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.
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.
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
The following essential documents are required for ethical review.
Deliver two completed copies, one signed original and one photocopy, to: Research and Ethics Service, Ballarat Health Services, PO Box 577, Ballarat 3353.
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 2015 are:
HREC Review Dates
5 November 2015
26 November 2015
BHS & SJGBH 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 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.