Human research ethics

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.

There is now a new, comprehensive, easy to use online application form for low and above low risk applications. All new applications must be submitted through the online system except negligible risk applications. If you think you may have a negligible risk application, please review the new Negligible Risk Guidelines. Please see the 'Applying for human ethics review' tab below for more information on submission requirements..

We will also be running information sessions about the new form - please see the 'Training' tab below for dates and times.

Contract research

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 relevant committee (UHEC at humanethics@latrobe.edu.au, or the relevant college either chesc.assc@latrobe.edu.au or chesc.she@latrobe.edu.au) to inform them that the application is for Contract research and provide the required commencement date for data collection as specified in the contract.

For more information and guidance documents please see the 'Applying for human ethics review' tab below.

Before you begin

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 humanethics@latrobe.edu.au

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 about Low Risk research to the relevant College you are based in, either chesc.assc@latrobe.edu.au or chesc.she@latrobe.edu.au.

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 the relevant College you are based in, either chesc.assc@latrobe.edu.au or chesc.she@latrobe.edu.au.

Applying for review by the UHEC or CHESC at La Trobe

  1. 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.
  2. 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.
    1. 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 humanethics@latrobe.edu.au.
    2. If you have difficulty logging onto the system, please email the Research Master team (researchmasteradmin@latrobe.edu.au).
  3. 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).
  4. 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 51KB] 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 54 KB] should be used to report Adverse Events, Serious Adverse Events and any incidents to the UHEC. Please contact the Executive Officer UHEC (humanethics@latrobe.edu.au) for further guidance or advice.

Progress Reports

It is a condition of approval that all approved applications must submit an annual Progress Report Form [DOC 55 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.

Final Reports

It is a condition of approval that all approved applications must submit a Final Progress Report Form [55 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
E: humanethics@latrobe.edu.au

2017 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 that applications for review can be submitted at any time.

Date for application

Agenda closing date

Meetings dates

Meeting times

Anytime

1 February

13 February

9.30am – 11.30am

Anytime

29 March

10 April*

9.30am – 11.30am

Anytime

24 May

5 June

9.30am – 11.30am

Anytime

16 August

28 August

9.30am – 11.30am

Anytime

28 September

9 October

9.30am – 11.30am

Anytime

22 November4 December

10.30am – 12pm

*The April meeting will be held in The Boardroom, Collins Street campus

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:

  1. a chairperson, with suitable experience, whose other responsibilities will not impair the HREC's capacity to carry out its obligations under this National Statement
  2. 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
  3. 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
  4. at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion
  5. at least one lawyer, where possible one who is not engaged to advise the institution, and
  6. 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) 9479 3370
    E: chesc.she@latrobe.edu.au
  • CHESC ASSC - Low risk applications for the College of Arts, Social Science and Commerce
    Shelley Batten – Human Ethics Officer (ASSC)
    T: (03) 9479 6012
    E: chesc.assc@latrobe.edu.au

Training

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.

Book now

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:

  1. Log in to La Trobe University LMS.
  2. 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 humanethics@latrobe.edu.au 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 humanethics@latrobe.edu.au 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 relevant committee (UHEC at humanethics@latrobe.edu.au, or the relevant college either chesc.assc@latrobe.edu.au or chesc.she@latrobe.edu.au) 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:

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:

Please ensure you indicate whether you would like us to follow up with you regarding your complaint or feedback.

Guidelines, Forms and Templates

Legislation, Codes and External Guidelines

Research integrity

Ethical conduct in human research

Privacy and Data Protection

Aboriginal and Torres Strait Islanders: guidelines and protocols

Autism spectrum research

Clinical Trials

Quality Assurance

Research involving children

Other