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Applying for Ethics Review

The Ballarat Health Services (BHS) and St John of God Hospital Ballarat(SJOG) Human Research Ethics Committee (HREC)

The Ballarat Health Services and St John of God Human Research Ethics Committee (BHSSJOG HREC) is a duly constituted Ethics Committee under the guidelines of the NHMRC, responsible for approving, overseeing and monitoring the conduct and performance of research in both institutions and partners throughout the Grampians Regions.

By obtaining appropriate ethical approval for human research work, researchers:

  • Receive assistance and advice to help conduct human research in accordance with the relevant regulations and legislation
  • Improve human research by ensuring that ethical considerations are an integral component of the project design
  • Ensure that the research is adequately indemnified.

The Ethics Committee must approve all research projects to be conducted by staff members and visiting clinicians and all projects involving participants who are patients/clients or staff members of Ballarat Health Services and St John of God Hospital and partner organisations.

Research involving humans must not be undertaken until a formal signed approval has been confirmed by BHSSJOG HREC.

APPLICATION PROCESS

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 electronically via the “Online Forms for Research website” https://www.ethicsform.org/au/SignIn.aspx

The online forms web site will ask you to log in or create an account if you are a first time user. You will then be able to 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.

The Victorian Specific Module form is required for research conducted in Victoria can be obtained via the Department of Health website http://www.health.vic.gov.au/clinicaltrials/application-instructions.htm

The Participant Information and Consent form (PICF) is to be constructed on one of the Victorian Department of Health master templates available at http://www.health.vic.gov.au/clinicaltrials/application-instructions.htm.

New versions (June 2014) of PICF templates (except for Participant Partner Pregnancy) have been modified to address guidance on the new Australian Privacy Principles and amendment to the compensation clauses for clinical trials.

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.

LOW / NEGLIGIBLE RISK ETHICAL REVIEW APPLICATION

There are nine 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 at 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.

SUBMISSION REQUIREMENTS

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

Deliver two completed copies, one signed original and one photocopy, to: Ballarat Health Services, Research and Ethics Service, PO Box 577, Drummond Street, Ballarat 3353.

Timelines

The BHSSJOG HREC meets at least six 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
14 August 2014 4 September 2014
25 September 2014 16 October 2014
6 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.