Research and Ethics

The Research and Ethics Unit (REU) oversees research activity that is carried out under the auspices of GV Health and encourages research that improves patient outcomes and promotes enhanced clinical practice and service delivery.

The REU:

  • provides advice and strategic guidance to the organisational research related activities
  • provides research, research ethics, and research related teaching, training, and mentoring
  • coordinates and convenes the GV Health Human Research Ethics Committee (HREC) and its Sub-Committee
  • manages governance, site specific assessment (SSA), for research projects conducted at or by GV Health
  • provides direct and indirect support and advice to researchers on research ethics and ethics applications, research and Quality Assurance (QA) project design, study protocol write-up, study tool design, study management and final outcome including dissemination and publication.

For correspondence, enquiries, or more information about GV Health’s REU, please email: Research.Ethics@gvhealth.org.au

GV Health Human Research Ethics Committee

The GV Health Human Research Ethics Committee (HREC) acts as a committee of ethical review for research conducted at GV Health. The Committee’s 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 previously approved by the Committee and maintain a register of all research projects. The Committee operates in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007, updated 2018). For all other HREC related information and forms, visit How to make an HREC application.

The Committee meets every second month, except for the December meeting. Applications must be received two weeks prior to the meeting. No late applications will be considered.

HREC Meeting Dates, 2021

19 February
16 April
18 June
20 August
15 October
19 November

HREC Sub-Committee

HREC Sub-Committee meets frequently online for electronically reviewing LNR research applications, QA applications, amended applications referred by the HREC, variation of approved research applications/amendments, and noting of final or progress reports.

Committee Information

HREC Processing Fees
Research Complaint Procedure
Appealing against a GV Health HREC Decision
Human GV Health HREC – Terms of Reference

Research Ethics and Governance Applications

Research projects require two types of approval prior to their commencement: ethics and governance. A Human Research Ethics Committee (HREC) provides ethics approval: permission to conduct the research on human participants, whilst an institution provides governance approval for a study to be conducted at a particular site i.e., GV Health. Ethics approval must be gained prior to governance approval being granted.

All multi-site research conducted at GV Health must receive both ethical approval by either a certified HREC under National Mutual Acceptance where GV Health is identified as a site, and Governance authorisation by the GV Health Research Governance Officer (RGO) before it can commence.

All single site research conducted at GV Health must receive both ethical approval from GV Health HREC, and Governance authorisation by the GV Health Research Governance Officer (RGO) before it can commence.

Ethics

Multi-site Research

GV Health is a participating organisation in the state and national systems for streamlining ethical review of multi-site projects. This means that GV Health will accept the ethics review and approval of an external accredited reviewing HREC if the project is approved under the National Mutual Acceptance. Please see the list of reviewing HRECs that are able to provide approval under the National Mutual Acceptance. Streamlining ethical review means that an eligible multi-site research project is only required to have one ethical and scientific review conducted by a HREC. Therefore, researchers need only to apply for one ethical approval, rather than separate approvals at each research site, preventing duplication. Governance authorisation is required from each participating site.

For more information on the process for streamlining ethical review of multi-site projects see the Department of Health and Human Services (DHHS) Clinical Trials and Research website.

Single Site Research

For a single site research project, the HREC provides review and approval for the study to be conducted at only one site. Single site research projects which are only to be conducted at GV Health require ethical approval from the GV Health HREC followed by Governance authorisation from the GV Health RGO. New ethics applications must be received two weeks prior to a scheduled GV Health HREC meeting date.

Low and Negligible Risk (LNR) Research

All single site research involving humans that is not greater than low or negligible risk is eligible for review by the GV Health HREC Sub-Committee. To determine if your project is classified as LNR Research, please complete the Risk Assessment Checklist. There are no submission deadlines for LNR research applications and they can be submitted at any time.

Submitting an Ethics Application

All ethics and related applications including LNRs, Greater than LNRs, QAs, Governance, amendments etc.   should be completed and submitted via the Ethics Review Manager (ERM) website. You can download the ERM Applicant User Guide for guidance for completing applications through ERM.

Applications must be complete at the time of submission. Incomplete applications will not be accepted and will be returned without being reviewed.

To determine whether fees are applicable to the review of your submission, please refer to the schedule of GV Health Research Governance and HREC Review Fees.

Your submission should include the following documents.

