Research Ethics and Governance

The Research Ethics and Governance Office (REGO) is responsible for the coordination and management of concurrent ethical and site governance review processes for ACT Health.

Research Ethics and Governance Office

The Research Ethics and Governance Office (REGO) is responsible for the coordination and management of concurrent ethical and site governance review processes for ACT Health. This includes scientific and ethical review of new research proposals, site governance review and ongoing monitoring.

Ethical and scientific review is provided by the ACT Health Human Research Ethics Committee (HREC). The HREC is constituted and operates in accordance with National Statement on Ethical Conduct in Human Research (National Statement; NS)

Research Pathways

The following pages provide information specific to the different types of research pathways:

Clinical Trials

Before undertaking any clinical research, the researcher and research unit must complete a feasibility assessment through the Clinical Trials Committee. 
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National Mutual Acceptance (NMA) Scheme

National Mutual Acceptance Scheme (NMA) is designed to reduce the administrative burden of research by providing one scientific and ethical approval for all sites in the participating jurisdictions. 
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Other Human Research

Research in which the risk for participants is more serious than discomfort is not low risk and will need to be reviewed by the Human Research Ethics Committee before commencing. Click to read more

Low Risk Research

The expression ‘low risk research’ is described in the National Statement as research in which the only foreseeable risk is one of discomfort.
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Quality Assurance/Improvement and Evaluation Projects

Quality Improvement activities are an essential aspect of improving the delivery of person-centred, safe, and efficient healthcare within the Australian Capital Territory.  Click to read more

Research Ethics Approval Pathways

The ACT Health Human Research Ethics Committee (HREC) is responsible for ensuring that researchers submitting proposals for its review and approval are aware of their ethical and legal responsibilities. As a condition of approval, every research project is required to provide formal reports to the Human Research Ethics Committee. Sponsors are required to review the Investigator Brochure at least annually and to provide updates to investigators and the HREC.

Sponsors must provide the HREC with reports of Data Safety and Monitoring Boards.  Click to read more

Submission Requirements

ACT Health conducts concurrent ethical and site governance review processes, including insurance review by the ACT Insurance Authority (ACTIA). The following outline the steps required for ethics and site governance approval at ACT Health:

Ethics submission

Information on the requirements and the application submission process.
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Site Governance submission

Information on the requirements for site governance submissions.
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Fees

Research Ethics and Governance services include ethical, scientific and site governance review of new human research proposals. This includes insurance vetting and ongoing monitoring of approved research proposals. To recover costs associated with this work, fees are charged for services provided.

Fees will be invoiced on receipt of submission. Please ensure that any requirements to secure a payment authority, such as a purchase order number, are completed BEFORE submission to the Research Ethics and Governance Office. Where a purchase order number or goods receipted authorisation is required please provide evidence of these with your submission. A full list of ethics and governance fees is below.

The Fee Schedule – contains a list of fees and charges.  Fees are reviewed regularly and subject to change.

Pharmacy and Pathology

The Pharmacy and Pathology Departments charges a range of fees for services provided to clinical trials. Fees are reviewed regularly and subject to change. In any given year fees will increase as of 1 July.

Project Reports to HREC

As a condition of approval, every research project is required to provide formal reports to the Human Research Ethics Committee.  These reports are generally required on an annual basis, but may be more frequent.  A final report is required to be submitted for all projects, including student projects.

The following are templates for the required reports.

Safety Reporting for Clinical Trials

Sponsors will be required to provide ACT Health HREC with an annual safety report that supports trial oversight, includes a clear summary of the evolving safety profile of the trial and evidence that the sponsor is conducting its own ongoing safety monitoring appropriately. Should there be any new safety information the sponsor will be required to provide an updated participant information and consent form. Please include any outstanding safety reports from pre-November 2016 in the study's first annual safety report.

  • Sponsors are required to review the Investigator Brochure at least annually and to provide updates to investigators and the HREC.
  • Sponsors must provide the HREC with reports of Data Safety and Monitoring Boards.

Principal Investigators are obliged to review the safety information that is sent to them by the trial Sponsor and to act on all safety advice.  The PI has primary responsibility to ensure that all investigators are up to date on all aspects of the safety of their protocol.  Questions of product or protocol safety are relevant to the conduct of any clinical trial.  Therefore, it is incumbent upon the investigator that they should be aware of, and act on, the latest available safety information and that this information should be discussed with participants as part of the ongoing assurance that consent is informed and remains valid.

NHMRC Guidelines

New NHMRC guidelines for safety monitoring and reporting in clinical trials involving therapeutic goods came into effect from March 2018.

In line with this guidance, ACT Health HREC no longer requires submission of individual Serious Adverse Events (SAEs), annual SUSARs or Line Listings.

Consent Guidelines

Consent Issues

Respect for human beings involves giving due scope to people’s capacity to make their own decisions. In the research context, this normally requires that participation ought to be the result of a choice made by participants.  This is commonly known as ‘the requirement for consent’. 

See the Consent page for detailed information.

Page last updated on: 13 Nov 2018