The Low Risk Research Subcommittee gives a faster review pathway for all projects which are considered low risk.
There are no closing dates applicable for low risk research.
'Low risk research' describes research where the only foreseeable risk is no greater than discomfort. Research where the risk for participants or others is greater than discomfort is not low risk (NHMRC National Statement chapter 2.1).
The Low Risk Research Subcommittee reserves the right to refer projects to a full HREC review at any time.
For more information, please contact the Grampians Health Research Ethics and Governance team at ResearchEthics@gh.org.au
Information links
Important notices keyboard_arrow_downAll progress reports must be submitted by April 30 each year.
Completed annual reports must be submitted via ERM.
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@gh.org.au
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HREC fees don't apply to local projects initiated by Grampians Health and SJOG Ballarat staff that don't have commercial support. Where fees do 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.
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Complete the Grampians Health HREC and Governance Fees Form. |
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2. Low Negligible Risk Research Application Form (LNRR VIC) Form Please refer to the ERM User Guide for Detailed Instructions on how to create a LNRR application on ERM |
Low Negligible Risk Research Application Form
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3. Pre-submission (peer) review of research proposal |
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4. 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:
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For adults giving their own consent: For all other PICF types (e.g. 'PICF interventional for parent or guardian'):
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5. Protocol or Research Plan |
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6. Budget as per sponsor or institution guidelines |
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7. Patient-facing Materials such as surveys, brochures, advertisements or questionnaires |
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8. Research Collaboration Agreement – if applicable * An RCA should be used if: - The study is multi-site - Involves any external investigator |
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9. Research Team Curriculum Vitae (CVs) |
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Governance fees don't apply to local projects initiated by Grampians Health and SJOG Ballarat staff that don't have commercial support. Where fees do 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.
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Complete the Grampians Health HREC and Governance Fees Form. |
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2. HREC Approval Letter |
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3. Site-Specific (SSA) Form
Please refer to the ERM User Guide for Detailed Instructions on how to create an SSA application on ERM |
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4. Pre-submission (peer) review of research proposal |
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5. Victorian Specific Module (VSM) * The VSM is only applicable if: - Study is seeking a Waiver of Consent - for Multi-site studies |
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6. Participant Information and Consent Form (PICF) The PICF must be either the single-site GH SJOG HREC approved PICF; or for multi-site research, a local site-specific PICF based on the approved (by the HREC) Master PICF for the study. For multi-site projects, both tracked and clean Grampians Health Specific Participant Information and Consent Form Version are needed for submission. The PICF footer needs to include the version and the date. Please see below for recommendation Site Specific - [Protocol No.] SVHM Specific PICF [type eg. Main/Optional genetic] Vers.x Date dd/mm/yyyy Local RGO contact details for complaints (must be inserted in all PICFs): Manager, Research Ethics and Governance |
The PICF used must be either the single-site GH SJOG HREC approved PICF; or for multi-site research, a local site-specific PICF based on the approved (by the reviewing HREC) Master PICF for the study.
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7. Protocol or Research Plan |
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8. Budget as per sponsor or institution guidelines |
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9. Patient-facing Materials such as surveys, brochures, advertisements or questionnaires |
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10. Research Collaboration Agreement – if applicable * An RCA should be used if: - The study is multi-site - Involves any external investigator |
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11. Research Team Curriculum Vitae (CV's) |
Research Curriculum Vitae |
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 online database.
Documents sent to the BHS Research Ethics and Governance Unit via 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 or SJOG Ballarat 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 it with your submission documents. This form makes sure we have the correct information to issue your invoice.
Monitoring of research at Grampians Health happens in different ways:
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.
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*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 |
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.
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*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 |
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
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