Mandatory

Research Application Risk Assessment Checklist To determine the level of risk associated with the project, please complete the Risk Assessment Checklist. This will indicate whether the project is eligible for electronic review by the GV Health HREC Sub-Committee as Low or Negligible Risk project, or requires full review by the GV Health HREC.
Ethics Checklist Please ensure the checklist is submitted with your application.
Research Application Form (HREA or LNR VIC) The Human Research Ethics Application (HREA) or the Victorian Low and Negligible Risk Ethics Application Form (LNR VIC) is completed depending on the level of risk of the research application. Use ERM to complete an HREA or LNR VIC. For help, download the ERM Applicant User Guide.
Victorian Specific Module (VSM) Form The VSM addresses Victorian legislation and is mandatory when the HREA is used. The VSM is completed in ERM as a sub-form of the HREA and is uploaded as a supporting document. A VSM is not required for projects utilising the LNR VIC application form. For help, download the ERM Applicant User Guide.
Project Protocol Complete and submit a detailed project protocol in the application. Researchers may elect to use the Project Protocol Template.
Curriculum Vitae (CV) A CV for all investigators and members of research team. Researchers may wish to use the CV Template.

If Applicable

Medical Physicists Risk Assessment Report Only applicable for research involving ionising radiation. If radiation exposure in a research project is additional to standard clinical management/care, an independent Medical Physicists Risk Assessment Report must be included in the ethics application.
HREC Radiation Notification Letter Only applicable for research involving ionising radiation. Use this template if radiation exposure in a research project is not additional to standard clinical management/care.
Participant Information and Consent Form (PICF) If the study involves participants from whom you are obtaining consent. PICF templates are available on the DHHS website; use the template(s) that are applicable for the type of research being conducted.
Waiver of Consent Request Form In some circumstances, you may be able to use tissue or data without complying with the requirement of individual consent from all participants. The National Statement on Ethical Conduct in Human Research states that a waiver of consent can only be granted by a fully constituted HREC. The HREC can only grant a waiver if sufficient justification is provided, and the necessary criteria are met. To assist the HREC in its consideration of a request to waive consent, please complete the Waiver of Consent Request Form.
Patient Facing Materials Patient cards/diaries, questionnaires, surveys, flyers, advertisements, interview scripts, telephone scripts, letter of invitation, letter to GP, etc. All study documents must have version number/date in the footer.
Investigator’s Brochure (IB) An IB is required for all drug and/or device Clinical Trials.
HREC Review Only Form of Indemnity For all commercially sponsored Clinical Trials where the indemnified party is providing premises for the conduct of HREC review only.
Clinical Trial Notification (CTN) Form The HREC may request a copy of the document that is to be submitted, however, the CTN should be lodged after ethical approval is received.

For further assistance and information on ethics applications, visit How to make an HREC application.

Research Governance

Research Governance is a framework where Institutions are accountable for the scientific quality, ethical acceptability, legal compliance, financial management, risk management and safety of the research they allow to be conducted under their auspices. Research Governance is separate from ethics review and is administered by the process of a site specific assessment (SSA) application. Governance approval can only be issued after ethics approval has been obtained from an accredited HREC. Governance authorisation must be obtained before conducting your research at GV Health. Research must not commence until Governance authorisation has been granted.

Submitting a Governance Application

Governance applications should be completed and submitted via the ERM website. You can download the ERM Applicant User Guide for guidance for completing applications through ERM.

There are no closing dates for Governance applications, they can be submitted for review at any time.

Applications must be complete at the time of submission. Incomplete applications will not be accepted and will be returned without being reviewed.

To determine whether fees are applicable to the review of your submission, please refer to the schedule of GV Health Research Governance and HREC Review Fees.

Your submission should include the following documents.

Mandatory

Research Governance Checklist Please ensure the checklist is submitted with your application.
Site Specific Assessment (SSA) Form Use ERM to complete the SSA. For multi-site projects, the lead site needs to create and share a SSA in ERM. For single site projects, a SSA needs to be generated from the ethics application in ERM. For help, download the ERM Applicant User Guide.
HREC Approval Letter Final approval letter and acknowledgements from the reviewing HREC.
HREC Approved Documents Submit all current approved trial documents as submitted to the Reviewing HREC, and provide site specific document versions (e.g. PICF, Advertisements, letters to patients, etc.). Site specific versions should be submitted as ‘tracked changes’ version of the Master documents, include all relevant site specific information (e.g. GV Health logos, PI contact details, complaints contact details, etc.), and contain site specific title, version number and date in the footer.
Curriculum Vitae A CV for all investigators and members of research team. Researchers may wish to use the CV Template.
Professional Registrations Evidence of Investigator’s professional registration (e.g. AHPRA).
Good Clinical Practice (GCP) Certification It is mandatory for all members of the research team to have completed GCP training (valid for 3 years). Please contact GV Health Clinical Trial Research Support Service to complete or update GCP certification.

