Overview

To support safe, high-quality research and good governance practices, all research and quality assurance studies require institutional governance authorisation from the Office for Research (OfR) before they start at Epworth Healthcare.

Our team of advisors and specialists work with you to help drive meaningful, relevant research that will improve healthcare and enable our patients to access the latest medical treatments.

This page provides an overview of the process to obtain research governance site specific assessment (SSA) authorisation.

Research governance SSA authorisation is required before starting any Quality Assurance study, research study or clinical trial at or under the auspices of Epworth.

Contact the Office for Research (OfR) team early in the study development and application process for specialist advice and troubleshooting. Our advisors and specialists work with you to navigate processes for successful and timely research outcomes.

Pre-application preparations

Check-in with the OfR

Develop key study documents

Confirm the study team
Call or book in a meeting at a time that suits you: For specialist advice on:
  • protocol & statistical assistance
  • determining review pathways
  • preparing research governance applications
 This will help you complete the application:

Identify all Epworth study members.

Ensure they have the skills, education and training to conduct duties that will be delegated to them.

Check if they are credentialled for research at Epworth.

Include persons on the application form in the following categories:

  • Epworth investigators/study team - Epworth staff/VMOs or externals undertaking activities at Epworth
  • Other Study Team Members - non- Epworth personnel / not at Epworth i.e. other site PI, university collaborators/ supervisors

Application process:

  • A summary of the application submission process is provided on this page.
  • For full details on the requirements and the submission process also refer to:
  • SOP-RG-01 Research Governance for HREC Approved Studies - Application and Authorisation Process
  • SOP-RG-08 Non-HREC Review

See: Resources for researchers - SOP - Related SOP forms and templates

Contact the Research Support Officer with queries or for support preparing Research Governance applications – P: 03 9426 8630 or E: [email protected]

A summary of the application review process is provided here

Step 1: Study Registration - obtain an Epworth Health (EH) study number

Register the study on the Governance Review & Oversight Workflow (GROW) research platform

  • This registers your study with the OfR and provides a study reference number
  • Register the study after feasibility is confirmed and prior to submitting a study for external ethics review
  • Use the study reference number in all documents and communications to support efficient processing of applications e.g. email subject line “EH2025-XXXX: abc”

Note: study registration does not provide research governance authorisation for the study to start

GROW research platform implementation note:
From 27 April 2026 - all research registration requests must be submitted via the GROW research platform.

Step 2: Complete the research governance application form

Complete the research governance application form on the Governance Review & Oversight Workflow (GROW) research platform

GROW research platform implementation note:

  • From 4 May 2026 - all research governance application forms registered after 27 April 2026 must be submitted via the GROW research platform. Paper application forms will no longer be able to be accepted for these studies
  • For studies registered prior to 27 April 2026 - a paper research governance application form may be submitted. Contact the Office for Research if you would like to submit the application form via the GROW research platform

Step 3: Submit research governance application supporting documentation

TIP – open https://www.epworth.org.au/research/resources-for-researchers in another window of the browser to easily access SOPs and forms listed in the instructions.

Complete supporting documentation

Part A: Core documents - complete these forms for all applications

Part B: Additional documents - complete/provide all elements as they apply to your study

Include the Epworth (EH) study number on all documents:

  • HREC approval letter and full ethics submission documentation
  • Study specific documents and forms including but not limited to:
    • Data collection forms/Assessment tools/Surveys
    • Participant Information Sheet (PIS) – not to be used for consent
    • Participant Information and Consent form (PICF) (Epworth specific) – for obtaining written informed consent
    • Trial wallet cards
    • Study flyers
  • Agreements – contact the OfR at [email protected] to establish and review agreements early in the application process to avoid delays, and to request Epworth sign-off

For full details and requirements for agreements refer to SOP-RG-03 Developing Contracts and Budgets See: Resources for researchers - SOP -Research Governance

Note – an agreement is required where external organisations are involved (i.e. the study involves external persons (including students), data sharing, services or transfer of funds) to document the terms of the arrangement and responsibilities of the parties

  • Clinical Trial documentation:
    • Medicines Australia Indemnity Form
    • Insurance certificate
    • Clinical Trial Notification (CTN) – Provide a copy of the CTN form listing Epworth as a site
      • It is the trial sponsor’s responsibility to submit the CTN form to the Therapeutics Goods Administration (TGA)
      • For Epworth sponsored clinical trials, Epworth is responsible for submitting the CTN to the TGA. This step us completed by the OfR. Researchers must make an appointment with the OfR via [email protected] to lodge the CTN application online together

The fees associated with the CTN submission will be set against the applicable research department cost centre.

