In this Section:
All submissions must now be submitted via the Ethics Research Management website.
This includes new project submissions and all post approval activity
The Office for Research has a 'Drop In' Service for researchers seeking advice, clarification or assistance with ethics and governance.
Days: Tuesday and Friday
Time: 12pm to 1pm
Location: Harold Stokes Building
Office for Research
To serve you better and process your submissions in a timely manner, it is appreciated if all appointments outside this time be made via email@example.com
Contracts and all other documents can be submitted in the in-tray at the front desk outside these times following completion of the supplied cover sheet.
The participant's scanned medical record should include documentation of the participant's consent to research. It should include an outline of what was discussed, including risks. The amount of recording necessary depends on the circumstances of the consent and the amount of information provided on a consent form. It is not necessary to repeat information already documented on the consent form.
The signed consent form in its entirety should be sent to Health Information Services (HIS) to be scanned into the participants scanned medical record (SMR). A copy of the signed consent form should be given to the participant for their personal records.
No, Governance submissions can be submitted at any time.
Please submit a cover letter providing HREC number and Study Title along with the correspondence document/s to the Office for Research for acknowledgment.
Any Contract/Agreement submitted to the Office for Research that deviates from the Standard Template must be reviewed by Corporate Counsel following submission to our office for processing.
This may delay the approval/authorisation of a project by several weeks.
· Identifiable: the identity of a specific individual can be determined
· Re-identifiable: data from which identifiers have been removed and replaced by a code; however it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets
· Non-identifiable: data that have never been labelled with individual identifiers or from which the identifier has been permanently removed and therefore no specific individual can be identified
Please refer Chapter 3.2 of the National Statement located at NHMRC National Statement for Ethical Conduct in Human Research
If your study includes radiation please follow the Radiation Submission Process Flowchart to assist with your project submission requirements.
Please complete the Medical Physicist Report Request Form
and forward the:
to the Radiation Safety Officer prior to submitting your ethics package.
Occupational therapists work in a variety of inpatient settings within Austin Health:
Refer to the Therapeutic Goods Administration (TGA) website for full details. However in short, a therapeutic device is one that is used in or connected with:
If you are using a therapeutic device outside of its approved indication, you must submit an eCTN.
The Australian Government Department of Health Therapeutic Goods Administration (TGA) require notification of completion from the Sponsor, this should be made only after the trial has been completed at all sites. It is not necessary to notify completion dates for individual sites.
This online form should be used by sponsors of clinical trials to notify the TGA of completion of trials of medicines, biologicals and medical devices conducted under the CTN and CTX Schemes.
For information regarding the role of a sponsor, please see: http://www.tga.gov.au/industry/basics-role-of-sponsor.htm
Please also e-mail a copy of the notification to firstname.lastname@example.org (refer to the HREC/Local Reference Number).
Case reports in medical journals describe and explain the way in which a patient has experienced a particular medical condition. The Consent Form required is to be used for a patient consenting to publication of information about them in a medical journal. In some cases journals may require their own consent form to be signed, for others you may use the Austin Health site specific Consent Form.
Austin Health site specific Consent Form (updated June 2013)
In the event that the HREC is presented with a first time in humans phase 1 clinical trial to be reviewed under the CTN scheme, the HREC follows the Protocol for review of First Time in Human Research Proposals under the CTN Scheme developed by the Victorian Managed Insurance Authority (VMIA), insurer of all public hospitals in Victoria.
This protocol is designed to assist HRECs to meet their obligations under the National Statement (2007) and the Therapeutic Goods Administration’s Guidelines, Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (2004), by providing a rigorous, standardised protocol for the review of first time in humans trials, which includes access to a comprehensive database of independent experts with extensive expertise in evaluating preclinical data.
Please ensure you contact the office for research to discuss arrangements prior to booking the study in for HREC review.