More than Low Risk Research

 

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 Helpdesk@infonetica.net

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

Where do I find ERM?

https://au.forms.ethicalreviewmanager.com/

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, KimSherry@phcn.vic.gov.au 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 scientific review process

Submit a protocol (templates below) to HREC@phcn.vic.gov.au

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

All applications must be submitted through ERM Applications.

Guidance for completing applications through ERM is available from here

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

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 

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

Final Submission (Due by Agenda Closure Deadline)

If there have been any modifications to the application after the Pre-Screen Submission, the revised application (including any documents modified based on feedback from the Office for Research) will need 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.