Human research ethics

Research Master will be de-commissioned on 1 March 2020.

All new Human Research ethics applications must be submitted using the following process:

1. Complete the relevant forms:
   • Download Application Form (DOC 58KB) (mandatory for all projects)
   • Download Project Description (DOC 54KB) (mandatory for all projects, except clinical trials)
   • Complete Study documentation (see below for templates. Example documentations might include Participant information statement and consent forms, advertisements, letters of support, surveys, etc..)
2. Email by the relevant closing date (see below) all completed forms and documents to humanethics@latrobe.edu.au
   • The email must be sent by the Chief/Principal investigator.
   • Copy (cc) in all co-investigators (including external people) and student investigators.

Contact the Ethics team

For any questions or concerns, please contact:

humanethics@latrobe.edu.au

+61 3 9479 1443

Submit or update an application already drafted in Research Master

1. Complete your form in Research Master.
2. Submit the form no later than 13 February 2020 for (low-risk) and 18 February 2020 (above low risk).

Update a current application with feedback

If you have received a feedback letter about an application (e.g., ‘subject to’ or ‘deferred’ letter):

1. Submit your changes in Research Master by 25 February 2020 for low risk and above low risk applications.
2. If you know you cannot submit changes by this date, contact humanethics@latrobe.edu.au as soon as possible for assistance with resubmission.

Access an approved application

1. Access your application via Research master by 25 February 2020; or
2. Email us at humanethics@latrobe.edu.au to request a copy.

Contact the Ethics team

For any questions or concerns, please contact:

humanethics@latrobe.edu.au

+61 3 9479 1443

*The HREC meeting (above low risk) is now held twice a month, please refer to below essential dates

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

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?

1. Complete Modification Form [DOC 63KB]
2. Attach a tracked changes and clean copy of all updated documents
3. Submit modification request to humanethics@latrobe.edu.au

1. Download and complete the annual/final report [DOC 59KB]
2. Submit to humanethics@latrobe.edu.au

1. Complete Incident and Serious Adverse Event Report Form
2. Submit to humanethics@latrobe.edu.au

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 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]

Template Letter of Support [DOC 25KB]

Template Letter of Invitation [DOC 64KB]

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 all the Categories above (a-e).

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

Enquires

• Submit your Expression of Interest to the Senior Human Ethics Advisor (+61394791443 humanethics@latrobe.edu.au).An Expression of Interest could include your resume and a brief cover letter describing your suitability for the position.