Human research ethics
The UHEC and CHESCs will be closed from Friday, 15 December until Monday, 15 January 2018. The submission date for new applications requiring human ethics review before 15 December is COB 24 November. Applications submitted after 24 November will be assigned for review but may not receive a response before the closure date. During summer closure, new applications to the University Human Ethics Committee and College sub-committees will not be reviewed.
Research involving human participants or human body samples are bound by the National Statement on Ethical Conduct in Human Research and relevant State legislation together with La Trobe regulations and policies. All research has additional research integrity responsibilities. Find out here about Research Integrity at La Trobe.
Before you begin
Review your research integrity responsibilities: Research Integrity at La Trobe
Review the La Trobe Human Research Ethics Guidelines [PDF 214KB]
Applying for human ethics review
Already have HREC approval from another institution? Please review the Externally Approved Project Guidelines for submission requirements.
Above Low Risk research – All research that is considered to be above low risk and/or involves specific participant populations as described in the National Statement must be reviewed by a registered Human Research Ethics Committee (HREC). At La Trobe the HREC is called the University Human Ethics Committee (UHEC). Please send all queries about applications which may require HREC review to email@example.com
Low Risk research – Low Risk research at La Trobe is reviewed by committees based in the colleges - known as College Human Ethics Sub-Committees (CHESCs). Membership consists of academic staff members from within the College. Please send all queries to firstname.lastname@example.org
Negligible risk research – Please review the Negligible Risk Guidelines to determine if your project can be classified as involving negligible risk. If you feel it meets the requirements, please submit the Negligible Risk Application form and Human Ethics Risk Assessment Checklist [PDF 1.7 MB] to email@example.com
Applying for review by the UHEC or CHESC at La Trobe
- Complete a risk assessment of your research project using the Human Ethics Risk Assessment Checklist [PDF 1.7 MB]. The Risk Assessment Checklist is designed to assist researchers determine the level of risk involved and in turn which Committee should review the application.
- All human ethics applications must use the online application form. For assistance with completing the online application form, please take a look at the Online Human Ethics Application Guide for Researchers.
- As this is a new system, we will be running training sessions via Collaborate (see Training tab below for dates). We can also come and meet with students and staff to provide assistance. For more information please contact firstname.lastname@example.org.
- If you have difficulty logging onto the system, please email the Research Master team (email@example.com).
- Review the Participant Information Statement and Consent Form Guidelines [PDF 21KB] and determine which documents you need to submit with your application. Please note Above Low Risk Applications will require the submission of a Participant Information Statement, Consent Form and Withdrawal of Consent Form. Also consider whether you require separate documents for your participant groups (for example, parents and children).
- Ensure all other documents are ready to be submitted with your application. Advertisements, questionnaires and letters of support from external organisations all need to be attached.
Reporting and meeting your conditions of approval
Modifications to an Approved Project
Any changes to your approved ethics application must be approved by the committee your original application was submitted to. Complete a Modification Form [DOC 52KB] and make necessary revisions to other approved documents such as the Participant Information Statement. Submit the modification and documents to the UHEC or CHESC.
Serious Adverse Events and Incidents Reports
The Serious Adverse Events and Incident Form [DOC 56 KB] should be used to report Adverse Events, Serious Adverse Events and any incidents to the UHEC. Please contact the Executive Officer UHEC (firstname.lastname@example.org) for further guidance or advice.
It is a condition of approval that all approved applications must submit an annual Progress Report Form [DOC 51 KB] on 12 February each year which reports on the previous year's progress. Please submit to the UHEC or CHESC depending on which committee reviewed your original application.
Ethics approval will be suspended for any study which does not submit an Annual Progress Report.
It is a condition of approval that all approved applications must submit a Final Progress Report Form [51 KB] within 6 months of completion of the study. If you require an extension to the study you are advised to submit a modification prior to expiry of your ethics approval. Please submit to the UHEC or CHESC depending on which committee reviewed your original application.
If a Final Report is not submitted for a study by a Chief Investigator, further applications will not be accepted for review until the Final Report is received.
