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

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 BHSSJOG HREC.

The HREC reviews studies such as:

  • Non-interventional
  • Qualitative
  • Laboratory or basic science
  • Observational studies
  • Clinical research involving drugs and devices. This includes both experimental agents, and those approved for use by the Therapeutic Goods Administration (TGA).
  • Non-standard clinical interventions. This includes both experimental agents, and those approved for use by the TGA.

Committee Information

HREC Meeting Dates

  • 2020 HREC Submission Dates/Closing Dates
  • Applications and correspondence items will not be reviewed by the committee unless all documents are signed and submitted within Ethics Review Manager (ERM)

The dates for 2020 are:

Closing Date for Submission

HREC Meeting Date

20 January 2020  (3:00pm)

13 February 2020

02 March 2020  (3:00pm) 

26 March 2020

13 April 2020  (3:00pm)

7 May 2020

01 June 2020  (3:00pm)

25 June 2020

20 July 2020  (3:00pm)

13 August 2020

07 September 2020  (3:00pm)

1 October 2020

19 October 2020  (3:00pm)

12 November 2020

16 November 2020  (3:00pm)

10 December 2020


Responsibilities of the Chief Principal Investigator (CPI), Principal Investigator and Sponsor 

Roles in Single Site Research Projects
Roles in Multi Site Research Projects 

Information links

 All progress reports must be submitted by the April 30 each year.

Completed Annual Reports must be submitted via ERM

Please refer to the attached “Flow Chart” to ensure compliance of the Annual /Final Progress Reports requirement for the continuation of your approved research project.

 

BHS & SJGBH HREC Research Governance Fees* - Effective 1 June 2019

*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
$5500
$880
$440
$220
2
Commercial clinical trial - sub-studies - additional site - sponsored
$2200
$440
$220
$220
3
Clinical trials - sponsored (eg grants/collaborative group)
$660
$440
$220
$220
4
Study - sponsored (eg grants/collaborative group)
$660
$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.

To make an online payment click here.

 

 

Process For Review

For any questions regarding submission, please contact the BHS Research Ethics & Governance unit via: ResearchEthics@bhs.org.au

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://au.forms.ethicalreviewmanager.com/Account/Login

The following essential documents are required for ethical review.

 

1. Confirmation of fee payment
please include remittance advice when paying with EFT

 

2. Human Research Ethics Application (HREC) Form

Please refer to the ERM User Guide for Detailed Instructions on how to create a HREA application on ERM

Human Research Ethics Application (HREA)

 

 

ERM User Guide

3. Victorian Specific Module (VSM)

Victorian Specific Module

4. Pre - submission (peer) review of research proposal

Download Form 

5. Medical Physicist Letter – if ionising radiation is involved

Please contact the E&G unit to obtain

6. Master Participant Information and Consent Form

There are different templates available on the Department of Health website. Please use the template(s) that are appropriate for the type of research you are conducting

Participant Information and Consent Form Footer needs to include the Version and Date. Please see below for recommendation:

Master Template - [Protocol No.]National Mutual Acceptance PICF [type eg. Main / Optional genetic] Verx.x Date dd/mm/yyyy 

Reviewing HREC Approving this Research and HREC Executive Officer Details

 

Reviewing HREC Name

BHS SJOG HREC

Position

HREC Executive Officer

Telephone

(03) 5320 8661

Email

ResearchEthics@bhs.org.au

Participant Information and Consent Form (PICF) (Section 5)

 

7. Protocol or Research Plan

Protocol Template

8. Investigator Brochure (IB) for drug and device studies
 
9. Budget as per sponsor or institution guidelines 
 
10. Patient-facing Materials such as surveys, brochures, advertisements or questionnaires
 

11. Form of Indemnity for clinical trials

BHS  Indemnified Party Details

Ballarat Health Services

Drummond Street, Ballarat, Victoria, 3350, ABN 39 089 584 391

Form of Indemnity

12. Clinical Trial Notification Form (CTN) for use of unapproved therapeutic goods under the CTN scheme

 

 

Clinical Trial Notification Form

13. Certificate of Insurance – as applicable
 
14.

Investigator Clinical Practice (GCP) Certificates

GCP Certificates will need to be submitted when making an ethics or governance application to BHS SJOG HREC for the following study personnel:

Ballarat Health Services as a study site–GCP Certificate of the Principal and all Associate Investigators
 
15. Investigator Curriculum Vitae (CVs)
 

 

Process of Review 

Alongside the requirements for Ethics approval to be obtained from an accredited HREC for your project, Governance authorisation must also be obtained before conducting your research at Ballarat Health Services. Research must not commence until governance authorisation has been granted. 

  • There is no closing date for Governance Applications. Applications must be complete at the time of submission.
  • We will endeavour to have a response within 7-10 working days once all necessary paperwork has been submitted

For any questions regarding submission, please contact the Research Ethics and Governance Unit via: researchethics@bhs.org.au

1. Governance Cover Letter and Checklist

 

2. Confirmation of fee payment - please include remittance advice when paying with EFT

 

3. HREC Approval Letter
 

4. Human Research Ethics Application (HREA) Form

Human Research Ethics Application (HREA)

5. Site Specific Assessment (SSA) Form *Please refer to the ERM User Guide for detailed instructions on how to create a SSA application on the ERM

ERM User Guide

6. Victorian Specific Module (VSM)

Victorian Specific Module

7. Medical Physicist Letter – if ionising radiation is involved

Please contact the E&G unit to obtain

8. Reviewing HREC Approved Master PICF

 

9. Site-Specific Participant Information and Consent Form (PICF)

Based on the Reviewing HREC Approved Master Participant Information and Consent Form.

Both tracked and clean BHS Secific Participant Information and Consent Form Version are required for submission.

