HREC Applications

Page contents: Reviewing human research ethics committees | Guidance relating to an HREC application | First Time In Human protocol

Organisations are required to sign a Memorandum of Understanding (MOU) with the Consultative Council in order to participate in this system. Applicants must check with their organisation on eligibility to apply.

The two requirements for commencement of a clinical trial are:

• HREC approval
• Site specific assessment authorisation (research governance associated with ethics review).

The Online Forms website has been 'refreshed.' Information about changes is available from the login page.

The Online Forms website must be used to complete the HREC application and the research governance Site Specific Assessment (SSA) Form.

Applicants and participating site Principal Investigators must register for an account on the Online Forms website (once only).

IT Help Desk - Contact the IT Help Desk regarding technical questions on Online Forms and AU RED.

Telephone: (61 2) 9037 8404 Monday to Friday 10am to 4pm EST
Email: helpdesk@infonetica.net

You can commence the process for ethics approval and SSA authorisation at the same time. However, it should be noted that SSA authorisation cannot be completed until HREC approval has been given as there are post HREC approval governance requirements.

Reviewing Human Research Ethics Committees

2012

*Applicants must submit a letter to Angela Henjak one week before this date.

Contact details for Research Governance Officers can be found on the Site Specific Assessment Research Governance page.

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Participating Organisations

To use the system you must ensure that your organisation is a participating site and has signed an MOU with the Consultative Council. This information can be obtained from the Coordinating Office on (61 3) 9092 1981 or by email Multisite.Ethics@health.vic.gov.au or by contacting organisations directly.

This information can also be obtained by contacting organisations directly or by contacting the appropriate Research Governance Officer.

Guidance relating to an HREC application

• Supporting documents can be uploaded before or after the HREC application has a 'submission code' generated.
• You can also import the NEAF using xml format from the National Health and Medical Research Council NEAF website.

First Time In Human protocol

The First Time In Human protocol has been developed to assist preparation of early phase clinical trials. This can be downloaded from the Victorian Managed insurance Authority (VMIA) website. The protocol can be found by proceeding to 'clinical trials' under public healthcare on the VMIA website.

Expert Review Database

The First Time in Human (FTIH) Database of Expert Reviewers can be downloaded below. Users must enter a user name and password to access this file.

Database of Expert Reviewers - Password protected (38kb, MS XLS)

To receive a username and password, please contact:

Ms Abigail Cooper
Telephone: (61 3) 9092 1998
Email: abigail.cooper@health.vic.gov.au

Related links

• Therapeutic Goods Administration
• Medicines Australia
• Medical Technology Association of Australia
• Victorian Managed Insurance Authority
• National Statement on Ethical Conduct in Human Research (2007)
• NHMRC Position Statement: Monitoring and Reporting of Safety for Clinical Trials
• Australian Code for the Responsible Conduct of Research

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