Submit a governance application for site specific assessment

The RMH is able to act in the capacity of Sponsor for investigator-initiated clinical studies to meet the regulatory requirements of the Therapeutic Goods Administration and GCP. If you would like RMH to be Sponsor, refer to the Sponsor Office web page for information and to schedule a pre-submission sponsorship meeting.

Our office will organise a meeting time to discuss. Ideally a study synopsis or study protocol should be provided at the time of the meeting request.

The RMH is a supporter of the Victorian Aboriginal Community Controlled Health Service’s marra ngarrgoo, marra goorri: The Victorian Aboriginal Health, Medical and Wellbeing Research Accord.

The Accord commits RMH to conducting research in line with its Guiding Principles for research practice and collaborating on a range of implementation activities. The Guiding Principles are:

• Aboriginal and Torres Strait Islander Leadership
• Trust and Equity
• Aboriginal and Torres Strait Islander Priorities
• Cultural Safety and Humility
• Knowledge Equity and Recognition
• Data Governance and Sovereignty

Self-Determination is embedded throughout the research process from prioritization, through data activities, to dissemination for impact and collective benefit. Different considerations apply for work that is for and with First Nations people versus work that will have an impact on First Nations people but may not be considering First Nations people as a primary population of interest.

Undertaking research will mean thinking about who you should talk to depending on whether your project is for and with First Nations people or will have an impact on First Nations people. Most work will have some kind of impact, especially work in key priorities areas where disparities are high. 

All research conducted for or with First Nations people should, ideally, be reviewed by a First Nations Human Research Ethics Committee where possible prior to being reviewed at RMH.

Additionally, the NHMRC sets out guidelines for undertaking work with Aboriginal and Torres Strait Islander people based in key values - Spirit and Integrity, Responsibility, Reciprocity, Respect, Equity and Cultural Continuity. These values sit alongside the guiding principles prescribed by the Accord. 

To facilitate culturally safe best‑practice research, we provide tools to guide you through project initiation, consider, define, collect and manage data, honouring data sovereignty, ensuring your projects deliver meaningful impact for the communities they serve.

Researchers can speak with the First Nations Health Unit about what to consider.

Contact us:

Bioethicist - Indigenous Health Practice, Education and Research, First Nations Health Unit
Email: fnhlo@mh.org.au

Priority Review (PR) pathway for the RMH Site Specific Assessment (SSA) Authorisation of Commercially-Sponsored Studies: This review pathway provides for SSA authorisation within 5 to 14 Victorian business days (stop clocks apply). 

The PR SSA pathway is available to commercially-sponsored studies where:

• RMH is the sole or lead site or
• RMH is a participating site for a multicentre study.

PR is available once the commercial organisation and the relevant study team at RMH have agreed to pursue this pathway, and it is subject to reviewer availability and Office for Research (OfR) agreed capacity at the time of submission. For study teams working with a commercial sponsor that is interested in this pathway, please contact the Governance Office for confirmation of acceptance of the PR pathway.  

All the following standard conditions apply if you are considering accessing this route.

• Prior clearance of intent to submit via the Governance Office 
• Complete governance submission packages only should be submitted to the Office through Ethical Review Manager (ERM) and the RMH Governance Inbox. Upon submission, applicants must confirm with the Office that the application has been received and accepted for PR (by telephone). 
• Timeframes to approval are based on ‘clock stops’ capturing for OfR review time. This means the time OfR are waiting on responses is not counted in the 5 to 14 business days.
• Priority Review of SSA is priced at a base rate of AUD $9,000 ex-GST and is an additional fee to standard review fee. 

Proof of payment should be provided as soon as possible.

• Standard Medicines Australia or Medical Technology Association of Australia contracts templates only. 

All other contracts to be discussed on a case-by-case basis.

• Standard Medicines Australia or Medical Technology Association of Australia Indemnities and valid Insurance Certificate
• Budgets finalised and complete prior to submission
• No amendments allowed to the submission package once the review clock commences
• SSA authorisation can only be issued when ethical approval has been provided for the project. 

Where the RMH HREC is the approving HREC, please discuss with us how to best align the ethics and governance application processes.

If you are interested in exploring Priority Review of non-commercially sponsored studies, enquire with the Governance Office.