To read the Latrobe Regional Hospital Response to Coronavirus (COVID-19): Clinical Trials and Ethics Review document click here

The following Committee Decisions were carried at the August 2020 HREC Meeting

1. Good Clinical Practice Certification:

a. Clinical Trials

It is mandatory for all team members working/participating in a Clinical Trial to have current certification in Good Clinical Practice.

b. High Risk Ethics Application (HREA)

While preference is for all team members to have certification of Good Clinical Practice, however if the PI has GCP Certification, then approval of the project can be granted.

c. Quality Application and Low Negligible Risk Application (QA or LNR)

Good Clinical Practice certification is of benefit to teams undertaking Quality Applications or Low or Negligible Risk, however it is not mandatory for team members to hold certification of Good Clinical Practice.

2. Signatures for applications:

a. SSA – Site Specific Application

All staff involved/listed in the application must sign or provide email confirmation that they are prepared to be involved in the project, and have read the application and protocols and understand their role.

b. HREA – High Risk Ethics Application

All team members to sign or provide email confirmation that they are prepared to be involved in the project, and have read the application and protocols and understand their role.

c. LNR – Low Negligible Risk

All team members to sign or provide email confirmation that they are prepared to be involved in the project, and have read the application and protocols and understand their role.

If your project is of low and negligible risk (LNR) and relates to collection of existing data or data that is collected as part of routine care or collected through routine auditing within your health service, your project would be considered a Quality Application (QA).

A QA form can be accessed via the link below. QAs do not require full ethical review, but the applicable health service will perform a governance review of the project which considers the expected benefits, operational practicalities and resources required to implement the QA project.

Download the QA application form for LRH and HREC affiliated health services here

For other research applications such as Low and Negligible Risk (LNR), Human Research Ethics Application - High Risk (HREA) and Site Specific (SSA), please complete the relevant online forms available on this link.

ERM is a paperless information management system for completion, submission and storage of documentation. ERM enables secure digital signature of applications and is an efficient way to share information with the research project team and the LRH research office. LRH uses the ERM to process new ethics and research governance applications and also communicate with applicants.

ERM will submit LRH applications to LRH HREC. Affiliated health services, West Gippsland Health Care Group (WGHG), Bairnsdale Regional Health Service (BRHS), Bass Coast Health (BCH) and Central Gippsland Health (CGH) will also use the ERM to submit research applications for ethical review by the LRH HREC committee.

Download: For support with the online application via ERM please refer to this user guide

You can also contact the ERM IT support team:

Infonetica - IT Helpdesk

Tel: +61 2 903 78 404 (available from 9am to 5pm AEDT Mon to Fri)

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Other valuable references to support your research application are listed below:

https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#toc__191

https://www2.health.vic.gov.au/about/clinical-trials-and-research

Interim or Annual Process Reporting

 LRH HREC is required to monitor all approved research in accordance with the National Statement on Ethical Conduct in Human Research (2007). Part of the monitoring process includes the review of annual progress reports.

 Researchers are required to submit a progress report to the HREC for each approved research project. Reports are usually due on the anniversary of approval, but may be requested more frequently.

Ethics approval is ongoing but will lapse if the annual progress report is not received by the approval anniversary date, or, if deemed unsatisfactory by the HREC.  If the Committee is not satisfied with the progress report, researchers will be informed about subsequent action.

Download LRH HREC Interim or Annual Report Form

Amendments/Modifications

Research project amendments may be required by the researchers. Request for all amendments must be submitted on the Latrobe Regional Hospital Amendment Request Form to the HREC officer, Latrobe Regional Hospital, PO Box 424, Traralgon, Vic, 3844 email This email address is being protected from spambots. You need JavaScript enabled to view it.

 Download Amendment Request Form here

Final Report

Reports are due on the completion of a project or if the research is discontinued before the expected date of completion.

Download LRH HREC Interim or Annual Report Form

Contact the LRH Research Unit on (03) 5173 8156 or email This email address is being protected from spambots. You need JavaScript enabled to view it.

HREC referral of research projects

Research Complaints Policy

Quality Assurance/Quality Improvement/Audit Activities Policy

Latrobe Regional Hospital is a participating member in the National Mutual Acceptance (NMA) system for mutual acceptance of scientific and ethical review for multi-centre clinical trials.

Under this system eligible multi-centre research projects are only required to have one ethical and scientific review conducted by a Human Research Ethics Committee (HREC), certified by the National Health and Medical Research Council (NHMRC). As such Latrobe Regional Hospital accepts ethics reviews undertaken by one accredited reviewing HREC in this system.

In addition, Latrobe Regional Hospital utilises the Site Specific Assessment (SSA) online form to address research governance and site specific authorisation for local organisation sites prior to the project being able to commence.  The SSA Form addresses the resources, study budget details, site-specific policies, and declarations from departments. 

Instructions for applications, links to the online forms website and help information can be found at: http://www.health.vic.gov.au/clinicaltrials  

Submission of research applications requires both an electronic submission and a hard-copy submission.

The streamlined ethics review process has been extended in Victoria to now include single ethical review for multi-centre health and medical research projects. This applies to any form of human research, as defined in the National Statement on Ethical Conduct in Human Research (2007), including low and negligible risk review.

Under this process, LRH accepts ethics reviews undertaken by one Victorian accredited reviewing HREC. Further information on the application process can be found at the Health and Medical Research website.

Prior to commencement of a research project both ethical approval and LRH research governance/site specific assessment authorisation is required.

Latrobe Regional Hospital utilises the Site Specific Assessment (SSA) online form to address research governance and site specific authorization for local organisation sites. The SSA addresses the resources, study budget details, site specific policies, and declarations from departments.

