Research Ethics and Governance Applications

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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 (NMA) 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 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 NMA. Please see the list of reviewing HRECs that are certified to provide approval under the NMA. 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 visit National Mutual Acceptance – Clinical Trials and Research

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 . 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. For further information on ERM, ERM guidance and training tools, visit Ethical Review Manager – Clinical Trials and Research.

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 GV Health HREC and Research Governance Review Fees.

Your ethics 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 Victorian Medical Physics Risk Assessment Form must be included in the ethics application. See the Use of Ionising Radiation – flow diagram for additional information.
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. The documents below are the recommended Participant Information and Consent Form (PICF) templates for interventional clinical trial research projects, genetic research and other research; use the template(s) that are applicable for the type of research being conducted. PICF interventional for self PICF interventional for parent & guardian PICF interventional for person responsible/medical treatment decision maker PICF genetic for self PICF genetic for parent & guardian PICF genetic for person responsible/medical treatment decision maker PICF non-interventional for self PICF non-interventional for parent and guardian PICF non-interventional for person responsible/medical treatment decision maker PICF health and social science for self PICF health and social science for parent and guardian PICF health and social science for person responsible/medical treatment decision maker Participant partner pregnancy PICF
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 Ethics Application – Clinical Trials and Research.

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 GV Health HREC and Governance 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 an SSA in ERM. For single site projects, an 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, Patient Facing Materials, 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. For clinical trials of a pharmaceutical which are commercially sponsored, use the applicable Medicines Australia Clinical Trial Research Agreement (CTRA): CTRA – Medicines Australia Standard Form CTRA – Contract Research Organisation acting as the Local Sponsor CTRA – Phase 4 Clinical Trial (Medicines) For Clinical Trials of a pharmaceutical which are run by collaborative groups (not for profit organisation or an academic or non-commercial institution), use the applicable Medicines Australia Clinical Trial Research Agreement (CTRA): CTRA – Collaborative or Cooperative Research Group (CRG) Studies CTRA – Phase 4 Clinical Trial (Medicines) Contract Research Organisation acting as the Local Sponsor For Clinical Trials of a medical device, use the applicable Medical Technology Association of Australia (MTAA) standard Clinical Investigations Research Agreement (CIRA): CIRA – MTAA Standard Form CIRA – MTAA Post Market Standard Form CIRA – MTAA Contract Research Organisation acting as the Local Sponsor CIRA – MTAA Post Market Contract Research Organisation acting as Local Sponsor For Investigator Initiated Clinical Trials, use Victorian Managed Insurance Authority (VMIA) Investigator Initiated CTRA. For Investigator Initiated research projects (non-commercial) involving two or more Melbourne Academic Centre for Health (MACH) group parties, use the MACH Group Research Collaboration Agreement.
Form of Indemnity	For all commercially sponsored Clinical Trials, indemnity must be provided by the Commercial Sponsor. For commercially sponsored trials of pharmaceuticals, use the Medicines Australia Standard Form of Indemnity. For commercially sponsored trials of a device, use the Medical Technology Association of Australia Standard Form of Indemnity.
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).