Human research ethics application

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

Please refer to Section two - National Statement on Ethical Conduct in Human Research (NS).

Information links

Important notices

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

Completed annual reports must be submitted via ERM.

You must complete an annual and/or final progress report to continue your research project. Please read the Flow Chart to help with your annual/final progress reports.

Fees

**GH SJOG HREC Research Governance Fees* - Effective 17 August 2020**

Fees apply for studies submitted for ethical oversight or research governance assessment, other than local projects initiated by Grampians Health or SJOG Ballarat staff that don't have commercial support. Please read the fee schedule.

For submissions which do incur HREC or governance fees, the Grampians Health HREC and Governance Fees Form must be completed and uploaded as part of your submission. This form makes sure we have the correct information to issue your invoice.

For more information, contact Grampians Health Research Ethics and Governance unit at researchethics@bhs.org.au

New ethics applications

Process for review

For any questions about your submission, please contact the Grampians Health Research Ethics and Governance unit at 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. Review the fee schedule. If fees apply, complete the Grampians Health HREC and Governance Fees Form and include this in your submission documents.
This form makes sure we have the correct information to issue your invoice.

Read the fee schedule.

Complete the Grampians Health HREC and Governance Fees Form.

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 Peer Review Template

5. Medical Physicist Letter – if ionising radiation is involved

Please contact the E&G unit to obtain

6. Participant Information and Consent Forms (PICFs)

For adults giving their own consent, we encourage you to use the beta version of the ‘CT:IQ InFORMEd PICF Template’, developed through CT:IQ’s project, and aiming for a simplified, consumer-centred PICF template that adheres to national and international guidelines. This template is available in the right-hand column.

For all other PICF types (e.g. ‘PICF interventional for parent or guardian’) please use the templates available via the Department of Health link in the right-hand column.

All PICFs must have:

Version control (e.g. specifying version number and version date, in the footer of the document, as well as the file name)
Details of the ‘Reviewing HREC Approving this Research’ and ‘HREC Executive Officer Details’, which should be as follows:

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

For adults giving their own consent:

For all other PICF types (e.g. 'PICF interventional for parent or guardian'):

Please use the appropriate template on the Department of Health website (See 'Templates' section)

7. Protocol or Research Plan

Protocol Template

The protocol document is a stand alone document. Please do not add attachments relating to the application to this document.

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

GH Indemnified Party Details

Grampians Health

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 GH SJOG HREC for the following study personnel:

Grampians Health as a study site – GCP Certificate of the Principal and all Associate Investigators

15. Investigator Curriculum Vitae (CVs)

Researcher Curriculum Vitae

New governance applications

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 Grampians Health. 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. Review the fee schedule. If fees apply, complete the Grampians Health HREC and Governance Fees Form and include this in your submission documents. This form makes sure we have the correct information to issue your invoice.	Read the fee schedule. Complete the Grampians Health HREC and Governance Fees Form.
3. HREC Approval Letter
4. Site Specific Assessment (SSA) Form *Please refer to the ERM User Guide for detailed instructions on how to create an SSA application on the ERM	ERM User Guide
5. Victorian Specific Module (VSM)	Victorian Specific Module
6. Medical Physicist Letter – if ionising radiation is involved	Please contact the E&G unit to obtain
7. Reviewing HREC Approved Master PICF
8. Site-Specific Participant Information and Consent Form (PICF) Based on the Reviewing HREC Approved Master Participant Information and Consent Form. Both tracked and clean Grampians Health Specific 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 Local RGO contact details: Manager Research Ethics and Governance ResearchEthics@bhs.org.au	Site-Specific Participant Information and Consent Form (PICF)
9. Protocol or Research Plan	Protocol Template
10. Investigator Brochure (IB) for drug and device studies
11. Budget as per sponsor or institution guidelines
12. Patient-facing Materials such as surveys, brochures, advertisements or questionnaires
13. Form of Indemnity for clinical trials Grampians Health Indemnified Party Details Grampians Health Drummond Street, Ballarat, Victoria, 3350, ABN 39 089 584 391	Form of Indemnity
14. Clinical Trial Research Agreement (CTRA) for commercially sponsored, multi-site clinical trials - OR – Research Collaboration Agreement (RCA) for investigator-initiated, multi-site clinical trials Please submit the unsigned agreement. The REGU will arrange for review and authorisation.	Clinical Trial Research Agreement
15. Clinical Trial Notification Form (CTN) for use of unapproved therapeutic goods under the CTN scheme	Clinical Trial Notification Form
16. Certificate of Insurance – as applicable
17. Training needs for investigators - For clinical trials, all members of the clinical trial team (including principal investigators, associate investigators, study coordinators, clinical trials pharmacists, etc.) must obtain ICH Good Clinical Practice (GCP) certification, and submit the GCP certificate with the SSA application - Further, principal investigators of clinical trials must also have completed the Australian Clinical Trials Education Centre (AC-TEC) course Trial Essentials for Investigators, and submit a certificate for completion of this course with the SSA application For more information, please see our Training needed to run clinical trials page.
18. Investigator Curriculum Vitae (CVs) Grampians Health as a study site–CVs of the Principal and all Associate Investigators	Researcher Curriculum Vitae

Post approval amendments

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

Notifications of protocol amendments must be processed via the ERM online database.

Documents sent to the Grampians Health Research Ethics and Governance office by email cannot be accepted.

Requirements:

Amendment requests must be submitted via 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.

Fees apply for most amendments. Fees don't apply for local projects initiated by Grampians Health and SJOG staff that don't have commercial support. Please review the fee schedule. Where fees apply, please complete the Grampians Health HREC and Governance Fees Form and include this in your submission documents. This form makes sure we have the correct information to issue your invoice.

Monitoring of research projects and annual reporting conditions

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 5.4, 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.