University Human Ethics Committee (UHEC)
Contacts and further information
Sara Paradowski - Senior Human Ethics Officer
T: (03) 9479 1443
2018 meeting dates
The La Trobe University Human Ethics Committee meetings will be held in the Library Seminar Room, Melbourne Campus unless otherwise indicated. All papers by UHEC members and reports for ratification should be submitted by the agenda closing date shown below for consideration at the relevant meeting. *Please note locations for April, Aug and October meetings to be determined.
Please note that applications for review can be submitted at any time.
Date for application
Agenda closing date
|29 January||12 February||9.30-11.30 am|
|9 April||23 April*||9.30-11.30am|
|4 June||18 June||9.30-11.30am|
|30 July||13 August*||9.30-11.30am|
|1 October||15 October*||9.30-11.30am|
|19 November||3 December||10.30-12pm|
As per Section 5.1.30 of the National Statement the UHEC will be comprised of at least eight members and will conform to the minimum membership of:
- a chairperson, with suitable experience, whose other responsibilities will not impair the HREC's capacity to carry out its obligations under this National Statement
- at least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work
- at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional
- at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion
- at least one lawyer, where possible one who is not engaged to advise the institution, and
- at least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant expertise.
The UHEC may also make use of additional members as required from time to time to assist with scientific review and ethical decision making.
For further information please see the UHEC Terms of Reference.
College Human Ethics Sub-Committees (CHESC)
College Human Ethics Sub-Committees accept summaries of negligible risk applications and assess applications for low risk projects.
Contacts and further information
- CHESC SHE - Low risk applications for the College of Science, Health and Engineering
Kate Ferris – Human Ethics Officer (SHE)
T: (03) 479 3370
- CHESC ASSC - Low risk applications for the College of Arts, Social Science and Commerce
Dr Senem Mallman – Human Ethics Officer (ASSC)
T: (03) 9479 6012
Training offered by the Research Education and Development (RED) unit
The RED unit offer an invaluable Introduction to Human Ethics workshop, offered as face to face sessions or online through Zoom.
Understanding the National Statement
An on-line training module is available to help you understand the National Statement on Ethical Conduct in Human Research. This training module is highly recommended for all students undertaking research that involves human participants (directly or indirectly). To access the training module:
- Log in to La Trobe University LMS.
- Once logged-in, select Course: EIU_M2 - Module 2: Human Ethics.
Online application form information sessions
Please get in touch to arrange an information session about the online application form. We can run sessions via Zoom or face to face.
Please note that we are able to see any application in the online system, so if you’re having trouble with a question or would like our advice, please don’t hesitate to get in touch - email email@example.com anytime and we can go through the form with you. If you are having trouble logging into the system, please email ResearchMasterAdmin@latrobe.edu.au for assistance
Training for specific departments and schools
Please contact firstname.lastname@example.org to organise a specific training session for your department or school.
Frequently Asked Questions
When is ethics approval required?
Any research involving humans, or requiring access to personal information for research purposes, will require approval from a Human Research Ethics Committee. The design, review and conduct of research must be ethically acceptable and in accordance with relevant standards and guidelines in the National Statement on Ethical Conduct in Human Research 2007 (updated May 2015).
Can I use the National Ethics Application Form or is there a preference for the La Trobe application form?
The La Trobe application form is preferred and should be completed whenever possible. But we are willing to accept research applications using the National Ethics Application Form (NEAF). Please note the NEAF will soon be replaced with the Human Research Ethics Application (HREA).
How is the human ethics review process structured at La Trobe?
The University Human Ethics Committee (UHEC) is the one National Health and Medical Research Council registered Human Research Ethics Committee at La Trobe. Low risk research is reviewed by the College Human Ethics Sub-Committees (CHESCs) of which there are two. Support is provided by Ethics & Integrity in the Research Office.
How long will it be before I can expect a response from the review?
Please allow three to four weeks for a response from the review. Please also inform us if you require a quicker review and we will try our best to assist you.
How long do I have to respond to comments from the Committee?
