HREC Application Forms and Guidelines

NEW! Please download the Submission Requirements for All Research Projects checklist. These requirements are mandatory for acceptance of a project for ethical review.

To ensure you are using the latest version of the application form, please download the document directly from the Research Directorate web site each time you prepare a new application.

The aims of this research project application package are to:

• facilitate the efficient and thorough review of research involving humans;
• ensure that the research is conducted in accordance with the National Statement on Ethical Conduct in Human Research (2007)

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HOW TO USE THIS APPLICATION FORM

This 'form' consists of a number of modules with accompanying guidelines. It is imperative that applicants read the guidelines before completing the corresponding form. These guidelines provide advice and instructions for answering the questions on the forms.

All researchers intending to submit research project applications to the Melbourne Health Human Research Ethics Committee (HREC) must read and complete Module One and the Module Six - Site Specific Requirements Form.

Additionally, depending on the particular type of research you wish to undertake, you must also complete the additional module(s) relevant to your particular project.

Module One - Core Application  
Module Two - Clinical Trials of Drugs and Therapeutic Devices
Module Three - Use of Human Tissue Samples (and genetics research)
Module Four - Ionising Radiation
Module Five - There is currently no Module Five.
Module Six - The Melbourne Health Research Directorate - Site Specific Requirements
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Module One - Core Application (all to complete)

• Form
• Guidelines

Participant Information and Consent Forms

• PICF Template for Non-Clinical Trials
• PICF Template for Clinical Trials
• Molecular Medicine Informatics Model (MMIM) Standard Clause
  The standard clause in this document should be incorporated into the 'Privacy, Confidentiality and Disclosure of Information' section of the Participant Information and Consent Form, with the subheading 'Molecular Medicine Informatics Model'.
• Molecular Medicine Informatics Model (MMIM) Project - Frequently Asked Questions

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Module Two: Clinical Trials of Drugs and Therapeutic Devices

• Form
• Guidelines
• Clinical Trial Research Agreement

For clinical trials - an indemnity must be provided by the sponsor for all sponsored clinical trials and the prescribed format must be followed

• Form of Indemnity for Clinical Trials
• Form of Indemnity for Clinical Trials HREC REVIEW ONLY

Research Governance

• Insurance Guidelines for Clinical Trials 2007
• Clinical Trial Costing Financial Process and Related Matters
• Melbourne Health Clinical Trial Agreements
• The Australian Clinical Trial Handbook
• Access to unapproved therapeutic goods in Australia
• Unapproved therapeutic goods - Authorised prescribers
• Pharmacy Involvement in Clinical Trials

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Module 3: Use of Human Tissue Samples (and Genetic Research)

• Form
• Module 3 - Guidelines for Human Tissue Samples in Research
• Guidelines for Use of Human Tissues Samples - Melbourne Health

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Module Four: Ionising Radiation

• Form
• Guidelines
• Research Involving Ionising Radiation

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Module Five

There is currently no Module Five.

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Module Six: The Melbourne Health Research Directorate Site Specific Requirements (all to complete)

For New Research Projects - At Initial Submission:

In addition to Module One and any of Modules Two to Four researchers submitting projects to the Melbourne Health HREC must complete the relevant Module Six forms below:

• Part 1: Forms are mandatory - these must be completed for every project.
• Part 2: Forms must be completed if they are relevant to your particular project.

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Part 1 - Mandatory - All to complete

• Site Specific Form (Formerly Forms 1, 2 and 3).
  Includes Type of Research notification (indicate whether your research involves humans, and/or animals, and/or genetic manipulation, which sites your research will be conducted at and the number of participants at each site); Hospital/Shared Services Required for this Research (indicate which Hospital services will be required, including host department, to undertake this research) and Site Specific Requirements Checklist

Part 2 - Complete if Relevant to Your Research Project

• FORM 4 Declaration_by_Researchers
  (For Mutual Acceptance Projects only)
• FORM 5 Certification by Principal Researcher and Head of Department
  (For Mutual Acceptance of Projects - Cancer Trials Australia/Clinical Haematology and Medical Oncology only)
• FORM 6a Statement of Approval
  (complete one form for each service/department to be involved)
• FORM 6b MPH Notification Form
  (complete this form whenever the research may involve Melbourne Private Hospital)
• FORM 7a Pathology Approval Application
  (complete this form where Hospital Pathology services are required)
• FORM 8a and 8b Health Information/Medical Records
  (complete these forms where Medical Records Services are required)
• FORM 8c MPH Health Information Service Accounting Agreement
  (complete this form whenever the research may involve Melbourne Private Hospital)
• FORM 9 Clinical_trials_information
  (completion of this form is mandatory for all Clinical Trials)
• FORM 11 Approval_to_Examine_Records_for_the_Purposes_of_Research
  (to be completed where a research project requires the review of medical records by clinical trial monitors or other persons not affiliated with the hospital)
• FORM 15 Documents for Approval and Signing by the Chief Executive or Board Template (must be completed in respect of all clinical trial agreements with a budget of $100,000 or more and where Melbourne Health is a party to the agreement. This applies to both commercially sponsored and investigator driven research)

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Submitting an Application

• How to submit you application
• Fees for new applications and for amendments