Streamlining ethical review

Page contents: Scope | Standard Operating Procedures | Retrospective entry to streamline system | Participating organisations | Accredited reviewing HRECS | Accreditation | Further information

• 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 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.

• This includes interventional clinical trials involving adults and children
• The scope also includes research involving radiation therapy, surgery and medical testing.

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

For organisations participating in the streamlined system, clinical trials in Victoria will undergo a single ethical review. Victorian reviewing Human Research Ethics Committees (HRECs) are accredited to review clinical trials by the Consultative Council. See HREC Applications for more information.

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Standard Operating Procedures

For more information refer to the Standard Operating Procedures:

• Standard Operating Procedures for Victoria’s Central Ethics Review System for Multi-site Clinical Trials (269kb, pdf)
•  Standard Operating Procedures for Coordinators of Reviewing HRECs
•  Standard Operating Procedures for Research Governance Officers

Commencement of a trial will require both ethical approval and research governance authorisation.  Research Governance must occur at all organisations conducting a clinical trial.

Retrospective entry to streamlined system

•  Retrospective entry to streamlined system

The Online Forms website is available to all researchers in Victoria to make an ethics application.

The streamlining of ethical review of multi-site clinical trials commenced in November 2009 in Victoria.

Participating organisations

Accredited reviewing HRECS

The following human research ethics committees have been accredited by the Consultative Council in the first instance:

• Alfred Health
• Austin Health
• Melbourne Health
• Peter MacCallum Cancer Centre
• The Royal Children’s Hospital
• Southern Health
• St Vincent’s Hospital (Melbourne)

Accreditation

The Consultative Council is responsible for the selection and accreditation of Human Research Ethics Committees for reviewing multi-site clinical trials. From time to time the Consultative Council will consider accreditation of new reviewing HRECs. The application documents below are for your information only.

• Application for accreditation as a Reviewing Human Research Ethics Committee (HREC) (116kb, MS Word)
• Guidelines for accreditation submission (41kb, MS Word)

Further information

 Streamline Ethical Review of Multi-Site Clinical Trials in Victoria