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 website here. The online forms web site will ask you to create a log in, once in you can create a NEAF and a 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. 

For form 4

The participant information and consent form is to be constructed on one of three Victorian Department of Health master templates:

Health and/or social science research: http://www.health.vic.gov.au/ethics/downloads/picf_health.doc

Clinical drug/device research: http://www.health.vic.gov.au/ethics/downloads/picf_drug.doc

Clinical non drug/device research: http://www.health.vic.gov.au/ethics/downloads/picf_nondrug.doc

 

  

 

 

Low / negligible risk ethical review application

There are 10 essential completed documents to submit:

1.  LNRR (Vic) Low Negligible Risk Research Application Form
2.  LNRR (Vic) SSA (Site Specific Assessment form)
3.  PICF (Participant Information and Consent Form)
4.  Protocol / Research Plan
5.  Cover letter go to http://docs.health.vic.gov.au/docs/doc/HREC-Applications-Cover-Letter
6.  Researcher/s Curriculum Vitae (if not previously submitted)
7.  Legal and regulatory documents (if required: http://www.vmia.vic.gov.au/Risk-Management/Clinical-trials.aspx
8.  Supporting documents eg: questionnaire/s, data collection tools, advertisements, letters of support, investigator brochures, etc.
9.  Confirmation of payment or request for invoice / or statement to confirm category for exemption for Fee.

 

For items 1 and 2

The Low and Negligible Risk forms are located at the bottom of the page of this Dept of Health link and provide instructions that will assist the researcher to determine if their research may meet this review method:

 

To ensure that you are using the LATEST version of the kit, you should download the relevant modules and review the corresponding guidelines EACH time you plan to submit a new application to the HREC.

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.

 

 

Submission requirements

Deliver one electronic copy of all documents to researchethics@bhs.org.au

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. 

Timelines

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 April 2013	2 May 2013
27 May 2013	20 June 2013
18 July 2013	1 August 2013
22 August 2013	5 September 2013
19 September 2013	3 October 2013
24 October 2013	7 November 2013
21 November 2013	5 December 2013

 

BHS & SJoGHC HREC Research Governance Fees* - Effective September 2012

*All fees are inclusive of GST

BHS Clinical and Research Governance Officer     researchethics@bhs.org.au

 

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	Research amendments	Research amendments	Administrative changes and updated investigator brochures
Category		a	b (major)	b (minor)	c
1	Clinical trials - sponsored	$4400	$880	$440	$220
2	Commercial clinical trial - sub-studies - additional site - sponsored	$2200	$440	$220	$220
3	Clinical trials - sponsored (eg grants/collaborative group)	$1100	$440	$220	$220
4	Study - sponsored (eg grants/collaborative group)	$1100	$440	$220	$220
5	Study - sponsored (eg not-for-profit organisations)	$550	$220	$220	$220
6	Internal BHS and SJoG initiated - non-sponsored	No fee	No fee	No fee	No fee
7	Internal BHS/SJoG quality improvement projects - non-sponsored	No fee	No fee	No fee	No fee
8	University studies ie. student/post-graduate projects	$220	$110	$55	No fee
9	Independent expert review	Case-by-case	Case-by-case	Case-by-case	Case-by-case

 

Payment methods

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.

To make an online payment click here.