  • Any other information and documentation relevant to the application and study procedures

Submit supporting documentation

Submit study supporting documentation via email to [email protected] with the following subject line information:

<Epworth study number> <name Principal Investigator> <Study short title/acronym>
i.e. EH2030-1999_Dr Brown_HOPE survey

  • Include ALL study documents with the Epworth study number on all documents and communications
  • List any documents that are missing/not yet available in the submission email and when they will be submitted

What happens after submission

  • Your submission will be processed by the OfR
  • The OfR will communicate feedback via email to the Epworth Principal Investigator, applicant, and sponsor contact (for commercially sponsored studies) with queries/requests for supporting information
  • As a guide, we aim to provide a written response within 10 business days of submission

Submitting replies to review queries

  • The Principal Investigator/applicants should:
  • Respond to all queries/requests for supporting information as soon as possible
  • Submit replies to queries via email via email to [email protected] with the following subject line information:

<Epworth study number> <name Principal Investigator> <Study short title/acronym>

i.e. EH2030-1999_Dr Brown_HOPE survey

  • Ensure all relevant documentation is included in the email
  • Delays in provision of responses to queries may result in application withdrawal
  • Also refer to the information below

Note: Do not book any Site Initiation Visits before receiving your research governance SSA  Authorisation

Note - the OfR will withdraw applications that are lost to follow-up i.e. where the applicants have not responded to monthly OfR follow for 3 consecutive months. In these cases, a new application will be required to review study and capture any updates if the study is to be conducted

Research governance FAQs

Click on the headings for information on common research governance questions.

  • What is Epworth Research?

    Epworth Research is defined as research carried out or conducted by, or on behalf of, Epworth Foundation or any of its subsidiary entities meeting one or more of the following criteria:

    • The research impacts directly or indirectly on Epworth patients - inpatients or outpatients, or family and friends
    • The research impacts directly or indirectly on Epworth staff, training, resourcing and service delivery
    • Health Workforce Research that involves any staff employed at Epworth or contractors (including Visiting Medical Officers (VMOs))
    • Epworth is funding the research directly
    • The study uses Epworth resources.
  • What is research governance?

    Research governance refers to the processes used by institutions to ensure that they are accountable for the research they conduct. It is the framework of organisational structures, systems and processes that are in place to optimise the patient experience and outcomes, reduce patient harm and continually improve the safety, quality of care, research and clinical trial services. Research governance is also about credentialing and training of researchers and managing institutional risk.

    Elements of Research Governance

    Research governance reviews of studies include but are not limited to the following elements:

    • Compliance with legislation, regulations, guidelines, codes of practice and organisational policy
    • Policies for responsible research conduct, monitoring, complaints, conflicts of interest
    • Study protocol feasibility, resourcing and operational impact
    • Study team education, training, credentialing and induction
    • Legal and insurance – consent, indemnity, agreements
    • Intellectual property and managing collaborative research
    • Financial management
    • Risk management
    • Ethical acceptability of research, ethical approval
    • Governance approval (Site Specific Assessment)
    • Monitoring and auditing research studies
    • Performance measurement, reporting and planning.
  • Why is research governance authorisation needed at Epworth HealthCare?

    Epworth has a responsibility to ensure its research is conducted ethically, legally, and responsibly, protecting participants, researchers, and the institution, in compliance with regulations, manages risks, and promotes good research practice.

    Issue of research governance authorisation is confirmation that the organisation knows about the study and agrees it can be conducted under the auspices of Epworth.

  • Does my study require research governance authorisation?

    A research governance review is required for all research, quality assurance studies and clinical quality registries to be conducted at or under the auspices of Epworth.

  • Does a clinical quality registry require institutional governance authorisation?

    Yes. While not strictly research, clinical quality registries need governance oversight via the OfR.

    Elements reviewed include confirming that the involvement in the registry:

    • Is supported by the organisation
    • Meets organisational requirements, including strategic priorities and data management
    • Is feasible, including in relation to funding and personnel resourcing

    The OfR will coordinate review with hospital stakeholders and issues authorisation for clinical quality registries to be conducted at or under the auspices of Epworth.

  • How is research governance review different to ethical review?

    Ethical review is an important aspect of research governance. In Australia, ethical review of research involving humans is conducted against the tenants of the National Statement on Ethical Conduct in Human Research.

    The ethical review of a project considers all aspects of the study overall including the scientific design and proposed conduct of the project, the level of risk involved and the protection from harm of research participants.

    Research governance reviews are an organisational responsibility and are conducted in accordance with organisational governance frameworks. They consider all aspects of a study at Epworth including ethical acceptability of the study, site feasibility, finances, legal and insurance requirements, study team skills and capacity, impact on hospital and our patients.

Following up with the OfR

Please update your own study timelines with the above review timelines provided here. Please wait until end of estimated review periods to follow up on the progress on your application

For any urgent queries, please contact OfR directly via [email protected]

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