If Applicable

Site budget If the project is funded, please provide a detailed budget.
Research Agreement All research involving GV Health and at least one other external party requires a written agreement. This is required even if there is no funding provided for the project. The type of research, who (if anyone) is funding it, and nature of the collaboration will determine which type of agreement is required.

Form of Indemnity For all commercially sponsored Clinical Trials, indemnity must be provided by the Commercial Sponsor.

Insurance Certificate For commercially sponsored Clinical Trials only, an Insurance Certificate must be submitted to accompany the Indemnity – this should comply with the requirements for Clinical Trial’s insurance as outlined in the VMIA Guidelines for Clinical Trials for Victorian Public Hospitals.
Clinical Trial Notification (CTN) Acknowledgment The CTN is required when a Clinical Trial investigates the use of a product in Australia which is either a) not on the Australian Register of Therapeutic Goods (ARTG) or b) on the ARTG, but being used outside the conditions of its marketing approval. A separate CTN form must be completed for each potential trial site (the Sponsor is responsible for lodging a CTN).

Quality Assurance Activities

Quality assurance (QA) activities are those in which the primary purpose is to monitor, evaluate or improve the quality of health care delivered by a health care provider (an individual, a service or an organisation). Terms such as ‘QA’, ‘clinical audit’, ‘quality improvement (QI)’, ‘quality activities’, ‘audit’ and ‘quality studies’ are often used interchangeably to refer to activities that fall under the auspice of QA review (NHMRC, 2014).

The GV Health REU aims to encourage and facilitate the process of QA activities, as it is an essential process for improving health services and patient outcomes. QA aims to gain information on specific services to create better outcomes and more effective processes.

Determining QA Eligibility

To determine the level of risk associated with the project, please complete the Risk Assessment Checklist. This will indicate whether the project is eligible for review as a QA activity.

QA activities must be initiated by a GV Health Principal Investigator. Any applications initiated by an external principal investigator are not considered QA.

Submitting a QA Application

The applicant should have a clear QA question/topic. For assistance in identifying a relevant question/topic discuss with Clinical Supervisors and/or the Director of Research/REU.

The applicant should have adequate discussion within the Department, with the Head of Department, and with the REU about the QA activity and whether there is a departmental process that needs to be complied with in order to get approval to conduct the study.

There are no closing dates for QA applications.

QA applications via ERM are encouraged by GV Health, however the use of ERM is not mandatory for QA activities and applications may be submitted electronically by email to Research.Ethics@gvhealth.org.au. For more information on how to submit a QA application via ERM, download the ERM Applicant User Guide.

To make a QA application, the QA Project Application Form must be completed. The QA Project Application Form must contain adequate background information; methodologies including sample estimate, data reviewing period with estimated duration of audit; data recording, management, and analysis; and dissemination plan for the QA activity. The Head of Department and the applicant must sign the QA Project Application Form prior to submission.

A Data Request Form must also be completed as a supporting document to the QA Project Application Form.

Following submission, the REU will review the QA application and the applicant will be notified with the outcome of within two weeks.

If the application is approved, the applicant must show a copy of the approval letter and the approved data request form to the Health Information Management Department for required data or data access.

The investigator must submit a final report of the audit to the REU after completion of the QA activity and within the given time frame outlined in the approval letter.

* All QA investigators must handover QA related data and paper-works to their respective department before they conclude their tenure at GV Health, irrespective of whether the project is complete or not.

Clinical Trials

GV Health encourages and actively participates in sponsored and investigator-initiated Clinical Trials. GV Health is currently conducting Clinical Trials in Oncology, Anaesthesiology, General and Geriatric Medicine, Surgery, Obstetrics & Gynaecology, Endocrinology, and Allied Health. For more information contact the GV Health Clinical Trial Research Support Service.

Information for Health Professionals and Sponsors

The GV Health Site Profile provides further details for health professionals and sponsors seeking to locate a Clinical Trial at GV Health.

Clinical Trial SOPs