How to make an HREC application

Page contents: Scope | Use of Ionising Radiation | Ethics Application Process Preparation | Allocation of an HREC application to a reviewing HREC | Completing the HREC application form | Submission of the HREC application to the reviewing HREC | Ongoing Communication with the reviewing HREC

A 'clinical trial' is defined as:

an interventional drug or device trial, radiation therapy, surgery, treatment and diagnostic procedure.

Scope

The central system for ethical and scientific review of multi-site research in Victoria will apply to research involving interventional clinical trials.

These will include drug and device trials that are conducted by:

• Commercial sponsors
• Collaborative groups/Consortiums
• Investigator-initiated groups

however at this stage it excludes research such as supportive care and psycho-oncology and these areas may be considered at a later stage.

Note:

• Intake of HREC applications for interventional clinical trials involving children will occur from February 2011 (for March 2011 HREC meeting)
• The central system will apply to interventional clinical trials, as defined above, and studies associated with ongoing activities relating to trials that have been conducted. This may include observational research and evaluation of a trial, developing a registry and other post-marketing surveillance activities.

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Use of ionising radiation

For more information refer to the Standard Operating Procedures for Victoria’s Central Ethics Review System for Multi-site Clinical Trials. A brief extract of SOP 06 ‘Use of ionising radiation submission requirements for HREC review’ follows:

The reviewing HREC will review all relevant documents relating to the HREC application, including the following that relate to use of ionising radiation:

• Victorian Specific Module completed by the Coordinating Principal Investigator (CPI)
• Section 4 - Use of Ionising Radiation. An individual Section 4 for all other study sites (not including the CPI site)
• The Master PICF for the CPI site that has the radiation risk statement for that site
• A Site Master PICF (if required) with a radiation risk statement for that site
• A Medical Physicists Report for each participating site. 

If the Medical Physicist(s) report(s) advises the relevant PI that the trial needs to be submitted to the Department of Health Radiation Safety Section, the following steps should be taken:

After HREC approval of a project, the CPI should submit the following to the Radiation Safety Section, Department of Health (DH):

• A cover letter stating the study is multi-site and has been reviewed in the streamlined system, title of the project, HREC Application Reference Number and all sites approved by the reviewing HREC
• Copy of the HREC approval letter
• Victorian Specific Module – (which includes use of ionising radiation details) at the CPI's site only
• Medical Physicists Report for the CPI's site
• Master PICF – approved by the reviewing HREC
• Study Protocol.

Following HREC approval of a project, the Radiation Safety Section, DH would require from each Principal Investigator (PI) at each of the other study sites:

• A cover letter stating the study is multi-site and has been reviewed in the streamlined system, title of the project, HREC Application Reference Number and all sites approved by the reviewing HREC
• Section 4 Use of Ionising Radiation for the individual site
• Medical Physicist's Report for the individual site
• The Master or Site Master PICF with the site's radiation risk statement.

The steps below are a guide to making an HREC application.

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1. Ethics Application Process Preparation

Approximately two weeks before the HREC application is ready to submit, call the Central Allocation System line to allocate the application to a reviewing HREC (see below).

The central allocation system requires applicants to identify disciplines that apply to the research project. All applicants should choose ‘clinical research’ then identify two additional disciplines that best describe the research project.

Identify categories that apply to your research from the attached list.

 NHMRC Categories

Ethics Submission Checklist and standard Cover Letter

The Coordinating Principal Investigator (CPI) or Principal Investigator (PI) (at a single site) must submit the Ethics Submission Checklist, standard Cover Letter and the HREC submission documents as indicated in the following steps:

 CPI PI Ethics Checklist 2012
 HREC Applications Cover Letter

2. Allocation of an HREC application to a reviewing HREC

Call the Central Allocation System line if your HREC application will be ready to submit to a reviewing HREC in approximately two weeks' time.

Central Allocation System line: (61 3) 9092 1983, Monday to Friday 10am to 5pm EST.

This phone call will involve answering questions about your research and you will be asked to provide relevant information.  The call will take approximately fifteen minutes.

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3. Completing the HREC application form

The HREC Form should be completed on the Online Forms website.  You must also upload all supporting documents electronically where possible.

The Victorian Specific Module is mandatory and must be uploaded as a supporting document.

The document below is the recommended Participant Information and Consent Form (PICF) template for clinical drug/device research projects:

 Participant Information and Consent Form - Clinical drug device

4. Submission of the HREC application to the reviewing HREC

When the HREC application is complete it must have a 'submission code' from the Online Forms website.
Print the HREC application and supporting documents. The Coordinating Principal Investigator must sign all documents in hard copy, where applicable.

Each Principal Investigator must provide the Coordinating Principal Investigator with (in hard copy) site specific documents, if applicable, and these must be attached to the HREC application by the CPI as a supporting document.
Site-specific documents could include (as applicable):

• Site Specific Participation Information and Consent Form(s) with site-specific wording
• Use of Ionising Radiation Section 4 and radiation risk assessment complete with signatures.

 Section 4 Use of Ionising Radiation
 Section 4 Use of Ionising Radiation Guidelines

Note that the HREC application must be of a high standard and fully complete.  If not the application may be deemed invalid and void.  In this case a new application will have to be submitted.

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5. Post-HREC Approval Reports and Amendments

It is essential that there is open and ongoing communication between the Coordinating Principal Investigator and the reviewing HREC Coordinator/Administration Officer regarding the progress of ethical review, and post-review processes.

For more information refer to the Standard Operating Procedures.

Standard templates for monitoring and reporting

The Reviewing HREC and Research Governance Standards Sub-committee have completed standard templates for monitoring and reporting to the reviewing HREC.

The templates can be filled in online and printed for submission to the reviewing HREC.

More templates will be developed by the sub-committee in 2010.

 HREC Amendment Form
 AE SAE Report
 Summary AE SAE Report
Protocol Deviation or Violation Report (88kb, MS Word)
HREC Progress Report CPI Cover Sheet (87kb, MS Word)
 HREC Progress Report Site Report
HREC Final Report (91kb, MS Word)
Site Audit for Research Governance (121kb, MS Word)
 Complaints Report to HREC - Site Report

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Low and negligible risk clinical trial research

For studies associated with interventional clinical trials and ongoing activities relating to these trials that have been conducted it may be appropriate to submit a Low and Negligible Risk Form for ethics approval. Such research could include observational research and evaluation of a trial, developing a registry and other post-marketing surveillance activities.

 VIC LNR HREC Application Form – January 2012
 VIC LNR SSA Application Form

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