Human Research Ethics Committee - HREC
All research projects involving human subjects undertaken in, or under the auspices of Austin Health, require the prior approval of the Austin Health Human Research Ethics Committee (HREC). The HREC is constituted in accordance with the requirements of the National Health & Medical Research Council (NHMRC).
Applications will be accepted from Austin Health employees, staff at institutions with formal affiliations with the Austin Health, or where independent researchers are seeking the expertise of an institutional ethics committee.
From 1 July 2009, only the NEAF (National Ethics Application Form) will be accepted. The relevant Austin Health site-specific documents should be submitted in conjunction with the Common Application Form. The use of the NEAF (mandated by the DHS SERP - streamlined ethical review process) requires not only the Austin Health site-specific documents but also the NEAF Victorian State-Specific Documents if required, (see template download). You should also complete the Victorian State-Specific Checklist (see template download).
At Austin Health the ethics approval process is a two-tier process with applications being reviewed by one of two scientific sub-committees - the Drug Trial Sub-committee or the Non Drug Study Review Committee, before being referred to HREC for final ethical review. This process takes a minimum of 38 days (30 working days).
Proposals meeting the following specifications can be submitted for scientific review to the delivery point below:
- Involving the administration of any substance by any route (ingested, injected or applied), it must be submitted through the Drug Trials Sub-Committee (DTSC).
- Not involving the administration of a substance it must be submitted through the Non Drug Study Review Committee (NDSRC). NB In the site specific documents there is a Cover Sheet to be submitted with all applications to NDSRC. Device trials (even CTN device trials) can be submitted through the NDSRC unless they also include administration of a drug.
- All submissions for new studies attract a submission fee. This must be paid up-front by either completing the HREC submission fee form (included in the site specific documents under DTSC or NDSRC) OR submitting a cheque (made out to Austin Health Research Ethics Unit). Submissions for commercially sponsored protocol amendments also attract a fee that must be paid up front when making the submission. New fees are in place from January 2010.
Streamlined Ethical Review Process (SERP)
Austin Health is participating in the Victoria SERP system as both a Reviewing HREC and a participating site. For full details of this process visit the website www.health.vic.gov.au/cchre/ If your study is to be submitted to Austin Health for review via the SERP system, you still need to notify the REU and book a space. SERP review submissions attract the usual HREC submission fees.This fee must be submitted at the same time as the study documentation.
To assist with document submission requirements, please use the SERP ethics checklist
If you plan to be a participating site (with review by another HREC) please notify the REU as soon as possible in order to facilitate approval. Participating site documentation requires submission of a 'governance' package. The Austin Health governance review fee is the same as the HREC submission fee. This fee must be submitted with the governance review documentation.
To assist with document submission requirements, please use the SERP governance checklist
If you have any queries about the SERP system itself, contact the Coordinating Office for Human Research Ethics on 03 9092 1987
Word versions of PDF files
Should you require a word version of any of the PDF file template forms, please email ethics@austin.org.au
Delivery point:
Research Ethics Unit (REU)
Henry Buck Building
Austin Hospital
145 Studley Road
Heidelberg
Victoria
Australia, 3084
The DTSC or NDSRC will then forward it to the Human Research Ethics Committee (HREC) for ethical review.
Principal Investigators & Co-Investigators
- If the Principal Investigator is not an Austin Health, ARI or Ludwig appointment, or the research is part of a student project, the application should provide justification of the competencies of the Investigators required to conduct the research.
- Investigators who are external to Austin Health must ensure that an Austin Health staff member is part of the investigating team and shown as a co-investigator who will be responsible for the study at this site.
- Students generally cannot assume the role of Principal Investigator since the Principal Investigator assumes full ethical responsibility for the conduct of the trial. A student is defined as any person doing course work through a university
- Undergraduates are not allowed to assume the role of Principal Investigator.
- Other students will be considered on a case-by-case basis. The issues considered will be their capacity to fulfil the role, their relationship with the institution etc.
