More than Low Risk Research

Page Contents

General Information | Registration of Projects | Application Information | Submission Requirements | Fees | Notification of Review Outcome | After Approval

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

 

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 NEW scientific review process

Register your project with the Office for Research by submitting a protocol (templates below) to ResearchEthics@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 and will be allocated a registration number.

Click here for an outline of the new 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

Clinical Trial Protocol Template available from Clinical Research Development Office at Murdoch Children’s Research Institute.  An annotated version of the template is available. Protocol must comply with Good Clinical Practice. 

  • For Health and Medical Research

Basic protocol template available. 

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:

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

ETHICS APPLICATION FORMS

  • Mandatory for all applications

 

 

HREC Coversheet

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

National Ethics Application Form (NEAF)

To be completed through Australian Online Forms for Research website. First time users will need to create an account

Victorian Specific Module (VSM)

Addresses Victorian specific legislative requirements not covered in the NEAF. Only complete and submit sections relevant to the project. VSM Guidelines to assist completion are available.

ETHICS SUPPORTING DOCUMENTS

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

 

Protocol

(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 Note for the Guidance on Good Clinical Practice Annotated with TGA Comments

Investigator CV for all researchers who have not previously submitted a research CV.

Investigator CV Template available

Full CV is not required

Fee Form

Refer to the Fee Schedule and complete relevant section (if applicable)

RESEARCH GOVERNANCE APPLICATION

  • Mandatory for all applications

 

Site Specific Assessment (SSA) Form

To be completed through Australian Online Forms for Research website.

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

RESEARCH GOVERNANCE SUPPORTING DOCUMENTS

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

Clinical Trial Research Agreement (CTRA)

Standard templates available

Required when a trial has a commercial, Contract Research Organisation (CRO) or Collaborative Research Group (CRG) sponsor.

A CTRA is also required for multi-site investigator-initiated clinical trials.

Only the standard CTRA templates will be accepted.

Collaboration Agreement

May be required for non-clinical trials. Contact Manager Office for Research

Clinical Trial Notification (CTN) Form

For projects involving the use of unapproved therapeutics goods. See TGA guidelines

Indemnity

Standard template available

Required when the trial has a commercial, CRO or a CRG (registered as a business) sponsor. Indemnity is not required for university or health service CRG.

Only the standard form of indemnity will be accepted.

Certificate of Currency

(Insurance)

 

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 (link to Peninsula Health Intranet – Staff only access).

Please contact the Drugs and Therapeutics Committee Convenor on 9784 7601, or email Ben Leung or Skip Lam for further information.

Submission Requirements

Submission of research applications involves both an electronic submission and a hard-copy submission. 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 (on hard-copy only).

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

Ensure electronic files are labelled according to the HREC -Requirements for Naming Electronic Documents.

Email completed application to ResearchEthics@phcn.vic.gov.au. Include HREC reference number in email subject line. 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 any documents modified based on feedback from the Office for Research to ResearchEthics@phcn.vic.gov.au.  

The hard copy submission is to be delivered/sent to the Office for Research.  Documents required in hard copy include:

  • One copy of complete application with relevant signatures
  • Required number of copies (as applicable) of
    • CTRA – signed by sponsor and Principal Investigator
    • Indemnity – signed by sponsor
    • CTN – signed by Reviewing HREC and Principal Investigator

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

Fees

The Human Research Ethics Committee charges a fee for consideration of some research projects.

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 are available from here