Low risk research

All 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@bhs.org.au

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.

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.

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