- Authorship requirements.
Duration of Ethical Approval
- Maximal approval period is 3 years. This is contingent on receipt of an annual report.
- Approval duration dates are include on the HREC letter of approval.
- Request for extensions of approval will be considered if submitted prior to approval lapsing and are best made in the annual report.
- A final report is expected for all studies.
Expedited Ethical Review
There is an Expedited Ethical Review process for Quality Assurance Projects or Research Studies that involve minimal or no risk to the study population. Studies must meet strict criteria to be eligible for review by this process, it is electronically based and review takes approximately four weeks. Please refer to Expedited ethical review.
Closing dates for applications
Details of closing dates for applications are listed with the meeting dates. DTSC submission dates 2010, NDSRC submission dates 2010
NHMRC Australian Health Ethics Committee (AHEC) Position Statement 'Monitoring and reporting of safety for clinical trials involving therapeutic products' May 2009
The Austin Health HREC adopted this position statement at their September 2009 meeting.
Self Audit Tool for Researchers
This document has been designed to help researchers reflect on their research conduct and to comply with guidelines for responsible research conduct. The HREC suggest that study coordinators complete this document annually when completing their annual report, discuss and obtain 'sign-off' from the Principal Investigator and then file the signed document with other study documents. The HREC may choose to audit researchers ad hoc. To download the tool, click here.
Austin Health Scanned Medical Record Requirements
Austin Health has converted to a scanned medical record. This change requires all Participant Information and Consent Forms [PICFs] to have barcodes attached. Please ensure that all future PICF submission contain the barcode (template PICF). In addition, any trials/studies still recruiting will also need to have the barcode inserted into their current PICF (instructions for inserting a barcode). The updated PICF needs to be submitted to the REU for approval. As long as no other changes are made, apart from the required formatting, approval will be given 'out-of-session'.
Drug Trial Sub-committee - DTSC
From 1 July, only the NEAF will be accepted. Use of the NEAF also requires the Victorian State Specific Documents if required, (see template download). You should also complete the Victorian State-Specific Checklist. In addition to the NEAF, the Austin Health site specific documents must be submitted (as appropriate).
Currently all submissions are paper based.
Proposals meeting the following specifications must be submitted through the Drug Trials Sub-Committee for scientific review via the delivery point below:
- Where a proposal involves the administration of any substance by any route (e.g. ingestion, injection or application)
Delivery point:
Research Ethics Unit (REU)
Henry Buck Building - Austin Hospital
Non Drug Scientific Review Committee - NDSRC
From 1 July, only the NEAF will be accepted. Use of the NEAF may also require the Victorian State-Specific Documents, (see template download). You should also complete the Victorian State-Specific Checklist (see template download). In addition to the NEAF, the Austin Health site specific documents must be submitted (as appropriate).
- Where a proposal does not involve the administration of a substance it must be submitted through the Research Ethics Unit to the Non Drug Study Review Committee (NDSRC), for scientific review. NB In the site specific documents there is a Cover Sheet to be submitted with all applications to NDSRC.
- Non-drug CTN device trials can be submitted to the NDSRC.
Please note: The Non Drug Study Review Committee (NDSRC) is trialling an electronic submission process. Please read the Important notice for Non Drug Review Committee Researchers from the list of downloads below.
Word versions of PDF files
Should you require a word version of any of the PDF file template forms, please email ethics@austin.org.au
Delivery point:
ethics@austin.org.au
Research Ethics Unit (REU)
Henry Buck Building
Austin Hospital
Animal Ethics Committee
All research performed on Austin Health campuses involving the use of animals is undertaken with approval from the Austin Health Animal Research Ethics Committee.
For further information visit the Austin Health Animal Ethics Committee website.
Institutional Biosafety Committee (IBC)
All work at Austin Health involving the conduct, management or containment of genetically modified organisms is undertaken with approval from the Austin Health Institutional Biosafety Committee.
For further information, visit the Austin Health Institutional Biosafety Committee website.
