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Application Forms

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 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

For item 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

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 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.

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 eight 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 2014 are:

Agenda Closure  HREC Review Dates
17 April 2014   1 May 2014
29 May 2014  12 June 2014
10 July 2014 24 July 2014
21 August 2014 4 September 2014
2 October 2014 16 October 2014
13 November 2014 27 November 2014

                                                                                                    

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.