Introduction to research ethics and governance

Conducting Research at Gallipoli Medical Research

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 approval in place.

National Statement on Ethical Conduct in Human Research (2007) – Updated 2018 | NHMRC

Australian Code for the Responsible Conduct of Research, 2018 | NHMRC

Research governance | Australian Clinical Trials

Ethics Applications

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. The National Statement is incorporated by reference in the Therapeutic Goods Regulations 1990. Compliance with the National Statement is a condition of approval for the conduct of a clinical trial.

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 reviewed and accepted.

The GMR Ethics and Governance team works closely with your Start Up team to ensure all required documents and applications are submitted according to the reviewing HREC’s policies.

Governance Applications

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 ensure patients safety during a research project and 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.

Ramsay Health Care’s National Research Unit’s Research Governance Office (RHC NRU RGO)

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)

GMR Governance

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 in order to facilitate a timely review, however, Research Governance Approval will not be granted until evidence of ethical approval has been provided.

GOVERNANCE FEES

The GMR RGO charge the following fees for Research Governance Applications.

Please note: all fees are exclusive of GST.

* N.B. Fees can be waived at the discretion of the GMR CEO

Notes:

1. Initial application review fees are charged upon submission and non-refundable.
2. Fees may be waived at the discretion of the National Research Unit.
3. All fees are payable to the Gallipoli Medical Research (ABN 42 077 750 693)

Contact Us

For further information and queries regarding HREC and Research Governance applications, please email enquiries.gmr@gallipoliresearch.org.au or call or the GMR Ethics and Governance team on 07 3394 7284.

The address for GMR is:

Gallipoli Medical Research
Greenslopes Private Hospital
Newdegate Street
Greenslopes 4120 QLD