A response from the Chief Investigator is expected within 6 months from the date the review comments are received from the Committee. If correspondence is not received from you within this time period, the application will be closed off and you will be obliged to lodge a new application for ethics approval.
My project has already received approval from another Human Research Ethics Committee. Will I also be required to seek ethics approval at La Trobe?
Project proposals that have approval from an external Human Research Ethics Committee should follow the Externally Approved Project Guidelines for review and acceptance of the original approval. This is on the condition that the approving Human Research Ethics Committee is registered with the National Health and Medical Research Council and operates in accordance with the standards and guidelines outlined in the National Statement on Ethical Conduct in Human Research 2007 (updated May 2015). Please be aware that this is a La Trobe process, if you are collaborating with another organisation or wish to conduct research elsewhere, prior to submitting to La Trobe, please check with processes of the partner organisation as not all organisations have a similar process in place.
I wish to conduct my research with patients in a hospital environment, how should I manage the ethics review process?
In a hospital, a key priority is the safety of patients, as such most hospitals will expect you to submit to a hospital HREC for review. You will also need to submit a Site Specific Assessment If you are conducting a multi-site project, the review process can be quite complicated and requires a fair bit of forward planning. Please review the Department of Health and Human Services’ website in the early planning stages of the project - https://www2.health.vic.gov.au/about/clinical-trials-and-research/health-and-medical-research
I have signed a contract which requires the research to be conducted in a short time period, what should I do?
The UHEC and CHESC are here to facilitate human research and understand that Contract research can have specific and short timelines for completion.
If you submit an application for Contract research please ensure the following:
Specify in Section 1.3 of the application form that it is Contract research.
Check the application is complete and ready for review, in particular ensure all questions are answered appropriately and all documents are attached.
If the project requires a review quicker than ten working days, email the Human Ethics officers at email@example.com to inform them that the application is for Contract research and provide the required commencement date for data collection as specified in the contract.
Feedback and Complaints
If you wish to provide general feedback on any aspect of the human research process at La Trobe University, including the human ethics review process, you can either:
- Email firstname.lastname@example.org
- Call the Senior Human Ethics Officer on (03) 9479 1443.
If you wish to make a complaint about your participation in a research project conducted by La Trobe University or more broadly about a researcher or the conduct of research please either:
- Complete the Ethics and Integrity Complaints Form [67KB] and send to email@example.com
- Send an email directly to firstname.lastname@example.org. Please ensure you include the project reference number, the title of the project and the Chief Investigator (all this information can be found on the Participant Information Statement).
- Call the Senior Human Ethics Officer on (03) 9479 1443.
Please ensure you indicate whether you would like us to follow up with you regarding your complaint or feedback.
Guidelines, Forms and Templates
Online application form
- Human Research Ethics Guidelines [PDF 214KB]
- Participant Information Statement and Consent Form Guidelines [PDF 21KB]
Forms to download
- Modification Form - Human Research Ethics [DOC 52KB]
- Progress Report Form - Human Research Ethics [DOC 51KB]
- Final Report Form - Human Research Ethics [51KB]
- Risk Assessment Checklist [PDF 2MB]
- Externally Approved Project - Application Form [58KB]
- External Researcher Declaration Form
- Ethics and Integrity Complaints Form [67KB]
- Negligible Risk Project - Application Form [DOC 64KB]
- Serious Adverse Events and Incident Form [DOC 56 KB]
Legislation, Codes and External Guidelines
Ethical conduct in human research
Privacy and Data Protection
- Privacy and Data Protection Act 2014(Victoria)
- The Office of the Commissioner for Privacy and Data Protection(Victoria)
- Privacy Impact Assessment Template – Commissioner for Privacy and Data Protection
- 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
- Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
- Keeping Research on Track: a Guide for Aboriginal and Torres Strait Islander Peoples About Health Research Ethics (NHMRC 2005)
- Indigenous Cultural Protocols for Producing Indigenous Australian Music, Writing, Visual Arts, Media Arts and Performing Arts (Australia Council for the Arts 2007)