In accordance with the ICH Guideline for Good Clinical Practice (annotated by the TGA), and the National Health and Medical Research Council (NHMRC), any research activity that is to be undertaken within Gallipoli Medical Research (GMR) must have both Human Research Ethics Committee (HREC) and Research Governance approvals in place.
National Statement on Ethical Conduct in Human Research (2023) | NHMRC
Australian Code for the Responsible Conduct of Research, 2018 | NHMRC
The National Statement on Ethical Conduct in Human Research (the National Statement) has been produced by the NHMRC as the Australian ethical standard against which all research involving humans, including clinical trials, are reviewed. Gallipoli Medical Research is required to comply with the requirements of the ICH’s Good Clinical Practice (annotated by the TGA) and the National Statement when conducting clinical trials.
GMR primarily submits ethics applications to Bellberry HREC or Ramsay Health Care HREC A and is experienced with taking on lead site responsibilities.
Bellberry HREC: Guidance and resources · Bellberry Limited
RHC HREC: Research Ethics | Ramsay Hospital Research Foundation (ramsayhealth.com.au)
Ethics approvals from other HRECs may also be accepted on a case by case basis.
The GMR Ethics and Governance Team works closely with partners to ensure all required documents and applications are submitted according to the reviewing HREC’s policies.
As defined by the NHMRC, 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 maximise patient safety during a research project. It is a mechanism whereby each institution 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.
For studies involving Greenslopes Private Hospital, governance approval must be sought from the RHC NRU RGO. Applications are made via their online REGGS portal, with a review period quoted as approximately 10 business days from the time that all required documents are provided. Governance approval will automatically expire when HREC approval expires.
Research Governance | Ramsay Hospital Research Foundation (ramsayhealth.com.au)
For studies which do not involve Greenslopes Private Hospital’s facility, staff or resources, GMR governance undertakes efficient and timely review of governance applications, with approvals usually generated within 5 business days of all required elements being completed.
Ongoing GMR governance approval is conditional on the study being conducted with all responsible care and in accordance with the NHMRC Australian Code of Responsible Conduct of Research, ICH-GCP regulations (annotated by the Therapeutic Goods Administration [TGA]), ethical standards and local regulatory requirements.
GMR Governance approval will automatically expire when HREC approval expires.
GMR are happy to accept Research Governance applications for studies pending HREC approval to facilitate a timely review, however, Research Governance Approval will not be granted until evidence of ethical approval has been provided.
The GMR Governance charge the following fees for Research Governance Applications.
For a Research project that is commercially sponsored $4,000
For a Research project that is a Collaborative Group study, a Not-for-Profit entity, a Medical Research Institute, a University, or Investigator initiated trials* $500
Amendments or additions to an already approved Research project (Major Amendment) $500
Amendments or additions to an already approved Research project (Minor Amendment) $0
Annual research governance administrative fee – commercially sponsored research projects * $1000 per annum
* N.B. Fees can be waived at the discretion of the GMR Governance
Notes:
All fees are displayed exclusive of GST.
Initial application review fees are charged upon submission and non-refundable.
Annual administration fee is charged in arrears and therefore will be invoiced on teh anniversary of the approval date.
Any requests for waivers of the governance fees need to be submitted with reasonable supporting evidence for consideration by GMR Governance.
All fees are payable to Gallipoli Medical Research (ABN 42 077 750 693)
For more information about Research Governance applications and Ethics applications email enquiries.gmr@gallipoliresearch.org.au or call or please fill in the form below.
enquiries@gallipoliresearch.org.au
Greenslopes Private Hospital, Newdegate Street, Greenslopes QLD 4120