Ramsay reviews Governance applications from Researchers who are accredited practitioners at Ramsay facilities, and Ramsay Health Care staff members.

Any research proposed to be conducted in a Ramsay facility that will;

• involve patients admitted to the facility for a procedure or treatment during the course of the research;
• involve research personnel, accredited healthcare professionals or other employees of Ramsay assisting with the recruitment and enrolment of patients who are or will be admitted to the facility for research;
• that involves our staff either as participants or in some other capacity under the proposed research;
• or involves access to patient medical records or other existing data of Ramsay Health Care.

Governance applications are prepared and submitted through our Research, Ethics and Governance portal (REGGS) - See our REGGS page for details and Helpful Resources.  

Research Governance applications will be reviewed by both the National Research Unit and the relevant Facility Executive (e.g. CEO, Director of Clinical 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.

To commence a Research Governance review, please log into the REGGS Portal and complete the Project Registration. This will establish whether governance approval and/or ethics approval will be required for your proposed study. It will also link all Ramsay Sites where you will be conducting your research.

To facilitate timely review, Ramsay Governance will review applications for research pending finalisation of other documents (such as a CTRA or CTN) as these changes are unlikely to impact on the Research Governance, which focuses on the impact of the research on the facility resources and any considerations for patient safety. However please note that applications will not be approved until HREC approval and any updated documentation are provided.

You can download a Governance Checklist of required documentation to be submitted as part of your application.

When preparing your Site- specific PISCFs: 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). 

Please note that any Research Governance approval from Ramsay Health Care 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 notification of approval.

Please contact the National Research Unit should you have any questions related to pending documentation.

Ramsay participates in various clinical registries throughout Australia collecting and reporting data to assist in maximising the value of Australia’s clinical quality outcomes data.

Typically, these are registered on the Australian Register of Clinical Registries. Applications for Ramsay to participate in clinical registries are reviewed and managed by the Ramsay Health Care National Research Committee.

To apply please contact researchgovernance@ramsayhealth.com.au to request a copy of the application form and our Clinical Registries Research Agreement. All post-approval management including additional Site participation should also be directed to the National Research Unit via this email address.

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

Effective 1 March 2023:

Please note: all fees are exclusive of GST.

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

Notes:

1. Initial application review fees are charged upon submission and non-refundable.
2. Annual management fee charged annually in advance upon approval and thereafter on the anniversary of the Approval Date.
3. Fees may be waived at the discretion of the National Research Unit.
4. All fees are payable to the Ramsay Hospital Research Foundation (ABN 11 607 036 948).

Typically, research undertaken within one of our facilities will require a research agreement. Depending on the trial this may be a Clinical Trial Research Agreement, an Investigator Initiated Agreement, a Data/Materials Transfer Agreement. Ramsay have pre-approved research agreement templates to suit your trial.

To enquire about the most appropriate agreement for your research, please contact our Contracts Team at RHCResearchContracts@ramsayhealth.com.au, you may also contact our Contracts Team should you require a Non-Disclosure or Confidentiality Agreement template. Any variations to existing agreements should also be submitted to our contracts team for review.

Post Approval Amendments

All post-approval amendments should be submitted via REGGS, these include:

• General Amendments - Updates to study documents such as Protocols, Investigator Brochures, Participant Information & Consent Forms.
• Addition of Site.
• Changes to contracts.
• Changes to Site Investigators or Administration Contact.
• Changes to Principal Investigator.

When submitting amendments, please complete the Site Amendment form in REGGS and include HREC approvals as well as both clean and tracked copies of all amended documents. CV and GCP should be provided for any new Investigators.

Instructions on how to submit amendments are available from our “REGGS Helpful resources” section. For more information, or if you have any questions, please email researchgovernance@ramsayhealth.com.au.

Progress Reports & Updated Insurance

You will be notified of the submission deadline for your next annual progress report or due date for Insurance certificates and you will receive a reminder from REGGS.

When submitting a progress report or certificate of currency, please ensure that relevant HREC approvals or Insurance certificates are attached to the form.

Instructions on how to submit progress reports are available from our “REGGS Helpful resources” section.

For more information, or if you have any questions, please email researchgovernance@ramsayhealth.com.au.

As per the Ramsay Health Care Safety Event Reporting requirements, all

• Serious Adverse Event (SAE)/Serious Adverse Reaction (SAR)
• Significant Safety Issue (SSI)
• Suspected Unexpected Serious Adverse Reactions (SUSAR)/Unexpected Serious Adverse Device Effects (USADE)
• Urgent Safety Measures (USM)

should be reported to the approving HREC in line with the NHMRC Safety Monitoring and reporting guidelines. These should also be reported to the Ramsay National Research Unit via a Reporting Safety Events Form in REGSS.

Please ensure that you attach all relevant correspondence with your form submission.

Instructions on how to submit progress reports are available from our “REGGS Helpful resources” section.

Please contact the National Research Unit at researchgovernance@ramsayhealth.com.au for further information or to obtain a copy of the CT-SOP-05 - Safety Event and Serious Breach Reporting.