Thank you for enquiring about your proposed research project at Ballarat Health Services. To get your ethics application under way you will either submit a full ethical review application or a low/negligible risk ethical review application.
When conducting research at Ballarat Health Services the lodgment of the project details on RiskmanQ is required.
Full ethical review application
There are approximately ten essential completed documents to submit.
1. NEAF (National Ethics Application Form)
2. SSA (Site Specific Assessment Form)
3. Victorian Specific Module
4. PICF (Participant Information and Consent Form)
5. Protocol / Research Plan
6. Cover letter go to http://docs.health.vic.gov.au/docs/doc/HREC-Applications-Cover-Letter
7. Researcher/s Curriculum Vitae (if not previously submitted)
8. Legal and regulatory documents (if required: http://www.vmia.vic.gov.au/Risk-Management/Clinical-trials.aspx
9. Supporting documents eg: questionnaire/s, data collection tools, advertisements, letters of support, investigator brochures, etc.
10. Confirmation of payment or request for invoice / or statement to confirm category for exemption for Fee.
For items 1 and 2
These forms are completed via the online forms websitehere. The online forms web site will ask you to create a log in, once in you can create a NEAF and an SSA. When completing the NEAF, the researcher is strongly advised to refer to the relevant section of the National Statement (2007) to understand the ethical implications of their answer.
For item 3
The Victorian Specific Module form is required for research conducted in Victoria can be obtained here.
Supporting documents eg: questionnaire/s, data collection tools, advertisements, letters of support, investigator brochures, etc.
Confirmation of payment or request for invoice / or statement to confirm category for exemption for Fee.
For items 1 and 2
These forms are completed via the online forms websitehere. The online forms web site will ask you to create a log in, once in you can create an LNRand an SSA. When completing the LNR, the researcher is strongly advised to refer to the relevant section of the National Statement (2007) to understand the ethical implications of their answer.
As the HREC reviews its procedures on an ongoing basis, please ensure that you also check this page for any new requirements before submitting your application. It is also strongly recommended that you forward an early or draft copy to the HREC secretary to ensure that you have met all requirements.
Deliver one completed and signed copy to: Ballarat Health Services, Research and Ethics Service, PO Box 577, Drummond Street, Ballarat 3353.
The Research and Ethics Service will advise you if further copies for your application are required after the receipt of your submission.
The BHSSJOG HREC meets at least nine times annually.
Applications and correspondence items will not be reviewed by the committee unless a signed hardcopy and an electronic copy has been received by the Research and Ethics Service by the closure of the agenda. The close of agenda and review dates for 2013 are:
Agenda closure 2pm
HREC review dates
18 November 2013
5 December 2013
BHS & SJoGHC HREC Research Governance Fees* - Effective September 2012
Fees apply for studies submitted for ethical oversight or research governance assessment and are categorised in the table following. This fee will be charged to studies whether they are reviewed under the centralised multi-site system or as a single site study.
New project applications
Administrative changes and updated investigator brochures
Clinical trials - sponsored
Commercial clinical trial - sub-studies - additional site - sponsored
University studies ie. student/post-graduate projects
Independent expert review
Fees are payable in FULL at the time of the initial submission of a project or amendment and are non-refundable after the committee review has taken place. Invoices will be issued for payment of fees. A receipt of fee will be issued only upon request.
Instructions on how to make an online payment are here.