It is essential that you read Getting Started before you do anything further
Please see this link for more information
All research projects involving humans undertaken in, or under the auspices of Peninsula Health, require formal approval +/- authorisation prior to commencement.
Projects are reviewed in accordance with the National Statement on Ethical Conduct in Human Research (2025).
Key Research Guidelines and Legislation
Researchers must be familiar with the following:
- National Statement on Ethical Conduct in Human Research (2025)
- Australian Code for the Responsible Conduct of Research
- Statutory Guidelines on Research (Health Privacy Principles 1.1(e)(iii) & 2.2(g)(iii), Feb 2002)
- Guardianship and Administration Act 2019 (Vic)
- Medical Treatment Planning and Decisions Act 2016
- ICH E6(R2) Guideline for Good Clinical Practice (for clinical trials)
The National Statement on Ethical Conduct in Human Research allows for different levels of ethical review of research, reflecting the level of risk involved.
Peninsula Health has established review pathway corresponding to the level of risk involved in a project. The review pathways are:
- Quality Assurance – review by the Director of Research
- Single Site Lower and Higher Risk – review by Peninsula Health Human Research Ethics Committee.
In addition to the levels of review above, Peninsula Health is a participating organisation in state and national systems for review of multi-site research projects. Peninsula Health will accept the approval of a certified reviewing HREC and will only undertake research governance/site specific assessment to determine whether a project can be authorised to commence at Peninsual Health.
More information on the approval/authorisation process for multi-site clinical trials and research is available at https:/www.clinicaltrialsandresearch.vic.gov.au .
Information on how to apply for ethics and research governance approval can be found using the links below or by contacting the staff of the Office for Research.
External researchers must ensure that they have a Peninsula Health investigator or contact person listed in their application.
Please note that ethics/research governance review fees are applicable for some applications