All research where the foreseeable risk is greater than that of discomfort to participants, patients, clients, residents or staff of Peninsula Health, whether undertaken by a Peninsula Health staff member or an external researcher, must be reviewed by the Peninsula Health Human Research Ethics Committee (HREC).

The HREC reviews research projects in accordance with the values and principles outlined in the National Statement on Ethical Conduct in Human Research (2007).

General Information

Researchers are expected to be familiar with the following legislation, guidelines and policies (as a minimum) relating to research:

• National Statement on Ethical Conduct in Human Research
• Australian Code for the Responsible Conduct of Research
• Statutory Guidelines on Research issued for the purposes of Health Privacy Principles 1.1(e)(iii) & 2.2(g)(iii), February 2002
• Guardianship and Administration Act 2019 (Vic)
• Medical Treatment Planning and Decisions Act 2016
• Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) (for clinical trials only)

Application Information

All applications must be submitted through ERM Applications.

Guidance for completing applications through ERM is available from here. 

• Protocol templates

Protocol templates and guidelines are available:

• • Clinical Trials – Template available from Clinical Research Development Office at Murdoch Children’s Research Institute.  Protocol must comply with Good Clinical Practice. 
  • Health and Medical Research – Basic protocol template available. 

A list of documents required for submission is available from here.  Please note this document also contains details of the documentation required for post-approval submissions.

• Additional Requirement for single-site clinical trials involving drugs or devices

The HREC will not approve single-site clinical drug trials until approval has been granted by the Peninsula Health Drugs and Therapeutics Committee. 

Submission Requirements

Click here for HREC meeting dates and submission deadlines for 2023.

A maximum of 5 new applications will be reviewed at each HREC meeting. The first 5 completed applications submitted will be accepted. 

• Pre-Screen Submission 

Submit completed application via ERM Applications by the New Study Pre-Screen Deadline.  The Office for Research will undertake a preliminary review of the application.  Recommendations regarding the final submission will be made where required.

• Final Submission (Due by Agenda Closure Deadline)

Any modifications to the application (including any supporting documents) after the Pre-Screen Submission are to be re-submitted via ERM Applications by the Agenda Closure Deadline.

ERM’s electronic signature process is to be used for all required signatures, including Head of Department and Head/s of Supporting Department/s.  Original signatures are required on Agreements and Indemnity documents.

Submit hard copy documents to the Office for Research.  Documents required in hard copy include:

• • Required number of copies (as applicable) of
    • Agreement – signed by sponsor and Principal Investigator
    • Indemnity – signed by sponsor  

Notification of Review Outcome

The outcome of the HREC review will be sent via ERM by the Office for Research.  The outcome will detail the decision of the HREC and any modifications/amendments required before the approval letter is issued. 

Research projects must not commence until a formal signed approval has been received.

After Approval

Researchers must comply with the monitoring and reporting requirements for approved research detailed in the approval to commence letter. 

Requirements for post-approval changes and reporting are available from here.