Ethics applications

Ethics applications

The Bendigo Health Human Research Ethics Committee (HREC), including its Low Risk Review Panel, is responsible for reviewing proposals involving Bendigo Health patients, clients, staff and resources. The HREC’s primary role is to protect the welfare and rights of participants in research. The HREC consists of representation sufficient to satisfy the requirements of the National Health and Medical Research Council (NHMRC) for constitution of institutional ethics committees. The functions of the committee are both advisory and executive. They include consideration of the ethical implications of all proposed research projects and monitoring of approved projects until completion to ensure they continue to conform to approved ethical standards. The committee ensures statutes relevant to ethical considerations are complied within the formulation and conduct of research practices and policies within Bendigo Health. They also establish procedures to assist the examination and review of research proposals and protocols for new forms of treatment and therapy. As part of this it is the responsibility of the HREC to review new research proposals, monitor existing research and maintain a register of all research projects.

Human Research Ethics Committee schedule 

Multisite 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. 

Single Site Health and Medical Research

Research that is not eligible for the streamlined ethical review system or 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 Research

In accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007), all low and negligible risk research will be reviewed by a Low Risk Review Panel. Projects must meet strict criteria to be eligible for review by this process. It is electronically based and review takes place out of session. Low and negligible risk applications are referred to two HREC members for detailed review, 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 using the HREA. 

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’. For quality assurance projects that require ethical approval please follow Bendigo Health’s low risk process.

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 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.

Application Process

A new ethics administration software system ‘Ethics Research Manager’ (ERM) has been introduced in Victoria. 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.

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.

Please ensure all other documents relevant to the project are also submitted. Failure to do this will result in delay.

If you previously had an Online Forms account your new ERM account will have the same login details as your old Online Forms account. You do not need to create a new account, just log in. Your password can be reset if you’ve forgotten it. If you need to create an account in ERM please go to the ‘New User’ tab.

This situation guide is available to assist in the transition to the new ERM system. Although there is no User Manual you can direct any enquiries to [email protected] or phone 02 9037 8404.

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

Information and instructions about clinical trials research can be found here.

Information and instructions for health and medical research can be found here.

Bendigo PICF requirements

The following information must be included in all PICFs submitted to Bendigo Health

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

Documentation Required

  • Hard copies of high risk HREC applications and governance applications are required. For high risk HREC applications please send 17 copies of all documents (apart from the CTN, CTRA, IB and SSA - 2 copies only) to the Bendigo Health Research Manager.
  • For governance submissions please send 1 copy of all documents (HREC and site specific).
  • For low risk applications please send 1 copy of all documents.
  • For major amendments and site notifications please send 1 copy of all documents.

All applications must be collated and individual documents stapled. Double sided printing is preferred. Failure to do this will result in delay.

HREC and Governance Fees

A GST of 10% will be applied to all external projects (that is, where the Principal Investigator is not a Bendigo Health staff member). 

Fees should not be sent with your application. On receipt of your application you will be invoiced for the appropriate fee. 

Contact details

Research Manager 
In the first instance all enquiries should be directed to:
Ms Sally McCarthy
Bendigo Health Research Manager
03 5454 6412 
[email protected] 

Mailing address
Bendigo Health
PO Box 126
Bendigo VIC 3552

HREC Membership

Chairperson
Dr Bev Ferres

Member with Knowledge of and Current Experience of Care, Counselling or treatment of People
Mr Tim Adam
Dr John Edington
Ms Michelle Hogan
Mr Wiehahn Maritz
Dr Helen Hickson

Member who performs a Pastoral Care Role in the Community
Ms Angela Allen

Lay Members
Ms Naomi Fountain
Ms Frances Pascoe
Mr David Conley
Mr Brian Loughran

Member who are Lawyers
Mr Greg Westbrook
Ms June Wilde

Member with Current Research Experience
Dr Robert Champion
Dr Nicole Johnson
Professor Peter O'Meara

Contact Us

Location

100 Barnard Street, Bendigo, VIC, 3550

Phone

03 5454 6000

Email

[email protected]