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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 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 HREA and a SSA. When completing the HREA, the researcher is strongly advised to refer to the relevant section of the National Statement 2007 (Updated 2015) to understand the ethical implications of their answer.

HREA E-Bulletin updates. 

Low risk ethics review 
The HREA form has capacity to be used for low risk research applications; the VSM must be reviewed with the HREA.
 
The LNR VIC and LNR VIC SSA are available for low risk research in Victoria only.  

If you would like to add a link on our website, the URL for the E-bulletin is:
https://www.vision6.com.au/em/message/email/view.php?id=919247&u=94475&k...
 
As always, please contact our office  (ResearchEthics@bhs.org.au) or Infonetica helpdesk if you require any further information. helpdesk@infonetica.net
 

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 (HREA) 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 HREA and a SSA. When completing the HREA , 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 (HREA)

The following essential documents are required for ethical review.

  1. Protocol/Research Plan
  2. Human Research Ethics Application (HREA)
  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
  10. Legal and regulatory documents (if required)
  11. Supporting documents eg: questionnaire/s, data collection tools, advertisements, letters of support, investigator brochures, etc.
  12. 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
  9. Legal and regulatory documents (if required)
  10. Supporting documents eg: questionnaire/s, data collection tools, advertisements, letters of support, investigator brochures, etc.
  11. Confirmation of payment or Executive Director Medical Services approval of waiver of Fee.

QUALITY ASSURANCE APPLICATIONS

BACKGROUND

An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a QA activity. Terms such as ‘peer review’, ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’ are often used interchangeably. In this document the term ‘quality assurance’ is used to include all of these terms.

QA commonly involve minimal risk, burden or inconvenience to participants, and, while some level of oversight is necessary, Human Research Ethics Committee (HREC) review processes are often not the optimal pathway for review of these activities.

Irrespective of whether an activity is QA, evaluation or research, the activity must be conducted in a way that is ethical. This should include consideration of whether the people involved will be exposed to any harm as a result of the activity. Those conducting the activity need to consider a range of issues including consent, privacy, relevant legislation, national/professional standards.

Taken from: NHMRC document Ethical Considerations in Quality Assurance and Evaluation Activities, March 2014

QA Application to be downloaded and submitted to -  ResearchEthics@bhs.org.au

 

SUBMISSION REQUIREMENTS

Upload all documents with your application via https://au.ethicsform.org/SignIn.aspx

Deliver signed originals to: Research and Ethics Service, Ballarat Health Services, PO Box 577, Ballarat 3353.

Timelines

The BHSSJGBH HREC meets at least eight times annually.

Applications and correspondence items will not be reviewed by the committee unless all documents are signed and the ethics applications are completed within the approved database and has been received by the Research and Ethics Service by 5pm on the closure of the agenda date.

The dates for 2018 are:

Agenda Closure HREC Review Dates
8 January 2018 8 February 2018
19 February 2018 15 March 2018
9 April 2018 3 May 2018
21 May 2018 14 June 2018
2 July 2018 26 July 2018
13 August 2018 6 September 2018
24 September 2018 18 October 2018
5 November 2018 6 December 2018

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.