More than Low Risk Research

Page Contents

General Information | Registration of Projects | Application Information | Submission RequirementsNotification of Review Outcome | After Approval

Please note that this section does not apply to the following types of studies:


Important information for researchers 

As from 16 July 2018 the Ethics and Governance database and submission process has changed.  All applications and post approval documents will need to be created and submitted through the newly released Ethics Review Manager (ERM) Database for approval.  ERM replaces Online Forms.

New Applications

Instead of using Online Forms you will need to create and submit through ERM.  If you already have an Online Forms login and password it will transfer to ERM.  If your Online Forms login and password does not work, contact

If you have not previously used Online Forms you will need to register in ERM.

Where do I find ERM?

The staff from the Office for Research will be able to assist you.  Call Kim Sherry on 9784 2680 to make a time to call in or email Kim, with your questions.


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:

Registration of projects and the scientific review process

Submit a protocol (templates below) to

The protocol will be reviewed by the Manager Office for Research to ensure it meets the criteria for HREC review and to determine if Scientific Advisory Subcommittee (SAS) review is required.  You will be notified by email of the outcome of this review.

Click here for an outline of the scientific review process and here for a summary.

Protocol templates

Protocol templates and guidelines are available to assist you in writing this document.

  • For Clinical Trials – Template available from Clinical Research Development Office at Murdoch Children’s Research Institute.  Protocol must comply with Good Clinical Practice. 

Application Information

Below is a list of the documents required for submission. Incomplete applications will not be accepted for review by the HREC.

All applications must:

  • Contain documents which have a version number and date (no draft documents will be accepted)
  • Comply with the submission instructions


  • Mandatory for all applications



HREC Coversheet

Must list all documents relating to the submission and be signed by the Principal Investigator

Human Research Ethics Application (HREA)

To be completed through ERM Applications website. First time users will need to create an account

Victorian Specific Module (VSM)

Addresses Victorian specific legislative requirements not covered in the HREA. Only complete and submit sections relevant to the project. The VSM is available as a sub-form of the HREA through ERM Applications.


  • Depending on the project, some or all of these documents may be required



(Mandatory for all projects)

Must match the protocol submitted as part of the project registration. See ‘Registering a project’ section above

Participant Information and Consent Forms (PICF)

  • Use the template appropriate for your project



Must use the templates available from Department of Health and Human Services. Other formats are not accepted.

Data Collection Tools including:

  • Questionnaires
  • Surveys
  • Focus group questions/themes
  • Telephone questionnaires
  • Data collection forms / Case report forms

This includes a printed version of online surveys and validated assessment tools.

Advertising/Recruitment Material

  • Letter / Email invitation
  • Posters
  • Brochures / Leaflets etc
  • Content for media (including radio, print and digital / social media)

See Advertising Guidelines

Additional Documents for Clinical Trials

  • Investigator Brochure / Product Information
  • Instructions for participants
  • Any other documents required under GCP

See Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2)

Investigator CV for each researcher (if one has not been submitted in the previous 3 years)

Investigator CV Template available

Full CV is not required

Projects involving ionising radiation

Contact the Manager Office for Research  

Ethics Payment Form

Refer to the Payment Form and complete relevant section (if applicable)


  • Mandatory for all applications

Site Specific Assessment (SSA) Form

To be completed through ERM Applications website.

Must be linked to the HREA (help information available from website)


  • Depending on the project, some or all of these documents may be required

Clinical Trial / Collaborative Research Agreements

Contact the Manager Office for Research if you are unsure if this is required for your project 

Resource Centre Declaration and Service Request Forms

Forms to be used by the service department to determine the cost of the services requested.  These are not considered as part of the research governance review but are to be sighted as part of the application.

Clinical Trial Notification (CTN) is completed online.

For projects involving the use of unapproved therapeutic goods. See TGA guidelines. Contact Manager Office for Research.


Contact the Manager Office for Research if you are unsure if this is required for your project.

Certificate of Currency


Must provide sufficient evidence that the commercial sponsor or CRO meets minimum insurance requirements.


Additional Requirement for single-site clinical trials involving drugs

The HREC will not approve single-site clinical drug trials until approval has been granted by the Peninsula Health Drugs and Therapeutics Committee. Please contact the Drugs and Therapeutics Committee Convenor on 9784 7601, or email Ben Leung for further information.

Submission Requirements

Click here for HREC meeting dates and submission deadlines for 2018.

Research applications will be returned if they do not comply with the submission requirements.

A maximum of 5 new applications will be reviewed at each HREC meeting. The first 5 completed applications submitted will be accepted. An application is considered complete when it complies with the submission instructions and includes all required signatures.

Pre-Screen Submission (Due by New Study Pre-Screen Deadline)

Email completed application to Application does not need to be signed at this stage.

The application will undergo preliminary review by the Office for Research who will make recommendations regarding the final submission where required.

Final Submission (Due by Agenda Closure Deadline)

Submit electronic copy of full application (including any documents modified based on feedback from the Office for Research) via ERM Applications website.  

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

Electronic signatures are preferred on application forms. Scanned signatures are acceptable as long as the original signed documents can be provided on request (such as during an audit). Original signatures are required on CTRA and Indemnity documents.

Notification of Review Outcome

The outcome of the HREC review will be emailed by the Office for Research to the research application contact person within 7 days of the HREC meeting.  The outcome will detail the decision of the HREC and any modifications/amendments required before the approval to commence letter is issued. 

Research 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 and submission templates for post-approval changes and reporting are available from here.