• Research

Research Governance

Introduction to Research Governance

As defined by the National Health and Medical Research Council, Research Governance refers to the processes used by institutions to ensure that they are accountable for the research conducted under their auspices. To be properly governed, research must be conducted according to established ethical principles, guidelines for responsible research conduct, relevant legislation and regulations and institutional policy.

Research governance is vital to ensure patient safety during a research project and is a mechanism whereby each facility can confirm that any departments or individuals required to perform activities as part of a research project are willing to undertake them, are aware of their responsibilities and are capable of fulfilling them.

Conducting Research in a Ramsay Facility

Any research activity that is to be undertaken within Ramsay Health Care must have both Human Research Ethics Committee (HREC) and Research Governance approval in place.

Details regarding HREC applications and how to apply can be found on our Research Ethics page.

Ramsay Health Care are happy to accept Research Governance applications for studies pending HREC approval in order to facilitate a timely review. Please note, however, that Research Governance Approval will not be granted until evidence of ethical approval has been provided.

Applications

All Research Governance applications should be prepared using the Site Specific Assessment Form and submitted to the National Research Unit via email at ResearchGovernance@ramsayhealth.com.au.

Research Governance applications will be reviewed by both the National Research Unit and the relevant Facility Executive (e.g. CEO, Director of Clinical Services or Director of Medical Services). Where required, an application may also be sent to the Facility’s Medical Advisory Committee or other relevant specialist clinical group/individual for more detailed review.

In order to commence a Research Governance review, the following documents must be provided at a minimum:

  • Complete Site Specific Assessment (SSA) Form
  • Study Protocol
  • The Patient Information Sheet / Consent Form (PISCF)
    N.B. Please note that an internal Ramsay person who is not directly involved in the research must be listed as a contact for complaints on the PISCF (e.g. Facility Director of Clinical Services or member of the National Research Unit).

Ramsay Health Care are happy to accept Research Governance applications for studies pending HREC approval or finalisation of other documents (such as a CTRA) in order to facilitate a timely review, however please note that applications will not be processed and will not commence review until the core documents outlined above (SSA, Protocol, PISCF) have been provided. We understand that there may be changes to these core documents as a result of ethical review. However, these changes are unlikely to impact on the Research Governance Office Review, as the focus of this process is the impact of the research on the facility resources and any considerations for patient safety.

A detailed checklist of all the documents required to be submitted as part of your application is provided at the end of the SSA form for your reference.

Research Governance Approval will not be issued until all required documents are submitted, the facility has provided consent for the research to be undertaken and HREC approval has been obtained.

Please note that any Research Governance Approval from Ramsay Health Care approval is subject to certain conditions, such as having a valid HREC approval for the study and maintaining all relevant insurances required for the research activity. These conditions will be outlined in your approval letter.

Forms

Please see below for copies of all current Research Governance Application Forms and information about when they should be used:

  • Site Specific Assessment (SSA) Form
    This form outlines the requirements of the study and how study activities will impact the facility. It must be completed and submitted as part of all initial applications.

  • Minor Amendment Form
    This form should be used when there is a minor amendment to a study which has already received Ramsay Research Governance approval.
    Examples of minor amendments include:
    • routine and/or administrative updates to study documents (e.g. insurance certificates of currency, annual report, site-specific PISCF with master PISCF previously acknowledged);
    • changes to eligibility criteria of participants;
    • updates to safety reporting documents (e.g. DSUR) or updates to Investigator Brochure (IB) to include data of ongoing and completed studies that concludes no change in the risk profile of the study;
    • temporary halt in recruitment (if not related to safety concerns);
    • report summarising findings and response to an audit conducted by a regulatory body, HREC or Sponsor;
    • minor changes to the study budget.

  • Major Amendment Form
    This form should be used when there is a major amendment to a study which has already received Ramsay Research Governance approval.
    A major amendment is defined as a substantial change to the protocol which changes how the study will be run at the site (e.g. amendments which result in additional patient visits, additional sample collections/procedures/scan or collection of additional data, amendments that require additional resources from the site which are deemed significant by the site. These amendments will also most likely require an amendment of the study budget.

  • Safety Report Form (under review)

If you are unsure whether your amendment constitutes a minor or major amendment, or you are unsure which form to use, please email ResearchGovernance@ramsayhealth.com.au.

Fees:

The National Research Unit charge the following fees for Research Governance Applications.

For a Research project that is commercially sponsored (single Facility) $3,000
Additional sites for an existing Research project that is commercially sponsored $1,000 per additional site (capped at a maximum additional fee of $2,000)
Clinical Registry Application $3,000
For a Research project that is a Collaborative Group study, a Not for Profit entity, a Medical Research Institute or a University* $500
For a Research project that is conducted at a Facility by a Ramsay Health Care employee, an accredited specialist or a student under the supervision of an accredited specialist which does not have external funding $0
For a Research project that is conducted at a Facility by a Ramsay Health Care employee, an accredited specialist or a student under the supervision of an accredited specialist which does have external funding* $500
Low-Negligible Risk Research or Clinical Audit* $500
Amendments or additions to an already approved Research project (Major Amendment)¹ $500
Amendments or additions to an already approved Research project (Minor Amendment)² $0

* N.B. Fees can be waived at the discretion of the National Research Unit

¹ Major amendment is defined as per “Forms” section above

² Minor amendment is defined as per “Forms” section above

All fees are payable to the Ramsay Hospital Research Foundation (ABN 11 607 036 948).

An invoice will be generated and sent to you for payment once your application has been lodged.

Contact Us:

For further information and queries, please email ResearchGovernance@ramsayhealth.com.auor call (02) 9433 3854 (for NSW/WA/SA applications) or (07) 3394 7819 (for QLD/VIC applications).

The address for the Ramsay National Research Unit and the Research Governance Office is:

Ramsay Hospitals Research Foundation
2 Frederick St,
St Leonards NSW 2065