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 having access to 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Access to participants’ information as part of an existing published or unpublished source/database.

If you have a question or would like some advice, we would really like to hear from you so we can be as helpful as possible. Please contact the friendly Human Research Ethics Team on:

E. humanethics@latrobe.edu.au

P. +61 3 9479 1443

The following templates can be used as a starting point for your PICFs (Please note that consent forms MUST no longer be separated):

Template PICF - General

Template PICF - Anoymous Online Survey

Template PICF - Parent_Guardian

Template PICF- Databank

Template PICF - Clinical Trials

Template PICF - Clinical Trials Parent/ Gaurdian

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
2. Attach a tracked changes and clean copy of all updated documents
3. Submit modification request to humanethics@latrobe.edu.au

1. Complete Annual Report Form or Final Report Form
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 Heidi Gaulke - Manager Ethics, Integrity and Biosafety

T: +61 3 9479 1443

E: researchintegrity@latrobe.edu.au

Research Integrity

• Australian Code for the Responsible Conduct of Research 2018
• National Statement on Ethical Conduct in Human Research 2007
• 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)
• 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)
• 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)

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

Declaration Form for External Investigator [Docx 39 KB]