Statewide Equipment Program

You are here

Applying for Ethics Review and/or Research Governance Authorisation - Processes, forms and fees.

Note: Before research can commence two separate Research Governance processes must be completed: Ethical Review and Site Specific Authorisation.

Ethics review and site specific authorisation

Note: If ethical review and approval has been obtained from another organisation then a Site Specific Authorisation (SSA) Form with applicable fee is to be submitted with a full copy of all approved ethics review documentation before research can commence at BHS, SJOGBH and partners.

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

The Ballarat Health Services and St John of God Ballarat Hospital Human Research Ethics Committee (BHSSJGBH 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 Ballarat Hospital and partner organisations.

Research involving humans must not be undertaken until a formal signed approval has been confirmed by BHSSJGBH 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 (NEAF) or a low/negligible risk ethical review (LNR) 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.

FULL ETHICAL REVIEW APPLICATION (NEAF)

The following essential documents are required for ethical review.

  1. Protocol/Research Plan
  2. National Ethics Application Form (NEAF)
  3. Site Specific Assessment Form (SSA) for each site
  4. Victorian Specific Module (See point 3 in link)
  5. Pre-Submission (Peer) Review of Research Proposal
  6. BHSSJOG HREC Researcher Investigator Declaration
  7. Researcher/s Curriculum Vitae (if not previously submitted)
  8. Participant Information and Consent Form (PICF) (see point 5 in link)
  9. Cover letter - http://docs.health.vic.gov.au/docs/doc/HREC-Applications-Cover-Letter
  10. Legal and regulatory documents (if required): http://www.vmia.vic.gov.au/Risk-Management/Clinical-trials.aspx
  11. Supporting documents eg: questionnaire/s, data collection tools, advertisements, letters of support, investigator brochures, etc.
  12. Ethics checklist - http://docs.health.vic.gov.au/docs/doc/Ethics-checklist
  13. Confirmation of payment or Executive Director Medical Services approval of waiver of Fee.

LOW / NEGLIGIBLE RISK (LNR) ETHICAL REVIEW APPLICATION

The following essential documents are required for ethical review.

  1. Protocol/Research Plan
  2. LNRR (Vic) Low Negligible Risk Research Application Form
  3. LNRR (Vic) SSA (Site Specific Assessment form) for each site
  4. Pre-Submission (Peer) Review of Research Proposal
  5. BHSSJOG HREC Researcher Investigator Declaration
  6. Researcher/s Curriculum Vitae (if not previously submitted)
  7. Participant Information and Consent Form (PICF) - (see point 5 in link)
  8. Cover letter at http://docs.health.vic.gov.au/docs/doc/HREC-Applications-Cover-Letter
  9. Legal and regulatory documents (if required)
  10. Supporting documents eg: questionnaire/s, data collection tools, advertisements, letters of support, investigator brochures, etc.
  11. Ethics checklist go to http://docs.health.vic.gov.au/docs/doc/Ethics-checklist
  12. Confirmation of payment or Executive Director Medical Services approval of waiver of 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: Research and Ethics Service, Ballarat Health Services, PO Box 577, Ballarat 3353.

Timelines

The BHSSJGBH 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 dates for 2016 are:

Agenda Closure HREC Review Dates
3 March 2016 24 March 2016
14 April 2016 5 May 2016
26 May 2016 16 June 2016
7 July 2016 28 July 2016
18 August 2016 8 September 2016
29 September 2016 20 October 2016
10 November 2016 1 December 2016

BHS & SJGBH 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 or governance assessment has taken place. Invoices will not routinely 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.