The SSA Form is available on the Online Forms website. It is recommended that researchers also access the help information for guidance on using the Online Forms website.

Submission of research applications requires both an electronic submission and a hard-copy submission.

Single site research projects to be undertaken at Latrobe Regional Hospital and sites of health services affiliated with the Latrobe Regional Hospital HREC, require ethical approval from the Latrobe Regional Hospital HREC prior to commencement. An alternative application process is outlined on this website for multi-centre research projects that are eligible for streamlined ethical review, as well as low and negligible risk or quality applications.

Latrobe Regional Hospital requires the standard online National Ethics Application Form (NEAF) to be used for single site and other research projects. This can be accessed on the Online Forms website. 

Documentation required:

Cover letter for HREC submission

NEAF online form with a submission code

Victorian Specific Module

Participant Information and Consent Form

CV for researchers who have not submitted a CV within the last 2 years

Latrobe Regional Hospital Application Module

LRH HREC Statement from Head of Department and Divisional Director

Copy of Scientific Merit of approval for project – either ethics approval by an Australian University HREC or verified scientific merit from an allocated LRH HREC member (contact the HREC secretariat to discuss further)

Submitting your application

The research application involves both an electronic submission plus one hard-copy of the completed application forma and all attachments. This should be submitted at least four weeks prior to the HREC meeting at which you wish it to be considered.

Applications and correspondence should be sent to:

The Secretary, Human Research Ethics Committee

c/- Executive Office

Latrobe Regional Hospital

PO Box 424

TRARALGON VIC 3844

For further information, please contact the HREC secretariat by emailing:This email address is being protected from spambots. You need JavaScript enabled to view it. or phoning 03 5173 8483.

Latrobe Regional Hospital has established a Low and Negligible Risk Research process to review research where the only foreseeable risk is that of discomfort or inconvenience as defined in the National Statement on Ethical Conduct in Human Research

If you believe that your proposed research project involves only low or negligible risk to participants and that it may be eligible for review by a non-HREC review, you must discuss the project with the LRH HREC Coordinator before completing the Victorian Low and Negligible Risk forms.

Application forms must be completed in full, including the eligibility checklist, and must include a cover letter signed by the Principal Investigator. The following must be included:

LNRR (Vic) Low Negligible Risk Research Application Form

LNRR (Vic) SSA (Site Specific Assessment form)

PICF (Participant Information and Consent Form)

Protocol / Research Plan

These forms are completed via the online forms website which can be accessed via the link below. The online forms web site will ask you to create a log in, once in you can create an LNR and an SSA. When completing the LNR, the researcher is strongly advised to refer to the relevant section of the National Statement (2007) to understand the ethical implications of their answer.

http://www.health.vic.gov.au/clinicaltrials/application-instructions.htm

If you are advised that the project has to be reviewed by the full HREC, you must complete an application for full HREC review using the Online Forms NEAF which can also be accessed via the link:

http://www.health.vic.gov.au/clinicaltrials/application-instructions.htm

Complaint Contact details to include in applications: The Latrobe Regional Hospital contact details for complaints that are to be included in research applications are Consumer Liaison Coordinator, Ph 03 5173 8530 or email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Applications submission: Applications must be submitted online to Latrobe Regional Hospital and two completed and signed copies forwarded to the HREC Secretariat, Latrobe Regional Hospital, PO Box 424, Traralgon VIC 3844.

A Quality Assurance (QA)/ Quality Improvement (QI)/ Audit activity is any project where the primary purpose is to monitor, evaluate or improve the quality of healthcare delivered by a healthcare provider (an individual, a department or service, or an organisation).

The review of medical records and existing datasets do not generally require formal ethical approval from a Human Research Ethics Committee (HREC).  However there are a growing number of journals that require evidence of ethical acknowledgement prior to publication. It is therefore recommended that this review process is undertaken by all Latrobe Regional Hospital staff members undertaking a medical record or existing data audit where it is anticipated that the results will be submitted for publication.

Projects reviewed under this process must only collect de-identified information which is stored in accordance with the Confidentiality Policy and information is only to be collected by a Latrobe Regional Hospital staff member.

Retrospective reviews of QA/ QI/ Audit applications will not be undertaken.

Projects that collect information beyond that available in existing medical records or databases and/or involve external personnel or data transfer are to be submitted through the Latrobe Regional Hospital HREC Low and Negligible risk process

Application process: The following documents are to be submitted to the HREC Secretariat for review:

Quality Assurance / Quality Improvement / Audit Application Form including sign off from Head of Department

Project outline

Data collection forms or tools

Submit one hard copy with original signatures to the HREC Secretariat, via the Executive Office, and one electronic copy to This email address is being protected from spambots. You need JavaScript enabled to view it.

Bairnsdale Regional Health Service

Central Gippsland Health

West Gippsland Healthcare Group

Bass Coast Health

Chair: Dr Philippa Hawkings (Chief Medical Officer)

Executive Members of Latrobe Regional Hospital:

Peter Craighead, Chief Executive

Don McRae, Chief Operating Officer / Chief Nurse

Lay person: Enid Kay

Lay person: (vacant)

Person who performs a pastoral care role: Rev. Daniel Lowe

Lawyer: John Sullivan (Central Gippsland Health)

Persons with current experience in the areas of research that are regularly consulted by the HREC:

Karen Missen

Anita Raymond

Cathy Haigh

Suzanne Hasthorpe

Person with knowledge of and current experience in the professional care/counselling of people:

Cayte Hoppner

Affiliated hospital representatives:

Frank Evans (Central Gippsland Health)

Lindy Washington (Bairnsdale Regional Health Service)

Audra Fenton West Gippsland Healthcare Group)

A/Prof Bruce Waxman (Bass Coast Health)