Human Research Ethics Committee
Bendigo Health’s Human Research Ethics Committee’s (HREC) 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.
Human Research Ethics Committee schedule
The launch of Human Research Ethics Application (HREA) in Victoria.
The Human Research Ethics Application (HREA) form is a new ethics application form developed by the National Health and Medical Research Council (NHMRC). The HREA replaces the National Ethics Application Form (NEAF). For further information see here.
Bendigo Health's Human Research Ethics Committee’s (HREC) primary role is to protect the welfare and rights of participants in research. 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. Secretariat duties for the HREC are undertaken by Bendigo Health's Collaborative Health, Education and Research Centre (CHERC).
Research projects that involve humans should not proceed without the approval of HREC.
In order to receive approval, an application should:
- Meet the National Health and Medical Research Council ethical requirements. Information about this can be found by accessing the National Statement on Ethical Conduct in Human Research 2007.
- Ensure the data collection and research methodology accords with the highest standard as required by quality research practice.
- Ensure that the research proposal accords with all relevant privacy and consent legislation. Consent under circumstances where the Guardianship and Administration Act 1986 and the Mental Health Act 2014 apply must meet legislative requirements in Victoria. Projects using participants who may not be able to consent should review the information available at the Victorian Civil and Administrative Tribunal website and the guidelines for when consent is required from VCAT on behalf of incompetent research subjects.
All applicants should review the application process before submitting a research project to the Human Research Ethics Committee.
Multi-site Health and Medical Research in Victoria
Bendigo Health is participating in the National Mutual Acceptance (NMA) system 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.
Research governance is a framework institutions such as Bendigo Health use to ensure research is conducted responsibly and safely and is scientifically and ethically sound. Research governance considers the legal compliance, financial management, accountability and risk management associated with research. Each site involved in a health and medical research project must conduct its own research governance authorisation before a project can commence. In the system for streamlined ethical review of multi-site research, research governance is administered by the process of site specific assessment (SSA).
Research governance/SSA is separate from ethics review. Research governance/SSA must occur at all organisations conducting research and both ethics approval and research governance/SSA authorisation are required before a research project can commence at a site. The site specific assessment (SSA) form is used to address research governance.
Information and instructions about clinical trials research can be found at: www2.health.vic.gov.au/about/clinical-trials-and-research
Information and instructions for health and medical research can be found at: www2.health.vic.gov.au/about/clinical-trials-and-research/health-and-medical-research
All NMA applications must use the National Ethics Application Form (NEAF) and all applications will require a full HREC review, including low and negligible risk applications. The Victorian Specific Module (VSM) is mandatory and must be uploaded as a supporting document. Note that at this stage, the streamlined system excludes research such as supportive care and psycho-oncology.
For a low and negligible risk research project taking place in Victoria only, the Victorian low and negligible risk application form (LNR VIC) may be used instead of the NEAF. A VSM is not required for projects using the LNR VIC.
The online forms website is used for completion and submission of all Victorian and NMA ethics applications. The online forms handbook provides assistance to applicants.
If your project does not fall into this category, please apply for ethics review using one of the processes indicated below.
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 (see below). For any research greater than low risk the following documents are required:
The following documents may be required, depending on the nature of your research.
See below for non-interventional and health & social science PICFs.
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 and final approval will be 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 NEAF.
Bendigo Health uses the Victorian Low and Negligible Risk (LNR VIC) Application Form and LNR Site Specific Assessment Form (LNR SSA) which are available for completion from https://ethicsform.org/Au/SignIn.aspx
The following documents may be required, depending on the nature of your research.
Please ensure all other documents relevant to the project are also submitted.
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 above.
Please follow the instructions in the Online forms handbook to e-submit your documents to Bendigo Health. In addition to e-submitting your application the following is required:
Send the original, plus 17 copies, of all documents (apart from the CTN, CTRA, IB and SSA - 2 copies only) to the Bendigo Health Research Manager (details below). All applications must be collated and individual documents stapled. Double sided printing is preferred. Failure to do this will result in delay. A soft copy is also required.
Low and negligible risk
Send the original, plus 1 copy, of all documents to the Bendigo Health Research Manager (details below). All applications must be collated and individual documents stapled. Double sided printing is acceptable. Failure to do this will result in delay. A soft copy is also required.
A covering letter is required for all applications and should include:
- Project title and summary
- Number of participants at Bendigo Health
- All documents (including version number) listed in table form.
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.
Ensure your application is submitted well in advance of the date you wish to commence.
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.
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 (see link to Progress Report Proforma below). 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.
HREC approval is required for all amendments to previously approved research. The Principal Investigator is responsible for ensuring that amendments are submitted to Bendigo Health’s HREC for consideration at least twelve weeks prior to implementation.
Major amendments are defined as those that involve any changes to existing documents, new versions of existing documents or additional documents, including those listed below:
- Participant Information and consent forms
- Questionnaires, advertisements.
Minor amendments are defined as those that do not involve any changes to existing documents, or additional documents.
For all amendments a covering letter explaining the requested amendment is required, including:
- Project title and reference number
- All documents (including updated version number) listed in table form.
Two hard copies (original plus copy) of both tracked and clean versions all revised documents are required (four in total).The Research Manager may request additional copies, depending on the complexity of the amendment. Double sided printing is required and individual documents stapled. Failure to do this will result in delay. A soft copy is also required. Please follow the instructions in the online forms handbook
to e-submit your amendment to Bendigo Health.
The HREC has the responsibility of monitoring all ongoing research being conducted at Bendigo Health. Primarily this is done by reviewing research progress reports which are generally required annually and on completion or discontinuation of a project. As a report of findings is required, project completion includes all data collection and analysis. Progress reports should be submitted on the Bendigo Health Progress Report proforma, and all questions must be completed. It is expected that researchers will also send in copies of any publications, conference abstracts (with details) and presentations arising from the research. Finally, the HREC encourages researchers to present their findings to the Bendigo Health unit or area in which the research was conducted.
Request for extension to HREC approval
Researchers may wish to extend their project beyond the original period for which the research was approved. The approval period is shown on the approval letter sent from the HREC at the commencement of the research. The need for an extension can arise from unforeseen consequences including difficulties with participant recruitment or the deferral of studies of key researchers. In cases where research is unlikely to be completed by the end of the approval period, researchers should apply for a request for an extension to HREC approval. This should be completed on the Progress Report Proforma (see link below) at least 12 weeks prior to the expiry of your project.
As part of its monitoring responsibilities, the HREC conducts an auditing program on approved projects, regardless of their nature. The purpose of this program is to ensure that research conducted at Bendigo Health is being conducted as per project protocol and in compliance with Bendigo Health’s Conduct of Research Policy. Once a project has been selected for auditing the Research Manager will notify the Principal Investigator and advise them of the requirements.
In the first instance all enquiries should be directed to:
Ms Sally McCarthy
Collaborative Health Education and Research Centre (CHERC)
PO Box 126
Bendigo VIC 3552
Level 3, Anne Caudle Centre campus
110 Barnard St
Bendigo VIC 3550
Forms and documents used by the Human Research & Ethics Committee for new and current research proposals can be found on the new proposals and monitoring of research pages respectively. The links included below are of interest to researchers preparing a research application or with an interest in ethics generally.
Other documents of interest:
A guide to research and projects at Bendigo Health
Bendigo Health HREC Appeals Protocol
Bendigo Health HREC Terms of Reference 2016
Bendigo Health Intellectual Property Policy