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:

1. 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. See link below.
2. Ensure the data collection and research methodology accords with the highest standard as required by quality research practice
3. Ensure that the research proposal accords with all relevant privacy and consent legislation. 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
4. Ensure that projects be submitted well in advance of the date you wish to commence the project.

All applicants should review the application process before submitting a research project to the Human Research Ethics Committee.

Multisite clinical trials - Streamlined Ethical Review Process (SERP)
Bendigo Health is participating in the Victorian SERP system as a participating site. This process streamlines the ethical review process for multi site clinical trials, meaning researchers need only apply for one approval, rather than separate approvals at each research site, preventing duplication.
If you have any queries about the SERP system contact the co-ordinating office for human research ethics on (03) 9092 1981 or email multisite.ethics@dhs.vic.gov.au or visit the Consultative Council for Human Research Ethics website: http://www.health.vic.gov.au/cchre/  
If your project does not fall into this category, please apply for ethics review using one of the processes indicated below.

Single site clinical trials and non-clinical trials
Research projects that are not eligible for the SERP system or are only being conducted at Bendigo Health require ethical approval from the Bendigo Health HREC prior to commencement. For low risk research there is a separate application process (see below). For any research greater than low risk the following documents are required:

• Application form - NEAF - https://ethicsform.org/Au/SignIn.aspx  
• Research protocol
• Victorian Specific Module (November 2012)
• Victorian Specific Module Guidelines (November 2012)

The following documents may be required, depending on the nature of your research.

• Participant information and consent form guidelines 
• Participant information and consent form - template for clinical drug trial project  
• Participant information and consent form - template for non-clinical drug trial projects  
• Participant information and consent form - template for health/social science research projects 
• Standard form(s) of indemnity (Medicines Australia Form of Indemnity for Clinical Trials)
• Current insurance certificate (two copies)
• CTN/CTX form - download the relevant form from TGA website (two copies)
• Clinical Trial Research Agreement (CTRA) (two copies)
• Four copies of the investigator's brochure

Low risk research
In accordance with the National Statement on Ethical Conduct in Human Research (2007), all minimal or low 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 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 low risk application form 
• Victorian Specific Module (November 2012)
• Victorian Specific Module Guidelines (November 2012)
• Participant information and consent form guidelines  
• Participant information and consent form - template for health/social science research projects 

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 Bendigo Health low risk application process.

Fees:

Bendigo Health fee policy

Bendigo Health HREC Review and Governance Fees (Revised 1 February 2013) 

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 an application. On receipt of your application you will be invoiced for the appropriate fee.

Other documents of interest  

• Bendigo Health progress report/request for extension (updated January 2013)
• Medicines Australia Form of Indemnity for Clinical Trials
• DoH website 
• NHMRC/AVCC National Statement on Ethical Conduct in Research Involving Humans 2007.

 Updated 07/03/12