Participant Information and Consent Form Footer needs to include the Version and Date. Please see below for recommendation:

Site Specific- [Protocol No.] SVHM Specific PICF [type eg. Main / Optional genetic] Verx.x Date dd/mm/yyyy

 

Reviewing HREC Approving this Research and HREC Executive Officer Details

Reviewing HREC Name BHS SJOG HREC
Position HREC Executive Officer
Telephone (03) 5320 8661
Email ResearchEthics@bhs.org.au

Site-Specific Participant Information and Consent Form (PICF)

10. Protocol or Research Plan

Protocol Template

11. Investigator Brochure (IB) for drug and device studies

 

12. Budget as per sponsor or institution guidelines  
13. Patient-facing Materials such as surveys, brochures, advertisements or questionnaires  

14. Form of Indemnity for clinical trials

BHS Indemnified Party Details

Ballarat Health Services

Drummond Street, Ballarat, Victoria, 3350, ABN 39 089 584 391

Form of Indemnity

15. Clinical Trial Research Agreement (CTRA) for commercially sponsored, multi-site clinical trials

- OR –

Research Collaboration Agreement (RCA) for investigator initiated, multi-site clinical trials

Clinical Trial Research Agreement

16 . Clinical Trial Notification Form (CTN) for use of unapproved therapeutic goods under the CTN scheme

Clinical Trial Notification Form

17. Certificate of Insurance – as applicable

 

  1. Investigator Clinical Practice (GCP) Certificates

GCP Certificates will need to be submitted when making an ethics or governance application to BHS SJOG HREC for the following study personnel:

Ballarat Health Services as a study site–GCP Certificate of the Principal and all Associate Investigators
 
19.Investigator Curriculum Vitae (CVs)
Ballarat Health Services as a study site–CVs of the Principal and all Associate Investigators
 

From time to time, Amendments to research projects are required. These are usually initiated by either the researchers or by external project sponsors.

Notifications of protocol Amendments must be processed via the ERM on line data base.

Documents sent to the BHS Research Ethics and Governance Unit via email cannot be accepted.

Requirements:

Amendment requests must be submitted vie Ethical Review Manager (ERM)
Applications for amendment should include background of the amendment, amended sections of the protocol, and any other relevant documentation. Changes should be highlighted for ease of review.

If the Patient Information and Consent Form (PICF) is to be amended, please utilize “tracked changes” or underline all additions and changes to the text and strikethrough any deleted original text. One approved copy is to be provided, along with one tracked copy and a final 'clean' copy. A new version number and date is required in the footer of each page of the PICF. If new researchers are to be included, their names and contact details are required on the PICF.

Confirmation of payment. Please refer to the Research Fees Schedule

Monitoring of research at Ballarat Health Services is undertaken through a number of different means:

1. HREC-Initiated Monitoring of Research Projects: where the HREC requests information from researchers about a project, e.g. annual project reports (or more frequent if required), final reports, safety reports, etc. All reports must be submitted to BHS Research and Ethics Service via ERM by the Principal Investigator.

Annual Progress Report/Final Report

It is a condition of approval by the HREC that the Principal Investigator should submit a Progress Report via Ethical Review Manager (ERM) for the study annually. If the study has been completed please use the same form to submit a Final Report along with any publications arising from the project.
Please refer to the attached “Flow Chart” to ensure compliance of the Annual /Final Progress Reports requirement for the continuation of your approved research project.

*Annual Reports for projects that have been approved in January – April in any year do not need to be submitted until 30 April the following year

Completed Annual Reports must be submitted via ERM

All progress reports must be submitted by April 30 each year. 

Requirement to report- amendments, adverse events, other relevant safety information or other matters which may impact the conduct of the project.

2. Researcher-Initiated Monitoring of Research Projects: where researchers provide information to the HREC in a timely manner as the requirement to report arises, i.e. serious adverse events (SAEs) and other safety information, requests for amendment of approved protocol/documents, other correspondence.

In accordance with the National Statement Chapter 5.5.3, researchers also have a significant responsibility to monitor their research activity and must submit the following to the HREC, in relation to a given project:

Reports of Adverse/Serious Adverse Events/Suspected Unexpected Serious Adverse Reactions- and advise the HREC if the event has resulted in an amendment to the protocol and/or to the informed consent document.

Protocol amendments, updates to Investigator Brochures or changes to informed consent documents- from time to time, amendments to research projects are required. These are usually initiated by either the researchers or by external project sponsors (such as pharmaceutical companies) and may also require a change to the informed consent process.

Correspondence- notification of start of recruitment, project closed to accrual, protocol deviations or project suspended for a period of time, or any other matters that need to be reported to the HREC (including reason or discussion where appropriate).

Annual Site Progress Report/Final Report

It is a condition of approval by the HREC that the Principal Investigator should submit a site progress report for the study annually. If the study has been completed please use the same form to submit a Final Report along with any publications arising from the project. Post approval reporting is made via ERM.


Please refer to the attached “Flow Chart” to ensure compliance of the Annual /Final Progress Reports requirement for the continuation of your approved research project.

*Annual Reports for projects that have been approved in January – April in any year do not need to be submitted until 30 April the following year

Completed Annual Reports must be submitted via ERM

 

3. Office for Research-initiated: where the Office for Research requests further information about research staff or approved research projects, including auditing of research project

Vacancies

There are vacancies across three categories of membership of BHSSJOG HREC.

The categories are:

  • (Category B) Lay member who is not affiliated with Ballarat Health Services or St John of God Hospital and do not currently engage in medical scientific, legal or academic work
  • (Category C) At least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional
  • (Category D) At least one person who performs a pastoral care role in a community, for example an Aboriginal elder, a minister of religion.

Expressions of interest close on 30 June 2020.

Click here for further information about these positions.

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