertisements
- 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?
- Complete Modification Form [DOC 63KB]
- Attach a tracked changes and clean copy of all updated documents
- Submit modification request to humanethics@latrobe.edu.au
Annual and final reports
- Download and complete the annual/final report [DOC 59KB]
- Submit to humanethics@latrobe.edu.au
Serious adverse events and incident reports
- Complete Incident and Serious Adverse Event Report Form
- Submit to humanethics@latrobe.edu.au
Complaints and feedback
For concerns about:
- an approved project
- the conduct of a researcher
- the conduct of the Human Research Ethics Committee (HREC) or Low Risk sub-committees
- or wish to provide feedback
Please contact the Heidi Gaulke - Manager Ethics, Integrity and Biosafety
T: +61 3 9479 1443
Legislation, codes and guidelines
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
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
Clinical Trials
Quality Assurance
Research Involving Children
Other
Templates and forms
The following templates can be used as a starting point for your PICFs (combines Participant Information Statement, Consent From and Withdrawal of Consent Form):
Template PICF - General [DOC 63KB]
Template PICF - Online Survey [DOC 59KB]
Template PICF - Parent/Guardian [DOC 64KB]
Template PICF- Databank [DOC 59KB]
Template PICF - Clinical Trials [DOC 67KB]
Template PICF - Clinical Trials Parent/Guardian [DOC 68KB]
Declaration Form for External Investigator [Doc 39 KB]
Template Advertisement [DOC 5MB]