Ethics applications

Ethics applications

Multi-site health and medical research in Victoria

Bendigo Health is participating in the National Mutual Acceptance (NMA) scheme as a participating site. This process streamlines the ethical review process for multi-site health and medical research, including interventional drug and device clinical trials and low/negligible risk.

This means that researchers need only apply for one approval, rather than separate approvals at each research site, preventing duplication. See side link to Multi-site Health and Medical Research in Victoria.  

For a helpful flowchart for choosing a review path for your application click here.

 

Single site greater than low risk (GLTR) research

Research that is not eligible for the streamlined NMA or Low/negligible risk ethical review pathway and is only being conducted at Bendigo Health requires ethical approval from the Bendigo Health HREC prior to commencement. For low and negligible risk research there is a separate application process. 

Single site low/negligible risk (LNR) research

In accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007 updated 2018), low and negligible risk research may be reviewed by a Low Risk Review Panel instead of within a full HREC meeting. Projects must meet strict criteria to be eligible for review by this process. Low risk panel review takes place out of session with final approval being ratified at the next full HREC meeting. It is possible that a project is denied a low risk approval and instead referred for a full HREC review. 

Quality assurance activities

Quality assurance activities do not normally require prior approval of the HREC except if they meet the criteria found on Bendigo Health’s policy ‘Identifying quality assurance activities that require HREC approval’, see Bendigo Health policies below. For quality assurance projects that require ethical approval please follow Bendigo Health’s low risk process.

Submitting your application via Ethics Research Manager (ERM)

An ethics administration software system Ethics Research Manager (ERM) has been introduced in Victoria.

Before submitting your application please use this helpful guide and checklist developed by Bendigo Health HREC to make sure your application has a smooth process to achieving Ethical approval: Bendigo Health Ethics Guidance and Checklist 

Bendigo Health requires researchers to submit all new HREC and governance applications, regardless of risk, and all post approval information, such as amendments, annual reports etc, via an online ERM account. If you need to create an account in ERM please go to the 'new user' tab.

Please direct any enquiries to [email protected] or phone 02 9037 8404. 

Please note that Bendigo Health accepts the Victorian Low and Negligible Risk (LNR VIC) Application Form and LNR Site Specific Assessment Form (LNR SSA). These are available for completion via ERM

Evidence of support for your project from Bendigo Health is required prior to submission. It is therefore desirable that your project has been discussed with the relevant manager and Executive Director to ensure all matters including budgeting and in-kind support have been addressed in your application.

All Bendigo Health SSAs must include signatures from investigators, relevant Heads of Departments and any Supporting Head/s of Department and the also the relevant Executive Director.

Please note that all supporting documents must be attached, including, CV AHPRA registration and evidence of GCP training. Failure to do this will result in delay.

A research protocol needs to be submitted with ethics applications, including with a University partner. We recommend using the Bendigo Health Research Protocol Template which can be found here.

Research being conducted in collaboration with an external organisation will require a research agreement approved by Bendigo Health’s Procurement department. 

Research must adhere to the criteria outlined in the National statement on Ethical Conduct in Human Research

Clinical Trial Research Agreement templates can be found on the Medicines Australia website.

Specific details of the Research should be detailed in the Schedules to the Agreement. An example Schedule is provided here.

National information on Ethical issues and resources can be found here. 

National information on how to make an HREC application can be found here.

National information and instructions about clinical trials, health and medical research can be found here.

Information about the applicant user guide to ERM can be found here.

Ensure your application is submitted well in advance of the date you wish to commence. 

Bendigo PICF requirements

The following information must be included in Patient Information and Consent Forms required as part of site specific authorisation applications (SSAs via ERM) submitted to Bendigo Health (SSAs via ERM). These will be available via our intranet to Bendigo Health researchers nominated on the SSA application.

  • Bendigo Health logo
  • Complaints section contact details
  • HREC/RGO contact details

Outcomes

HREC review of new projects will result in one of the following outcomes: 

  • Approval without amendment
  • Approval following further information and/or minor amendment/s
  • Request to revise and resubmit 
  • Approval is not given 

 

Upon receipt of both the HREC letter of approval and Bendigo Health site governance authorisation letter  you are free to commence your research project. The HREC letter of approval lists the conditions of approval, the HREC expiry date and the date of your first HREC report.

If you are having trouble meeting your project time frames, you should apply for an extension of approval either at the time of annual reporting or as an amendment at least twelve weeks prior to the expiry of your project.

If you fail to submit a regular progress report, or conduct research beyond the approved time period, the HREC may rescind approval for the research and notify the relevant institutions that research approval has been rescinded. 

Documentation Required  

Effective from 16 March 2020, it is no longer a requirement of the Bendigo Health Human Research Ethics Committee to provide paper copies of applications. Please check that all documents required to support your application are uploaded to ERM. 

Contact details

Research Governance Manager

In the first instance all enquiries should be directed to: [email protected]

Mailing address
Bendigo Health
PO Box 126
Bendigo VIC 3552

 

Contact Us

Location

100 Barnard Street, Bendigo, VIC, 3550

Phone

03 5454 6000

Email

[email protected]